[HN Gopher] US agencies call for pause in Johnson & Johnson vaccine
___________________________________________________________________
US agencies call for pause in Johnson & Johnson vaccine
Author : kjakm
Score : 369 points
Date : 2021-04-13 11:40 UTC (11 hours ago)
(HTM) web link (www.bbc.co.uk)
(TXT) w3m dump (www.bbc.co.uk)
| UncleOxidant wrote:
| John Campbell suggested on his video the other day that perhaps
| this is happening because some injectors are not aspirating. What
| that means is that when an intramuscular injection is given you
| want to ensure that it goes into the muscle and not into a vein.
| So the proper way to do this is for the person doing the
| injection to first pull out the syringe (after it's been stuck
| into the arm) a bit to make sure there's no blood coming out.
| Then if not, the vaccine is pushed in. If blood is seen then a
| new site has to be chosen. Apparently Denmark has included
| aspiration in their directions for usage of the AZ vaccine.
| jolux wrote:
| Injecting IM solution into a blood vessel is excruciating and
| you and the provider would notice it immediately if it
| happened. It is likely to cause an embolism and possibly kill
| you, but I don't think it would be unnoticeable and then cause
| a thrombus multiple days later.
|
| There are also not a lot of major vessels near common injection
| sites, for this reason. It's possible and rather common to nick
| a surface capillary or something, and those can bleed quite a
| lot, but a vein or artery would be totally different. Swelling,
| horrible pain, likely a cough.
|
| Source: inject myself with intramuscular estrogen every week.
| sterlind wrote:
| hah, I inject myself with estrogen subcutaneously. it gets
| absorbed quicker which causes peaks and troughs, but I get to
| use a smaller needle (25g x 5/8") and I don't have to worry
| so much about bruising or locating the right sites.
| jolux wrote:
| I should ask about subq. My current regimen gives me a lot
| of anxiety, even though I know it's pretty safe.
| [deleted]
| [deleted]
| thehappypm wrote:
| Any theory on why this is occurring needs to have a solid
| explanation for why women under 55 are suffering this effect
| more than anyone else. Does John Campbell have one?
| JediWing wrote:
| If this were the case it would be odd that this is happening
| a.) in a consistent subset of women 18-38 b.) that it would
| emerge in a 1-shot regimen rather than a 2-shot regimen,
| because it would seem more likely that any one individual would
| experience this more frequently with 2 chances for human error
| rather than 1
| UncleOxidant wrote:
| The Pfizer & Moderna 2-shot vaccines use mRNA instead of an
| adenovirus vector. The AZ vaccine is 2 shot, but also uses a
| similar adenovirus vector - the bloodclot issue has also been
| seen in the AZ vaccine which has led to some countries in
| Europe not allowing it for women under 60.
| wholinator2 wrote:
| Yes, we know that. But what does adenovirus vs mRNA have to
| do with aspirating an injection? Does the adenovirus become
| more dangerous when accidentally placed in a blood vessel?
| JediWing wrote:
| I would assume the guidelines for aspirating would be the
| same across all of these vaccines, though? If so the
| original point still stands regardless of adenovirus vs.
| mRNA
| y-c-o-m-b wrote:
| That's interesting to know. When I got my Pfizer jab, the lady
| said "oops, I did it wrong" and blood came out. She didn't jab
| me again though and I just assumed it was good to go. Should
| she have done it again at a different site? I was told
| elsewhere that it doesn't make the vaccine any less effective,
| but I'm curious what others on here think now...
| UncleOxidant wrote:
| As I understand it the concern isn't effectiveness so much as
| potential for side effects. An intramuscular injection is
| meant to stay pretty much in a small area of muscle tissue.
| If it goes into the vein the vaccine then travels into
| tissues all over the body.
| catblast01 wrote:
| That makes no sense of course. You're innoculating the
| whole body, especially bone marrow and lymph nodes, not a
| small area of muscle.
| robbiep wrote:
| That's not really true, we give lots of drugs IM because
| the muscle is highly vascular so it generally shoots out
| all over the body really quickly. Ie want to take down a
| patient with Ice (crystal meth) induced psychosis? IM.
| Also, it's hard to miss most of the time.
|
| If you want something to sit around for a long time, you go
| for less vascular areas. (Ie insulin for diabetics, subcut
| abdominal fat)
|
| IM is preferred because of the vascularity which helps in
| the immune response (ie quick immune response, antigen
| distributed around the body) as well as any immune reaction
| confined to the muscle rather than, say the skin. (0) is a
| quick and dirty on mechanisms of administration.
|
| To your earlier point about 'into' a vein, I'd never heard
| of Dr Campbell before you mentioned him, he seems to have
| great credentials, but I can't easily explain why an
| accidental IV administration of an IM vaccine would cause
| CVST, my gut is that it's a bit of a hand wave but who
| knows.
|
| (0) https://www.forbes.com/sites/quora/2017/11/07/why-
| arent-vacc...
| amluto wrote:
| IV injection of adenovirus gene therapy vectors is well
| known to cause thrombocytopenia.
| [deleted]
| robbiep wrote:
| Right, thanks, I wasn't aware.
|
| Time periods seem off (5-14hrs) in mouse models compared
| to what's being seen here though, which seems more like
| an immune reaction rather than a response to the
| antigen/delivery system
| AlimJaffer wrote:
| Medical professionals are often taught these days that
| aspiration is not necessary for IM injections, particularly in
| commonly used sites such as the delts.
|
| From the CDC [1]: Aspiration before injection of vaccines or
| toxoids (i.e., pulling back on the syringe plunger after needle
| insertion but before injection) is not necessary because no
| large blood vessels are present at the recommended injection
| sites
|
| [1] https://www.cdc.gov/vaccines/hcp/acip-recs/general-
| recs/admi...
| raverbashing wrote:
| Still, even if it gets close to a small vessel it might be
| problematic
|
| Maybe we'll need to do it for AZ. Or maybe subcutaneous?
| birken wrote:
| This lines up exactly with what Dr. Daniel Griffin talked
| about in the most recent clinical update podcast for TWIV
| [1]. Apparently aspirating makes the shot more painful,
| because the needle is in the body longer, and serves no
| benefit as long as the vaccinator is putting it in the right
| location.
|
| 1: https://www.microbe.tv/twiv/twiv-741/ (towards the end)
| jerf wrote:
| "no large blood vessels are present at the recommended
| injection sites"
|
| That's a bold statement. Sure, no large blood vessels may be
| present at the recommended injection site on an _average
| human_ , but it's well known there is more divergence in
| anatomy than they necessarily teach about in primary school,
| and vaccines are supposed to go in basically everyone.
| hn8788 wrote:
| So this past year the government has been willing to let
| unemployment, suicides and drug overdoses jump due to isolation
| and loneliness caused by lockdowns, child abuse to skyrocket and
| mental health to plumment due to schools being kept closed, all
| because we needed to stop covid at any cost. Now one person dies
| out of almost 7 million who received the vaccine, and we need to
| stop administering the J&J vaccine "out of an abundance of
| caution"? I'm starting to think more and more that the shitty
| decisions regarding covid in the past year were because it was an
| election year.
| captainredbeard wrote:
| Government over-reactions to COVID19 have been disastrous.
| There would have been an economic hit for sure but things would
| have returned to near normal by August 2020 if they had
| respected freedom (or if people had disobeyed in mass).
| hedora wrote:
| Yeah. The US is apparently already at ~50% antibodies, not
| counting vaccination. So, there's a floor on the upside of
| the vaccine: It did no more than halve deaths. We're in the
| middle of a surge, and it looks like most of the remaining
| 50% will end up catching covid before being vaccinated, so
| the percentage saved by vaccination will continue to drop.
|
| The ideal strategy without hindsight was conventional wisdom:
| Protect the vulnerable and stiff upper lip for the rest. That
| would have more than halved casualties.
|
| With the benefit of hindsight, a 3 month shutdown while
| hospitals got their acts together (combined with protecting
| the vulnerable) would have roughly quartered the remaining
| deaths, but at far lower cost than the full shutdown.
|
| This was predicted by some of the old-guard epidemiologists,
| which is why they were against the shutdown in the first
| place.
|
| The cancel culture folks lumped them in with MAGA anti-
| vaxxers (I blame both sides) and got them censored by the big
| platforms. Here we are, with 100,000's unnecessarily dead,
| trillions squandered, and many careers, businesses and
| educations ruined.
|
| I suspect roughly zero people have learned a lesson from
| this. Hopefully I'm overly cynical.
| DiogenesKynikos wrote:
| > The ideal strategy without hindsight was conventional
| wisdom: Protect the vulnerable and stiff upper lip for the
| rest.
|
| China, Vietnam, Australia and New Zealand used strict
| lockdowns to eliminate community spread, and then largely
| opened things up again. People in those countries have been
| able to live much more normal lives than people elsewhere
| during the pandemic. With hindsight, that was clearly the
| correct strategy: eliminate the virus, then reopen and keep
| a hawk eye out for any new cases.
| cujo wrote:
| I suspect a lot of folks learned (in the US) is that if you
| have a president who politicizes a pandemic and shits the
| bed on leadership, the populous is screwed.
|
| Let's not pretend that rational discourse was ever an
| option, and the media isn't the place for blame.
| MockObject wrote:
| I don't know. Seems like a sane, sober, professional,
| mature, and objective media would go quite far in
| moderating the overheated partisan rhetoric from
| politicians.
| pionar wrote:
| No, in the age of social media and the internet, the
| media is no longer a check or filter on partisan rhetoric
| from politicians.
| cma wrote:
| Something close to a full shutdown was done in China, etc.,
| not Florida.
| URSpider94 wrote:
| CDC data shows that more like 25% of Americans have
| antibodies to COVID, so your number is off by a factor of
| two. [https://covid.cdc.gov/covid-data-tracker/#national-
| lab]
|
| Additionally, you make a few glib statements that don't
| really check out - you say give hospitals three weeks to
| prepare - how? There's been a lot made of hospitals getting
| ready, but for the most part, the limiting factor for covid
| treatment has been how many icu care teams are available.
| More ventilators don't help much if there's nobody to use
| them. Second, I'm not sure how you protect senior citizens
| when everyone else, including the people who provide their
| care, is swimming in a soup of COVID.
| Izkata wrote:
| Like a while bunch of places did in March and April last
| year: build emergency capacity during what was supposed
| to be only a short several-week lockdown. Instead, when
| the capacity went mostly unused during the lockdown, it
| was quietly dismantled and lockdowns continued.
|
| Also, we knew by April last year that ventilators were a
| bad choice: Doctors were jumping to it because of a
| specific weird symptom (blood oxygen levels impossibly
| low), but they had to keep turning the ventilators to
| higher settings to get an effect - to the point it was
| causing further lung damage. There's a bunch of less
| damaging ways to get more oxygen into a patient they'd
| been shifting to:
| https://www.statnews.com/2020/04/08/doctors-say-
| ventilators-...
| croes wrote:
| You can't really protect the vulnerable, especially when
| the vaccines wasn't developed. Any source for the 50%
| antibody claim?
| Izkata wrote:
| > You can't really protect the vulnerable, especially
| when the vaccines wasn't developed.
|
| If true, then social distancing, masks, and lockdowns
| couldn't have done anything for the rest of us for the
| past year either.
|
| The argument for "protect the vulnerable" is that these
| precautions could be more targeted and so, hopefully,
| more effective.
| Deregibus wrote:
| Putting aside that these claims are presented without any
| evidence, "most" of 50% of the US population is a minimum
| of 82M people. ~31M have contracted COVID so far. That
| we're going to see almost 3x the number of cases,
| concentrated in half the population, as we enter summer,
| and with 3-4M vaccines administered per day, is a pretty
| bold claim.
| 1cvmask wrote:
| And then we had excess deaths in NY State because Governor
| Cuomo FORCED nursing homes to take in infected patients!
| And then he gave immunity to the whole industry from
| liability if they didn't take precautions.
|
| And he became the darling of the media and even won an
| Emmy.
|
| https://www.vanityfair.com/news/2021/03/cuomos-nursing-
| home-...
| UncleOxidant wrote:
| > With the benefit of hindsight, a 3 month shutdown while
| hospitals got their acts together (combined with protecting
| the vulnerable) would have roughly quartered the remaining
| deaths, but at far lower cost than the full shutdown.
|
| Where was this "full shutdown" you speak of? Not anywhere
| in the US. In Wuhan, and some other Asian countries, sure.
|
| Didn't we kind of have the 3 month shutdown-lite you're
| referring to? Mid-March through about June for most places
| were at varying levels of shutdown in the US. But recall
| things started opening up in June of 2020. And cases
| started rising again into July.
|
| > The US is apparently already at ~50% antibodies, not
| counting vaccination.
|
| Citation? That seems like about 3X the most optimistic
| numbers I've heard from credible sources.
| [deleted]
| hedora wrote:
| As for shutdown vs shutdown lite: No; the economy didn't
| completely reopen in July. The recommendations from March
| 2020 were for more strict targeted shutdown protocols,
| but over a shorter duration (Strict reverse quarantines
| for nursing homes, but only for a few months for
| example.). The idea was to get less vulnerable groups to
| herd immunity faster. I'm saying a general, country wide
| shutdown for three months, concurrently with a strict
| targeted lockdown for about 5-6 months would have been
| more effective and cheaper (and, we'd have been done by
| last August, as the parent of my other post suggested.)
|
| Source for 50%: Wall street journal. We were above 33%
| (based on random sampling, not confirmed cases) a few
| months ago.
|
| This one from Feb predicted herd immunity a bit too
| early. They ran one with updated numbers last week, but I
| can't find it:
|
| https://www.wsj.com/articles/well-have-herd-immunity-by-
| apri...
| UncleOxidant wrote:
| > returned to near normal by August 2020
|
| The problem is the virus, not the government reaction to it.
| Personally, I tend to think governments under-reacted in most
| Western countries. I'm not sure how things would have
| returned to "normal" if the virus was raging out of control.
| A good precentage of people would see the deaths and still
| avoid going out to shop or whatever. I'm assuming you mean by
| "normal" that people would return to some normal pattern of
| economic activity - and even if 10 or 20% of people changed
| their behavior that would still impact the economy.
| umanwizard wrote:
| > A good precentage of people would see the deaths and
| still avoid going out to shop or whatever.
|
| That seems hard to believe, since significantly more people
| die every year of all causes than could possibly have died
| of Covid, even if every single person in the world caught
| it. Most people probably wouldn't have noticed anything was
| different.
|
| > even if 10 or 20% of people changed their behavior that
| would still impact the economy.
|
| Maybe so, but the economy is not the only or even the most
| important casualty of our Covid response. The importance of
| human social gatherings, the freedom to leave one's home
| and go wherever one pleases, the education of children, and
| so on cannot be measured in economic terms.
|
| > The problem is the virus, not the government reaction to
| it.
|
| Places where there were very few or only brief
| restrictions, like Serbia, Belarus, or Florida, largely
| avoided the issues I described above with only a small or
| in some cases unmeasurable increase in all cause mortality
| for 2020.
| InitialLastName wrote:
| How many dead people would that "normal" have been worth to
| you?
|
| If, instead, people had behaved responsibly in mass and we
| had used the time we got from that to establish coherent
| contact tracing and testing, things would have returned to
| normal by August as well, only without many the deaths your
| way would cause.
| sp332 wrote:
| It is not stopped. It is paused for a few days while updated
| training is rolled out.
| joelfolksy wrote:
| Suicides decreased in 2020, btw: https://www.axios.com/suicide-
| decreased-in-2020-pandemmic-me....
| scienceOverFear wrote:
| Like the article mentioned, there may be long term effects we
| can't foresee.
|
| Seeing the chaos in the economy and current real estate
| prices make me concerned that anyone without a home/mortgage
| in 2020 will be permanently lower class and renting due to
| inflation.
|
| Free government money for a year is like eating candy. The
| stomach ache has yet to come.
| Miner49er wrote:
| Deaths of despair increased though:
|
| https://www.marketwatch.com/story/deaths-of-despair-
| during-c...
| spookthesunset wrote:
| As did unintentional injury, which was due to overdoses.
| webdevadventure wrote:
| Alcohol and drug abuse is way up as well, that will have
| long term ramifications.
| Izkata wrote:
| The CDC only tracks actual suicides, not attempts. Suicidal
| thoughts and attempts are up: https://www.aappublications.org
| /news/2020/12/16/pediatricssu...
|
| Besides, in the CDC table, "unintentional injuries" is up by
| way more than suicides are down. This includes things like
| car accidents, and is a little suspicious, like suicidal
| behavior led to a death that wasn't classified as suicide.
| Also note that the table is "deaths with covid or presumed
| covid", not "deaths by covid":
| https://jamanetwork.com/journals/jama/fullarticle/2778234
| regextegrity wrote:
| If attempts are up but actual suicides are down, did we
| just get way worse at suicide?
| ceejayoz wrote:
| Six cases in seven million administered doses. One death.
|
| Meanwhile, hormonal birth control causes clots in 1/1,000 women.
| No one blinks an eye.
|
| The vaccine hesitancy this engenders is likely gonna kill more
| than that one person.
|
| https://twitter.com/NateSilver538/status/1381936112311148548
|
| > Public health bureaucrats have some weird habits in how they
| reason under uncertainty and how they communicate to the public.
| It might help if they sought out experts from economics,
| sociology, psychology, etc., instead of telling everyone to stay
| in the their lane.
| shmel wrote:
| Why is it relevant? So far nobody forces me to take birth
| control and threatens for exclude me from the society if I
| refuse to do so (UK wants to require vaccine passports to go to
| cinema, for example). Nobody paints me as stupid anti-vaxxer if
| I just say I don't want to take BC pills. Nobody tells me that
| I won't be able to travel unless I agree to take BC.
| ceejayoz wrote:
| If your fetus could spread to other people while you're
| pregnant, those would all be great points.
| flexie wrote:
| I am a guy, so maybe I don't know what I am talking about.
| But I have a strong suspicion that the consequences for young
| women that chose not to take birth control pills can be felt
| as well and that they often feel quite a pressure from
| friends, boyfriends, parents, etc. to take the pill.
| shmel wrote:
| I am sorry, this is the whole other level. First of all,
| you are not obliged to discuss your medication with friends
| or parents. Second, your reply is pretty much like:
|
| >> In China you disappear if you publicly say bad things
| about CCP.
|
| > Yeah, I know what you mean, I called somebody
| motherfucker and got banned on HN. Freedom of speech is
| nowhere these days.
| raverbashing wrote:
| Paraphrasing one famous science commenter, we're playing
| Pandemic Trolley Problem and running over hundreds of people
| because we're not sure if the other path has one or two
| persons.
|
| It's ridiculous.
|
| Or as per someone that actually knows statistics:
| https://twitter.com/NateSilver538/status/1381925025964515330
| mxcrossb wrote:
| Only if you assume that utilitarianism is the answer to the
| Trolley Problem
| raverbashing wrote:
| Yesterday, 400 people died of Covid in the US. That's a
| good day, in January the peaks were around 4k people per
| day
|
| This is what vaccine delays cost us
| pbhjpbhj wrote:
| It may be ridiculous, but it seems necessary if you're
| managing populations of people:
|
| Build a dam, which if it broke would kill hundreds-of-
| thousands, or let millions die for lack of water? Oh, we'll
| just over-engineer it, now we can't afford to buy food to
| keep the people alive long enough to need the dam; or the
| lead engineering firm embezzles the money and installs dodgy
| iron.
|
| We can't wait around for long term studies, whatever point we
| decide to start vaccines - where they can still be effective
| for the current population - it's always possible we should
| have waited a bit longer.
| raverbashing wrote:
| You're blowing the problem out of proportion
|
| Deaths by Covid are still much more likely than deaths by
| the vaccine.
|
| Hospitalizations as well, except for the 20-29 cohort https
| ://twitter.com/VikiLovesFACS/status/1379833789334089734
| pbak wrote:
| If we are talking death, OK, but what about other issues
| in the "harm spectrum" in either the case of Covid or
| Vaccine ?
|
| I mean there's still stuff between "fully healthy" or
| "deadly dead".
| calvano915 wrote:
| Deaths by COVID implies that those at risk will forego
| all other options to decrease risk of infection, such as
| masks, distancing, etc. Those options are opt in the same
| as a vaccine, though the vaccine is 2x and done.
|
| Nonetheless, just because version 1/2 COVID vaccines are
| good enough for you does not others should just jump on
| board when other options exist that can vastly reduce
| risk of infectionand/or death.
|
| In short, blowing the death problem our of proportion
| unless the options are only nothing vs vaccine.
| throwawayboise wrote:
| Also: losing weight, getting more exercise, improving
| your diet, getting proper amounts of vitamins. All things
| that will _greatly_ reduce your risk of death from many
| causes, not just COVID. But requires some effort compared
| to taking a pill or a shot.
| Mediterraneo10 wrote:
| > Deaths by COVID implies that those at risk will forego
| all other options to decrease risk of infection, such as
| masks, distancing, etc.
|
| Masks are supposed to protect others from you. Wearing a
| mask is not meant to help a person who may be at risk
| decrease his/her own risk of infection.
|
| In any event, now that spring weather is here in the
| northern hemisphere and the vaccination campaign has
| given people hope, social-distancing rules are being
| flaunted in many countries and at-risk populations may
| find it hard to properly distance when they leave their
| homes for e.g. basic shopping. So, since the "other
| options" don't always work, keeping up the vaccination
| campaign is very important to reducing infections.
| calvano915 wrote:
| While mask effectiveness may be skewed the direction you
| state, you can't tell me that wearing one along with
| other precautions has no positive impact on your own
| infection risk.
|
| For those willing to receive vaccination right now under
| informed consent, I'm all for it. I agree people are over
| the pandemic and making the situation worse. I disagree
| with many commenters here that are shaming and/or
| implying that people like myself are anti-vax vs simply
| being willing to wait for much more evidence before
| jumping on board with incredibly widespread usage of an
| incredibly not well understood treatment.
| awd wrote:
| > shaming and/or implying that people like myself are
| anti-vax.
|
| I'm in a low risk bracket. My country saw an uptick in
| people canceling vaccination appointments. 40% of 60+
| people here are now 'unsure' of taking the vaccine.
|
| I've done nothing but work and follow the rules since
| this whole thing began. Young people without partners, or
| young people in general, that are active, have a social
| life did a complete 180* in their "allowed lifestyles".
|
| I've paid with money, time, a year of my otherwise busy
| life, for people in risky age brackets, at _little_
| benefit to myself. *
|
| But I'm so done, don't tell me you're asking people like
| me to be stuck in our anti-social and unhealthy living
| arrangements, while there's a solution that's _safer_
| than going to a covid shower?
|
| People like me are done paying, I'm not going to wait
| around another year, you take the vaccine or you take
| covid for all I care.
| johnnyapol wrote:
| I'm not saying your calculus is wrong but this does make an
| assumption that all clots are created equal and I don't believe
| that is the case.
|
| The specific issue being observed is "cerebral venous sinus
| thrombosis (CVST)" in combination with "low levels of blood
| platelets (thrombocytopenia)" per the Joint CDC and FDA
| statement (1).
|
| Low blood platelets means anti-clotting treatments can pose a
| substantial bleeding increase, making this already dangerous
| condition difficult to treat.
|
| (1) https://www.fda.gov/news-events/press-announcements/joint-
| cd...
| Pyramus wrote:
| To add, from the German Federal Institute for Vaccines
| (regarding AZ not J&J):
|
| > Birth control pills can also cause thrombosis. So why is
| there all the fuss about the COVID-19 Vaccine AstraZeneca? >
| It is true that for birth control pills thromboses, even with
| fatal outcome, are known as a very rare side effect. They are
| listed in the Summary of Product Characteristics (SmPC). The
| birth control pill is available only on prescription. Every
| woman must be informed of this risk by the prescribing
| physician. For the COVID-19 Vaccine AstraZeneca, there is
| currently a suspected very rare side effect of sinus vein
| thrombosis with accompanying platelet deficiency, sometimes
| fatal. It is not listed in the SmPC.
|
| https://www.pei.de/EN/service/faq/coronavirus/faq-
| coronaviru...
| HillRat wrote:
| And we know adenoviruses interfere with the coagulation
| cascade through FX binding, so it's well worth taking a pause
| and taking a closer look into what's going on. With two well-
| tolerated and safe mRNA vaccines in the market, we can afford
| -- to a degree! -- to put Ad-based vaccines through
| additional scrutiny, especially since they're likely to be
| the primary vaccine type on a global level.
| krooj wrote:
| Sorry, what's the effect adenoviruses have on FX? I'm a
| male with a mild hypercoag disorder and history of DVT. Am
| scheduled to get the JJ vax today and will be skipping and
| seeking out mRNA instead.
| HillRat wrote:
| Not a doctor, so talk to your hematologist! Ads bind to
| blood factors (Ad5s to FX, HAdVs to FIX, etc), which
| facilitates organ uptake and interferes with the
| coagulation cascade and triggers complement activation.
| Thrombotic thrombocytopenia is a known complication from
| gene therapy studies, so it's not surprising, but
| concerning, that rare but serious coagulatory disorders
| are appearing in the widespread use of a zoonotic
| adenovirus. I'm certain quite a few other folks on here
| are better-informed than me, so hopefully we'll get some
| more discussions going on this topic.
| HillRat wrote:
| I'll also say that the most significant risk is probably
| mistreatment of clots, since most doctors probably
| wouldn't go right to non-heparin/warfarin DTIs unless
| they had reason to suspect HIT or had gotten a CBC back.
| lbeltrame wrote:
| I agree if you're in the US or in any other place with
| abundant supply of other vaccines. If you're in a place
| like the EU, like myself, every single dose counts and a
| setback can seriously screw things up.
| StavrosK wrote:
| > With two well-tolerated and safe mRNA vaccines in the
| market, we can afford -- to a degree! -- to put Ad-based
| vaccines through additional scrutiny
|
| This assumes that we have enough safe vaccines, which we
| wildly don't.
| HillRat wrote:
| Yeah, that "to a degree" is US-centric and, even then,
| doing a _lot_ of work -- in the US, J &J is probably
| about 1/3 of the total vaccinations when accounting for
| the prime/boost mRNA protocol, so even here it's a mess,
| and we're in much better shape than the rest of the
| world.
| jjk166 wrote:
| > Cerebral venous sinus thrombosis is rare, with an estimated
| 3-4 cases per million annual incidence in adults. While it
| may occur in all age groups, it is most common in the third
| decade. 75% are female. [0]
|
| 6 cases in 7 million over 3 months with mostly women being
| affected is exactly what we'd expect to see.
|
| [0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_throm
| bos....
| slver wrote:
| The individual blood clots that birth control increases the
| risk of has nothing to do with the massive immune system
| induced clotting that these vaccine cause. The former is rarely
| lethal, the latter most often is.
|
| Is it too much to bother with details, or we'd rather
| generously assume everyone is dumb except on Internet forums?
| ceejayoz wrote:
| > The former is rarely lethal, the latter most often is.
|
| Again, we're looking at one in a million stats for _getting_
| the clots, and _one in six deaths_ amongst that tiny group of
| cases - without information yet on their comorbidities.
|
| COVID itself causes clots. A lot more than 1/1,000,000. If
| you're afraid of clots, get the vaccines. Even the J&J one.
|
| https://health.ucsd.edu/news/releases/Pages/2020-11-23-study.
| ..
|
| > Overall, 20 percent of the COVID-19 patients were found to
| have blood clots in the veins...
| hedora wrote:
| Also, and perhaps more relevant, covid kills about 0.5% of
| people. Presumably whoever set this policy divided things out,
| and decided that's about 1 in a million.
|
| I honestly don't understand how we've managed to put people
| that demonstrate this level of incompetence in charge.
| bognition wrote:
| I agree that on the surface these numbers are not alarming.
| That said I trust that the government agencies know what they
| are doing here. If anything there is tremendous political
| pressure to NOT scrutinize the vaccines.
|
| There is enough anti-vaccine & Covid rhetoric that we should
| all cool it a little bit and let the experts do their jobs.
| jMyles wrote:
| I generally agree with your comment, but
|
| > That said I trust that the government agencies know what
| they are doing here.
|
| If 2020 didn't finally shatter that trust, is there anything
| that can? FDA was already obviously a regulatory capture
| vehicle for pharma. And CDC got nearly everything wrong in
| the ebola outbreak of 2014. Then, both of them blundered
| their way through this pandemic.
|
| For example, we know from the email leaks that FDA felt it
| was under pressure from Trump to approve vaccines[0], and
| then never disclosed this fact to the public. That doesn't
| seem like dispassionate science and expertise to me.
|
| By contrast, many of the medical journals, preprint houses,
| and academic institutions have looked like far more stable
| sources of knowledge.
|
| It seems to me that the internet age asks us to replace our
| state institutions of expertise with something more
| thoughtful and genuinely connected to science.
|
| 0: https://www.bmj.com/content/372/bmj.n627
| crazy1van wrote:
| > That said I trust that the government agencies know what
| they are doing here.
|
| I'm the opposite. Covid caused my trust in them to plummet.
| Perhaps made with the best of intentions, but all the noble
| lies have eroded my trust.
| huffmsa wrote:
| They're letting perfect -- even a single death is too many --
| get in the way of good -- a small number may have shitty
| outcomes, but the overwhelming majority will not.
|
| Same framework that's lead to all of the poor policy
| decisions over the past year.
| roenxi wrote:
| Possibly they are nervous because it could signal deeper
| problems. If there is anything people should have learned from
| the pandemic is that it takes a few months for the medical
| profession to sort themselves out when new data appears on the
| scene.
| refurb wrote:
| This is the thing. A similar issue was seen with heparin a
| decade or so back. Basically the heparin molecule (an
| impurity I believe) was causing an immune reaction that cross
| reacted with a protein that activates platelets. Not a minor
| side effect and until the full extent of the issue is known
| (who is at high risk? How do we treat if it happens) I don't
| blame them for being cautious.
| mhb wrote:
| Your sympathy for them being cautious begs the question of
| whether the vaccine, with its uncertainty, is worth using.
| The cost of waiting to use it is significant - people will
| die from COVID.
|
| It's not enough to say you're being cautious. You have to
| explain why you think it is better to be cautious about
| administering the vaccine with its attendant risks or to
| pay the QALYs incurred by the delay when people who would
| have received this vaccine don't.
| abduhl wrote:
| All of a sudden we need a QALY analysis to justify an
| immediate reaction from the government? Things sure have
| changed in the past couple hours when it comes to What
| people think is required of America's COVID19 response.
| toast0 wrote:
| Pausing this one vaccine type to collect data and
| determine appropriate actions to mitigate this side
| effect is reasonable.
|
| This is a low probability event, and the appropriate
| mitigation may be to do nothing; but there may be some
| common factor for these patients that might indicate use
| of a different vaccine or maybe informing people of
| symptoms of blood clots and what to do if they see
| symptoms.
|
| The real risk here is eroding confidence in government
| health sources in general, and vaccines in specific.
| There were certainly unknown risks before, but now there
| is a known risk which deserves some study.
| mhb wrote:
| That's all hand-waving. Why is it reasonable to delay
| vaccinating people based on these events? Maybe it is,
| but not because your gut feel says so.
|
| What erodes confidence is the complete absence of
| cost/benefit discussions about virtually any decision
| that has been made. Including this one.
| toast0 wrote:
| We've now got a known risk that's quantifiable, but
| hasn't been quantified. You can estimate the risk based
| on the current information, but now that it's a known
| risk, I would expect to have more complete information in
| a few weeks.
|
| If this turns out to be about what it looks like now,
| unpause and go forward. If it turns out to be much more
| significant, all the better for having stopped; maybe
| restrict this vaccine to populations at higher risk of
| COVID or lower risk of blood clots (if that risk can be
| determined). Both mRNA vaccines and modified adenovirus
| vaccines are new types of vaccines not used before on a
| wide scale; pausing to get clarity on a major negative
| side effect is warranted.
| mhb wrote:
| You've hinted at a framework for making a decision but
| left out an important component.
|
| A credible decision would give your estimates of
| harm/benefit for delaying vaccinating people. You seem
| all too willing to ignore the people who will become sick
| or die because of delaying the vaccine. You are only
| looking at potential harm from not delaying the vaccine.
| Unfortunately, you have a lot of company.
| dragonwriter wrote:
| > A credible decision would give your estimates of
| harm/benefit for delaying vaccinating people.
|
| It seems to me that the delay imposed by a pause in use
| of the J&J vaccine to make sure healthcare providers are
| informed of and have appropriately updated diagnostic and
| treatment protocols is minor, its basically pulling
| forward by a few days the effects of the 80% week-over-
| week drop in J&J vaccine supply that was just in the
| news.
| toast0 wrote:
| The risk isn't just the blood clots, it's that the
| vaccine is perceived as rushed (it was) and warning signs
| were ignored, so maybe other things were ignored.
|
| Leading to more people delaying their vaccination. Supply
| is currently at a level that all doses available are
| administered, but to the extent lost confidence results
| in longer delay for high risk patients, that has a cost.
| When supply exceeds demand, lost confidence will have a
| cost for those low risk people who delay, as well as the
| general population which loses out on wider immunity.
| Delaying the vaccine now certainly also has some cost of
| the same type, but it's bounded. Another case of a
| vaccine campaign ignoring warning signs and proceeding
| without pausing to consider appropriate response to
| issues as they arise will affect this campaign as well as
| future campaigns.
| mhb wrote:
| I don't think anyone would disagree that if there were no
| cost to delaying supplies of the vaccine then we should
| do that. But that's simply not credible. The governor of
| Michigan seems to think that additional vaccine does
| would be helpful.[1]
|
| Suggesting that effects on the order of the ones seen
| here is a good reason to delay the vaccine should make
| people doubt the ability of our public health authorities
| to make reasonable tradeoffs.
|
| [1] _Michigan 's Democratic Gov. Gretchen Whitmer
| declared her state a "COVID hotspot" as cases continue to
| rise and has asked the federal government to increase
| vaccines in response._
| https://abcnews.go.com/Politics/cdc-director-michigan-
| vaccin...
| toast0 wrote:
| Sure, maybe don't delay it in hotspots then. Or send my
| state's allocation of J&J to Michigan for the next couple
| weeks.
| Daho0n wrote:
| People keep repeating this myth of birth control. I don't know
| how doctors do their job in other countries but if they look at
| the patients health history this number is a myth. Luckily
| health officials here (ETA: Denmark) inform about these myths
| on television whenever the government holds a press conference
| about new Covid-19 measures but this isn't so everywhere so
| please stop spreading FUD.
|
| ETA: I see you made ninja edits to your comment....
|
| Edit 2: So now you replied that you only added a word or two
| and then deleted you comment while I were replying. Your
| comment was only half as long when I replied (all the Twitter
| stuff wasn't there for example).
| peytn wrote:
| Keeping on the myth of birth control...
|
| > A joint statement from the FDA and CDC clarified that the
| blood clotting was cerebral venous sinus thrombosis (CVST).
|
| I don't believe birth control is associated with CVST at a
| rate of 1/1000. It feels very misleading to use it as a point
| of comparison.
| [deleted]
| ceejayoz wrote:
| Yes, I realized I'd edited to add the quote. Retracted my
| comment.
| yojo wrote:
| Seems like a "damned if you do, damned if you don't" kind of
| scenario. If you don't pause the rollout, there will be news
| articles that the government ignored deadly side effects,
| resulting in lack of trust and vaccine hesitancy. If you do
| pause the rollout, you get vaccine hesitancy.
|
| Agreed that if everyone is rational/good at math the optimal
| outcome is proceed with dosing, but sadly that is not the world
| we live in and the "broken trust" scenario might be more
| damaging.
| [deleted]
| kbos87 wrote:
| Something that has fascinated me about the last year is that
| the pandemic has sped up the feedback loop on decisions like
| this. Seeing the impact of this decision won't take years and
| the outcome won't be unclear. In another few weeks, we'll very
| likely know that this was an overly cautious call that directly
| led to even more vaccine hesitancy, and lives lost as a result.
| Eduard wrote:
| This is kneejerk statistics 101 reaction.
|
| * Hormonal birth control - years of research. Years of evidence
| and practice. Knowing what to do when this and that happens.
| Recommendations for women with known conditions not to take
| this and that hormonal birth control.
|
| * Novel vaccination - barely month of research. Weeks of
| evidence and practice. We don't have best practices yet.
|
| I'm fine with anyone to make a decision on them own to take
| these vaccinations. As someone with a not-so-uncommon mutation
| causing thrombosis easily, I'm happy I hesitated and haven't
| received either J&J or AstraZeneca.
| jdminhbg wrote:
| > This is kneejerk statistics 101 reaction.
|
| Sometimes the answer is easy.
|
| > Hormonal birth control - years of research
|
| This is kneejerk status quo bias.
|
| > I'm fine with anyone to make a decision on them own to take
| these vaccinations.
|
| Great, but the FDA is not. That's the issue here.
| bosie wrote:
| >> Hormonal birth control - years of research
|
| > This is kneejerk status quo bias.
|
| mind expanding why years of research is a 'bias'?
| jdminhbg wrote:
| Citing "years of research" that nevertheless demonstrate
| a product has side effects as bad or worse as a reason
| something should be allowed is status quo bias.
| 1337biz wrote:
| It goes even deeper than that. I have seen that meme catch on
| in so many feminist Twitter and Instagram accounts that it is
| essential to look at the play here.
|
| The "you woudn't care about women dying" narrative completely
| derails the essential discussion (aka when do we determine
| vaccine to be save) by selectively picking facts from a
| completely unrelated health area to turn it into an activist
| subject.
|
| It reminds me on the magnet-troll-logic memes, only this one
| trying to come up with the completely insane narrative: "If
| you are concerned of a few more people dying because of a
| vaccine, you hate women."
| ceejayoz wrote:
| The narrative - and I think it's a correct one - is "we
| accept far riskier interventions in our everyday lives
| already, of which birth control is one good example".
| DangerousPie wrote:
| > * Novel vaccination - barely month of research. Weeks of
| evidence and practice. We don't have best practices yet.
|
| That is completely untrue. This vaccine has been through
| several clinical trials for months. We know that there are no
| side effects that are common enough to be of real concern.
| The reason we are only seeing this one now is that it is so
| rare.
| bluGill wrote:
| The clinical trials have been for months on limited numbers
| of people. Given this seems to be a 1 in a million
| situation the odds are against those trials discovering
| them.
| mikem170 wrote:
| Actually they did notice extra blood clots during the
| trials, but didn't think it was statistically significant
| [0] (15 blood clots versus 10 in the placebo group, in a
| trial of 20k people).
|
| [0] https://www.cnn.com/2021/04/13/health/johnson-
| vaccine-blood-...
| bluGill wrote:
| I stand corrected.
| octopoc wrote:
| > We know that there are no side effects that are common
| enough to be of real concern
|
| No, we can't know that. Some affects don't show up for a
| long time. One example is women.
|
| Women's bodies are complex because they go through so many
| changes. These changes affect how they respond to medical
| treatments. In other words:
|
| - Just because pre-menopause women respond well doesn't
| mean post-menopause women will.
|
| - Just because pre- or post-menopause women respond well
| doesn't mean women who are going through menopause respond
| well.
|
| - Just because non-pregnant women respond well to the
| vaccine for a month doesn't mean that pregnant women will
| respond well.
|
| - Just because 6-month pregnant women respond well doesn't
| mean 3-month pregnant women will respond well.
|
| - Any issues with the vaccine during pregnancy may not show
| up until after the child is born.
|
| - Women's hormones are fluctuating wildly at the beginning
| and after pregnancy. These are also times that need a lot
| of representation in the study.
|
| In fact, the amount of change women's bodies undergo
| affects medical treatment so much that many clinical trials
| deliberately under-represent women to simplify the study,
| and then use the results of the trial to recommend
| prescriptions for women.
| cheph wrote:
| > We know that there are no side effects that are common
| enough to be of real concern
|
| How did they establish that there are no long term side
| effects?
| _Understated_ wrote:
| You've been unfairly downvoted. Your question is
| perfectly reasonable.
|
| This seems to be characteristic of HN in the last couple
| of years... very reminiscent of Reddit imo.
|
| Long-term effects are one of the main points of study in
| clinical trials so why would these drugs ben any
| different?
| abduhl wrote:
| Probably the same way they established that long covid is
| an apparent death sentence.
| majewsky wrote:
| Not a doctor, but from what I've heard from
| immunologists, vaccines in general are incredibly
| unlikely to have long-term side effects on the scales
| that you think about. When an immunologist talks about
| "long-term side effects" of a vaccination, they're
| usually considering time ranges on the order of 6-8
| weeks. Meanwhile, the 10000s of patients from the big
| Phase 3 trials have been vaccinated for 6-9 months, so
| the usual scale of long-term side effects has long been
| registered.
|
| That's not to say that it's completely out of the
| question that there will be long-long-term side effects.
| But if anything is going to cause long-term issues, my
| money is on the virus, not any vaccine.
| cheph wrote:
| > Not a doctor, but from what I've heard from
| immunologists, vaccines in general are incredibly
| unlikely to have long-term side effects on the scales
| that you think about.
|
| Fair enough, but the comment I responded to said: "We
| know that there are no side effects that are common
| enough to be of real concern."
|
| Given this statement is not qualified for timescale, I
| want to know what the basis for it is.
|
| How does the person who made it know there are no side
| effects on the order of six months or a year that are
| common enough to be a concern?
|
| Look I am all happy chappy with the vaccine, I will
| inject that sweet MRNA Pfizer or Moderna vaccines as soon
| as someone lets me at it, but I still think we need to
| avoid what Fauci does, which is knowingly lie in order to
| get people to do what we want them to do.
|
| There is blood clotting risk from AZ? Great, tell me what
| the risk is and I can deal with it, but lie to me and we
| are done talking.
| nightski wrote:
| mRNA has a short life span. It merely tricks the body
| into producing the spike protein. It breaks down in the
| body fairly rapidly. What long term effects would you
| anticipate from this?
|
| There is a good chance for long term effects from covid.
| Completely the opposite for the vaccine.
| cheph wrote:
| > What long term effects would you anticipate from this?
|
| Maybe you are responding to the wrong person? I never
| made any claims regarding what long term effects to
| anticipate. I asked how the person I responded to know
| there are no serious side effects on time scales longer
| than we have tested things on.
|
| > There is a good chance for long term effects from
| covid. Completely the opposite for the vaccine.
|
| Yes. I know.
| peytn wrote:
| I think the concerns would be around the delivery
| vehicle, which presumably is some big polycationic lipid
| thing.
|
| From what I can gather, there's not terribly much info on
| what's known about what's going into people's bodies, and
| what info does exist has arisen from a thick soup of
| trade secrets and conflicts-of-interest.
| throwaway894345 wrote:
| People need to remember that we're not taking the vaccine
| for fun, we're taking it because COVID is out there and
| we know for certain that it has some lethal side effects
| as well as non-lethal side effects and possibly other
| long-term side effects that we don't yet know about. We
| weigh that risk against the risk that there might be some
| long-term side effects of the vaccine. To the best of our
| knowledge, the risks posed by COVID are more dire than
| those posed by the vaccines and we basically have to
| choose one.
| cheph wrote:
| Maybe you responded to the wrong person. I am in no way
| suggesting it is better to not take the vaccine, or that
| there is good reason to think that the risks posed by
| COVID are less dire than those posed by the vaccines.
| jrockway wrote:
| > Given this statement is not qualified for timescale
|
| Keep in mind that we also don't know the long-term
| effects of COVID-19. It's possible that people who were
| infected with mild cases drop dead 1 year and 6 months
| after the infection. The disease hasn't been around that
| long, so we simply don't know.
| DangerousPie wrote:
| You can never know anything for sure. This is why
| science, medicine and drug approvals are all about
| probabilities and calculated risks. If everyone suddenly
| dropped dead 10 years after taking a drug that was
| approved in 2015 there is no way we could know that right
| now. But we know it's very, very unlikely, so we accept
| that risk.
|
| With vaccines we know from decades of experience that
| severe side effects tend to occur very shortly (days or
| maybe weeks) after the injection. So this is why vaccine
| trials observe participants for weeks or months, not
| years, before concluding that the vaccine is safe. Of
| course this doesn't guarantee that the Covid vaccine
| don't happen to be an exception. But if that was the
| approach we took then we would never be able to approve
| anything, and never get the benefits we know for sure it
| brings.
| cheph wrote:
| > You can never know anything for sure.
|
| But you can? e.g. "We know that there are no side effects
| that are common enough to be of real concern."?
|
| What deficiency do I have that prevents me from knowing
| anything for sure that you don't have?
| dnautics wrote:
| Your deficiency is that you're not a time traveller. You
| can't know what the long term consequences are no matter
| how many studies you do, until the long term has come to
| pass.
|
| You can however guess, and make good guesses (I'm
| planning on getting the vaccine). But it does no one any
| good to fail to outline unknowns that are steelmanned by
| "we can't possibly know".
| pcl wrote:
| DangerousPie probably meant "One can never know anything
| for sure", not "you, cheph, can never know anything for
| sure, but I, DangerousPie, can".
|
| This is a common, but confusing, use of "you" in American
| English.
| DangerousPie wrote:
| Fair enough, I clearly should have phrased that
| differently. I simplified the wording at the cost of
| accuracy. The correct wording would be "We know that it
| is highly unlikely that there are any side effects that
| ...".
| cheph wrote:
| Thanks, that is a much more reasonable statement, and I
| agree. On the one hand we don't know, but on the other
| hand a lack of knowledge does not mean everything has
| equal probabilities.
|
| I personally don't see any good reason to think that the
| risk for long term side effects from the vaccine is
| higher for the vaccine than for COVID itself.
| Solstinox wrote:
| The only reason we think that is because vaccines in the
| past have had most of their recorded side effects present
| in the first few weeks.
|
| Past performance...
| ceejayoz wrote:
| ... is a pretty decent indicator in this case.
|
| Vaccines are not the stock market. No one doubts gravity
| because "past performance is not indicative of future
| results".
| laurensr wrote:
| Past success is an invalid indicator on the stock market
| as well
| loceng wrote:
| mRNA vaccines are a new way to cause the body to develop
| an immune response - it's not using dead/deactivated
| tissue of the virus that the body detects and then its
| holistic system develops a response to. From my current
| understanding with this new type of vaccine it's skipping
| step(s), bypassing mechanisms, that leads to the body
| producing something that targets the "spike" of the virus
| - basically making it inoperable.
|
| I don't think we know long-term how this may impact the
| immune system: does bypassing certain systems/mechanisms
| cause other problems with future immune response?
|
| It took how long for us to realize as common sense that
| use of antibiotics allows superbugs to more likely
| evolve?
| Solstinox wrote:
| I don't think gravity and medical intervention risk and
| uncertainty are in the same domain. I could be wrong.
| ceejayoz wrote:
| I'm suggesting you apply the same cross-domain skepticism
| to your adage that comes from the financial domain.
| Solstinox wrote:
| The situation here is closer to financial domain than the
| law of gravity failing.
| dnautics wrote:
| > Vaccines are not the stock market
|
| How many genetically engineered adenovirus vaccines have
| there been before?
|
| The vaccines that are your prior are typically attenuated
| or inactivated virus.
|
| Majorly different category, we are in untreaded space
| (I'm still planning on getting one)
| shezi wrote:
| Apparently there were studies on adenovirus 5 vector
| vaccines against HIV in 2007. The vaccine was not
| successful, but I cannot find any data on long-term
| adverse effects.
| lbeltrame wrote:
| At least one for Ebola, IIRC.
| dnautics wrote:
| so, no long-term studies.
| ceejayoz wrote:
| The Ebola vaccine in question has been tested in humans
| since 2015. How long-term are you looking for?
| dnautics wrote:
| more than 5 years? Cancer risk, etc. is probably
| something decadal in scope.
| lbeltrame wrote:
| Biology doesn't work like that. Certainly not for
| replication-deficient adenoviruses used by AZ, Gamaleya
| and J&J.
| Ericson2314 wrote:
| You realize attenuated virusues are also genetically
| modified? Just via artificial selection.
| throwawayboise wrote:
| The mRNA vaccines are new. We don't know that our
| experience with other vaccine types will be exactly the
| same.
| dr-detroit wrote:
| It was researched as quickly as possible on a for-profit
| basis. All my friends from college who went into biomed
| quit because of how corrupt it was and they would start
| with a profitable hypothesis and work backwards its
| antiscience and honestly capitalism has a proven track
| record of poising everyone and anyone to make a penny.
| fit2rule wrote:
| It hasn't been established yet.
| pbak wrote:
| You kind of answer your own question : only time will
| tell, ironically, and nobody else.
|
| Also, to all those saying "clinical trials have
| succeeded", I strongly suggest them to read said
| published trial results and look at _measured_ sample
| sizes used in the results, not total inoculation numbers.
|
| Applying the precautionary principle, particularly if you
| are not at risk, is a perfectly reasonable position,
| IMHO.
| somedude895 wrote:
| Factor V Leiden gang represent. Afaik AZ clotting is caused
| through a different mechanism though. Have there been any
| official recommendations for us thick-blooded folk?
| krooj wrote:
| Same fam. Skipping AZ/JJ till I can get mRNA. 3 years since
| my last ride on the DVT rollercoaster. 0/10 - would not
| recommend.
| [deleted]
| jMyles wrote:
| This take seems a little short-shrift to me.
|
| This is a highly unusual situation insofar as phase III
| monitoring is far from complete and there is no 'phase IV'
| (confirmatory) trial data at all yet. In the normal course of
| research, this is how we'd catch rare but consistent adverse
| effects.
|
| So, if we had complete trials on a normal timeframe, then
| obviously there's a different calculus to apply.
|
| But given what we know at this moment, these six incidents
| might actually be far more normal than the crude use of six as
| numerator and seven million as a denominator.
|
| A pause to assess the data and allow any lag to resolve seems
| prudent.
|
| And, while this will be very difficult to quantify until much
| later, if then, I surmise that this will only create temporary
| vaccine hesitancy and only outside the high-risk tier, which is
| perfectly rational.
|
| For people in the low-risk tier, there's nothing wrong with
| waiting until the conclusion of the RCT monitoring in the first
| place, even if adverse events weren't the basis of that
| decision.
| ceejayoz wrote:
| > A pause to assess the data and allow any lag to resolve
| seems prudent.
|
| I don't think the drug safety system is set up to effectively
| evaluate the cost/benefit of the pause itself in a pandemic
| scenario.
| eloff wrote:
| That's the thing. Pausing the vaccine will kill people.
| Judging by the numbers so far - probably more people. But
| different and older people.
|
| How does one do that math ethically? There are risks if you
| do and risks if you don't. The FDA is the wrong group to
| make that call, because they're only concerned with the
| first kind of risk.
|
| In Canada we reserved the Astra Zenica vaccine for people
| over 55 because of the blood clot issue. I think that's
| probably the right call.
| sokoloff wrote:
| None of our societal systems are setup to do rational cost-
| benefit trade-offs in a pandemic.
|
| "Don't wear masks." "No, no: wear masks." "COVID kills over
| 10%." "COVID kills less than 0.1%." Once we realized the
| difference in makeup between the over-10% and sub-0.1%
| populations, we still couldn't bring ourselves to make
| data-backed differentiations for many, many months (and
| still today have many small businesses closed or restricted
| based on _what they do_ rather than the _risk profile_ of
| their owners and employees).
|
| These are difficult decisions to be sure, but when being
| seen as on the "safe side" confers benefits without a
| commensurate charge for the risk of the "safe" action, you
| get a society which moves in the direction of perceived
| safety (and where perceived safety may be strongly sub-
| optimal).
| clairity wrote:
| > 'These are difficult decisions to be sure, but when
| being seen as on the "safe side" confers benefits without
| a commensurate charge for the risk of the "safe" action,
| you get a society which moves in the direction of
| perceived safety (and where perceived safety may be
| strongly sub-optimal).'
|
| yes, security theater abounds. it's a multidimensional
| optimization problem with no absolutely safe side in the
| long run, only relatively, but often initially
| unintuitively, safer non-linearly intertwined sets of
| actions. it's hypocritical to discount the tiny risk of
| vaccines while dramatizing the tiny (but larger) risk of
| death by covid. further, it's myopic to look at the risks
| of covid in isolation (which is what all the frenzy
| around it has been doing for over a year) rather than in
| relation to all the similar risks in our lives and
| couching our responses now within our existing responses
| to those other ongoing risks.
| ghaff wrote:
| >For people in the low-risk tier
|
| I don't disagree. But I will observe that _many_ people in
| the low(er) risk tier are going to be traveling, eating out,
| having parties, etc. sooner rather than later--vaccine or
| not. In my very Blue state people are very obviously relaxing
| a whole lot more. So the question isn 't whether things open
| up or not. It's whether people are vaccinated when they do.
| (Which doesn't mean all vaccines are equally safe.)
| lsllc wrote:
| It seems like people in the low-risk tier might be more
| likely to get J&J. Firstly, it's just the one shot and
| secondly, people who are worried about COVID are vaccine
| shopping because they want the perceived "higher efficacy"
| of the mRNA vaccines vs J&J (whereas lower-risk people
| might be more interested in vaccine passports than
| preventing symptoms).
| ghaff wrote:
| Maybe. In a lot of places you don't really have a choice
| and, in the US, AFAIK the mRNA vaccines are more common.
| Also, while "vaccine passports" have started being
| discussed, they're not really a factor yet--given how
| many people still need to vaccinated--and may never be
| outside of scenarios like schools. (That said, I have
| heard people who see getting a vaccine as more pro forma
| saying they prefer J&J because it's just a single shot.)
| lsllc wrote:
| It's pretty easy to "vaccine shop" (if you care about it)
| at least in the US with all of the scheduling being done
| online. Sure, if you go to one of the big vaccination
| sites, you may not get a choice, but it seems that sites
| offering J&J have been advertising that and ones that
| don't indicate seem to be Pfizer & Moderna (or if J&J,
| give you a choice, at least around Massachusetts).
|
| J&J is also widely used in the US for people who might
| have issues with scheduling a second shot, for example
| people who are homeless, or are home-bound.
| ghaff wrote:
| Fair enough. It was still quite hard to get one when I
| scheduled and I was going to take whatever I could get
| even if I favored the mRNA ones. That said, if I didn't
| really care about getting a vaccine but was going to get
| one anyway, I'd probably just choose whatever I could get
| most easily.
| lovedswain wrote:
| Put another way, you're about 38 times more likely to develop a
| blood clot than win the UK's national lottery.
| maxerickson wrote:
| I doubt the correct communication strategy is obvious. Rumors
| about people dying from a vaccine can be worse than a pause.
|
| A legitimate reason for the pause is to assess whether the
| people impacted have anything else in common. There are
| alternative vaccines that can be used if a commonality is
| identified.
|
| As far as hesitancy, the idiot media already does a story for
| every vaccinated person that gets sick, this isn't going to tip
| huge swaths of people in either direction.
| temp8964 wrote:
| Seriously I can't believe this is that simple. There is no way
| public health bureaucrats don't understand this common sense
| logic. Otherwise they would all become vaccine deniers.
| goonogle wrote:
| Healthcare is extremely weak on science. The profession
| existed before the scientific method so there is a tendency
| to value authority over science.
|
| Even today Physicians still think the body is Art, or a
| combination of Art and Science.
|
| And the only reason we don't have a science based alternative
| to the Physician cartel is that they spent literally
| $400,000,000 on lobbying/bribery in the last 30 years.
|
| Edit- for further reading look up "evidence based medicine
| debate"
| memling wrote:
| > The profession existed before the scientific method so
| there is a tendency to value authority over science.
|
| Anecdotally, my pediatrician has an inverted "trust
| pyramid" in some of their examination rooms. At the bottom
| --least trust--is "expert opinion."
|
| > Even today Physicians still think the body is Art, or a
| combination of Art and Science.
|
| I'm not sure why you would think these two things are
| opposed?
|
| Science most broadly speaking means knowledge, and the
| scientific method is a means (but certainly not the only
| means) of acquiring knowledge. But what you do with it is
| art/craft. Separating the two seems unnecessarily
| dualistic.
| goonogle wrote:
| When you have a Physician recommend a dangerous procedure
| because of their feelings over scientifically proven
| procedure it's dualistic.
|
| This actually happened.
| dahfizz wrote:
| The obvious difference is that the vaccine is being forced upon
| people. A woman can talk to her doctor, understand the risk,
| and decide to take birth control or not.
|
| The vaccine was given to people, under threat of exclusion from
| society, without knowledge of the side effects. Not comparable.
| endisneigh wrote:
| Why do people keep posting this nonsense?
|
| Who cares how many clots birth controls produce? What matters
| is the outcome compared to the thing birth controls prevent -
| pregnancy.
|
| Do you get more blood clots from being pregnant or from being
| on the pill? It's order of magnitudes more from being pregnant,
| therefore if you're sexually active it's safer to be on the
| pill compared to not.
|
| How is this the top post? People have no knowledge of basic
| Bayesian statistics.
| ceejayoz wrote:
| > What matters is the outcome compared to the thing birth
| controls prevent - pregnancy.
|
| Same with the vaccine.
|
| > Do you get more blood clots from being pregnant or from
| being on the pill?
|
| Again, same with the vaccine. COVID itself causes clots, in a
| very substantial percentage of hospitalized patients.
|
| "The benefits of this medical intervention are worthwhile,
| despite the risks, given the alternative" is precisely the
| point being made.
| endisneigh wrote:
| > Same with the vaccine.
|
| No, because there are other vaccines that don't give you
| blood clots at all. Your entire point is moot. Pausing
| temporarily to investigate is hardly controversial. The
| comparison with birth control is nonsensical.
|
| A vaccination for COVID is not the same as getting birth
| control. Even if it was, why would you get J&J if you could
| get Pfizer that doesn't have the same issue?
|
| If _all_ vaccinations had the same blood clotting issue
| then perhaps you and the original poster would have a
| point. Given a huge disparity between them with regards to
| blood clotting taking a moment to investigate this is
| simply prudent. Making nonsensical comparisons to birth
| control, well, is not.
| ceejayoz wrote:
| > No, because there are other vaccines that don't give
| you blood clots at all.
|
| Not enough to go around. Pfizer's goal is 2B doses (1B
| people) this year. Moderna's is even smaller. 8B people
| in the world.
| endisneigh wrote:
| Sure, but J&J isn't being permanently discontinued. Why
| are you against simply pausing vaccinations to
| investigate this? If the USA was this prudent with COVID
| in its beginning we wouldn't even be having this
| conversation.
|
| Your argument would be reasonable if it was being
| permanently suspended.
| ceejayoz wrote:
| It doesn't have to be permanently discontinued for the
| public to lose trust in it and refuse to take it.
| endisneigh wrote:
| The mere publication of the blood clots would also cause
| the public to lose trust in it.
|
| Should the government also just not disclose any side
| effects? By definition any bad information will make the
| public lose trust.
| ceejayoz wrote:
| I think there should be an investigational period to see
| if there's an actual issue first. In software, we'd call
| it "responsible disclosure".
|
| The goal is to avoid this sort of consequence:
|
| https://www.fiercepharma.com/marketing/yougov-poll-finds-
| dis...
|
| > The skepticism shows no sign of slowing, YouGov
| reports. While trust for the Pfizer and Moderna vaccines
| rose in all country surveys between December and March,
| trust for the AZ vaccine slipped in Germany over that
| span. By early March, 40% said the AZ vaccine was unsafe,
| an increase of 10% since its earlier December poll.
|
| > The result? Anecdotal reports in Germany and across
| Europe of people refusing the AZ vaccine and supplies
| sitting unused in warehouse, YouGov reported--real-world
| evidence of "the extent of the damage done to the
| perceived safety of AstraZeneca vaccine."
|
| https://www.economist.com/graphic-
| detail/2021/03/22/increasi...
|
| > The AstraZeneca jab, which is cheaper to produce and
| easier to store and distribute than the vaccines
| currently being administered across Europe from Pfizer-
| BioNTech and Moderna, was meant to be a workhorse of the
| continent's vaccination drive. That plan could be in
| trouble, however, if citizens across Europe continue to
| believe that the AstraZeneca vaccine is unsafe and, as a
| result, refuse to bare their arms for it.
| endisneigh wrote:
| This is not software. So do you believe the government
| should be transparent or not? If anything you should
| blame the media, not the government.
| ceejayoz wrote:
| I believe there are significant public health
| implications to how information is released to the public
| that need to be considered better than they have been in
| the case of this pause and the similar case with the AZ
| vaccine.
|
| I believe, as with software, that _immediate_ release of
| unvetted, incomplete, and still-being-investigated
| information can be actively harmful to people.
| endtime wrote:
| I don't see your point. The J&J vaccine also presumably
| prevents much more blood clot-related harm than it's causing.
| OP is pointing out that we seem to have weirdly high
| standards for COVID vaccines vs. stuff we're used to.
|
| Also, how does Bayes' Theorem apply to your comment?
| endisneigh wrote:
| There's no "high standard" to begin with.
|
| J&J is paused because there are alternatives that don't
| have clotting to the same degree.
|
| A comparison with birth control makes no sense. Is there
| some magical birth control that's used orders of magnitude
| more (Pfizer) and orders of magnitude safer with respect to
| blood clotting and also prevents pregnancy?
|
| No? Then the comparison is stupid.
| SpicyLemonZest wrote:
| The primary concern people have here isn't the review,
| it's the immediate withdrawal. People who had
| appointments to get the J&J vaccine will now go vaccine-
| less until they can be rescheduled, even if they would
| have been happy to take it knowing about the blood clots.
| endisneigh wrote:
| Sure, but my point is that a comparison with birth
| control is stupid at best, harmful at worst.
|
| J&J isn't being permanently suspended - I bet you within
| the coming days this ban will be reversed and people can
| get J&J if they'd like.
| allturtles wrote:
| There currently isn't enough vaccine to meet demand.
| Pausing J&J distribution will cause a larger gap between
| supply and demand. The 7 day average of deaths from Covid
| in the U.S. is 985. Even a week's delay in getting to
| full deployment of the vaccine thus means thousands of
| deaths.
| endisneigh wrote:
| What would need to happen in your view to justify pausing
| vaccinations for even a single day?
|
| IMO that lack of caution is why the USA is in this
| situation to begin with.
| allturtles wrote:
| I am not saying outright that the pause is not justified.
| But it has a substantial cost, and it would be good to
| see that our health authorities have considered this and
| weighed the balance of costs and benefits. e.g. it might
| have made sense to pause J&J for under age X and continue
| it for over age X, based on relative risk.
|
| I don't agree with your analysis, I think you can see it
| entirely the other way, that both this pause and the
| initial "wait and see" attitude towards Covid are the
| result of an excessive bias towards the status quo. I
| remember back in January-February 2020 when people were
| saying it would be crazy to just shut down air travel,
| think of the massive economic cost.
| yread wrote:
| Note that in EU it also started with 7 cases ~1 month ago. Then
| doctors went through the records and now there are 200+ sick,
| 25 people dead from CVST alone (clotting that causes bleeding
| in the brain) with incidence in Norway 5 out of 130000
| vaccinated. If you look at women only it will probably go even
| higher. And if you compare that to CFR from COVID for person
| <50 years old without diabetes and hypertension it will be
| within an order of magnitude
|
| www.medscape.com/viewarticle/949108
| ceejayoz wrote:
| > Then doctors went through the records and now there are
| 200+ sick, 25 people dead from CVST alone (clotting that
| causes bleeding in the brain) with incidence in Norway 5 out
| of 130000 vaccinated.
|
| Per https://vaccinetracker.ecdc.europa.eu/public/extensions/C
| OVI..., that's 30M AZ doses. You're still talking about one
| in a million chance of death here.
|
| > And if you compare that to CFR from COVID for person <50
| years old without diabetes and hypertension
|
| Add a few more exclusions and no one dies of COVID, sure.
| symlinkk wrote:
| The point he's trying to make is that if you're in a low
| risk group (let's say under 30 for example) maybe it's a
| better idea to just skip the vaccine.
| conistonwater wrote:
| Wait, that doesn't sound quite right: the benefit of
| taking the vaccine goes not only to you, it's also to the
| people you would have otherwise infected by spreading the
| virus yourself.
| loonster wrote:
| And if they get infected, they will also become immune
| (and likely a better immunity than the vaccine).
| davewritescode wrote:
| I'm calling BS here.
|
| It's highly likely that natural infection provides worse
| protection that vaccination and we have real world
| evidence that already suggests this.
|
| 1. Two exposures to the spike protein are likely to
| create a much better long term immune response simply
| because of multiple exposures in a short period of time.
|
| 2. The spike protein produced by the mRNA and J&J
| vaccines is engineered to produce better response against
| variants.
|
| 3. We've already seen evidence of natural infection
| performing poorly in rural parts of Brazil with very high
| initial infection rates (> 70% which is near the herd
| immunity threshold) like Manaus where we're seeing
| significant evidence of reinfection where it should be
| have been difficult for COVID to spread.
|
| https://www.bmj.com/content/372/bmj.n394
| loonster wrote:
| 1. The current mRNA vaccine, only produces antibodies to
| the spike protein. A natural immunity produces antibodies
| to several components of the virus. If the virus mutates
| its spike, a natural immunity will still provide some
| protection.
|
| 2. A vaccine producing (IIRC) two orders of magnitude
| more antibodies than natural immunity is not necessarily
| a good thing.
| justapassenger wrote:
| Long COVID, that vaccines seem to help with (but still
| need more study) disagrees with you.
| loonster wrote:
| Ivermectin is also a potential treatment for long covid.
| I personally feel much safer using one of the safest
| medicines known to mankind.
| ceejayoz wrote:
| Or, you know... die. Like 3M+ people have worldwide
| already.
| loonster wrote:
| Some methods work on the numerator, other methods work on
| the denominator. Both will contribute to herd immunity.
| dahfizz wrote:
| Can't you still spread covid if you are vaccinated? Don't
| you still have to wear a mask and social distance? That
| doesn't add up with what we are being told.
| ceejayoz wrote:
| > Can't you still spread covid if you are vaccinated?
| Don't you still have to wear a mask and social distance?
|
| There's been jumbled messaging on this.
|
| The "you still need to wear a mask" thing was, if you dig
| in on the actual statements instead of the media
| headlines, "because we don't _know_ yet ". An abundance
| of caution.
|
| Since then, we've gotten quite a bit of good data on that
| front.
|
| https://www.reuters.com/article/health-coronavirus-
| israel-va...
|
| > Data analysis in a study by the Israeli Health Ministry
| and Pfizer Inc found the Pfizer vaccine developed with
| Germany's BioNTech reduces infection, including in
| asymptomatic cases, by 89.4% and in syptomatic cases by
| 93.7%.
| jdavis703 wrote:
| I was just riding a government-run subway, and they had
| an automated announcement saying "Masks are required over
| the mouth and nose even for fully vaccinated people as
| vaccinated people can still spread coronavirus." There
| was nothing muddled at all about the message. (Of course
| the message itself is probably wrong, but the public
| messaging itself is pretty clear.)
| ceejayoz wrote:
| A lot of public messaging on COVID appears driven by
| "humans are incapable of nuance", which I suppose I can't
| entirely fault them for.
|
| I think it's the wrong call, though, as we saw with
| masks.
| dahfizz wrote:
| Has there been any sort of retraction or correction? I
| believe "fully vaccinated people have to wear masks /
| distance" is still the official stance.
|
| I do not believe the government response has been
| exceptionally data-driven throughout this whole mess.
| ceejayoz wrote:
| The data isn't conclusive yet. Still being analyzed. It
| looks good, but there's more to collect.
|
| There'll be new guidance issued if it pans out.
| throwawayboise wrote:
| If I'm vaccinated, I'm protected. I don't really care if
| anyone else is vaccinated or not, as I'm not at risk from
| their decision. Or is this not true?
| temp667 wrote:
| We have been told we have to wear masks and socially
| distance with or without vaccine, so you can ABSOLUTELY
| still spread it even if fully vaccinated. Please follow
| the health guidelines and do not spread disinformation.
| ceejayoz wrote:
| That advice is based on "we don't _know_ if you can
| spread it ". Evidence is starting to show it may indeed
| reduce/stop transmission.
|
| https://www.nbcchicago.com/news/local/dr-fauci-explains-
| why-...
|
| > "It may be that we will show that if the level of virus
| in your nasopharynx because you're vaccinated is so low
| that you don't have to worry about transmitting, that's
| going to be a game changer for what a vaccinated person
| can or cannot do," Fauci said.
|
| > The doctor explained that if the findings are
| corroborated, Americans will likely see a pulling back on
| some restrictions, but emphasized "we're not there yet."
| temp667 wrote:
| That's not been the messaging.
|
| Note that other vaccine's that prevent infection also
| reduce your risk of spreading the disease (measles etc).
|
| So the fact that COVID spreads (not just in rare cases,
| but enough we all have to remain masked AND socially
| distant even if vaccinated) is a CRAZY big difference
| here.
|
| The messaging has been clear - even if vaccinated you
| MUST wear masks and socially distance - which shows how
| different this is then other viruses. Given that, it's
| understandable that people are a bit more meh on the
| vaccines - because you can still spread it to others
| either way.
|
| I do wonder about the experts messaging at times.
| Initially I thought airbone virus, began wearing my
| leftover N95's from wildfire season. Then they said those
| don't stop this airborne virus and to take them off. Then
| they said put them back on. and on it goes.
| ceejayoz wrote:
| > The messaging has been clear - even if vaccinated you
| MUST wear masks and socially distance
|
| That's been the media summary of it, but Fauci and others
| have been pretty clear in their actual statements on this
| to say "for now", not "forever".
| spazrunaway wrote:
| Put your life on the line for the community, comrade! And
| sign away your right to legal recourse should you die as
| a result. You're on your own! You owe the community your
| life, and the community owes you nothing!
| justapassenger wrote:
| Feel free to move to deserted island and have 0 contact
| with rest of human race if concept of community is so
| offensive to you.
| spazrunaway wrote:
| I'd rather all the people gaslighting the public by
| saying the vaccines are completely safe, totally worth
| any risk, "trust the experts", etc - when in reality
| young people seem to have a better chance of dying from
| CVT than COVID - move to a deserted island.
|
| If the real argument is "the cure has a better chance of
| killing you than the disease, but please risk your life
| for the community", I'd rather people be honest and say
| that in the first place.
| justapassenger wrote:
| Please link results of the study that supports your
| statements of mortality among young people. In USA alone
| more than 10k young people died from COVID so far. JJ
| vaccine has one potentially linked death after 6 million
| doses.
| weakfish wrote:
| A 1 in a million chance is not nearly worth the FUD
| you're spreading, "comrade"
| strictnein wrote:
| In your weird argument you are somehow not part of the
| community.
|
| Everyone else is doing the same thing you are, thus the
| community is giving you the same thing you're giving to
| the community.
| jschwartzi wrote:
| I think there's a really big difference between being
| FORCED to get the vaccine, and being reminded that your
| actions have consequences on other people and not just on
| yourself. Nobody is saying that you should be required to
| get vaccinated. So really this is just a straw man that
| you're burning down.
| yread wrote:
| I would still take the vaccine but the point I'm making
| is that it's serious enough to offer younger people some
| other vaccine, investigate why is it happening, how to
| fix it (use a different vector, adjuvant or dosage?) and
| roll it out safely. Call it version 1.1
| rgbrenner wrote:
| 1 in a million chance of vaccine death for AZ. Maybe 1 in
| 10m for JJ. 0 in 10 for the mrna vaccines.
|
| 10 in a million chance of death from covid in the 5-9 age
| group (the lowest risk group)
|
| This is the perfect example of anti-vacc logic. They pick
| the latter because they heighten the risk of the former
| in their mind, while ignoring or downplaying the risk of
| the latter. Looking at the actual numbers, it makes no
| sense for anyone at any age to take their chances with
| covid over the vaccine.
| mikem170 wrote:
| This article [0] mentions 50% more blood clots observed during
| vaccine trials, which at the time was characterized as a slight
| numerical imbalance (15 blood clots versus 10 in the placebo
| group, in a trial of 20k people)
|
| [0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-
| blood-...
| DennisP wrote:
| People keep saying this will add to vaccine hesitancy but I'm
| not convinced. The vaccine-hesitant are already skeptical of
| authorities and aren't going to be especially reassured just
| because US agencies say it's fine, when it's already hit the
| news that European agencies have halted J&J.
|
| Seeing US agencies halting J&J while continuing the other
| vaccines could even be reassuring. It shows that US agencies
| really are pretty cautious, and are willing to halt vaccines
| that show signs of problems.
| jghn wrote:
| What we've seen in the US is that the J&J was the choice of
| people who legitimately wanted a vaccine but were leery of
| the novelty of the mRNA vaccines. This is going to crush that
| group of candidates and some non-zero number of them will
| wind up in the camp of people who don't get vaccinated at
| all.
| jellicle wrote:
| What you will find is that the vaccine-hesitant are perfectly
| happy to take the word of authorities who say "this vaccine
| is unsafe" and only have trouble accepting the word of
| authorities who say "this vaccine is safe".
| vageli wrote:
| I think that is likely because the two states have
| different levels of confidence, similar to how "not guilty"
| is not the same state as "innocent". It is relatively easy
| to identify unsafe, especially when negative effects arise
| quickly. It is harder to reliably determine safe as it may
| just be a matter of time before negative effects arise.
| DennisP wrote:
| For people who won't accept the vaccine regardless, it
| doesn't matter either way. For people who can be convinced,
| I think that obvious evidence of caution may be helpful in
| convincing them.
| huffmsa wrote:
| Being obese also causes deep vein thrombosis at a rate of
| 1/1000, but we're perfectly okay with people eating their way
| to blood clots.
| pbak wrote:
| The difference being that you can't "catch" being obese with
| a viral infection.
| throwawayboise wrote:
| The plot twist being that the virus we're discussing is by
| far more dangerous to the obese than to the healthy.
| jonplackett wrote:
| There's lots of other things to compare it to as well. It's a
| roughly 1 in a million chance of dying - which is called a
| Micromort https://en.wikipedia.org/wiki/Micromort
|
| We 'spend' about one micromort of risk per day of being alive.
| Or you can spend one walking for 6 hours, or driving 250 miles
| (or 6 miles on a motorbike)
|
| I just made a website to show all the other stuff we do all the
| time without worrying with the same (extremely low) level of
| risk
|
| https://whatoneinamillionmeans.com
| hellohiyesokay wrote:
| Your link only has IPv6 records but the www. subdomain has
| IPv4.
| jonplackett wrote:
| Hey. What will that mean exactly? DNS is through Cloudflare
| using their magical CNAME pointer. Can you access OK?
| jrockway wrote:
| I see IPv4 A records. I am guessing what's happening is
| that when you look up the DNS over IPv6, it gives you
| AAAA records instead of A records. Or, it can depend on
| locality. Cloudflare is not a DNS provider that gives the
| same answer to everyone -- its goal is to direct traffic
| to the cache that's closest to the end user.
|
| Edit: I looked into it more and I can get IPv6 and IPv4
| DNS servers to serve me both A and AAAA records. The site
| is now down, however :)
| jonplackett wrote:
| Thanks for checking. Much appreciated.
|
| Yeah I banked too much on Cloudflare... I've ramped up
| its dyno a bit now too. Hopefully that'll keep it up!
| ravedave5 wrote:
| Ok I really need your stat on canoeing. "That's much less
| risky than going canoeing "
| graeme wrote:
| Less, no? 1/million is the risk so far of clots, not of
| death.
| jonplackett wrote:
| There's about 1/250,000 risk of clots, but they are
| treatable.
|
| In the UK there's been 19 people die after ~20 million
| vaccinations.
| graeme wrote:
| That's assuming J and J has same incidence as AZ. J and J
| so far has had 6 clots for seven million doses.
|
| Of course some more may show up in coming days from prior
| vaccinations.
| mikem170 wrote:
| That's 6 unusual/dangerous cerebral clots per 7 million
| doses, not all blood clots. There were 50% more clots of
| any types in the vaccine trials of 20k people [0] (15
| blood clots in vaccinated group versus 10 in the placebo
| group).
|
| [0] https://www.cnn.com/2021/04/13/health/johnson-
| vaccine-blood-...
| jonplackett wrote:
| Ah yes, that is true! This site is based on AZ, but
| you're right it might be a different story with J+J. I
| wonder if as well, they'll get better at spotting the
| blood clots and treating which could also be happening -
| but that's just conjecture / hopeful thinking at this
| point.
| rsynnott wrote:
| One caution here; at least with AZ, apparent rate of
| clots varied dramatically by country, and rates generally
| went up once people knew what they were looking for. It's
| plausible that a lot of early ones were missed entirely
| or misattributed.
| [deleted]
| jaegerpicker wrote:
| 7 people out of 7 million dose's. That's why they stopped. My
| wife and I got the J&J shot on Saturday so I'm directly at risk
| and I'd take it everytime even if the risk was 10 times what it
| currently is. I've already seen a bunch of anit-vaxers referring
| to this in new articles this morning. So let's see, 1 in a
| million chance that the vaccine will make you sick (only 1 person
| has died so far, which is terrible but it's 1 out of 7 million)
| vs a worldwide pandemic that has killed millions. All these anti-
| vaxers talking about living in fear of a virus that has 98%
| survival rate are AFRAID of a vaccine that has a 99.999998% (
| 7/7,000,000 == 0.000001) survival rate, oh and is 100% effective
| at stopping you from dying. Literally no one that has received
| the vaccine has died from COVID19. The fact that modern society
| can be SO smart some times and yet so incredibly idiotic is so
| frustrating to me.
| williesleg wrote:
| You've got those numbers wrong.
| kodah wrote:
| > a virus that has 98% survival rate
|
| You know, for all the continual fear mongering about
| coronavirus last year, the constant reminders of who was most
| at risk, the hyper importance put on masks and cleanliness, etc
| it is shocking to see things put this way now.
| HWR_14 wrote:
| That's because long term consequences of COVID are real, and
| worrying just about the worst case (the death rate) is like
| saying that data leaks are no big deal because only 2% of
| them lead to the loss of their customer's life savings.
| tomjen3 wrote:
| I am not so sure those long term effects (except those that
| lead to blood cloths) are real.
|
| A quick duck duck go shows that these are the symptoms:
| Tiredness or fatigue Difficulty thinking or
| concentrating (sometimes referred to as "brain fog")
| Headache Loss of smell or taste Dizziness
| on standing Fast-beating or pounding heart (also
| known as heart palpitations) Chest pain
| Difficulty breathing or shortness of breath Cough
| Joint or muscle pain Depression or anxiety
| Fever Symptoms that get worse after physical or
| mental activities
|
| Apart from the loss of smell, those are all things that are
| hard to quantify and could be something you are not aware
| of until you start looking for them. At which point you
| might become anexious and really start to notice them.
| kodah wrote:
| Sure, but this is the downside of technocracy. The
| messaging and subsequent whiplash are entirely kafka-esque
| to normal people.
| lukifer wrote:
| WWII killed roughly 75 million people, "only" 3% of the
| world's population at the time. Scale matters.
| AndrewBissell wrote:
| The actual survival rate is far higher than 98%, that's just
| the number you get if you use _confirmed_ cases as the
| denominator.
| Pyramus wrote:
| Not far higher, the population-based average is roughly
| 99.0%, but varies depending on gender and age [1].
|
| [1]
| https://www.nature.com/articles/s41586-020-2918-0/figures/2
| sp332 wrote:
| They didn't pause it because they're considering cancelling it.
| They're pausing it so they can communicate to patients and
| providers what to look out for after they take it. Once
| processes are in place to handle future blood clot events, they
| will resume vaccinations.
| caddemon wrote:
| They might also add additional guidelines for who is eligible
| for J&J. A bunch of countries have set a minimum age for AZ
| vaccine, I could see something similar happening here with
| J&J. Perhaps excluding women under 50 for example.
|
| But I agree J&J will definitely resume in some capacity in
| the near-ish future.
| modularform123 wrote:
| The fatality rate for this adverse event was almost 30% with
| the similar Astra Zeneca vaccine. Fuck your vaccine
| propaganda. Nobody in my family will be getting this vaccine.
| vmception wrote:
| I've been thinking about this, the communication has been so
| bad from public and private health officials for 15 months
| straight.
|
| When not considering any externalities, anti-vaxxers and
| everyone that comes up with anti-industry and anti-
| establishment conclusions is rational, but inaccurate only
| because they dont consider what was not said.
|
| Even with regard to COVID itself, most of the official
| communication is about avoiding death when the reality is
| that its not about only avoiding death its about all the
| additional debilitating effects in the vast "recovered"
| statistic, so it is rational to decide to ignore that once
| you do your own math and noticing who is actually dying. But
| it is not accurate because it doesn't factor in the unsaid
| aspect.
| sp332 wrote:
| The reason for the pause was explicitly stated by the
| health officials as quoted in the article, so I don't know
| why you'd say this was unclear let alone unsaid.
| vmception wrote:
| Because the headline drives sentiment
|
| Its not just the internet, TV and radio also jump on the
| headline
|
| The entirety of my comment is a cohesive statement and
| not just about this headline
| ridethebike wrote:
| I wonder if we randomly select 7 million people (without
| vaccine) and observe them for couple of months - how many of
| them will get the blood cloths
| lsllc wrote:
| According to this BBC News article, it's 4 per 1M:
|
| https://www.bbc.com/news/health-55302595
|
| Quote:
|
| _" The MHRA said about four people in a million would
| normally be expected to develop this particular kind of blood
| clot - though the fact they are so rare makes the usual rate
| hard to estimate."_
| atq2119 wrote:
| That was my first thought as well. However, both vaccines
| with this issue are viral vector vaccines. Might be
| coincidence of course, but it gives me pause.
| cowmoo728 wrote:
| On the medical benefits alone it seems obvious to continue
| giving J&J. The counter-argument I understand is that J&J's
| supply is severely limited due to manufacturing problems right
| now, so pausing it doesn't significantly slow down the vaccine
| rollout. There are a lot of people right now that saw headlines
| about J&J's manufacturing defects, and now this one death, and
| are convinced those are related. Visibly pausing something that
| is such a small percentage of the vaccine rollout might be a
| good political move.
|
| Full disclosure: I took the J&J vaccine last Thursday, and
| would do so again right now.
| weeblewobble wrote:
| It could be that the side effect has delayed onset, so there
| could be many people out there who are about to have the side
| effect but haven't showed up in stats yet. In that case I think
| it makes sense to pause for a while and wait for updated
| numbers
| rhino369 wrote:
| Nobody has investigated 7 million doses, so its at least 7, but
| probably more. The UK incidence rate (for the same issue in the
| AZ vax) was like 10X what was initially reported.
|
| And its probable that these incidents are concentrated in a
| small segment of the population (young & health maybe women).
| So your denominator is very inflated.
|
| If you can save 20-40 lives by just giving young women Pfizer
| and using J&J on 50+ year olds (for whom the risk might be
| literally nothing) then its a no brainer.
|
| Not doing so is killing 20-40 people for no reason.
| cmrdporcupine wrote:
| Yes this is the rationale Canadian authorities have used in
| making AZ 55+ only here. Some calculation based on risk of
| COVID mortality in that population vs the hypothetical AZ
| risk. At first I was skeptical of this but the more I read
| about it the more it seems like a reasonable approach.
|
| Even more so because here in Canada we do not have much AZ
| yet anyways (and no J&J yet), mostly Pfizer and Moderna.
| sharken wrote:
| It's all pretty speculative at this point, but it seems very
| reasonable to investigate the J&J vaccine as it causes the
| same problems as AZ.
|
| When that investigation ends, then the J&J vaccine can be
| opened up for those willing to take the risk, which by that
| time is better known.
|
| I think we still have to remember that vaccinating everybody
| is not needed to resume a normal life.
|
| Personally I wouldn't want a vaccine with the problems that
| AZ and J&J have, but if others are willing then they should
| have the opportunity.
| outworlder wrote:
| > That's why they stopped.
|
| More to the point, they have temporarily paused because the
| usual treatment for blood clots can make this particular type
| of blood clot worse. So they are pausing to give the medical
| community enough lead time to get up to date on treatment
| protocols.
|
| Vaccines are held to such a high standard. We wouldn't have
| approved even Aspirin if we applied the same standards.
| throwaway8581 wrote:
| We usually test vaccines for a decade because of the risk of
| unknown short term and long term side effects. If we don't know
| why people are getting blood clots from the vaccine, then we
| don't understand the vaccine and could be creating long term
| issues for many people.
| hef19898 wrote:
| We don't. Vaccines are monitored, called phase 4 trials.
| Taking place _after_ approval. No vaccine was tested for
| decades before approval. It is only that development and
| approval takes longer, in case of the Covid vaccines approval
| red tape was cut. And not trials.
| baggy_trough wrote:
| An utterly appalling decision by CYA bureaucrats or innumerate
| idiots. The leadership of the CDC and FDA must be replaced.
| whatshisface wrote:
| Rare big problems may be indicative of common small problems.
| miketery wrote:
| Good point, I hadn't considered this. Also there was the
| factory QA issue. Possibly much like in aviation , multiple
| small factors here that need to be addressed and they're
| using this as easy excuse to put pause.
| joshgel wrote:
| This is possible, but I work in medical research, and
| this pause is pretty standard practice. When there is a
| potential problem, you pause, gather more data, come up
| with a mitigation plan (if needed) and submit all this to
| the ethics authority (usually IRB). Its rote standard
| practice. And i think much more likely that they are
| following standard practice than there are hidden issues
| that haven't otherwise been revealed publicly yet.
|
| That said, this is not a usual situation at all, and I
| think it's absurd, not least because of lives potentially
| saved during this pause, but because of the carry on
| effects with vaccine hesitancy, etc.
| whatshisface wrote:
| We can only guess, but I would imagine that pausing would
| show that issues were being taken seriously and reduce
| hesitancy. Compare:
|
| - Government breaks standard practice in favor of J&J
| corporation, allowing sales to continue After These
| People Died!!1!
|
| - Government pauses J&J vaccine, experts condemn them for
| extreme caution.
| oneepic wrote:
| You'd replace an entire team due to one decision you didn't
| like?
| baggy_trough wrote:
| Half a million Americans are dead. This is wartime. We
| don't have time to coddle bureaucrats who make awful
| decisions.
| Verdex wrote:
| > This is wartime.
|
| Wrong. In a war you win by outsmarting other people.
| Maybe that's through democracy, maybe it's by moving
| faster, maybe it's by having better technology, maybe
| it's by having more technology.
|
| This is a pandemic. A health crisis caused by a virus. In
| this situation you win by carefully understanding the
| nature of the virus and then determining what needs to
| happen in order to shut it down. Making rash decisions
| because it's "wartime" doesn't actually stop the virus.
| We can't blitz a virus. We have to take time to
| understand the consequences of our actions.
|
| > coddle
|
| Actually, we do have to coddle. If we squash people's
| concerns about the vaccine, then they just won't get it
| because they don't feel listened to. On the other hand,
| if we show people that we're taking their concerns
| seriously, they're more likely to go and take one of the
| other vaccines. Because the "unsafe" ones were pulled
| after all, so the ones left over have to be safe (not
| true, but it's going to work for a non-trivial number of
| people).
| baggy_trough wrote:
| I don't think you're appreciating the magnitude of the
| error here. This kind of complacency, typical of the
| public health bureaucracy, has led to a large net
| increase in death.
| 34679 wrote:
| Or maybe someone in a position to influence this decision was
| heavily invested in a different vaccine. It's perfectly
| reasonable to assume they're not idiots at all.
| jonplackett wrote:
| Perhaps one that costs half as much and only needs one
| dose...
| tomjen3 wrote:
| You are mixing certain numbers. It absolutely makes sense for
| my grandfather to get any vaccine, because of his risk, but the
| age braket for me means that I am more at risk of dying from
| Astra-Zeneca than Covid, but I am also a man and those who have
| died so far have been women.
|
| I haven't seen enough numbers for J and J, but you have to
| untangle the various risk factors before you can say anything
| about what you should do as an individual.
|
| I know this pandemic is fustrating as hell, but if you call
| people who use science and numbers to see problems with the
| current vaccines anti-vaxers then you will be taken as
| seriously as you deserve.
| duckfang wrote:
| Birth control is already severe blood clots at 1:1000 . Only
| affects people with uteruses. That's cool.
|
| This is 1:1000000 of a severe event, but affects men as well.
| HOLD THE LINE - It affects a.... Man!
| covid_throwaway wrote:
| According to the article, all 6 cases were in women
| AndrewBissell wrote:
| > _oh and is 100% effective at stopping you from dying.
| Literally no one that has received the vaccine has died from
| COVID19._
|
| This is misinformation (and I call it that because it is being
| widely repeated in major new sources). It's an improper
| generalization from what was observed in a very small sample of
| confirmed Covid cases in the vaccine trials.
|
| https://www.forbes.com/sites/brucelee/2021/04/11/3-breakthro...
| lefrancaiz wrote:
| You're correct. NPR has reported some deaths in vaccinated
| people in this article. https://www.npr.org/sections/health-
| shots/2021/04/13/9864114...
|
| >So far, more than 74 million people have gotten fully
| vaccinated in the United States. It's unclear how many have
| later gotten infected with the coronavirus anyway. But
| Michigan, Washington and other states have reported hundreds
| of cases. Most people have gotten only mildly ill, but some
| have gotten very sick. Some have even died.
| coding123 wrote:
| By not stopping it will forever by 7 out of 7 million.
|
| By stopping they can at least find out if it's 5000 out of 7
| million (and more deaths).
| [deleted]
| FabHK wrote:
| If I have my numbers approximately right, getting the J&J
| vaccine is a bit safer than taking a plane trip, while getting
| COVID is about as safe as taking a trip in the space shuttle.
| josephcsible wrote:
| Your chance of dying from COVID is heavily dependent on your
| age and any preexisting conditions, so any comparison that
| uses a single probability for everyone is totally wrong for a
| very large number of people.
| CyberRabbi wrote:
| The exact same caveat can be made for people who are
| vulnerable to the extreme side effects of the J&J vaccine.
| It depends on specific characteristics of the person taking
| the vaccine. "any comparison that uses a single probability
| for everyone is totally wrong for a very large number of
| people."
| josephcsible wrote:
| Yes, with the key point that the people who are most at
| risk of dying from the vaccine are a different set of
| people than those most at risk of dying from COVID.
| JoshuaDavid wrote:
| One person, out of the 6.8 million who have gotten the J&J
| vaccine, died from blood clots. A second is in critical
| condition.
|
| Yes, your risk of dying from COVID varies with age, but not
| to _that_ extent. Even among children, the death rate for
| COVID is an order of magnitude over the 0.000015% to
| 0.000030% chance of death it would have to be for the
| decision to stop using the J &J vaccine to make sense,
| based on the numbers we're making that decision based off
| of. Among the people who are actually being blocked from
| getting the J&J vaccine (e.g. mostly 20s/30s/40s adults),
| the decision looks much worse.
| rightbyte wrote:
| To be fair space launches are probably quite lethal for the
| many in the general population.
| sergiotapia wrote:
| The #1 indicator is obesity. Unless you're fat, you'll be
| fine.
| toast0 wrote:
| > Your chance of dying from COVID is heavily dependent on
| your age and any preexisting conditions, so any comparison
| that uses a single probability for everyone is totally
| wrong for a very large number of people.
|
| It also depends on the rate of community spread (and what's
| spreading) in the communities you're in.
| Nacdor wrote:
| > The fact that modern society can be SO smart some times and
| yet so incredibly idiotic is so frustrating to me.
|
| The CDC and FDA both agree that use of the J&J vaccine should
| be paused so they can further study this previously unknown
| side effect.
|
| Maybe someone here could help you get in touch with them since
| you clearly know something they don't?
| devwastaken wrote:
| I believe their concern is more of long term effects and not
| short term. A vaccine isn't meant to cause blood clotting,
| unless we know the specific mechanism of how that's happening
| it could be much more dangerous.
| hef19898 wrote:
| No doctor or expert. But I did follow the AZ story. I
| understood, that Covid can cause blood cloths. A vaccine
| triggers an immune reaction, in that case Covid, so a
| particularly strong immune reaction, maybe together with a
| preposition of developing blood clots, can be a reason. Not
| sure if we know already what causes these side effects with
| AZ an JJ.
|
| From a risk perspective, I wouldn't restrict either vaccine.
| But since we can easily use Moderna and BiontechPfizer
| instead for the most at risk groups it doesn't really change
| things, does it?
| pvarangot wrote:
| Most immune reactions will cause blood thickening. If your
| arteries are already full of crap they will clot, this is why
| if you are at risk of blood clots you need to be careful even
| when you get the common cold.
| throwawaysea wrote:
| I think that's not a very charitable take on "anti-vaxers".
| People are against injecting something new that has not stood
| the test of time. We have no idea what the actual frequency of
| this issue is (maybe more reports will come in), or if there
| are other lurking side effects waiting to be observed as a
| pattern, or if there are long-term effects. What if news of
| this spurs others to make the connection with the J&J vaccine
| and more such cases are reported to the CDC? Or looking at the
| other vaccines, what if in 30 years we somehow establish a link
| between mRNA vaccines and cancer?
|
| I'm sure people will be tempted to jump in here and state their
| case as to why certain long term effects are not possible, and
| why this is conspiracy theory misinformation. But that's not
| the point. The reality is that humans regularly fail to
| understand infrequent or long-term consequences of new
| innovations, despite the best of intentions and despite the use
| of the best science available at the time. This has happened
| repeatedly in the past - see numerous prescription drugs that
| were recalled, or the use of phthalates in shampoos, or
| asbestos, or whatever else.
|
| In the case of J&J, consider that this is happening against a
| backdrop of a continuously changing story about the AstraZeneca
| vaccine, increasing reports of COVID vaccines affecting
| menstruation (https://vajenda.substack.com/p/the-
| covid-19-vaccine-and-mens...), and a rushed emergency use
| authorization process that bypasses typical methodology for
| approvals of vaccines. The comparison isn't between the IFR of
| COVID-19 and the fatality rate associated with this vaccine.
| It's between the IFR of COVID-19, which is known to be very
| low, and the unbounded potential of near-term or long-term
| fatality or other side effects from the vaccine.
| tomjen3 wrote:
| I am not concerned with impossible to predict future events,
| but all effective vacines[0] will cause cancer in that they
| prevent people from dying early and so make it more likely
| they get cancer.
|
| [0] that don't target cancer
| Verdex wrote:
| In addition, I'm very concerned that if we call people afraid
| of the covid vaccines anti-vaxxers that they will decide to
| join forces with real anti-vaxxers.
|
| I know several people who are not interested in covid
| vaccines for what as far as I can tell are political reasons
| (although there are a few concerns about using a new
| technology before long term studies are performed). Right now
| they aren't anti-vaxxers. They get vaccines and they get
| their children vaccinated. It's just the new covid ones that
| they're hesitant about.
|
| If we just lump them in with anti-vaxxers then they might
| decide to go make friends with the real anti-vaxxers. And as
| a big of a problem as covid has been, I'm more concerned
| about polio making a comeback tour.
| Dumblydorr wrote:
| Modern society is not monolithic. It is a vast chaotic network,
| many nodes of which are surrounded by other nodes, all of which
| are misinformed.
| jonplackett wrote:
| I just made this website to show you how really, _really_ small
| the risks are for the AstraZeneca vaccine which also has this
| 'issue'.
|
| It compares the risks of dying from a blood clot after the AZ
| vaccine (about 1 in a million) to the risks we happily take
| every single day.
|
| http://whatoneinamillionmeans.com
|
| If you're not willing to take 1 in a million chances, it's
| gonna be pretty hard for you to get out of bed today
| throwawayboise wrote:
| > If you're not willing to take 1 in a million chances, it's
| gonna be pretty hard for you to get out of bed today
|
| People's brains don't work that way. It requires a lot of
| education on probability, and even then the math often
| conflicts with our instincts.
| CJefferson wrote:
| The one thing you miss, what is the risk of dying of COVID,
| as a healthy person under 30?
| jonplackett wrote:
| I'm not sure about under 30, but if you take natural causes
| out of it, you have around about the same chance of dying
| today - check out 'the micromort' for more details!
|
| https://en.wikipedia.org/wiki/Micromort#Baseline
| andy_ppp wrote:
| Yes, and probably staying in bed will have its own risk of
| blood clots and depression leading to suicide.
| JoshuaDavid wrote:
| I'm not sure where you're getting your stats, but so far I've
| gotten
|
| > That's about 10 times less risky than walking down the
| stairs
|
| and
|
| > That's the same risk as driving for 5 hours
|
| Which implies that walking down some stairs is equivalently
| risky to driving for 50 hours. That seems... unlikely.
|
| There are about 150 deaths per 10 billion passenger-miles in
| the US [1]. That means that a micromort (a 1 in a million
| chance of death) corresponds to about 66 miles driven, which
| would probably be about 2 hours of driving.
|
| In 2000, 1,307 people died from falling down stairs[2]. The
| US population in 2000 was about 280 million, so 1307 / 280e6
| / 365 = 1.27e-8, so the average person had about a 12.7 in 1
| billion chance of dying by falling down stairs on a given
| day. It seems reasonable to estimate that on average, each
| American goes down stairs about once per day (some people
| never go down stairs, others go down them multiple times per
| day). As such, I think the estimate for "risk of going down
| the stairs" should be more like 10 in a billion and less like
| 10 in a million.
|
| [1] https://en.wikipedia.org/wiki/Transportation_safety_in_th
| e_U...
|
| [2] https://danger.mongabay.com/injury_death.htm -- "Fall on
| and from stairs and steps"
| jonplackett wrote:
| Hey thanks for this. I have the sources next to each. Just
| click the link in the bottom left corner. Let me know if
| you don't think they're accurate after having a look.
|
| I took the driving risk as being 250 miles of driving with
| an average 50mph speed (The risk of dying must be higher at
| high speed so wanted to take a high average to be fair).
| JoshuaDavid wrote:
| The source on the "10x less risky than going down a
| flight of stairs" is https://static.guim.co.uk/sys-
| images/Guardian/Pix/pictures/2.... That shows that in the
| UK in 2010, 655 people died from falling down stairs.
| That translates to a 1 in 100,000 _annualized_ risk from
| falling down stairs -- the relevant comparison is "10x
| less risky than using stairs a typical amount for an
| entire year".
|
| Interestingly, running the numbers for the UK shows that
| the annualized per-capita risk of dying on stairs in the
| UK is more than twice as high as it is in the US.
| vibesngrooves wrote:
| Love this work!
| hyko wrote:
| I'd probably be careful using this as a public health
| communication tool; you're comparing these risks to things
| like flying, which people are viscerally afraid of. Not to
| mention that the CVST issue is a poorly understood and
| evolving picture, so it's hard to confidently assert that the
| risk is actually a micromort.
|
| The perceptive gap between zero risk and extremely small risk
| is enormous. If I'm young and healthy, I can easily avoid the
| _additional_ 1 micromort risk of taking the vaccine by simply
| not taking it. Now what?
| jonplackett wrote:
| That is of course true, and you're free to weigh up the
| risks however you like. Also true that there are unknowns.
| But the benefits of the vaccine are known too, and the
| risks of COVID include death and long covid, which also has
| unknowns and does not look nice.
|
| Let me try one more way I have been thinking about it. I'm
| also weighing up whether I should get the vaccine and TBH
| made this site as much for myself as anyone else.
|
| The point of the site is really to show the fallacy of
| there currently being zero risk in your life. Comparing
| 'none' to 'additional' isn't really what is happening. You
| have risks in your life every day, every time you do
| anything.
|
| On any given day you already have about 1 Micromort's
| chance of dying from any unnatural causes. So that's 365 a
| year. So getting that vaccine puts it up to 366.
|
| That's an increase in risk of just under 0.3% for the year,
| from an already pretty low baseline of likelihood of dying
| that we enjoy these days.
|
| This way of thinking helps me. I'm hoping it might help
| some others too.
| primitivesuave wrote:
| This is brilliant, I manage IT systems for hospitals and
| clinics and hear the front desk staff using analogies like
| this to put the risk into perspective. For something like
| this it shouldn't matter if you're even an order of magnitude
| off, the point is to help the non-mathematically-inclined
| general population understand how low the risks are in a
| context they understand (and anecdotally I'd say this
| strategy works well).
| jonplackett wrote:
| That's really great to hear. Someone I know who works in as
| a volunteer in the vaccination centre said the same kind of
| thing as that too.
| CamelCaseName wrote:
| Application Error
| jonplackett wrote:
| HN classic. upgraded its dyno a bit. Thought cloudflare
| would save me...
| throwawaysea wrote:
| This is true, but I find it funny and frustrating that people
| are so ready to selectively treat rare odds as catastrophic
| in other circumstances that suit their worldview. For
| example, urbanists are ready to accept the premise of Vision
| Zero, which aims to push road fatalities down to zero. Today,
| there is approximately 1 traffic fatality per 100 million
| miles traveled in the US. It's so rare that it doesn't
| deserve attention, but here we are, with people looking to
| force cars to drive slowly (or ban them outright) to try and
| chase a world with perfect risk-free conditions. I am betting
| the same cohort that supports Vision Zero overlaps
| significantly with the group that thinks none of these
| vaccines should be paused. I'm sure there are similar
| examples of logical inconsistency that we can highlight for
| any political/social cohort as well - that's just one
| example. But my point is people tend to selectively make data
| driven arguments only when it suits them.
| tomjen3 wrote:
| The only relevant question is is my chances better with covid
| than with the vacine?
|
| Of course the real answer is to get more phizer and then stop
| using second rate shit.
| jonplackett wrote:
| I think there is another relevant part to it. I'm probably
| on the cusp of risk between Covid and vaccine at 39. But
| getting the vaccine stops it spreading and protects other
| people and will generally help the would and country get
| back to normal. So I'll get the vaccine as soon as it's
| offered to me.
| ryankemper wrote:
| > All these anti-vaxers talking about living in fear of a virus
| that has 98% survival rate
|
| Please cite a source here. Survival rate usually means IFR not
| CFR, and even the CDC's own number (the CDC is going to be
| incentivized to overstate risk) puts it at around a 99.4%
| general survival rate. Other estimates put it closer to 99.7%
| or even higher.
| sergiotapia wrote:
| Question for you, if you like those odds, why get the vaccine
| at all? If you're not obese covid won't do anything to you
| except give you a lil flu.
|
| Curious about your answer.
| sdenton4 wrote:
| 1) Vaccination is also about stopping the overall spread of
| infections. Vaccination is for the greater good, not just
| your own good.
|
| 2) It's still very possible to have a Very Bad Time with
| covid if you're not obese.
| sergiotapia wrote:
| >Vaccination is also about stopping the overall spread of
| infections.
|
| Then why are people still asked to wear masks in stores
| even if they are vaccinated? I've heard from the media non-
| stop that even if you have the vaccination you need to wear
| a mask - it doesn't make sense.
| sdenton4 wrote:
| Because:
|
| a) it's not entirely whether vaccinated people can still
| be carriers. I think it's now /mostly/ clear that they
| don't.
|
| b) people are fscking awful. If you let vaccinated people
| not wear masks, you're going to have a bunch of
| philosophical zombies lying about their vaccination
| status to avoid wearing masks in public spaces. So,
| everybody wears masks until this thing is over and then
| some.
| JediWing wrote:
| 7 people in a fairly specific demographic (women 18-38, I
| believe), when there are 2 other alternative vaccinations
| available.
|
| Do we have any data on the total number of women 18-38 who
| received this vaccine? It may actually be fairly low given we
| may have selection bias to give these vaccines to an older
| population.
|
| The outcome may simply be to recommend that members in this
| demographic avoid this particular vaccine until further
| analysis is done.
| mzs wrote:
| six women 18-48y
|
| Though rates of increasing the risk of blood clots for
| different birth controls vary, the ones that do range from
| 2-6x. The FDA estimates that in US out of every 10 thousand
| women using combination oral contraceptives or birth control
| pills 3 to 9 will develop blood clots each year while for
| comparison the same rate for women who are not pregnant and
| do not take COCs is 1 to 5 which is interesting considering
| the age range of the six cases.
|
| https://www.fda.gov/drugs/drug-safety-and-
| availability/fda-d...
|
| That said research is beginning to understand the mechanism
| of these rare blood clots in connection to adenovirus vector
| meds and since it is so rare it's hard to get a precise
| number but other studies predict an excess increase of severe
| blood clots in the range of 1 in every 500 thousand to
| million patients.
|
| https://www.sciencedirect.com/science/article/pii/S000649712.
| ..
| moate wrote:
| 6 Women aged 18-48.
| nickthemagicman wrote:
| Whether it's .0000000001 or .001 chance of dying it's a non-
| zero chance of dying.
|
| So where does one draw the line?
|
| What level of shutting something down is justifiable in the
| name of safety?
|
| Who is allowed to make that subjective decision?
|
| It's a slippery slope.
|
| It's arguable that we should wear masks FOREVER because they
| reduce death rates for every respiratory disease.
|
| This feeling. Of why are shutting down because of these few
| lives.
|
| Is exactly how people have felt about shutting down the whole
| economy over the small-ish fatality rate of Coronvirus.
|
| There's just different levels of risk tolerance.
|
| Who is the more moral person?
| HWR_14 wrote:
| It's not the risk of clots. It's the risk of vaccine hesitancy
| because people fear a cover up. I think that's outweighed by
| the increased vaccine hesitancy because people only hear this
| scary story and not the low numbers (see also AstroZeneca).
| spikels wrote:
| Unfortunately this "pause" will also result in vaccine
| hesitancy (on top of vaccination delays). We know this from
| the EU experience with the AstraZeneca vaccine which is now
| distrusted by many people.
|
| This will almost certainly now be a problem with the J&J
| vaccine in the US. More people will get sick and die because
| of this.
|
| https://www.politico.eu/article/trust-oxford-astrazeneca-
| cor...
| Verdex wrote:
| > I've already seen a bunch of anit-vaxers referring to this in
| new articles this morning.
|
| So, take pause and examine the situation. Are these people
| actually anti-vaxxers, ie they oppose all vaccination due to
| weird paranoia about autism due to a discredited "study". OR
| are they against this one vaccine because of political
| affiliation.
|
| I'm really concerned that if we call out the people who are
| afraid of this one vaccine as anti-vaxxers that we'll only
| succeed in introducing them to the wider world of being afraid
| of all vaccines.
|
| Find a different term so that we don't introduce these two
| groups of people to one another and give them a reason to join
| forces.
| caddemon wrote:
| It goes beyond "radicalizing" potential anti-vaxxers IMO,
| because at this point it's become like its own religion,
| where every vaccine must be equally good and questioning a
| vaccine is somehow outrageous.
|
| US agencies are the ones recommending a halt. US refused to
| approve AZ, and Europe halted it, in many countries imposing
| additional restrictions when resumed. Doctors specializing in
| the field agree these are legitimate concerns.
|
| If people want to argue cost/benefit tradeoffs, or speculate
| on things we aren't sure about yet that's totally cool, as
| long as they are upfront about it. And I understand if
| someone still wants to get J&J and is upset or just generally
| disagrees with the total/forceful pause.
|
| But I don't understand treating anyone that has a concern
| about J&J like a brainwashed neanderthal, when literally the
| actual medical community has reservations about this
| particular vaccine. As a young woman I would not get J&J
| right now. Luckily I was able to get Pfizer instead.
|
| Anyway, I agree there is a problem more generally with
| scientific education that can push "moderately misinformed"
| people into much deeper rabbit holes instead of working to
| educate them. I guess my point is just that I think this is a
| good example of how people have gotten so entrenched in the
| issue that it has reached a new level. There will be cases
| when the science is legitimately unclear, but the popular
| sentiment will all of a suddenly decide "science says X" and
| then the internet runs with it.
|
| Another example - there was an ~2 week period last March
| where I had multiple educated/"science supporting" friends
| talk down to anyone considering a mask. No it was not coming
| from a hoarding perspective and it had 0 sense of uncertainty
| about it. These were strongly worded statements about how
| "masks don't do anything for COVID, the science is pretty
| clear".
| AndrewBissell wrote:
| > _OR are they against this one vaccine because of political
| affiliation._
|
| It's not easily attributable to "political affiliation."
| Trump was touting the vaccines through his whole campaign and
| is still bragging and taking credit for them. MSNBC did one
| of those TV segments where they go and interview backwards
| people from America's hinterland who weren't planning to get
| vaccinated, and although most were Trump voters, not a single
| one said they would change their mind if he advocated taking
| it.
|
| The actual difference between these vaccines and others which
| is driving skepticism is that we have no observational data
| about their long-term effects.
| doikor wrote:
| The problem isn't 7 out of 7 million odds. It is that it is an
| unknown side effect that did not come up in the original
| studies.
|
| We have approved vaccines with worse side effects before. The
| difference is that we knew what those side effects were and
| weighed the risk vs reward and made the call to use it.
| [deleted]
| handmodel wrote:
| While I understand this to a degree - this still pretends the
| long-term risks of covid are zero or less than the Johnson &
| Johnson vaccine.
|
| It is a two sided equation.
| caddemon wrote:
| For young people (it seems especially young women) I think
| the answer could end up going in either direction honestly.
| I think it's completely reasonable to redirect them to mRNA
| vaccine until we know more.
|
| Not sure why the J&J vaccine had to pause for older
| population where clearly the vaccine has a much better
| benefit/risk profile though. But at least in my area of the
| US the vaccination rate for senior citizens is quite high
| already.
| FunnyLookinHat wrote:
| Yeah and we only just started to roll this vaccine out - so
| it's fair to say that the risk will likely grow beyond that.
|
| You're right that 7 / 7,000,000 are good odds, and most
| people would likely take them - but it would be unwise to not
| give people an educated choice between vaccines if there are
| known risks.
| dev_tty01 wrote:
| Agreed. Another unknown is how many people may have had
| some clotting issues that were mild and unreported. As you
| note, even though the 7/7M odds are compelling, the effect
| is still unexpected and there are two other vaccine
| alternatives. Taking a pause to consider the issues and
| perhaps make adjustments in suitable patient profiles
| and/or adjust follow up observation and early intervention
| treatment protocols for the issue makes sense.
|
| Don't know if it matters to anyone, but the "FDA has
| suggested that health care providers pause the use of the
| vaccine while the side effects are being studied. However,
| providers are not prohibited from using the vaccine if they
| feel the benefits to an individual patient outweigh the
| risks." [1]
|
| 1. https://www.npr.org/sections/health-
| shots/2021/04/13/9867670...
| lghh wrote:
| > but it would be unwise to not give people an educated
| choice between vaccines if there are known risks
|
| They are not giving people an educated choice, they are
| taking that choice away until they deem it okay to give it
| back. Education is knowing that 7/7,000,000 had a blood
| clot + the other tests that were done leading up to its
| release. We know that now. We're educated.
| FunnyLookinHat wrote:
| Sorry you are correct - I should have been more specific
| in my wording.
|
| We _should_ give people an educated choice. With unknown
| side effects we _are not_ doing that. Thank you for
| pointing that out.
| 8note wrote:
| We should be very specific though: If you take this
| vaccine, there's a 1 in 10 billion chance that a meteor
| strikes the pharmacy while you're in it.
|
| Make sure you cover every possible thing, no matter how
| unlikely.
| lghh wrote:
| It is impossible to rule out unknown side effects. The
| blood clots are now known. Any side effect that is
| unknown will always remain unknown. You could always be
| the first person to experience a symptom, whether it's
| Tylenol or this vaccine.
| josefx wrote:
| > They are not giving people an educated choice
|
| Hard to give people an educated choice without looking
| into the issue first. Once they know what is going on it
| will most likely be back to normal. There was a similar
| issue in Europe, but that neatly overlapped with a
| delivery shortage of the affected vaccine.
| fspeech wrote:
| It is CVST not just blood clots. There are a lot more
| blood clots with or without the vaccine. CVST is rare so
| is the proverbial canary in the coal mine here.
|
| The CVST incidents give a lower bound on risk. The trial
| data give a rough upper bound on risk (rough due to the
| small sample size). Knowledge is being refined here. We
| can't make educated choices without knowledge.
| lamontcg wrote:
| > so it's fair to say that the risk will likely grow beyond
| that.
|
| not really. that's not how statistics work. it could grow,
| it could shrink.
| kube-system wrote:
| In this case, the numerator lags the denominator.
|
| > All six cases were in women aged between 18 and 48,
| with symptoms appearing six to 13 days after vaccination.
|
| Presumably, some of the 7 million people who have gotten
| the vaccine did so in the prior 5-12 days. It is
| reasonable to expect to see more cases over the next 6-13
| days from the moment we pause J&J vaccination.
| caddemon wrote:
| Also, if the effected group is only young women, the
| denominator isn't really the same as the total number
| vaccinated. Not saying it isn't still very rare, but in
| young people COVID deaths are also very rare. We have
| alternative vaccines, it makes perfect sense to advise
| young women against J&J for the time being while this is
| sorted out.
|
| And for anyone that thinks this is just normal incidence
| of blood clots being blamed on the vaccine - that's what
| was said about AstraZeneca originally, and if these clots
| are anything like those it is absolutely not the case.
| Those are serious clots that are very rare to see period,
| let alone in young people, and require different
| treatment than normal clots (they have surprisingly low
| platelet count).
|
| I suspect US agencies had good reason to want to pause
| J&J given all of that - the AZ vaccine issues were also
| disproportionately affecting women interestingly.
| FunnyLookinHat wrote:
| I guess I wasn't being specific - good correction.
| Reporting medical side effects can easily lag with new
| treatments, especially when we're not sure what we're
| looking for.
|
| I suspect that, as soon as we start looking for blood
| clotting post-vaccine, then you'll find more cases that
| may have not been caught otherwise due to their not being
| severe enough to be noticed.
| AndrewBissell wrote:
| This exact thing happened with the AstraZeneca vaccine,
| which works very similarly to J&J. The EMA is now
| recognizing thrombocytopenia (not the same fatal issue
| but possibly related) as a "common" side effect, i.e.
| somewhere between 1 in 10 to 1 in 100.
|
| https://twitter.com/HamidMerchant/status/1381797044495466
| 504
| joshjdr wrote:
| Provided a larger sample size, doesn't an increasing rate
| of an outcome suggest existence a confounding variable
| that the smaller previously tested sample failed to
| identify, and (not absolutely- but more likely than not)
| would apply increasingly at the larger scale? Not a
| statistician here- and honestly asking.
| doikor wrote:
| Lets say these side effects only happen in certain
| populations.
|
| If that is the case we could then target this vaccine to
| the rest and have it be much safer while giving out the
| Pfizer-BioNTech or Moderna vaccines to this group.
|
| End result is everyone still getting their vaccine fast but
| less side effects (and possibly deaths due to worst case
| side effects). This is why we need more data or the time to
| study the data in this case most likely
| raverbashing wrote:
| > It is that it is an unknown side effect that did not come
| up in the original studies.
|
| Well, obviously it didn't. Exactly because _it is so rare_
|
| A clinical study with (I think) 30k people can't detect
| something that's 1 in a million case
| doikor wrote:
| Yes. And that is why when something like this pops up we
| stop giving out the treatment while we look at the new data
| and make the decision.
| njarboe wrote:
| So we stop giving out treatment and an extra
| 1000-10000(?) people die and we delay the economy getting
| back on track for a week or two with the delay. No skin
| off the FDA bureaucrats teeth, but they are hurting a lot
| of people with this decision.
| doikor wrote:
| We don't know any of that. What if it ends up killing
| more than that?
|
| > FDA bureaucrats
|
| You mean doctors. These decisions are done by doctors as
| they should be. The current (acting) head of FDA is a
| physician too.
| tharne wrote:
| > It is that it is an unknown side effect that did not come
| up in the original studies.
|
| It's not clear that this even has to do with the vaccine. If
| you gave 7 Million people a glass of water on the same day,
| I'm sure at least 7 of them would experience some sort of
| moderate to serious health outcome in the days that followed.
| argvargc wrote:
| "Doctors For COVID Ethics" a (non anti-vax) group of 150+
| medical professionals/university professors etc, warned in
| March about the likelihood of deaths resultant from exactly
| this issue. They went public with their previously private
| correspondence with the European Medicines Agency, as they
| were unsatisfied with EMA's responses. Who picked up their
| pleas? Conspiracy, fringe and some right-wing websites - that
| seems to be it.
| theptip wrote:
| > an unknown side effect that did not come up in the original
| studies.
|
| You shouldn't expect side-effects this rare to show up in the
| trials. The AZ trial was based on ~32k participants
| (https://www.astrazeneca.com/media-centre/press-
| releases/2021...). Your probability of observing a
| 1/1,000,000 occurrence in 32k observations is something like
| 3%.
|
| It's impossible to uncover (with statistical significance)
| 1/1,000,000 side effects without giving millions of doses.
|
| The fact that a rare side-effect has (maybe!) shown up should
| not negatively impact your priors for how safe the vaccine
| is. If anything, the fact that we're talking about 7 /
| 7,000,000 cases should reassure you that we're catching
| extremely rare stuff, which means we would have caught
| anything more serious too.
|
| A more general way of putting this is that, by doing a trial
| you don't prove there are _no_ side-effects, you just put an
| upper bound on how common they can be. This is the best that
| science can do! Epistemologically speaking, you can never
| prove the non-existence of something, you can just show that
| it doesn't occur in the places you've taken measurements, at
| a frequency that your experiments would detect. (This is the
| "black swan fallacy", as John Stuart Mill originally
| formulated it.)
| thelean12 wrote:
| > side effect
|
| To be clear, we haven't determined that it's actually a side
| effect. That's why they've stopped, to get a better handle on
| what actually happened, and what to do about it.
|
| It could be related to the vaccine, it could not be. It could
| be 1 in a million, it could be 1 in 100k.
| hamadj wrote:
| I think it is a disservice to outright label people as anti-
| vaxers simply for questioning the risk-calculus of vaccines.
| The (1/7 million) is the current, unconditional and empirically
| observed adverse effect of the vaccine - this is a somewhat
| noisy measure of the true prevalence of this issue. It is okay
| to be cautious and there are legitimate concerns, and quite
| frankly, I trust the FDA have good reason to pause this if
| Moderna/Pfizer are readily available anywy. In countries where
| there are not alternative vaccines available, the risk
| calculations change, and as such, you might be better off
| taking J&J or AZ. In any case, to your earlier point of why
| they stopped it: they didn't stop it because (7/7 million),
| they stopped it because it was not observed in the trials and
| now they have to recalculate the risks for various age-groups
| and inform people, accordingly. If these events were observed
| in the trials and the prevalence was the same (in trial, and
| out of trial) then it would not be a cause for concern.
|
| Edit: got the wrong agency, it was FDA, not CDC
| heywherelogingo wrote:
| Agreed, I've had all other vaccines, but this batch is
| rushed, experimental, and not necessary for me - labelling
| people such as myself "anti-vaxers" is just dishonest,
| bitter, childish, name calling. Very few people in my area of
| London have bothered with the so-called lockdown (too much
| was open to be called a lockdown), masks, etc - I expect I've
| had all variants, and apparently my immune system is on top
| of it, in which case there's nothing to pass on; and the
| people in my area clearly don't care if I did. I'm no more an
| "anti-vaxer" than I am an anti-martian.
| arcticbull wrote:
| > Agreed, I've had all other vaccines, but this batch is
| rushed, experimental, and not necessary for me - labelling
| people such as myself "anti-vaxers" is just dishonest,
| bitter, childish, name calling.
|
| No, it's not. That's a misunderstanding of how the vaccine
| development process works and what takes time.
|
| What takes time in the normal course of development is
| testing the vaccine, yes. Specifically, determining how
| effective it is. The reason that takes so long is that in
| general there are very, very few cases of most of the
| diseases vaccines are developed to prevent -- and you can't
| just go giving people Ebola to check how many of them catch
| it.
|
| It's fearmongering, plain and simple.
|
| There's mountains of data for your perusal online
| explaining how and why it got done fast -- here's one
| example. [1]
|
| [1] https://www.immunology.org/coronavirus/connect-
| coronavirus-p...
| koolba wrote:
| Nine women cannot work together to produce a baby in one
| month.
|
| Similarly, while wider population testing for safety and
| efficacy would likely correlate with long term safety,
| it's not a total substitute.
|
| I think it could be completely rational for young,
| healthy, low BMI people to delay vaccination till they're
| more comfortable with any potential long term issues.
| arcticbull wrote:
| Well I guess it's a good thing nobody's trying to produce
| a baby, but rather, a vaccine. Because they succeeded,
| and you hand-waved away my completely rational
| explanation with a nonsequitur about pregnancy.
|
| Those folks aren't being immunized to protect themselves
| but those around them. This is a team effort and
| everyone's gotta pitch in.
|
| I got my J&J a week ago. No side-effects here.
| atleta wrote:
| Well, you may not be (or see yourself) an anti-vaxxer, and
| your right that it's not necessarily wise to label everyone
| as such who have concerns with these vaccines, but it also
| doesn't mean that your excuses make sense.
|
| The batch is not "rushed" more than it's needed: there IS
| an emergency. It's also not experimental. The experiments
| have all been done (up to phase 3). It's perfectly normal
| to only see 1 in a million (or even 1:100 000) side effects
| after starting the vaccination of the general public.
| Simply because the phase 3 will never contain _millions_ of
| people. I 've checked, and the 30-40k studies we had with
| these seem to be indeed large. I.e. _safe_.
|
| What you _think_ about your immune system is kind of
| irrelevant for a few reasons, but talking up their immune
| system seems to be a general self-convincing strategy for a
| lot of people. First of all, it 's not apparent that you
| have contracted the virus. Unless you have an antibody test
| showing that you are seropositive, you simply don't know,
| but the chances aren't very high. What you can be sure
| about is that you have not contracted "all" variants. If
| you live in the UK then you had the chance to meet the UK
| variant (B117, IIRC) and the base variant (D6....
| whatever). Very likely not both. And the immunity for the
| base variant seems to work pretty well for the UK variant,
| so it doesn't even matter if you met both.
|
| But even if _you_ know you are already immune, the natural
| immunity doesn 't last that long. The vaccines give you
| higher antibody levels (at least the mRNA ones do, again
| IIRC) and better immunity especially due to the second
| dose. (Which you can't really simulate with a second
| infection within a few weeks.)
|
| And at last: you can't generalize from your own experience.
| Looking at the numbers, which we do have a lot of, people
| who haven't met the virus and don't have immunity should by
| all means get the vaccine. Because the virus is a _lot_
| more dangerous (several orders of magnitude more dangerous)
| than even the J &J or the AZ vaccine. Though the exact risk
| profile will depend on individual factors, of course, but
| since you've talked about all vaccines...
| argvargc wrote:
| Zero experiments have been done on long-term effects, and
| you cannot, and no one can, counter this point.
|
| That's the definition of "rushed".
|
| Vaccines typically take several years of testing before
| being approved. These aren't approved according to those
| standards. Manufacturers are absolved from risks because
| of this "emergency use" status. Why absolve them if there
| are no risks? If they truly believed these were safe and
| of tremendously important benefit, they could stand up
| and say "we accept responsibility for negative outcomes
| in accordance with ordinarily approved medication, and
| waive our rights to emergency use protections". Then
| everyone would rush to take them as doubts would be
| broadly eliminated.
| tharne wrote:
| The technology behind this vaccine has been actively worked
| on for over a decade. Yes, these vaccines have been sent to
| market faster than normal, but they certainly have not been
| "rushed".
| ryankemper wrote:
| I hear this line being trotted out all over - especially
| from the "experts" - and I find it nothing short of
| enraging. There is a difference between saying "an mRNA
| platform in general might not be safe" and the actual
| claim real people make which is "this specific vaccine
| has not existed for more than a year and is being hastily
| rolled out on the world population via implicit or
| explicit coercion". The mRNA platform in general can be
| safe and, say, the Moderna vax could still have a poor
| safety profile. This is why we perform rigorous long-term
| testing and why most vaccine approvals (not that these
| are FDA approved of course) take several years.
|
| If you can't be intellectually honest enough to admit
| that there is a difference between "we've used this
| platform in theoretical research in small numbers" to "we
| mass-market and roll out this novel vaccine to billions
| of humans worldwide", you shouldn't be in the discussion,
| IMO.
| clcaev wrote:
| J&J is not mRNA platform, it uses an adenovirus platform.
| ryankemper wrote:
| Thanks. To avoid repeating myself:
| https://news.ycombinator.com/item?id=26799734
|
| TL;DR you can probably s/mRNA/adenovirus vector/g
| although I will grant that adenovirus vector seems less
| "experimental" than mRNA does
| atleta wrote:
| It's not dishonest. It's a very adequate answer to the
| over-simplifying claim above. I.e. there is a difference
| between a newer and an older platform and there is a
| difference between an experimental platform and a new
| platform (that's not experimental but has been in
| development for a long time).
|
| You can always argue for making things slower and
| experiments longer, the problem is, that there is a
| pandemic going on with 3M deaths in the past year.
| Actually people seem to think that you can develop
| vaccines without being rushed, but it doesn't seem to be
| the case. There are several reasons why other vaccines
| took years:
|
| - it was a long time ago and scientists had a lot less
| knowledge, experience and older technology. (Think e.g.
| the mRNA vaccines, which J&J is _not_ one of, where the
| first candidate could be completed in something like 2
| weeks after the isolation and sequencing of the virus.) -
| they had to start from 0 for a new virus (because they
| new less, etc.). Like for the polio, or HIV. In the case
| of SARS-CoV2, they could build a _lot_ on the experiments
| from SARS-CoV1. As far as I know, there was a vaccine
| candidate back in 2003, but by the time it would go into
| phase-3, the epidemic was over. Also, it seems that
| research never stopped about the coronavirus vaccines, so
| there were new results between 2003 and 2020 that the
| mRNA vaccines built on. - some viruses are easier to
| develop a vaccine for. (E.g. the HIV is not one of them,
| because it 's very good at evading the immune system) -
| I've already mentioned this, but if the vaccine candidate
| doesn't get ready on time because of the above reasons,
| then you may have to wait for _years_ before you can do a
| phase3 trial because there will be no people getting
| infected, so you won 't be able to measure the
| effectiveness. This is what happened with the ebola
| vaccine in 2014. Now the vaccine is 7 years old, but it
| doesn't make it any safer, because there weren't people
| who could be vaccinated. (Well, of course, you could
| vaccinate them and wait for any long term side effect,
| just in case, that would show up without being infected,
| but that doesn't seem like a very important data point.)
|
| But again: why would you want to wait for several years
| in a situation like this when we do have a pretty clear
| picture of both the worst case risks of the vaccines and
| the risks of the disease (which are higher than the worst
| case risks of the vaccines).
| ryankemper wrote:
| > It's not dishonest. It's a very adequate answer to the
| over-simplifying claim above.
|
| I would disagree that calling it "rushed, experimental,
| and not necessary for [the original commenter]" is an
| over-simplifying claim. Indeed I find the "we've done
| theoretical research with platform X for years" to be the
| oversimplification. That being said I do agree that there
| is a difference between an experimental platform and a
| new platform.
|
| > But again: why would you want to wait for several years
| in a situation like this when we do have a pretty clear
| picture of both the worst case risks of the vaccines and
| the risks of the disease (which are higher than the worst
| case risks of the vaccines).
|
| Starting with the "higher than the worst case risks of
| the vaccines" part, FWIW, this is true in general but not
| for all individuals. For someone like me (20's, active,
| no major health conditions), the acute side effects of
| getting a SARS-2 vaccine far outpace the expected level
| of symptoms from SARS-2 infection itself. (Speaking from
| a personal risk reduction standpoint only, I don't want
| to get into the ethics of medical collectivism for the
| purposes of this discussion). I don't think you would
| dispute that, but just wanted to mention it because it's
| because taboo (and indeed you can get actively censored)
| to say "for my specific health circumstance the vaccine
| is more dangerous to me".
|
| As for the more general point about understanding the
| risks of the vaccines and the disease fairly clearly, I
| would say that we understand the virus far better than
| the vaccines. Indeed it really saddens me how we've
| wasted public health dollars on messaging to people that
| immunity to reinfection is not a thing (when it is most
| definitely a thing) and to be super spooked about
| variants despite the fact that SARS-2 is not going to
| magically mutate away from the spike protein anytime soon
| (i.e. there's plenty of epitopes for our immune system to
| work with even for the highly artificial immunity
| produced by making the body's cells manufacture spike
| protein exclusively).
|
| I will grant though that we have bounds on how bad short
| or medium-term adverse reactions could be to the
| vaccines. Personally I worry less about the (using mRNA
| as an example here to illustrate a general point) "it's
| going to turn me into a human GMO" pseudo-argument than I
| do things like (a) "is the rate at which spike proteins
| get produced in the body much more of a steep increase
| followed by a steep dropoff leading to greater potential
| for acute inflammatory episodes than via naturalistic
| infection" as well as (b) "could we be over-sentitizing
| the immune system to react too strongly when it detects
| spike protein, particularly for those who already had
| COVID-19 before ever getting the vaccine". If you're not
| aware, an absurd amount of people who have already gotten
| COVID-19 and therefore have naturalistic immunity are
| still getting the vaccine, either because they're
| "required" to (aka they don't know or want to fight their
| job's requirements) or more often because they've been
| brainwashed to think that the variants evade natural
| immunity which is just a total media-propagated
| falsehood.
|
| > In the case of SARS-CoV2, they could build a lot on the
| experiments from SARS-CoV1
|
| Totally agreed and I wish more people knew that the virus
| causes COVID-19 is called SARS-2 and that it is directly
| related to SARS-1 (I'm referring to layfolk here). As a
| separate tangent I wish more people understood that the
| emergence of SARS-2 means we don't really need to worry
| about SARS-1 anymore because anyone exposed to SARS-2
| will be cross-reactive with SARS-1.
|
| > I've already mentioned this, but if the vaccine
| candidate doesn't get ready on time because of the above
| reasons, then you may have to wait for years before you
| can do a phase3 trial because there will be no people
| getting infected, so you won't be able to measure the
| effectiveness.
|
| This is simply not the case for an endemic seasonal
| respiratory virus. You'll have plenty of cases,
| especially since we're basically PCR-testing the whole
| globe (I don't think we should be, to be clear). But I
| totally agree that the apparent benefit of vaccines
| declines exponentially as time goes on, particularly with
| SARS-2 where the fact that it is deadly for the very
| elderly and harmless for the very young means that yearly
| recurring mortality is going to essentially vanish after
| it's propagated through the current world population (as
| an aside, this fact is one of many reasons why all the
| hysteria around the virus was absurd from the get-go;
| amortized over several years the mortality of SARS-2 is
| entirely unremarkable)
|
| > But again: why would you want to wait for several years
| in a situation like this when we do have a pretty clear
| picture of both the worst case risks of the vaccines and
| the risks of the disease (which are higher than the worst
| case risks of the vaccines).
|
| Yeah, to conclude I want to bring it back to my earlier
| point which is that once the virus has propagated through
| the current world population (more or less), the set of
| SARS-2-naive individuals will become dominated by the
| very young, who are not at real risk of COVID-19 and
| therefore they will develop immunological memory while
| young when they are incapable of being harmed by SARS-2.
| This means that recurring yearly mortality will fall off
| a cliff (albeit, if we keep labelling deaths the way we
| do we won't see that reflected in the numbers nearly as
| much as we should). Which is why I think the restrictions
| and everything else, even if they had worked in places
| like the US or Europe where they totally failed, were
| always a bad idea. But the other side of that coin is:
| yes, insofar as you do think SARS-2 is something worth
| really freaking out over, we absolutely have to rush the
| vaccines because if we wait 2 years then there won't be
| any real COVID-19 deaths left to mitigate.
| meepmorp wrote:
| It's not an mRNA vaccine; it uses an adenovirus vector,
| like the Oxford/AZ virus.
|
| The mRNA vaccines both seem to be fine, by comparison.
| ryankemper wrote:
| Thanks for the important clarification; I didn't read
| closely enough.
|
| My argument was definitely tailored for the mRNA
| discussion, although the purpose was more to illustrate
| the broader principle, but, not knowing a whole lot about
| adenovirus vector vaccines specifically, is it even the
| case that adenovirus-vector vaccines have been widely
| used in the general population?
|
| I couldn't find great info with a cursory search (indeed
| the top result is the CDC which consistently fails to
| cite anything they ever claim, ugh), but I wonder if the
| general argument still applies for these types of
| vaccines as well.
|
| Anyway, thanks so much for catching and pointing out my
| error there.
| meepmorp wrote:
| I believe there's an Ebola viral vector vaccine. The only
| other ones approved for use are for COVID, so it is
| definitely a newer technology.
|
| fwiw, new and better better technologies need to get used
| for the first time, eventually.
| ryankemper wrote:
| > fwiw, new and better better technologies need to get
| used for the first time, eventually.
|
| No-one disputed that, I'm just pointing out that it is a
| very valid point for someone to say "I have concerns that
| we're rushing out an experimental vaccine". You might
| take issue with the specific wording (I don't) but the
| general point I hope we can agree on.
| meepmorp wrote:
| Let's say that I think the point is understandable, and
| shouldn't be dismissed out of hand if only because nobody
| likes being treated like that.
| 8note wrote:
| It's the same thing with flu vaccines, mind you. They
| only get a few months testing before entering mass use
|
| The speed of access for these vaccines is that they
| started mass production while testing was ongoing, rather
| than waiting until after testing to start production
| pyronik19 wrote:
| They slapped the word "experimental" on the disclosure
| form and waived liability to the manufacturer... it was
| rushed... as it should be. I took it. But the reason
| people don't "trust the science" is that its obvious
| people are lied to on a regular basis around covid and
| trust has flatlined.
| loveistheanswer wrote:
| If you've already had the virus, and had only mild symptoms
| from it, what additional level of protection does the
| vaccine confer?
|
| Do you still really need to get the vaccine in that case?
|
| The CDC says yes, but their reasoning is purely based on
| FUD: "experts do not yet know how long you are protected
| from getting sick again".
|
| According to the available data, there has been only _71
| confirmed cases of reinfection out of over 137,000,000
| cases_.[1]
|
| Meanwhile, states in the US are reporting hundreds of
| "breakthrough cases" of fully vaccinated people.
|
| So, the data we have indicates naturally gained immunity is
| stronger than vaccinated immunity.
|
| It's funny how many people treat nuanced, data driven
| discussion like this as _heresy_ to be shamed and censored.
|
| [1]https://bnonews.com/index.php/2020/08/covid-19-reinfecti
| on-t...
| thelean12 wrote:
| You may not be full on anti-vax, but you're very clearly
| anti-science.
|
| > I expect I've had all variants
|
| No evidence of this.
|
| > and apparently my immune system is on top of it
|
| No evidence of this.
|
| > in which case there's nothing to pass on
|
| Even if the above were true, we don't know how long you'd
| have immunity.
|
| > and the people in my area clearly don't care if I did.
|
| They would if they caught it and had severe symptoms.
| tryonenow wrote:
| Resorting to calling people "anti-science" is just as
| counterproductive and unnecessary as calling them "anti-
| vax". You're only solidifying animosity and mistrust.
| People have every right to question what they're being
| told by the same governments who mishandled this epidemic
| from the start - especially since there such strong
| political incentives that aren't necessarily aligned with
| scientifically based recommendations.
| jimbokun wrote:
| You are vaguely waving your hand at unspecified
| "political incentives" with absolutely no specifics or
| evidence of anything.
|
| I mean, you can question anything, but that has about
| zero value. Answers with evidence backing them have
| value.
| ironmagma wrote:
| Everything should start from a place of questioning. If
| there is data and the data makes sense, that can replace
| questioning with certainty. But often the data has a
| limited or tenuous connection, possibly even a fraudulent
| connection. This is why it's important to actually read
| the studies and understand the science, not just to hand
| wave it away as "evidence = value."
| [deleted]
| jrockway wrote:
| Did you get an antibody test to confirm that you've already
| had it? I don't think data supports the assumption that
| you've already had it; it's a rare disease even where it's
| spreading widely. I also have a gut feeling that people
| didn't take "lockdown" or social distancing seriously, but
| some counterevidence is that nobody in the UK has gotten
| the flu in 2021:
| https://www.independent.co.uk/news/health/flu-cases-covid-
| en... That's not because they're already immune, it's
| because diseases simply aren't being transmitted. As bad as
| people are about masks and social distancing, there is some
| measurable effect.
|
| I'll also point out some anecdata. I know someone in their
| late 20s that got COVID. They have felt miserable every day
| in the 9 months since having it. Others have relayed
| similar stories. Public health authorities are worried
| about severe consequences like death, but death isn't the
| only possible outcome. You could just feel like shit for
| the rest of your life.
|
| To me, this is a nasty disease that I do not want to
| contract. I probably won't die if I get it, but there is
| more to life than merely not being dead. As a result, I got
| the vaccine as soon as I could.
| [deleted]
| thelean12 wrote:
| > I think it is a disservice to outright label people as
| anti-vaxers simply for questioning the risk-calculus of
| vaccines.
|
| It's the same idea though, and should still be called out.
| It's people who have unqualified medical opinions, and who
| are then often spreading that opinion to others as if it's
| useful.
|
| Let the agencies figure it out, pay attention to the latest
| recommendations from them, and go with that. Anything else is
| just the blind leading the blind and should be called out.
| JoshuaDavid wrote:
| I agree that, unless you have specific concrete reasons to
| think a public health agency is distorting the facts or
| making decisions based on politics and ass-covering instead
| of optimizing for health, you should trust that agency.
| However, once you have concrete reasons to think that the
| public health agency is acting on politics and not science,
| you should not continue to blindly trust them.
|
| There are other sources of information besides the public
| health agency of your particular country, for example
| public health agencies in other countries, or directly
| looking at the stats and research papers. In this case,
| looking at the stats makes it blatantly obvious that your
| risk from the J&J vaccine is much, much lower than your
| risk from getting COVID, so if your choice is "J&J" or "no
| vaccine for another month or two", you should probably pick
| J&J.
| AndrewBissell wrote:
| In 2012 if someone decided against their doctor's advice
| not to take an opioid which the FDA had greenlit as safe in
| far too many cases, would you call that "blind leading the
| blind"?
|
| Iatrogenesis rivals strokes as a cause of death. Most
| doctors are just slavishly following official doctrines
| from authorities, and sometimes those authorities get it
| wrong. We don't even have to look to the Before Covid Times
| to see examples!
| thelean12 wrote:
| > sometimes those authorities get it wrong
|
| Yes. That's correct. That doesn't change what I said.
|
| Answer me this: why do you think unqualified individuals
| are better suited to get it right?
|
| Just because there are examples in the past of people who
| went against the recommendations who ended up being
| right, doesn't mean you should take everything else into
| your own hands. Unless, of course, it's literally your
| job.
| blitz_skull wrote:
| It's not a question of getting it right, really. I
| haven't heard a single uneducated opinion say, "You
| should not get it because X". I've seen several say, "I
| will not get it because X"
|
| It's a subtle, but IMO important distinction. If people
| wanna rationalize not getting the shot based on their own
| misunderstanding of the science, that's fine. That's
| okay.
|
| We don't need universal understanding here for the
| vaccine to do it's thing. Let those who want to get it,
| get it. And those who don't, to not get it.
| spion wrote:
| That's a good method to not develop immunity and develop
| resistant strains.
| thelean12 wrote:
| > I haven't heard a single uneducated opinion say, "You
| should not get it because X".
|
| It's not even 3 hours into my day and I've already
| received 3 texts from family saying something along those
| lines regarding J&J, even if it gets unpaused. It's a
| much more prevalent thing to say than you think.
|
| > If people wanna rationalize not getting the shot based
| on their own misunderstanding of the science, that's
| fine. That's okay.
|
| It's not okay. We need shots in arms. And you're doing
| your part by enabling those who are misunderstanding the
| science by making them feel like it's okay to not get the
| shot.
| cbkeller wrote:
| Deciding that your pain is well managed without opiates
| has always been a perfectly reasonable and medically-
| accepted option, and unsurprisingly there has never been
| any sort of social stigma against people who _decline_
| painkillers.
|
| Most to the point, declining to take painkillers does not
| adversely impact _other people 's_ health.
|
| This is not a good analogy.
|
| eta: ironically, the problem with the opioid crisis was
| not too much regulation and oversight by "the
| authorities", but too little; too much freedom for
| doctors to prescribe stronger painkillers, and for
| patients to request them.
| ironmagma wrote:
| Careful to not play the appeal to authority. Anyone can
| understand anything, regardless of their so-called
| qualifications. Are they likely to? No, and that's why
| someone's qualifications are purely a heuristic, not a
| prerequisite.
| ryankemper wrote:
| It's extra frustrating because organizations like the CDC
| get held to lower standards than anyone else. They can
| make a pronouncement recommending the use of face masks
| for SARS-CoV-2 community transmission when the body of
| the research confirms that (a) such intervention has
| never been tried in an RCT and indeed the whole "my mask
| protects you" hypothesis is intentionally unfalsifiable,
| (b) the research literature documents numerous negative
| impacts whereas the positive impact on transmission is
| completely unproven _at best_ , and yet their evidence-
| less pronouncement is considered evidence in its own
| right and such a pronouncement is used as a citation in
| Wikipedia articles, etc.
|
| (Just using masking as an example, if any onlookers
| strongly believe that masking is efficacious for the
| stated purpose just imagine I gave a different example,
| although I don't see how anyone could reach that
| conclusion about masking specifically based on the
| research literature out there which is neutral at best)
|
| Or as another example, the CDC loves to try to encourage
| people to take the flu vaccine, and yet I was shocked to
| discover that it takes 71 flu shots to prevent a single
| flu case, 29 flu shots to prevent one ILI (this is a
| better number than the flu case number since really we
| care about ILI in general, but even so 29 is an abysmal
| number), AND that regardless of the mediocre reduction in
| cases/ILI, it makes essentially no difference in
| hospitalizations.
|
| Citation on the flu vaccine stuff:
| https://www.cochrane.org/CD001269/ARI_vaccines-prevent-
| influ...
|
| --
|
| I didn't realize until this year how much of "public
| health" involves (a) actively and intentionally lying to
| the public (for example, if you read about the AIDS
| crisis you learn about the "noble lies" told about who
| was vulnerable as well as the not-even-noble lies like
| when Fauci told people you could get AIDS from close
| contact with someone with AIDS when the scientific
| evidence showed that to be false), and (b) is really a
| giant marketing campaign for various big pharma interests
| (I say that as someone who is an unashamed free-market
| capitalist, not that the US is actually a true free
| market when it comes to the pharma/medical industry)
| thelean12 wrote:
| I'm not insisting that a claim is true just because an
| authority says it is. You can't just bring up "appeal to
| authority" and call it a day.
|
| I'm insisting that the average unqualified individual
| should not think they have a better chance of being
| correct over the authorities in question.
|
| There's no other rational option for unqualified
| individuals than to listen to medical authorities unless
| you have a medical degree yourself and have read and
| analyzed the research yourself.
| ironmagma wrote:
| There are actually a lot of reasons to be skeptical of
| experts -- the same as why you should be skeptical of
| anyone. Appeal to authority has a contrapositive: the
| disappeal to lack of authority. The arbitrary person can
| be right just as much as the expert can. The whole point
| of logic and reason is that it's about facts, not the
| people.
|
| Critically the problem with your reasoning is the last
| sentence. No, you do not need to have a medical degree to
| be right when a doctor is wrong; ask anyone who's had a
| medical issue that all doctors agree does not exist.
| vmladenov wrote:
| Isn't that inverse, not contrapositive? Here's how I'm
| understanding it:
|
| > appeal to authority
|
| authority -> trust
|
| > disappeal to lack of authority
|
| not authority -> not trust
|
| The contrapositive of the first proposition would be
|
| not trust -> not authority
|
| which is a rather different claim.
| ironmagma wrote:
| True, the word was wrong. The point though is that for
| this logical fallacy, there is an equal and opposite
| logical fallacy. Saying authority implies truth is just
| as wrong as saying lack of authority implies falsehood.
| rajin444 wrote:
| How does authorities being wrong / changing their
| recommendations factor in to what your consider a
| rational option? If you were a high risk individual back
| in January 2020 who ignored their advice and quarantined
| + wore a mask (an effective mask, i.e N-95), you made the
| right choice.
|
| Despite how much smarter and informed humanity is, we
| still make decisions based on trust. Science can only
| explain so much and runs out of answers eventually.
| thelean12 wrote:
| > If you were a high risk individual back in January 2020
| who ignored their advice and quarantined + wore a mask
| (an effective mask, i.e N-95), you made the right choice.
|
| Did they? Or was the chance they'd come in contact with
| Covid at that point very low and those masks would be of
| much better use at hospitals where the chance of coming
| into contact with Covid was very high? At least, that was
| what the experts were saying at the time. I donated my
| N-95 masks (that I had from California fires) not because
| we thought they didn't do anything in January 2020, but
| because the experts said they were of better use in
| hospitals.
|
| > Science can only explain so much and runs out of
| answers eventually.
|
| You say this as if there's a better place to find
| answers. Where is that place?
| rajin444 wrote:
| > Did they? Or was the chance they'd come in contact with
| Covid at that point very low and those masks would be of
| much better use at hospitals where the chance of coming
| into contact with Covid was very high? At least, that was
| what the experts were saying at the time. I donated my
| N-95 masks (that I had from California fires) not because
| we thought they didn't do anything in January 2020, but
| because the experts said they were of better use in
| hospitals.
|
| You're saying a high risk person (high risk meaning they
| would likely die from covid - immunosuppressed, etc.)
| wearing an N95 mask and quarantining was a bad choice?
| I'm not sure how those masks would be better used if the
| person is at a high risk of dying to covid.
|
| > You say this as if there's a better place to find
| answers. Where is that place?
|
| Interpreting all the data available to you. Would you
| have shamed a person for not choosing this man as their
| surgeon https://en.wikipedia.org/wiki/Christopher_Duntsch
| after they researched his past operations. There are more
| factors than just the research that need to be
| considered.
| kordlessagain wrote:
| > I've already seen a bunch of anit-vaxers referring to this
|
| It's not only a disservice, it's a biased way of thinking
| which only serves the one making the statement, given it
| allows them a way to alleviate their concerns about having
| received a level of uncertainty from their actions. I get
| them them because I also got that shot!
| arcticbull wrote:
| > The (1/7 million) is the current, unconditional and
| empirically observed adverse effect of the vaccine - this is
| a somewhat noisy measure of the true prevalence of this
| issue. It is okay to be cautious and there are legitimate
| concerns, and quite frankly, I trust the FDA have good reason
| to pause this if Moderna/Pfizer are readily available anywy.
|
| How many injections do you personally need to feel
| comfortable? Seven _million_ people is way more than any
| clinical trial for any drug you 've ever taken, and I
| _guarantee_ you any of them is more likely to kill you.
|
| Every single year 150 people die from taking Tylenol in the
| US in the normal course of treatment -- and 500 die of acute
| liver failure due to acetaminophen overdose. 25,000 hospital
| admissions. 50,000 ER visits. If we pretend that 350,000,000
| people take Tylenol each year, that makes Tylenol 50% more
| likely to kill you than this vaccine.
|
| It's simply not ok. They are anti-vaxxers.
| vmladenov wrote:
| This comment is a prime example of why we're in this mess
| with vaccine denial in the first place. You're either not
| allowed to say anything negative about vaccines, or you're
| an anti-vaxxer who thinks your kids will get autism and 5G
| chips. It's so cult-like.
|
| We should be honest about the (low) risks and benefits of
| vaccination without turning it into a political campaign of
| shame and bullying, and trust people to make the right
| choice for them and the public.
|
| Perhaps you also think the US government is anti-vaxxer, as
| it runs a publicly funded National Vaccine Injury
| Compensation Program - https://hrsa.gov/vaccine-
| compensation/index.html
| arcticbull wrote:
| IMO, no - I'm saying that folks risk management is
| completely out of wack. The chance the disease kills you
| is 1 in 100. The chance that the vaccine kills you is 1
| in 7 000 000. One is bigger than the other. By, like, a
| lot.
|
| The government's response is to pacify anti-vaxxers.
| ryankemper wrote:
| > The chance the disease kills you is 1 in 100
|
| It's 6 in 1000 if you listen to the CDC; personally I
| think the real number is closer to 3 in 1000. That's not
| too far off from what you said but I prefer being more
| explicit rather than using such a fuzzy resolution.
|
| And just to be explicit, that's the general IFR, the IFR
| for, say, people in their 20's, or even people in their
| 40's, is a fraction of that.
|
| ---
|
| Anyway, your point about risk management is somewhat
| true, but it is much more true if you apply that logic to
| the general public's fear of SARS-2 in the first place. I
| can't find it in my notes but surveys that have asked
| people what their chance of dying is if they catch the
| virus, are off by MULTIPLE orders of magnitude. And young
| people rank their individual risk of death higher than
| old people do (both estimate too high, even the old
| people), presumably due to them being more "plugged in"
| to "the system" so to speak.
|
| Personally speaking, since I'm in my 20's, almost
| everyone I know who has gotten the vaccine has done so
| because they believe outright falsehoods about the virus
| that have been propagated not just by the media but by
| our so-called health experts themselves.
|
| For example, I have multiple friends who had PCR-
| confirmed COVID-19, recovered months ago, and still got
| the vaccine. In the times I've probed at them to see why,
| they muttered some vague things about "the variants" and
| essentially said that the variants bypass naturalistic
| immunity which is just completely false.
|
| I know for a fact that my likelihood of an acute adverse
| reaction (the all-too-common "feeling like death for a
| day" reaction) is far higher than the likelihood of
| comparable symptoms from SARS-2 infection. So I'm not
| getting the vaccine, and I'm not embarrassed to say so.
| For many people, the risks of the virus are less than
| risks of the vaccine; however, much less people than you
| would think. We don't have good enough data yet but I'd
| bet it crosses over somewhere in the 40's or 50's age
| range.
|
| There's a huge difference between being an "anti-vaxxer"
| in the true sense of the word - i.e. you think all
| vaccines are inherently bad, period - and being someone
| who takes the same attitude towards vaccines that we do
| towards drugs: no drug is inherently safe; rather drugs
| that are proven to be safe are safe. By extension, no
| vaccine is inherently safe; vaccines that are proven to
| be safe are safe.
|
| The latter statement is my personal view of it, and
| unfortunately such a statement can get you banned from
| social media platforms if you get unlucky.
|
| This binary way of dividing the world into "anti-vaxxer"
| vs not, "AIDS denialist" vs not, etc is not just
| oversimplified but is intentionally done to suppress
| dissent. I refuse to participate in such a culture and I
| humbly implore you to do so as well.
| vmladenov wrote:
| Again with the made up numbers that erode trust.
|
| I'm 25 and I'm relatively healthy. The risk that the
| disease kills me is significantly less than 1 in 100;
| it's hard to find numbers but one chart had the
| _hospitalization_ rate for me at 1%, and the death rate
| 0.01% (edit: though the death rate only covered age and
| didn't divide by other factors such as obesity). The
| "chance" the vaccine kills you is currently zero as there
| have been no recorded deaths that have been linked to a
| COVID vaccine. The blood clotting risk has been cited as
| 1 in a million, but we're working with limited data. This
| is the problem with making such extrapolations.
|
| I write all of this as I'm on day 2 of dealing with the
| side effects of J&J.
| arcticbull wrote:
| Yep, I used averages not made-up numbers.
|
| The reason everyone has to get it is so that the average
| goes down to 0, for everyone.
|
| 7 million trials is not limited data. It's dramatically,
| and I do mean _dramatically_ more data than basically any
| other clinical trial for any other drug you 've ever
| heard of. By probably 2 orders of magnitude. It's simply
| not limited data.
|
| The average phase 3 trial has 300-3000 participants [1].
| Not seven million.
|
| Also a week in after J&J.
|
| [1]
| https://en.wikipedia.org/wiki/Phases_of_clinical_research
| vibesngrooves wrote:
| This really is a sad, sobering reality. "6 cases in 6.8
| million", ~0.00000089% chance of death via J&J vaccination.
| Extremely disheartening to see, but rather telling, where
| priorities lie. Politics aside, this is sheer stupidity, as you
| mentioned. Brace for another year as mutations continue to
| develop throughout the developing world while we waffle over
| infinitesimally minimal risk.
| vmception wrote:
| There are 7 other vaccines in use simultaneously across major
| markets. JnJ has little effect on the strategy.
| oceanplexian wrote:
| Multiple advanced health care systems in the world are
| independently pulling these vaccines. I wouldn't brush it off
| as the FDA being overly cautious. None of these vaccines have
| been tested in humans for more than 12 months. And you're
| assuming that health authorities can wave a magic want and
| instantly know who is having some kind of undetected brain
| clotting? I think the risks are extremely unclear even though
| people are throwing statistics around like they mean anything.
| ggreer wrote:
| Not a single one of those health authorities allowed vaccine
| challenge trials. That tells you how much they care about
| saving lives versus how much they care about not getting
| blamed for any deaths.
| yellow_postit wrote:
| It does appear that challenge trials are starting, a search
| easily turned up this UK one:
| https://ukcovidchallenge.com/covid-19-volunteer-trials/
|
| The main benefit of challenge trials is to speed up
| development as I understand it not to broaden risk
| estimates.
| ggreer wrote:
| > The main benefit of challenge trials is to speed up
| development as I understand it not to broaden risk
| estimates.
|
| Right, which is why it was crucial to have such trials a
| year ago. We could have shipped vaccines 3 months sooner
| and saved hundreds of thousands of lives.
|
| Unfortunately, no health authority was willing to risk
| blame for any disabilities or deaths stemming from
| deliberately exposing consenting people to covid. So we
| had to use much larger sample sizes and wait longer to
| know which vaccine candidates were effective.
| Ericson2314 wrote:
| Well this seems stupid.
|
| The thing I'm trying to understand is whether Johnson & Johnson
| and AstraZeneca are meaningfully different. All the media just
| assumes they are (until proven equivalent), but is the genetic
| code publicly known so we can compare? The Pfizer and Moderna
| ones are extremely similar. Now, I imagine the adenovirus ones
| have an order of magnitude more genetic material, but is the code
| publicly know to compare?
|
| As far as I can tell, they both should have been approved ages
| ago, if only to depress prices and get more redundancy.
| whazor wrote:
| One difference is that J&J has been tested for only one shot
| and AZ is tested for two shots. Also the amount of vaccin you
| get shot in your arm could be different. The clotting incidents
| between the two are certainly different, AZ has much more at
| the moment.
| gher-shyu3i wrote:
| Does the fact that they're made in the same lab mean anything
| when it comes to these side effects? Are the
| fillers/stabilizing materials the same?
| viklove wrote:
| Yes, they are meaningfully different. For one, Pfizer and
| Moderna are mRNA vaccines, while J&J and AZ are not.
| Moto7451 wrote:
| That's not the difference the parent is asking about. He's
| asking if the adenovirus based vaccines available are
| meaningfully different.
|
| Reaching beyond the parent's words, both AstraZeneca and J&J
| have now had issues with blood clots. If it's a similar
| formulation then perhaps you've found something and
| Adenovirus vaccines with a different formulation are
| unaffected. If they're very different then perhaps other
| variations of Adenovirus vaccines need more attention.
| viklove wrote:
| The mechanism of delivery isn't a meaningful difference?
| Okay, if you just want to ignore half of the equation be my
| guest.
| ivalm wrote:
| They are comparing jj and astro zeneca, both use
| adenovirus delivery. Albeit very different variants.
| GavinMcG wrote:
| The parent comment wondered
|
| > whether Johnson & Johnson and AstraZeneca are
| meaningfully different
|
| Grammatically, that asks about the difference between J&J
| & AZ. Your response instead compared them collectively to
| the mRNA vaccines, rather than comparing them to each
| other. Thus the response saying "[t]hat's not the
| difference the parent is asking about."
| tobessebot wrote:
| J&J uses a very rare human adenovirus, AZ uses a more common
| chimpanzee adenovirus. J&J also has the so-called 2PP
| modification on the Spike protein compared with the AZ vaccine.
| Good writeup here: https://berthub.eu/articles/posts/genetic-
| code-of-covid-19-v...
| yboris wrote:
| Relevant tweet:
| https://twitter.com/robertwiblin/status/1381967753234411530
|
| J&J doses delivered: 7 million.
|
| Reported blood clotting events: 6.
|
| Daily risk of dying of COVID19 in the US: 1 in 330,000.
|
| CDC and FDA: Pause the J&J vaccine.
|
| Draw your own conclusion on how aligned these folks are with your
| interests.
| UncleOxidant wrote:
| But there are 2 other vaccines that are still available so it's
| not like they're stopping all vaccinations. Another
| consideraton: J&J was/is having production problems so
| deliveries have been cut considerably - as such this probably
| won't be a very significant change to vaccination rates. I
| suspect the FDA will allow J&J vaccinations to resume in a
| couple of weeks. Maybe they'll recommend it not be used in
| women under 60 as has been done with the AZ vaccine in Europe.
| Even if they do that there would still be plenty of men
| eligible to get the J&J.
| ceilingcorner wrote:
| This is misleading. If you're young and healthy, the chances of
| dying from COVID are basically zero. The chances of dying from
| a blood clot from a rushed vaccine are not. The people who died
| from blood clots probably would still be alive had they not
| taken the vaccine.
| javagram wrote:
| > If you're young and healthy, the chances of dying from
| COVID are basically zero.
|
| Hundreds of young and healthy people have died from Covid-19.
|
| The risk is "basically zero" but so is the current known 1 in
| 7 million risk of dying from this blood clotting.
| ceilingcorner wrote:
| Most of those cases haven't quite been "healthy."
|
| Even then, let's assume they were. COVID is largely
| avoidable, if you don't mind being avoiding others.
| Directly getting a vaccine is not.
|
| It's like saying X% of people riding in cars will be in
| accidents and die. Yeah, maybe, but that doesn't apply to
| you if you _don 't ride in a car in the first place._
| curryst wrote:
| The risk is low, but I think the last I saw was a 0.01% IFR
| in the young, which comes out to 1 in 10,000. Still a higher
| risk than COVID at this point, although it's possible that
| they'll discover a higher incidence like with AZ.
| root_axis wrote:
| > _If you're young and healthy, the chances of dying from
| COVID are basically zero_
|
| Death is not the only risk factor. Covid-19 carries the risk
| of serious complications for those who recover, even
| including those who are infected but asymptomatic.
|
| https://jacksonhealth.org/persistent-pulmonary-problems-
| in-a...
| ceilingcorner wrote:
| > While the long-term consequences are still unknown
|
| > Additional studies are required to fully understand the
| virus, but for now, follow-up testing is essential to
| understand the long-term effects of the virus.
| cma wrote:
| > The people who died from blood clots probably would still
| be alive had they not taken the vaccine.
|
| Isn't it just person (1 person), not people, at this point?
| ceilingcorner wrote:
| No, there are many.
| cma wrote:
| Only one blood clot death suspected to be from the J&J
| vaccine, and another in critical condition.
| cbm-vic-20 wrote:
| > Draw your own conclusion on how aligned these folks are with
| your interests.
|
| What's this supposed to mean? Is the implication here that the
| CDC and FDA want to keep people from being vaccinated? WHy?
| nscalf wrote:
| I think this is an illustration of an issue that has been seen
| throughout the entire pandemic. Medicine != Public Health
| Policy. In general, I would say medicine is too dogmatic to
| decide on public policy, and public policy is too loose to
| operate medicine.
| ChrisLomont wrote:
| That tweet ignores that there are alternatives to the J&J
| vaccine, so implying that there is a binary decision between
| J&J or 1 in 330k death chance is flawed reasoning.
| mr_cyborg wrote:
| Also ignores risk by age group, which can be significant and
| relevant to someone's risk profile.
| ars wrote:
| Message to anti-vaxxers: As you can see the government is very
| carefully tracking any kind of safety issues with vaccines. They
| are being open and telling you about issues despite people
| fearing it would cause vaccine hesitancy.
|
| So this should actually give you _more_ confidence in vaccine
| safety, because if there are problem, you _will_ be informed.
| kevin_nisbet wrote:
| Unfortunately I think the anti-vaxxers can twist the logic
| however they want. The government is putting on a show about
| how transparent they are to win trust... etc.
|
| I'm not sure how to get through that... from what I understand
| it takes alot of effort and time per person.
| bluGill wrote:
| Sadly, as news papers discovered years ago, publishing
| corrections makes you seem less trust worthy than papers that
| never publish any, even though the later at best equal, and
| often worse.
| mmcdermott wrote:
| I see this as making the safety of the specific vaccines an
| unfalsifiable proposition. If the absence of side effects
| proves that it's safe to vaccinate and the identification of
| side effects proves it's safe to vaccinate, what could ever
| prove that a specific vaccine is unsafe?
| ChadHomenim wrote:
| Hormonal birth control boasts clot rates of 1 per 10k, yet we
| hand that out like candy to little girls. Yet this is considered
| "too dangerous..."
|
| Edit: mods locked my account for this, lol. Some of the idiots
| replying are purposely conflating progestogen stats with non-
| progestogen stats, which is dishonest at best and willfully evil
| at worst. 2/3 of the market causing clots is fine? What a
| braindead take. I expected better of the HN crowd.
|
| Edit 2: The top comment on the other thread literally says the
| same thing as my comment
| https://news.ycombinator.com/item?id=26790922
| endisneigh wrote:
| > yet we hand that out like candy to little girls.
|
| Do we? What a silly post. And if there were an alternative that
| was 1 in a billion I'm sure that would be paused, too.
| ChadHomenim wrote:
| Yes, we do, and a cursory Google search will confirm this.
| Stop spreading disinformation and FUD.
| endisneigh wrote:
| Please then, post your source and post the alternative that
| doesn't have the issue (orders of magnitude more).
| ChadHomenim wrote:
| "Citation needed" is a lazy way to throw FUD at an
| argument; if someone who didn't even leave the comment
| you are responding to can spend 30 seconds to find the
| citation on Google to answer your question, you could
| have done so yourself instead of demanding other people
| cite every single thing they say lest they aren't
| believed.
| endisneigh wrote:
| Good grief. You make the claims:
|
| > Hormonal birth control boasts clot rates of 1 per 10k
|
| This differs depending on the age from my research. Your
| overall seems too high when risk adjusted. I asked you to
| post your source so we could discuss from the same
| source. In any case per
| (https://www.healthline.com/health/birth-
| control/pulmonary-em...):
|
| - Out of every 10,000 women taking birth control pills, 3
| to 9 of them will develop a blood clot.
|
| - Out of every 10,000 women who are not pregnant and who
| do not use birth control pills, 1 to 5 of them will
| develop a blood clot.
|
| - Out of every 10,000 pregnant women, 5 to 20 of them
| will develop a blood clot.
|
| - Out of every 10,000 women in the first 12 weeks after
| giving birth, 40 to 65 of them will develop a blood clot.
|
| In other words, taking birth control pills actually
| _reduces_ blot clot rates compared to pregnancy, the very
| thing birth control pills prevent. Your entire point is
| moot.
| theli0nheart wrote:
| The burden of proof falls on the accuser.
| ChadHomenim wrote:
| Not my fault you cant read CDC stats.
| dang wrote:
| Whoa - you can't post flamewar comments like this one and
| others. We've banned this account. If you don't want to
| be banned, you're welcome to email hn@ycombinator.com and
| give us reason to believe that you'll follow the rules in
| the future. They're here:
| https://news.ycombinator.com/newsguidelines.html.
| ars wrote:
| No, it's not "too dangerous", rather it's "we did not warn
| people about the known risks".
|
| If you warn people about the small risk of blood clots from the
| vaccine, then you can let them decide if to receive it.
|
| That's what informed consent is all about.
| ChadHomenim wrote:
| The company that is still litigating the fact that it
| knowingly put asbestos in baby powered made a dangerous
| vaccine? Color me shocked.
| thomasfromcdnjs wrote:
| Honest question, what is your take on vaccine passports?
| jsight wrote:
| Not the OP, but my take is that the name is terrible. The
| concept is probably needed in some places, though. It'd be
| fairly shocking if there aren't some strict entry
| requirements on crowded venues for a while, though maybe a
| recent test can substitute for a vaccine.
| altacc wrote:
| While this is an interesting point to consider it's not
| completely equivalent. In short, taking an action that might
| harm in exchange for a small possibility of a benefit is much
| less appealing than taking an action which might harm you but
| will definitely bring a benefit.
|
| To expand, people accept a level of risk depending upon the
| benefit they expect to get from it. In the case of the
| contraceptive pill the user has a clear & definite benefit
| (e.g. they are very unlikely to get pregnant from the sex they
| are definitely having). The benefit of the vaccine for the
| individual is less clear & loosely defined. It's another
| probability that's hard to know. The recipient might not get
| Covid-19 and if they did they might not get it badly. So it's a
| much more difficult benefit to weigh against the risk.
|
| The assessment is easier the more at risk the recipient is
| (hence restricting use to older generations) and on a larger
| scale, where policy makers can compare that 1 in a million
| increase to the x in a million that will die from Covid-19. But
| for individuals, most people are not good at making those
| judgements correctly.
| danielbln wrote:
| At least a third of the market of hormonal birth control is
| progestogen-only pills, and those do not raise the risk of
| blood clots. At best your comment is reductive, at worst
| misleading and the tone is uncalled for.
| kevinpet wrote:
| Given COVID prevalence in my state (approx 1 out of 10,000 people
| test positive each day, so assume 20 out of 10,000 are infectious
| at the moment), and the IFR for those under 50 of about 0.01% (1
| out of 10,000 coincidentally), I would have to come into close
| contact with 20 people over the time from when I could get the
| J&J shot to when I could get Pfizer or Moderna.
|
| That's not anti-vax denialism, those are the actual numbers. A
| one in a million risk isn't a good deal for the individual when
| case rates and IFR are low.
|
| This would be a good deal if you were in Michigan, or if you were
| over 65.
| mzs wrote:
| Birthday paradox means ten not 20 and while I MIGHT be able to
| go two weeks without encountering ten others my oldest son
| works at a restaurant, my wife at a school, and my youngest son
| is full-time HS student. They meet 20 people a day easily and
| live with me at home.
| paulwilson05 wrote:
| J&J must not be paying the right people...
| baldfat wrote:
| We are never getting anywhere with these vaccines being used by
| 80% of the population when less then 1:1,000,000 issues are a
| cause to pause.
| [deleted]
| mschuster91 wrote:
| Agreed, anti-vaxxers are already using this for their
| propaganda efforts. The core problem is that statistics isn't
| something that's well taught in schools, and so people can't
| understand effects of scale.
|
| 330M people means that (assuming an 1:1M incidence and a 80%
| vaxx rate) there will be 264 people dying from thrombosis.
| Which is bad, but nowhere near as bad as the millions that
| would die from an actual covid19 case.
| captainredbeard wrote:
| The bigger problem is that many people no longer trust the
| institutions providing the data. As such, they can understand
| statistics but will mistrust the conclusion as the data could
| be bunk.
|
| Lying through statistics is easy, easy, easy.
| Trasmatta wrote:
| Your math is off, there was only one death after around 7
| million shots. And this has only been seen with the J&J,
| which will only be a fraction of the total shots given.
| atleta wrote:
| It's a very interesting dilemma indeed. Obviously, if it's 7 out
| of 7 millions, then pausing it for the duration of the
| investigation does _way more_ harm than good, given how many
| infections happen these days.
|
| On the other hand this extra cautiousness shows how robust the
| safety of the system is: even minor glitches get caught and
| examined which practically pretty much rules out that there are
| side effects of orders of magnitudes more likely that we don't
| realize. And that may indeed worth it overall. Though in practice
| it would still make more sense if they continued until it reached
| a higher threshold ( _if_ it is ever to reach it).
|
| Unfortunately, while this should be seen as very reassuring WRT
| the safety and the level of trust we can have in the vaccines,
| fear is irrational and for some people it proves that the
| vaccines are _not_ safe.
|
| E.g. here in Hungary, we have the EMA licensed vaccines (same as
| the FDA licensed ones) and also a Chinese (Sinopharm) and a
| Russian (Sputnik-V), with a permission from the Hungarian
| authorities. Now when the blood clotting issue emerged with
| AstraZeneca, some started to say "see, that's how much the EMA
| license is worth. BUT the Sputnik-V is good because you never
| heard about such issues with it". Which is, needless to say,
| completely upside down. (Not suggesting that the Sputnik does
| have the same problem, though I wouldn't be surprised, since it's
| the same technology as the AZ and the J&J. Also, I wouldn't be
| surprised if _all_ vaccines had the same issue as the virus
| itself causes clotting.)
| 0xfaded wrote:
| > "This announcement will not have a significant impact on our
| vaccination plan: Johnson & Johnson vaccine makes up less than 5
| percent of the recorded shots in arms in the United States to
| date," White House Covid-19 response coordinator Jeff Zients said
| in a statement.
|
| At least they have alternatives. Meanwhile, in Europe ...
| jhoechtl wrote:
| ... JJ stopped to deliver to Europe due to the decision which
| has been taken in the US.
| fasteddie31003 wrote:
| The CDC and FDA have done a terrible job in my opinion with the
| pandemic. They are prime example of government institutional
| decay. The consiquentalists will win because the J&J vax helps
| more people than it hurts. This will only add to vax hesitancy.
| When the dust settles this decision will kill more people than it
| saves. I had the J&J vax. I got side effects but I now have some
| immunity to COVID-19 and it's worth it.
| laplacesdemon48 wrote:
| Both the AstraZeneca and J&J vaccines use an adenovirus to
| deliver DNA instead of mRNA wrapped in lipid (like Moderna &
| Pfizer).
|
| Everywhere I read about the J&J vaccine, I see something like
| "the DNA vaccine doesn't alter your DNA". Can somebody please
| clear this up?
|
| As far as I understand, the mRNA just stays in the cytoplasm of
| the cell and gets used up by the ribosome to create spike
| proteins. The adenovirus vector used in the J&J (and other
| vaccines) injects DNA in the cell's nucleus, which seems at odds
| with the widely circulated "it doesn't change your DNA"
| statement.
|
| Do people make this claim because the cell displaying spike
| proteins is basically always eliminated by CD8 killer T cells?
|
| Btw here's a nice high-level summary by the NYT about how all the
| vaccines work:
| https://www.nytimes.com/interactive/2021/health/how-covid-19...
| carnivalWilson wrote:
| I'm a bioengineer. Everyone that gives an answer mostly ignores
| epigenetics and the fact that RNA can permanently alter the
| _shape_ (or conformation) of how your DNA is tightly wound up.
| For example, RNA can direct methylation of DNA and alter
| histones, which can lead to transgenerational epigenetic
| effects on gene expression and phenotype [1]. The fact is,
| molecular cell biology is incredibly complex and the models we
| have are just that, models. Saying that these mRNA strands
| don't affect the genome long-term may be correct, but this is
| an educated guess based on theoretical models. There's a reason
| why FDA approvals traditionally took 10+ years, we normally
| verify our educated guesses empirically.
|
| It almost certainly won't have long-term affects, but it may
| not be trivial to identify if mRNA vaccines have been altering
| epigenetics.
|
| [1] https://en.wikipedia.org/wiki/RNA-directed_DNA_methylation
| noetic_techy wrote:
| Thank you for this explanation. I've been wondering this
| myself especially when it comes to methylation.
| UncleOxidant wrote:
| Wouldn't catching the virus itself also have these epigentic
| effects?
| splithalf wrote:
| Everything in life has potential epigenetic effects! Not sure
| what you are trying to communicate with your comment but it
| sounds like you are saying people should avoid the mRNA vax
| but then you also say "almost certainly no long term
| effects." Your thesis seems to be that 10 years is enough
| time to know for sure that they are safe. Why is 10 years the
| right amount of time? Why not 50 years or 5? In other words
| what's your model for relative risk/reward and why is it
| better than what is being done in terms of public health
| outcomes?
| nend wrote:
| You seem to be putting a lot of words in OPs mouth. I
| didn't see OP making any sort of suggestion about whether
| to avoid the vaccine or not. It looked like they were
| simply explaining some possible outcomes of the vaccine
| that are unknown.
|
| OP also didn't say 10 years is enough time to know the
| long-term effects of these vaccines, just that it's
| traditionally been the minimum amount of time needed for
| some other drugs.
| base698 wrote:
| 50 would certainly cover all life stages of humans. I
| assume you could be sure with shorter.
|
| I have an aviation, biochem, and skydiving background. My
| rule is for aviation: "if it hasn't been out five years
| you're a test jumper."
|
| Humans are way more complex than airplanes. I personally
| wouldn't take the mRNA vaccine because of this rule.
| Coupled with being unable to sue or get help from the
| government I think people IN LOW RISK groups have been way
| too enthusiastic to sign up.
|
| https://www.cnbc.com/2020/12/16/covid-vaccine-side-
| effects-c...
| kypro wrote:
| I'd be happy to take the vaccine if I was in a higher
| risk group and I'll be happy to take the vaccine in a
| year or two, but right now I just don't think it's right
| decision for someone like myself.
|
| Given my risk is very low I'm not too worried about
| COVID, but I am a little worried (perhaps wrongly) about
| the risk of finding out about some long-term side effect
| from these vaccines a few months down the road. I suffer
| from long-term side effects from another drug I took in
| the past, and at the time I was told there was no risk of
| long-term side effects and that it was safe to take. Only
| recently has the labeling been updated to reflect the
| discovery that permanent side effects can occur in some
| cases and for me it's too late, but I learnt my lesson to
| allow others to be the guinea pig for new drugs wherever
| possible.
|
| It's really quite alarming how little we know about the
| body, espically considering the certainty of some
| "experts" about how extremely low the risk of adverse
| effects are from newly approved vaccines. I'm aware of a
| number of drugs which are approved and frequently
| perscribed which we don't even understand the mechanism
| of action for -- accutane, for example. Of course in this
| situation, we do know the mechanism of action, but it
| would still be wrong to assume we know the full surface
| area of possible side effects which could occur because
| our model of the human body is so basic.
|
| I'm happy for someone to explain why I'm wrong on this.
| I'm obviously not an expert, just an average guy trying
| to assess the relative risk of two very unlikely events.
| fspeech wrote:
| There is no reason to expect that side effects from the
| vaccine are not present or actually dramatically higher
| from the live virus. An infection by the virus, even if
| asymptomatic, will likely introduce way more alien
| genetic material and viral proteins into your body than
| the non-reproducing vaccine ever would. So one should
| trust the FDA panel of experts on risk unless there's
| strong evidence pointing otherwise.
| Izkata wrote:
| > I think people IN LOW RISK groups have been way too
| enthusiastic to sign up.
|
| About that...
|
| > In December, we asked, "What percentage of people who
| have been infected by the coronavirus needed to be
| hospitalized?"
|
| > The correct answer is not precisely known, but it is
| highly likely to be between 1% and 5% according to the
| best available estimates, and it is unlikely to be much
| higher or lower. We discuss the data and logic behind
| this conclusion in the appendix.
|
| > Less than one in five U.S. adults (18%) give a correct
| answer of between 1 and 5%. Many adults (35%) say that at
| least half of infected people need hospitalization.
|
| https://www.brookings.edu/research/how-misinformation-is-
| dis...
| base698 wrote:
| From what I can deduce using CDC data my chance of
| hospitalization is 0.5 to 2%. Assuming linear
| relationship of obesity in the population and assuming
| the same risk at the top of my cohort to the bottom.
| Izkata wrote:
| My point was more the last part:
|
| > Many adults (35%) say that at least half of infected
| people need hospitalization.
|
| This is why so many in low-risk groups have been so
| enthusiastic - misinformation that has them thinking it
| really is the Black Death.
| hvac wrote:
| Or maybe people are just terrible at judging acute risks?
| This isn't unique to covid - ask them about flying on an
| airliner or living next to a nuclear power plant and you
| would get some equally comical numbers. At any rate risk
| of hospitalization/death isn't the complete picture since
| some of those young people are ostensibly doing it to
| protect the people around them.
| billti wrote:
| > we normally verify our educated guesses empirically
|
| Love that quote! That's going to be my standard comment from
| now on when I see a pull request that doesn't include any
| test cases :-)
| laplacesdemon48 wrote:
| How would you test the extent of the mRNA's/DNA's impact
| within the cell?
|
| Is it possible to do something like tagging the molecules
| with radioisotopes and following their path?
|
| Here's an example:
| https://www.nejm.org/doi/full/10.1056/NEJM199001253220403
| lamontcg wrote:
| Everyone is the world is either going to be exposed to the
| spike mRNA from the vaccines or the virus.
|
| Pointless FUD to worry about that or even bring it up.
| Pyramus wrote:
| Follow-up question: Do these effects (which are very
| unlikely) differ between vaccine and the virus itself? Or
| maybe: Is the epigenetic risk higher/different?
| UncleOxidant wrote:
| Would this be an advantage for the Novavax vaccine as it
| doesn't do anything to hijack cellular machinery to create
| the spike protein, it just (as I understand it) has a bunch
| of pre-made spike proteins.
| UncleOxidant wrote:
| Whenever you catch a cold or flu those are generally DNA
| viruses (unless it's a coronavirus cold). Those don't alter
| your DNA.
| base698 wrote:
| Eh, yeah they do. We have tons of base pair sequences in our
| DNA that we suspect came from viruses.
|
| https://newsroom.uw.edu/news/genes-%E2%80%98fossil%E2%80%99-.
| ..
| Pyramus wrote:
| Parent specifically stated DNA viruses. From your article:
|
| > Most of these viral genes come from retroviruses, RNA
| viruses that insert DNA copies of their own genes into our
| genomes when they infect cells. HHV-6 is unique because it
| is the only known human DNA herpesvirus that integrates
| into the human genome and can be routinely inherited.
| ceejayoz wrote:
| Being in the nucleus and being integrated into your chromosomes
| so that they are copied during cell division aren't the same
| thing.
|
| https://www.medpagetoday.com/special-reports/exclusives/9160...
|
| > Adenoviruses -- even as they occur in nature -- just do not
| have the capacity to alter DNA. Unlike retroviruses such as HIV
| or lentiviruses, wild-type adenoviruses do not carry the
| enzymatic machinery necessary for integration into the host
| cell's DNA. That's exactly what makes them good vaccine
| platforms for infectious diseases, according to Coughlan.
|
| > And, engineered adenoviruses used in vaccines have been
| further crippled by deleting chunks of their genome so that
| they cannot replicate, further increasing their safety.
| dahfizz wrote:
| This sounds a bit like a technicality. The DNA makes it into
| the cell nucleus and is used by the cell machinery to make
| proteins. The changes aren't carried over after cell
| division, but lots of cells in your body last your whole life
| (nerves, brain cells, eye cells, important stuff).
| ipaddr wrote:
| I was under the impression all cells in the body will be
| regenerated in 7 years.
| laplacesdemon48 wrote:
| Loss of neurons and cardiac muscle cells is permanent.
| Emergency medical personnel are usually taught "time is
| brain" and "time is heart" for this reason.
|
| Some body cells can bounce back after serious trauma,
| liver cells being a prime example:
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2701258/
| chaorace wrote:
| I think the argument hinges on the technicality that it's not
| splicing itself into the host genome, so no chance of it
| becoming a retrovirus or something like that (in the event that
| the cell's lineage is not extinguished by the immune system).
|
| I'm not a genetic engineer (what a time to be alive, eh?), but
| I'm pretty sure an adenovirus that _did_ permanently modify
| cell DNA would be more like CRISPR, including the risks that
| entails (such as the risk of incorrectly splicing the host
| genome and potentially creating a precancerous mutation)
| laplacesdemon48 wrote:
| I didn't want to put this into the parent comment because I
| didn't want to get just shoved into the "vax" vs. "anti-vax"
| bucket by the replies.
|
| But there's a very well known case where DNA delivered via an
| adenovirus killed a teenager during a genetic engineering
| study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC81135/
|
| >> "No one realized that the vector itself might pose a risk"
|
| I'm sure the dosage, type of adenovirus, and modifications to
| the adenovirus are different. But there are obviously still
| risks we don't know about.
| ghthor wrote:
| Don't look at things like that. Shut down your brain and
| take your pilllls.
| laplacesdemon48 wrote:
| I want to be perfectly clear that I didn't bring this up
| to be alarmist. Jesse Gelsinger's death shed a lot of
| light on the risks involved with adenoviruses [1]. Those
| lessons have been carried forward.
|
| >> An autopsy and subsequent studies indicated that his
| death was caused by a fulminant immune reaction (with
| high serum levels of the cytokines interleukin-6 and
| interleukin-10) to the adenoviral vector.
|
| >> The data suggested that the high dose of Ad
| [adenoviral] vector, delivered by infusion directly to
| the liver, quickly saturated available receptors ...
| within that organ and then spilled into the circulatory
| and other organ systems including the bone marrow, thus
| inducing the systemic immune response.
|
| He was injected with >3 x 10^13 viruses [2]. The typical
| J&J dose contain: low-dose (5x10^10 viral particles) or
| high-dose (1x10^11 viral particles) [3].
|
| [1]
| https://www.uab.edu/ccts/images/steinbrook_Gelsinger_-
| _Oxfor...
|
| [2] https://www.cell.com/molecular-therapy-
| family/molecular-ther...
|
| [3] https://www.jwatch.org/na53085/2021/01/26/adenovirus-
| vectore...
| roody15 wrote:
| Just a hunch but I suspect there may be more than "6" cases of
| blood clotting with the vaccine in the US.
| Mvandenbergh wrote:
| Interesting. Almost definitely something to do with adenoviruses
| then. I would imagine that Sputnik probably also has this side-
| effect. I wonder if "wild" adenovirus infection does this too.
|
| Deciding whom to give these vaccines to is a complicated decision
| for each country to make and depends on:
|
| a) The incidence rate for each demographic of CSVT-type clotting
| from the vaccine[s].
|
| b) The expected distribution of clinical outcomes from those
| events, making reasonable assumptions about likelihood of early
| detection and outcomes with treatment for heparin induced
| thrombosis.
|
| Those two give you the clinical cost.
|
| Then you compare those with the clinical benefit from:
|
| 1) The relative likelihood of infection for a person, given their
| demographics, personal exposure profile etc.
|
| 2) The absolute likelihood of infection in the country / region
| in question based on assumptions about the future of the pandemic
|
| 3) The expected distribution of clinical outcomes from infection
| given the person's characteristics
|
| (2) is important because you're comparing a one-time risk of
| side-effects with a time-related risk of infection.
|
| Clearly, the same person in Manaus or Adelaide is not really
| making the same trade-off even if in the abstract, the side-
| effects and IFR are the same.
|
| You also need the counterfactual: If you decide not to give an ad
| vectored vaccine, you are _not_ deciding never to vaccinate, you
| are deciding that this person will get a different vaccine,
| probably later. How much later depends on the location. If you
| 're in the US, you've got Moderna and Pfizer/Biontech coming out
| of your ears so it might only delay any individual vaccination by
| a few weeks. If you're a healthy 25 year old who can work from
| home, the risk trade-off of having to wait an extra 6 days is
| very different than that same person if they have to wait another
| 6 months.
|
| As a result, different countries, looking at the same data will
| rationally make different decisions. The US has lots of mRNA
| vaccines so will choose one thing, the EU has been badly hit by
| the failure of Sanofi/GSK to deliver a working vaccine (and by
| AstraZeneca scaling problems) but has quite a lot Pfizer
| production capacity, the UK has used up its Pfizer stocks and
| will now only use it for second shots. CureVac and Novavax may be
| able to supply some doses at some point but aren't in the picture
| yet. Several European countries are negotiating to get Sputnik
| but that is also ad vectored so may have the same problem. That
| changes the risk calculation because it changes the time that
| people will remain unvaccinated in the counterfactual where ad
| vectored vaccines are not used for their age group.
|
| All of this is before the complicated public health element of
| keeping messages for the public simple and the issues caused by
| changing that message frequently.
|
| I don't know to what degree countries that had set relatively
| high minimum ages for the use of AZ had been counting on J&J for
| younger people. In many cases, AZ deliveries were sufficiently
| slow due to yield problems that it was "free" from a scheduling
| point of view to restrict it to only the oldest since the
| expectation was that they would only receive enough for those
| anyway and could use other vaccines for younger groups. If J&J
| was a big part of that, then they now have to update that
| calculation because the counterfactual to using AZ for those
| people is no longer "do them with J&J next week". That may be
| hard to communicate to people who had been told that a particular
| vaccine was not safe in their age group previously but may now be
| asked to take it anyway.
|
| I'm glad that I don't have to make these decisions. They are not
| easy ones.
| gdubs wrote:
| The online argument about this is raging about whether this is a
| stupid decision and I'd like to side step that well-trodden path
| of vitriol to ask more broadly: what's the deal with Covid and
| blood clotting?
|
| I know personally a long hauler who has blood clotting issues and
| low platelets. They fall into the demographic of concern with the
| JJ and AZ vaccine. Anecdotally we have lost both a close relative
| and a young and healthy friend to Covid blood clotting related
| issues.
|
| Again, I'm not weighing in on the FDA's job. But just saying: as
| someone who's anecdotally been hyper-aware of the blood related
| aspects of Covid, this thread has picked up my ears and I'm
| really interested in finding out what the linkage here is.
| mzs wrote:
| decent layman's explanation - basically similar to heparin
| induced thrombocytopenia and you should be able to find more
| describing that:
|
| https://www.theguardian.com/world/2021/apr/13/astrazeneca-bl...
| mschuster91 wrote:
| Not fucking _again_ , we had enough of this scaring with the AZ
| vaccine. While it definitely is sensible to investigate what
| causes thrombosis in the covid vaccines, the risk of thrombosis
| caused by either Covid19 itself or by everyday medication such as
| the anti-baby pill is _many orders of magnitude_ larger.
|
| It would be great if media still had actual science reporters who
| could inform their readers that while, yes, there _is_ a
| thrombosis risk from the vaccine, you 're way more likely to get
| a thrombosis from your contraceptive.
|
| Unfortunately, most media these days rather prefers scare-
| mongering for clicks.
| Y_Y wrote:
| > anti-baby pill
|
| German is such a pretty language.
| throwaway823882 wrote:
| _The Food and Drug Administration (FDA) said it was acting "out
| of an abundance of caution"._
|
| How is putting millions of people at risk of long-term (or fatal)
| complications from COVID-19 _an abundance of caution_? An
| abundance of caution would mean you give people the vaccine
| because that way, less people will die! Unless a thousand people
| are dying from the vaccine a day, the math is simple!
| fasteddie31003 wrote:
| The FDA are honestly being way too conservative in their
| vaccine ethics. They are letting deontological ethics trump
| consequentialism. My motto lately is FDA PLEASE GET OUT OF MY
| WAY.
| Der_Einzige wrote:
| Deontology is the worst thing that ever happened to ethical
| philosophy. Kant can rot in hell where he belongs for it.
| Y_Y wrote:
| This is the trolley-problem/CYA type of caution.
| ineedasername wrote:
| 6 cases doesn't seem high enough to rise above the baseline
| incidence rate that I would expect for a population of millions
| that have received the vaccine.
|
| The reported data simply doesn't explain stopping use of this
| vaccine. It seems like either:
|
| 1) They are overreacting based on sparse data, which will cast
| doubt on the validity of their actions.
|
| 2) There is information being withheld that implicates, though
| perhaps without certainty, that the vaccine is the specific cause
| of these issues.
|
| Either way, the net result will be more distrust & greater
| reluctance to get vaccinated. There has to be a better way to
| handle this problem.
| bluGill wrote:
| This vaccine is similar to the AZ one which seems to have an
| elevated rate over a much larger sample size. Thus a pattern
| here that matches patterns we expect of the AZ vaccine suggests
| this has the same problem even though if we take the data alone
| it is still within the range of normal.
|
| As such 1 is no longer correct, if we didn't have a compare
| these numbers are high but within expected chance. However
| these numbers are looking like within the range of the compare
| even more than normal.
| ineedasername wrote:
| I agree that 1 seems unlikely, and yet #2 just feels too
| close to a conspiracy theory. The only explanation for #2
| that I can think of that doesn't verge into crazy land of
| coverups is that there may be very specific reasons to
| believe the vaccine is the cause, but not enough confidence
| in that conclusion to release the details publicly without
| risking the vaccination effort if it turns out the vaccine
| was not the issue.
|
| It would help if details were released about the physical
| condition of the 6 people impacted by this. If all of them
| were otherwise perfectly healthy people with no risk factors
| for this sort of issue, then yes-- that's a bit of a smoking
| gun.
|
| But where things stand right now I just don't know what to
| make of the issues, which is just so damn frustrating because
| I know it gives ample reason to anyone inclines to doubt the
| experts or avoid vaccination a reason to do so.
| smiley1437 wrote:
| I think that simple news reporting inadvertently screws up how
| the general public perceives low-probability events.
|
| Whether it's an airplane crash or a blood clot caused by a
| vaccine, human minds simply can't 'feel' that a phenomenon is
| rare when it is repeated over and over again in their newsfeed.
| endisneigh wrote:
| I love how people are complaining about this decision without
| addressing the fact that there are two other vaccines that don't
| have this issue that have been used orders of magnitude more.
|
| Why wouldn't you pause J&J? It's just a drop in the bucket in
| total vaccinations anyway and the other two don't have this
| issue.
| xwdv wrote:
| J&J was the best option for those who didn't want to dabble in
| experimental vaccine tech. Now there is no choice.
| endisneigh wrote:
| J&J is objectively more dangerous. So what argument do you
| have to not pause it given the "experimental" tech is orders
| of magnitude safer?
| amluto wrote:
| J&J is an adenovirus vector vaccine, which is barely less
| experimental than mRNA. AFAICT the _only_ licensed adenovirus
| vector vaccines are for Ebola, and those have not been used
| very widely.
|
| Earlier attempts to use adenovirus vectors for gene therapy
| had issues due to, wait for it, thrombocytopenia.
|
| The the one and only COVID vaccine that uses more or less
| tried and true technology and looked excellent in trials is
| Novavax. (AIUI Novavax's adjuvant is newish, fancy, and not
| necessarily that easy to scale, and it may well be
| responsible for the excellent performance.)
| stickfigure wrote:
| According to the article, 6.8 million people in the US have
| received the J&J shot. Without the J&J vaccine, those people
| (6.8 million others) would not be vaccinated due to lack of
| supply.
|
| The US CDC website[1] currently says the 7-day death rate per
| 100k people is 1.4. Without the J&J vaccine, that's almost 100
| additional people dying _per week_ - and just in the US.
|
| [1] https://covid.cdc.gov/covid-data-
| tracker/#cases_deathsper100...
| endisneigh wrote:
| Is your logic basically that as long as the vaccine kills
| fewer people than COVID all is well?
|
| Pausing briefly to investigate this seems prudent. If we had
| the same prudence with COVID overall we wouldn't be in this
| situation to begin with.
| stickfigure wrote:
| We know with near-certainty that pausing to investigate
| will produce _more_ death than not-pausing while
| investigating.
|
| It's really not complicated. Count up the bodies in Column
| A, count up the bodies in Column B, then pick one.
| dylan604 wrote:
| Isn't this why Europe pushed pause on Astra Zeneca's vaccine?
| hnburnsy wrote:
| From the CDC, updated today...
|
| "Over 189 million doses of COVID-19 vaccines were administered in
| the United States from December 14, 2020, through April 12, 2021.
| During this time, VAERS received 3,005 reports of death
| (0.00158%) among people who received a COVID-19 vaccine."
|
| https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/ad...
| paulcole wrote:
| Everyone posting here confidently saying that the FDA is clearly
| wrong is pretty disappointing to me.
|
| I think of all the comments about how "MBAs" and "marketing
| people" just don't get software development. And then I look at
| software development people who seem to think they clearly get
| medical research and regulation.
| benchaney wrote:
| The problem is with how they are handling their data. You don't
| have to know anything about biology per se to see the issue. It
| is entirely mathematical. By the way, the medical establishment
| has a terrible track record surround use of and understanding
| of statistics. I don't think it's right to suggest that self
| described experts are somehow infallible.
| paulcole wrote:
| I'll take self-described experts who work at the FDA over
| self-described experts on a social media site like HN.
| textman wrote:
| "The incidence of cerebral venous thrombosis (CVT) varies between
| studies, but it is estimated to be between 2 and 5 per million
| per year. A recent study in the Netherlands with comprehensive
| ascertainment suggested a much higher incidence."
| https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0...
|
| So the six reported cases in 6.8 million vaccinations seems low.
| Glad I read about all this because I got the J&J vaccine 12 days
| ago. No noticeable side effects so far. I exercise a lot and did
| a 5 mile hike four days ago that resulted in a slightly strained
| a calf muscle. I have been taking it easy the past few days,
| meaning sitting and reading a lot more than usual. So after
| learning about the blood clotting, have started exercising the
| legs frequently. My optimistic thinking is that even if the
| vaccine does cause an increased risk of CVST that risk can be
| eliminated via exercise.
|
| It will be most interesting to learn if those six cases involved
| people at high risk, if they exercise regularly, etc.
| ffggvv wrote:
| seems like they were all young women. so let's say young women
| make up 1/4 of those vaccinated.
|
| for them it's more like 1/250k
| foobiekr wrote:
| But not _young_ women. We may be seeing something legitimate.
| Decabytes wrote:
| That's what I keep saying! People are saying it's 1 in a
| million chance, but unless all the people who got the vaccine
| were women than it's not. The instance could be far higher
| but it's not possible to know without knowing how many were
| given to men vs women
| jerf wrote:
| "So the six reported cases in 6.8 million vaccinations seems
| low."
|
| No, because those 6 cases are something more like "1 per day"
| rather than "per year". Or maybe "per week". But either way,
| you need to multiply the "per year" base rate by a large number
| to get the base rate for "coincidentally happened immediately
| after a particular event", for some definition of
| "immediately".
| foobiekr wrote:
| They also appear to cluster in young women and one young man
| (from the phase 3), do it's quite probable that the "6
| million" is not representative.
| foolmeonce wrote:
| It's reports within 3 weeks, so something like 18 per million
| per year.. The larger danger is any interaction with an
| automobile to get to the appointment.
| foxhop wrote:
| My wife says this is not about exercise, while living a healthy
| lifestyle is good, apparently this specific condition causes
| clots to form in the brain itself as a result of low platelets.
|
| CVST with Thrombocytopenia is the name.
| phnofive wrote:
| Similar to AZ, all six were women between the ages of 18 and
| 48.
| 5cents wrote:
| 20% male (1 patient) in this report
| https://www.nejm.org/doi/full/10.1056/NEJMoa2104882
| robbiep wrote:
| If you're doing the calf exercises to ward off a DVT, (and not
| to just stretch your strained calf!) you may be barking up the
| wrong tree.
|
| The preliminary theories (backed by the thrombocytopaenia) are
| that, if there's a vaccine induced thrombosis with
| thrombocytopenia, it is probably immune-mediated (similar to
| HITT - heparin induced thrombocytopenia and thrombosis).
|
| And then there's some weird thing that makes them form in your
| venous sinus.
|
| But there were also reports of more typical blood clots (ie
| DVTs), the first European Medicines Agency advisory (0) said
| that this was within the level of noise (im now talking
| AstraZeneca, so apologies for shifting vaccine as generally
| they should be considered separately until the evidence catches
| up, although everyone is quickly drawing parallels between
| them)
|
| (0) https://www.ema.europa.eu/en/news/covid-19-vaccine-
| astrazene...
|
| Ps apologies for not referencing around HITTs and theories
| around antibody-mediation for CVT. Basically it's all pretty
| noisy anyway at the moment and so my here-say from the medical
| tea rooms is as good a gossip as any, as long as everyone is
| aware that no one really has any definitive idea what _may be_
| going on yet
| davak wrote:
| Good take.
|
| Arterial clots with thrombocytopenia is incredibly rare.
| Additionally the PF4 activity in these patients is very
| abnormal and appears to be to immune mediated. Lots of
| science and focus going into the mechanism around this now.
| The other recent NEJM articles around clots associated with
| the other adenovirus COVID vaccines are likely a similar
| phenomena.
| chemeng wrote:
| Agreed, I don't think anyone knows clearly what is happening.
| Some additional points that are related.
|
| Thrombocytopenia has been a known complication of adenovirus
| vectors that researchers have worked to overcome in recent
| decades.
|
| These incidents mirror HITT (women are at higher risk for
| HITT) and seem to be happening in the timeperiod where IgG
| titers spike post vaccination.
|
| To me this indicates it's not unlikely something with the
| adenovirus vectored vaccines (J&J, AZ) is causing this issue.
| And because this thread seems to have gone to hell, I'll add
| that I support doing subgroup specific risk calculations and
| allowing vaccinations to proceed where it makes sense.
|
| https://jvi.asm.org/content/81/9/4866 https://ashpublications
| .org/blood/article/109/7/2832/125650/...
| https://pubmed.ncbi.nlm.nih.gov/17148587/
| Pyramus wrote:
| Just want to add that this is not a new theory and has been
| circulating in medical circles for roughly a month [1].
| There is also the hope that when it happens it can be
| diagnosed and treated.
|
| [1]
| https://twitter.com/LJohnsdorf/status/1371721321336475651
| (in German)
| tpoacher wrote:
| 2-5 per m per y is an incidence over the entire year. Assuming
| a uniform distribution over the 365 days, then the probability
| of getting it "on that day" becomes a probability of 1-2 per
| billion.
|
| So the reported cases of are not comparable. They are really,
| really high.
|
| And while I agree about the relative risk vs covid, again this
| is not a fair comparison. For many people who are isolating,
| then a person never leaving the house has a very low risk from
| covid, both personally and transmitting it. You are not asking
| people to exchange a very small risk from the vaccine vs a very
| high risk from covid. You are asking them to exchange a very
| small but roulette-like risk from the vaccine, versus a
| presumably equally small if not smaller risk from covid due to
| their circumstances.
|
| Note, what I am "not" saying is that peoples shouldn't be
| vaccinated. I'm just saying artificially trivialising the risk
| further using bad math isn't doing anyone any favours.
| pablodavila wrote:
| I was planning on getting the J&J because I will most likely only
| be able to get one dose. Is a single dose of the mRNA vaccines
| effective in any meaningful way?
| jghn wrote:
| It has similar efficacy as the single dose J&J
| Trasmatta wrote:
| Yes, perhaps around 80% effective after one dose of mRNA:
| https://www.cnbc.com/2021/03/29/cdc-study-shows-single-dose-...
| brian_herman wrote:
| I got the Johnson and Johnson vaccine and I feel fine but this
| news troubles me.
| InTheArena wrote:
| I see a lot of arguments that are basically "people are too
| stupid to understand risk". That, in turn, comes from the fact
| that the FDA/CDC/NIH has not covered itself in Glory the last
| many years. Covid just uncovered the rot, while Trump danced
| around it, and poured gasoline on the fire.
|
| The best thing to get people to understand risk is to actually
| follow the process in the EUA. Pause, evaluate the outcomes,
| change the labels and dosing. Which this does.
|
| At the same time, the FDA/CDC need to start taking other
| countries data into account. At this point, there is no excuse
| not to be using a UK style "first dose first" strategy,
| especially if mRNA is all we have for a while.
| hedora wrote:
| I'm not sure I understand your argument (and I'm guessing the
| downvoters aren't either). This is a situation where the
| process will definitely, unambiguously, kill more people than
| moving forward with the vaccine.
|
| I guess you're suggesting culling a small fraction of the
| population might encourage better behavior at the voting booth?
| We already have plenty of historical evidence suggesting that's
| not true.
| edmundsauto wrote:
| I'm not sure how your last graph followed from GP's post -
| are you replying to the right comment?
|
| GP was saying that the US health agencies haven't looked very
| good in the past few years, and on Covid, they really have
| fumbled the comms execution. Before Covid, these issues
| existed in the agencies, but that was highlighted by the
| emergency + executive branch that was either incapable or
| unwilling to make it a priority. That's when it's even more
| important for our processes, led by our major agencies, to be
| crisp.
|
| None of this past year was unpredictable. If these health
| agencies are so affected by the whims of politics, it reveals
| a systemic flaw.
| RIMR wrote:
| "Killing people to teach them about risk" seems like a bad
| decision, especially if the endgame is to save lives.
| jdauriemma wrote:
| Behold, the vaccine experts of Hacker News!
| throwaway0a5e wrote:
| Who are just as accurate, trustworthy and impartial as the
| technology experts on the 5pm news and the life coaches of
| Reddit.
| symlinkk wrote:
| Are we not allowed to discuss something unless we have a PhD in
| that field?
| weakfish wrote:
| You can discuss it, but platforms tend to allow echo chambers
| to pop up where people listen to non-experts to confirm their
| biases.
|
| We should only be taking medical advice from PhD, I would
| argue.
| js2 wrote:
| The risk of dying from a blood clot after receiving the J&J
| vaccine is six in 6,800,000 (6.8M). The world population is
| 7,900,000,000 (7.9B). If everyone on the planet got the J&J
| vaccine tomorrow, and if it is the cause of the clots, then 6,971
| people would die from the vaccine.
|
| Yesterday, Covid19 killed 8,803 people (according to
| worldometers).
|
| We don't want anyone to die from vaccination, and we don't fully
| understand what the clotting issue is, so it probably makes sense
| to pause using J&J as long as the mRNA vaccines (Pfizer, Moderna)
| have not been implicated (which they haven't). OTOH, if this
| being in the news causes fewer people to get vaccinated, pausing
| it may be a mistake that will cause more overall deaths.
|
| Now, your risk of dying either from vaccination or Covid19
| depends on various demographic factors not accounted for in my
| math above. But, nonetheless, the risk of dying from the J&J
| vaccine is really, really, really tiny.
|
| Like, if I knew there was a 0.00009% chance my car were going to
| explode every time I got in it and started it, I would not be at
| all nervous about starting my car everyday for the rest of my
| life. I'm way more likely, even accounting for my age
| demographic, to choke to death eating dinner tonight (5,051
| deaths from choking in the U.S. in 2015 of which 2,848 were older
| than 74).
|
| Edit: lifetime risk of car exploding assuming I start it every
| day for 50 years is about 1.6%. Okay, maybe I wouldn't play that
| game.
| [deleted]
| wincy wrote:
| I went to the emergency room for earth shattering headaches (no
| history of headaches like this) after getting the J&J vaccine
| last week. I mentioned I'd got the vaccine and asked if it was
| possible the two were linked. The doctor did everything but
| actually roll his eyes and thought that the headache being
| caused by the vaccine was ridiculous.
|
| I bet if I went today he wouldn't be so dismissive.
| cyberlurker wrote:
| Would he somehow check for blood clots? What could that
| doctor have done?
| pvarangot wrote:
| Give you blood thinners like aspirin?
| tpoacher wrote:
| Actually, I bet he'd be even more dismissive.
| nawitus wrote:
| That's odd, as headache is a common symptom for many vaccines
| (or pretty much any medicine).
| autokad wrote:
| a thunder clap headache is also a symptom of a stroke.
| lupire wrote:
| ...which is a kind of blood clot.
| AndrewBissell wrote:
| Did you report it to VAERS?
| textman wrote:
| I read one of the six died. Has there been a news update that
| all six have died?
| da_big_ghey wrote:
| But you are having conflate for deaths from each of things.
| Rates in dying are not homogeneous in J&J vax versus corona.
| J&J vax maybe is received by many younglings who are not
| risking death so much from Corona for benefit of old. It is not
| yet being known for if J&J vax is having any greater risk for
| older people or younger people. So calculus is maybe not so
| simple. If I are healthy young person maybe it is not a
| beneficent risk for taking.
| xiii1408 wrote:
| This is an excellent point, and exactly the reason why the UK
| decided to stop administering the AstraZeneca vaccine to
| people under 30. Not sure why you're being downvoted.
|
| For people under 30, particularly women, the risk of blood
| clots from AZ is _higher_ , while at the same time the risk
| from coronavirus infection is _lower_. When there are
| alternative vaccines available with no evidence of similar
| side effects, it makes sense to temporarily stop
| administering AZ /J&J to those groups to investigate if there
| are any risk factors we can use to predict and protect those
| who may be most vulnerable to side effects. (It has been
| suggested that young women on certain types of birth control
| are at highest risk of blood clots after AZ.)
|
| That said, as some have pointed out, the risk of blood clots
| is still thought to be _very_ low, even for women under 30,
| and anti-vax groups as well as the vaccine hesitant may see
| this news as a sign that it 's not safe for anyone to take
| any vaccine. However, I don't think we as a society should
| actively try to conceal news or research about vaccine safety
| so that people don't worry. In my opinion, people have a
| right to know, and efforts to conceal concerning information
| often backfire, producing more public distrust.
| [deleted]
| tacitusarc wrote:
| 6 obvious deaths that we're aware of. The risk of the vaccines
| is in their novelty and morbidity. An abundance of caution is
| required in this instance. It would be very bad to discover
| that there's a vanishingly small chance of blood clots within
| the first 3 months but a significant chance when paired with
| other events over the following decade.
| dragontamer wrote:
| > 6 obvious deaths that we're aware of.
|
| 1 death. The other cases are severe blood clotting but still
| alive by my understanding.
|
| That's literally one-in-6-million chance of death with
| regards to this blood-clotting issue. A vanishingly smaller
| chance than the 1-in-40,000 (or 150-in-6-million) a healthy
| young person has of dying of COVID19.
|
| So 1 death, 5 severe reactions related to blood clotting.
| Definitely a cause of concern, but lets not overplay the
| stats here.
|
| This just another "Trolley problem": 150-people (even
| youngsters) would die from COVID19 vs the 1-person who died
| from the J&J vaccine.
|
| If we include the general population (instead of focusing on
| the youngest and healthiest of us): COVID19 mortality rate is
| 1%ish, or 6000-people-per-6-million.
| strikhedonia wrote:
| It's actually one obvious death we're aware of--the other
| five are still alive. Though that doesn't change the calculus
| much.
| rllearneratwork wrote:
| yeah, and how many got "non-severe" clots? Obviously, it
| isn't a binary situation like: you are 100% OK vs you are
| dead from clot.
| Exmoor wrote:
| You'd have to compare that to the chances of the long term
| effects of COVID causing issues down the line, which I'm
| willing to heavily bet is much more likely given what we've
| seen so far.
| MikeCapone wrote:
| There's already been large scale phase 3 trials, and we've
| deal with vaccines for decades, they're not entirely novel
| and unknown each time.
| ttesttom wrote:
| The phase 3 trial for JnJ/Janseen had only ~44k
| participants whereas here we are talking on the order of ~1
| per million (that are reported as of today)
| SV_BubbleTime wrote:
| > we've deal with vaccines for decades
|
| I don't think that's accurate in this case. The type of
| vaccine that J&J released had up until months ago only ever
| been deployed in animals.
|
| IIRC pigs had a problem with corona viruses that we solved"
|
| The J&J is not a heap of dead virus like the common ones we
| have had forever. But a live harmless (we think) virus
| dolled up to look like Rona Corona.
| adgjlsfhk1 wrote:
| Live harmless vaccines aren't anything new. Some of the
| TB vaccines from the 60s are of that variety. Live virus
| vaccines have safely been used for at least the past 5
| decades. Stop spreading bullshit.
| titzer wrote:
| I wish people applied this much caution to the virus. Who
| knows what cancers it causes 10 years down the road.
| TrevorJ wrote:
| Do any corona-family viruses cause cancers that we know of?
| titzer wrote:
| I don't know. But HPV and Herpes definitely can. Here's
| some more:
|
| https://www.cancer.org/cancer/cancer-causes/infectious-
| agent...
|
| It takes quite a long time to prove the link between a
| viral infection and a cancer that develops decades later,
| so it'll be a while before we know for sure.
| TrevorJ wrote:
| I think that given the fact that we've been getting sick
| from corona-family viruses for years with no suspected
| link to cancers, this should be of relatively low
| concern, barring any specific information.
|
| There are other potential longer term side effects that
| at least seem to have some emerging data to back them up,
| which seem more concerning to me.
| krona wrote:
| We have 17 years of SARS-CoV-1 patient data. We're even
| using their antibodies to treat COVID-19.
| titzer wrote:
| 8000 infections of SARS worldwide. It took how many
| hundreds of millions of HPV infections and cancers to
| detect the link?
| [deleted]
| amelius wrote:
| Some experts have said that it's probably an immune reaction
| to the adenovirus which is used as the delivery mechanism in
| the vaccine. Wouldn't the side effects therefore be limited
| to the first weeks after the injection only?
| newaccount7 wrote:
| So I created a new account for this to avoid linking personal
| information...
|
| I had blood clots in my lungs last week a few days after
| getting the J&J vaccine. I'm an otherwise totally healthy man
| in my 30s, no preconditions. The hospital reported it to the
| vaccine reporting agency, which I assume is reviewing all
| this information.
|
| I'm not sure if they considered my case when making this
| decision. My clots were different type than what these women
| experienced (pulmonary, not cerebral).
|
| Of course vaccinating the public is extremely important right
| now. If the risks of clotting really are 1 in a million, it
| makes sense to re-instate it. I also think that's an obvious
| conclusion and the people working on this are well aware of
| the public health trade-off.
|
| I suspect they are working with more information than what's
| in the press release, and its prudent to give them some time
| to work through it.
| fspeech wrote:
| Clotting happens much more frequently with or without
| vaccination. The reported cases are a kind of very rare
| type of clotting. It's easier to spot something unusual
| going on when mutiple rare events are observed.
|
| In comparison there have been over 2000 deaths reported
| (US, all vaccines). But death is not unusual and unless one
| can find a specific link to vaccination that number alone
| is not alarming. Sometimes we live with known risk,
| anaphylactic shocks e.g., because they are unavoidable and
| benefits outweigh risk. But we do what we can to mitigate
| such risk.
|
| In summary the current pause is triggered by the particular
| type of clotting, not just any clotting. But your case
| should contribute to the overall evaluation of the likely
| cause and risk.
| SV_BubbleTime wrote:
| The PR release tells people to watch for pain in their
| legs. So I think it's possible and likely that clots are
| not only cerebral but arterial and venous.
|
| But, IDK and I'm super skeptical they're willing to halt
| vaccine and take this hit for 6 known cases. My guess is 6
| deaths they're willing to acknowledge and a few more cases
| that will come out.
|
| But again, I know nothing and I would've expected their
| stock price to take a hit today.
|
| Hope you get better soon.
| newaccount7 wrote:
| Thanks. As I've now learned, almost all of these clots
| originate in the legs and pelvis and then travel to other
| parts of the body (lungs, brain).
|
| So I think that's why they're telling people to watch for
| leg pain. I didn't have any issues with my legs, but it's
| apparently a common symptom to have pain and swelling
| there.
| roody15 wrote:
| I agree for the US to pause the rollout is likely based on
| more data than 6 known cases of clotting. Not trying to be
| conspiratorial but my two cents is the authorities have
| more data then what is publicly being shared.
| chrisco255 wrote:
| These are not vaccines. They are gene therapy marketed as
| vaccines. No one has any clue as to their long term side
| effects. The under 30 odds of death for Covid-19 are
| statistically zero percent. The rush to inject a brand new
| medication into the entire world pop without regards for
| individual risk profile is ridiculous, reckless, madness.
| lucasmullens wrote:
| > No one has any clue as to their long term side effects.
| The under 30 odds of death for Covid-19 are statistically
| zero percent.
|
| Can't you flip that around? No one has any clue as to the
| long term side effects of Covid-19. The under 30 odds of
| death for getting the vaccine are statistically zero
| percent.
| titzer wrote:
| 110+ million vaccinations in the US and holy goddamn, no
| major issues. 31 million infections and 550,000+ dead, in
| a year. Millions of long haul COVID cases. Debilitating
| lung conditions, brain fog, last consequences _already_
| from the virus, and you wanna crow about long term
| consequences _of the vaccine_. What in the actual
| roasting hell.
|
| I've noticed you, specifically, posting pro-virus
| misinformation since the very beginning. Half a million
| people died, man. I wish you would just spare us your
| trolling, damn it!
| chrisco255 wrote:
| You have no idea, those people received this treatment 2
| months ago. You absolutely have no clue what long term
| effects are one year out, five years out, 10 years out.
|
| Stop violating people's human rights to make their own
| individual medical choices. Their body, their choice,
| none of your business.
| jjulius wrote:
| >Stop violating people's human rights to make their own
| individual medical choices.
|
| What are you even referring to? Literally no one has to
| get a vaccine if they don't want it. Nobody in the
| comment chain you're replying in had advocated for forced
| innoculation. This is 100% already a "their body, their
| choice" situation.
| adgjlsfhk1 wrote:
| This is false. MRNA vaccines have no relation to gene
| therapy. MRNA is not turned into DNA by the body, and is
| fully gone from the body within a couple days. As such,
| there are no possible long term effects related to the
| vaccine being MRNA vs traditional protein based vaccines.
| yumraj wrote:
| what were your symptoms that led you to go to the hospital
| to get checked for clots?
|
| What is someone getting a vaccine as such is supposed to
| look for?
| newaccount7 wrote:
| I got a little out of breath doing simple tasks like
| walking briskly or picking up my kids, and I had a pain
| in my back (actually lung) that gradually got worse over
| a few days.
|
| Eventually the pain was severe enough that I went to the
| ER.
|
| Looking back, the shortness of breath was a key
| indicator. It wasn't that I was struggling to breathe or
| anything, but I felt like I couldn't take a big deep
| breath easily and that's not normal.
|
| The pain would also get worse at night when I tried to
| lie down to go to sleep. I thought I had pulled a muscle
| in my back at first, but it was quite painful.
| yumraj wrote:
| Thanks. I'm hoping you're well now and the clot was
| treated.
| blub wrote:
| "Now, your risk of dying either from vaccination or Covid19
| depends on various demographic factors not accounted for in my
| math above. But, nonetheless, the risk of dying from the J&J
| vaccine is really, really, really tiny."
|
| Unless this is a repeat of AstraZeneca, where many were
| lamenting the interruption of vaccination and calculating the
| risk for the entire population of people injected with AZ.
| Meanwhile, in some countries, the risk of dying from the
| vaccine for _young women_ was higher than the risk of dying
| from the virus.
|
| After the concerns about AZ turned out to be justified and AZ
| being banned for certain age groups you'd think that people
| would get a clue about unconditional vaccine cheerleading.
| kaczordon wrote:
| _OTOH, if this being in the news causes fewer people to get
| vaccinated, pausing it may be a mistake that will cause more
| overall deaths_
|
| This is the reason people lost trust in the medical community
| during COVID.
| cyberlurker wrote:
| Yes, the fact that they are being this cautious is a good
| thing for public trust. We have other vaccines as well. I
| rather have this level of transparency then blindly tell
| people to get JJ and we will figure out edge cases later.
| mujina93 wrote:
| Is it that good? There are places where lots of people are
| refusing to get the vaccine if they hear it's Astra-Zeneca,
| because of all the overblown nightmarish news around it. I
| can tell you for example that in Italy there are examples
| of regions where 80% of people refuse.
|
| I understand the need for being cautious and for
| transparency. Actually, I would like to have even more
| transparency and actual scientific data and numbers from
| the news. That would help the public understand better why
| certain decisions are made.
|
| (Maybe my main problem is just with mainstream press, not
| much with stopping vaccinations per se. I'd just like to
| know more and be told by politicians: we are listening to
| scientists, these are the data, this is how numbers compare
| to the incidence of other side effects for well known
| medicines and to the numbers of daily deaths and long term
| problems caused by COVID, and the decisions are taken
| because X > Y).
| niyikiza wrote:
| Another factor to consider is that COVID is contagious but
| blood clots are not. The multiplicative (if not exponential)
| nature of COVID spread makes this a no brainer that the vaccine
| should be reinstated (and just monitored).
|
| I suspect that what's happening is that these institutions
| don't think in consequentialist point of view. They are not
| comfortable with diverting the trolley even if the math checks
| out.
| dheera wrote:
| Why is everyone worried about blood clots, and not that the J&J
| vaccine has a crap-tastic efficiency of 66.3%?
|
| Would you want the chef at your local takeout to be vaccinated
| to 66.3% efficiency? or 94%?
|
| Why was this vaccine even approved, instead of just having J&J
| produce the same vaccine Pfizer and Moderna are making, which
| would be in the best interest of the world? Is this some
| utterly idiotic capitalism bullshit that prevents J&J from
| making a 94% vaccine as well?
|
| Why can't we just take $100B out of the $1T military budget,
| throw it at Pfizer and Moderna to shut up their patent lawyers,
| and then hand the formula to J&J to become a 3rd factory for a
| good 94% mRNA vaccine?
|
| And then hand that formula to the rest of the world including
| Brazil, India, China, and other recent new COVID hotspots so
| that the virus doesn't boomerang back to the US in an evolved
| form?
|
| At least that's what I would do if I was president.
| e9 wrote:
| This is not full story. 65% efficacy against symptomatic
| COVID-19 but 100% efficacy against death and hospitalization
| due to COVID-19. So there is real benefit to it.
| dheera wrote:
| Yes, but 65% efficacy still means that 1/3 of the
| vaccinated people will continue to be spreaders, which
| doesn't sound great, especially if that allows the virus to
| spread and evolve into a harsher variety.
| savanu wrote:
| The different efficacy rates of the vaccines do not
| directly imply anything about spreading covid.
|
| A vaccinated person can have no symptoms of covid and
| still be spreading (This may or may not be true).
|
| Folks are still studying how effective the vaccines are
| at preventing spread.
| cactus2093 wrote:
| > A vaccinated person can have no symptoms of covid and
| still be spreading
|
| Aren't the efficacy numbers from the phase 3 trials based
| on giving periodic PCR tests to everyone that was
| participating in the trials? And not just based on people
| self-reporting symptoms?
|
| It would be very surprising if there were a new kind of
| asymptomatic carrier that emerged only for people having
| taken certain vaccines in which they would never test
| positive on a PCR test but could still spread covid. The
| odds that this is how the vaccines work seems very small,
| relative to the number of times this argument that "we
| don't know yet" is getting repeated.
|
| It just seems strange to me that so many people are hung
| up on pointing out that this small possibility is still a
| possibility. It seems more likely that this will drive
| more people to skip the vaccine, since they're being told
| they can't even go back to normal once vaccinated, than
| anything else.
| xiii1408 wrote:
| Depends on the particular trial, but the clinical trial
| data used to get FDA approval usually measures
| _symptomatic cases_ , which is a combination of
| coronavirus symptoms and positive PCR test.
|
| There's some additional data which indicates Pfizer and
| Moderna are likely to limit transmission, but from my
| understanding it's not as ironclad as the symptomatic
| cases data.
| DiogenesKynikos wrote:
| > Aren't the efficacy numbers from the phase 3 trials
| based on giving periodic PCR tests to everyone that was
| participating in the trials?
|
| For most trials, no. You have to look at each individual
| study, but most commonly, they only test _after_ people
| show specific symptoms.
| savanu wrote:
| I don't think the fact that you _might_ be still
| spreading covid when vaccinated is enough of a reason to
| continue lockdown. As long we are continually getting
| people vaccinated, we should be fine for returning to
| normal.
| kazinator wrote:
| Keep in mind that a door handle is completely immune to
| Covid and can be spreading it.
| dheera wrote:
| Only for a few hours though, not 2 weeks+, and viruses
| don't mutate on a doorknob. Someone who got vaccine and
| falls in the ineffective category will likely not die but
| will be a spreader for a few weeks, with some nonzero
| probability of mutation, and that times 1/3 of the
| population that got the vaccine would give the virus a
| lot of opportunity to mutate.
| kazinator wrote:
| According to some experts, Covid-19 can endure on certain
| surfaces for as long as six days.
| [deleted]
| dheera wrote:
| Okay, but until they're done studying, maybe let's just
| make more of the 94% vaccine using J&J's facilities?
| ghaff wrote:
| You do realize that different manufacturing facilities
| are not interchangeable? They're not a rack of x86
| servers.
| thelean12 wrote:
| At this stage, getting as many people to near 100% death
| avoidance and with some immunity is the goal.
|
| We're not at a stage yet when we can play favorites.
| It'll be a long time before we have the supply to prefer
| one over the other (except maybe in the US where there
| will be enough mRNA vaccines to go around).
| M_bara wrote:
| Not necessarily. Efficacy measures are about protection
| from hospitalisation or death if you contract COVID. It
| doesn't imply loss of viral shedding. There's a vox video
| on YouTube that explains this...
| TrevorJ wrote:
| This is a leaky vaccine, which is actually a big health
| risk. You remove selection pressure for lack of virulence,
| so more fatal strains can spread more easily. Definitely
| not a good thing.
| narrator wrote:
| I know about Marek's disease in chickens, but has a leaky
| vaccine ever caused a virus to evolve like that in
| humans?
| TrevorJ wrote:
| Would there be anything in particular about the study of
| that case which would not be valid in humans? I've seen
| articles/studies from before Covid that suggest this sort
| of thing could be a concern in humans, but no reported
| cases of it happening. On the other hand, we don't
| exactly have a control group, so there's not a good way
| to tell.
| Reason077 wrote:
| > _" Why is everyone worried about blood clots, and not that
| the J&J vaccine has a crap-tastic efficiency of 66.3%?"_
|
| The J&J vaccine is marketed as a single-dose vaccine, unlike
| the others which all require two doses to reach their
| reported efficacy. Single-dose is a massive advantage which
| will greatly speed up vaccination progress, especially in
| developing countries.
|
| And 66% seems pretty good for a single dose.
| happycube wrote:
| If nothing else, the logistics of transporting J&J make it a
| lot better in a lot of cases. Pfizer in particular needs to
| be transported super-cold, and Moderna needs to be frozen as
| well. J&J can be handled much more like a flu shot.
|
| That said, I'm smarting a bit (even though I understand why)
| that the fully vaccinated guidelines cover 2 weeks after J&J,
| while it's looking likely the mRNA vaccines give you better
| protection even 2 weeks after the first shot. (You really
| _do_ want the second... the 6-month Moderna study shows you
| get about 10x the antibodies from the second one, which means
| the protection lasts much longer if nothing else.)
| Exmoor wrote:
| The limits of mRNA vaccine manufacturing are that it's a new
| process and the technology and supply chain required to
| produce it are very hard to get right. Derek Lowe does an
| excellent job of debunking the simplistic "Why don't they
| share the design" argument here:
|
| https://blogs.sciencemag.org/pipeline/archives/2021/02/02/my.
| ..
| morpheuskafka wrote:
| > And then hand that formula to the rest of the world
| including Brazil, India, China, and other recent new COVID
| hotspots so that the virus doesn't boomerang back to the US
| in an evolved form?
|
| Such a vaccine would also have two doses and require intense
| refrigeration which are the primary issues blocking it...
| additionally many of those jurisdictions might not accept a
| US vaccine. China, maybe, since they admitted their own
| vaccines aren't working super well. Russia doesn't have
| anything wrong with its vaccine but the Kremlin admitted no
| one is taking it, apparently because they don't believe in
| covid.
| happycube wrote:
| It's kinda funny how Sputnik-V felt like a rushed publicity
| stunt... and later on it turned out it might actually work.
| DiogenesKynikos wrote:
| > China, maybe, since they admitted their own vaccines
| aren't working super well.
|
| Despite what the press has reported, that's not really what
| happened. In a conference talk on vaccines, the head of
| China CDC made a general statement about what to do about
| "low vaccine efficacy." That's been blown up in the Western
| media into an "admission" that all Chinese vaccines
| supposedly have low efficacy.
|
| It doesn't even make sense to talk about the efficacy of
| "Chinese vaccines." Chinese vaccines run the gamut, from
| inactivated whole virus to protein subunit to adenovirus
| vectors. There's even a Chinese partner to Biontech, which
| is going to manufacture the latter's mRNA vaccine.
| jackbrookes wrote:
| The percentage efficacy can be misleading, it is not a like-
| for-like comparison.
|
| https://www.vox.com/22311625/covid-19-vaccine-efficacy-
| johns...
| TrevorJ wrote:
| >The risk of dying from a blood clot after receiving the J&J
| vaccine is six in 6,800,000 (6.8M)
|
| _that we know of_.
|
| I suspect the lack of understanding about what is happening,
| and what other knock-on effects there might be is what is
| behind this.
|
| If a wing falls off of one airplane in a million, we still stop
| and try to figure out what happened because as far as we know,
| wings are not supposed to fall off _any_ airplanes, so there 's
| something about the system we need to learn more about.
| lupire wrote:
| Every day, 300 people in USA get a blood clot. It's not
| wanted, but it's expected.
|
| https://www.cdc.gov/ncbddd/dvt/features/blood-clot-risk.html
| TrevorJ wrote:
| I had wondered about this as well - in the pool of people
| who have gotten the J&J vaccine, how many would we expect
| to have developed a blood clot under normal circumstances
| anyway?
| mujina93 wrote:
| But airplaines are engineered by humans, we know everything
| about how they are supposed to work until the last bit of
| physics.
|
| We don't have the same absolute understanding of mechanisms
| with vaccines. Therefore, I am not sure we can use this
| metaphore to suggest that it is the right choice in this
| terrible time to stop vaccinations, causing slowdowns to
| happen and scepticism to spread in the population that is
| bombarded by the press which creates an echo chamber
| repeating over and over superficial news.
|
| I personally don't expect a vaccine, nor any medicine in
| general, to be supposed to have absolutely zero incidence of
| possible negative side effects.
| TrevorJ wrote:
| >stop vaccinations
|
| We aren't stopping vaccinations. We are stopping _this_
| vaccine. For the moment. To gather more information. Which
| is _precisely_ the kind of responsible behavior that we
| need, if we want people to be less skeptical of the vetting
| process for these vaccines.
|
| >We don't have the same absolute understanding of
| mechanisms with vaccines.
|
| Wouldn't this support _more caution_ , not less?
| slibhb wrote:
| If there is solid evidence that a vaccine will kill people, it
| should not be used. It's intolerable that people die taking a
| prophylactic.
|
| It's much, much worse to kill someone with a vaccine than to
| allow that person to perhaps die of a virus.
|
| Thankfully, in this case, sanity prevailed.
| IvyMike wrote:
| > If there is solid evidence that a vaccine will kill people,
| it should not be used.
|
| Don't all vaccines have some extremely low but nonzero
| probability of killing someone?
|
| > It's intolerable that people die taking a prophylactic.
|
| What do you think about airbags in cars?
| slibhb wrote:
| If airbags kill someone who didn't crash their car, that
| model of car/airbag should be recalled. If a vaccine kills
| someone, people should stop taking that vaccine.
|
| The point here is simple. It's worse for someone to die of
| a vaccine than for someone to die of the coronavirus. How
| much worse is up for debate, but it's a significant factor
| and napkin math has to take that into account or it's
| morally bankrupt.
| FooHentai wrote:
| I think I see your point but the probabilities are an
| important factor, as well as the freedom to choose based
| on being well informed. Unfortunately at this stage we
| don't have sufficient information to provide solid
| information to make an informed choice.
|
| If there's (hypothetical overly high numbers here) a 10%
| chance of dying from a disease or a 1% chance of dying
| from the vaccine from that disease, I want the vaccine
| and would like the freedom to do so. But if a new vaccine
| is coming out and soon after we see a 1% death rate from
| it, now I'm gonna want to hold off and take my chances
| with the disease because that 1% may turn out to be as
| high as or greater than 10% down the track when more is
| known.
|
| The main complexity here is just like the early days of
| coronavirus - until things have played out for a while
| you can't have confidence about the extent of the harm
| and that's true for both the disease (which we now have
| over a year of information about) and the vaccines (which
| we have a month or two of in-the-wild info so far).
| maxerickson wrote:
| There's solid evidence that foods kill people.
| mywittyname wrote:
| 100% of people who eat food eventually die.
| maxerickson wrote:
| For certain foods, some people die very quickly from
| immune reactions.
|
| My comment is more or less ridiculous, but I'd like to
| understand why an effective vaccine that is dangerous to
| a few people is different than peanuts, which are
| dangerous to a few people (many of whom discover this by
| consuming peanuts).
| ppezaris wrote:
| If a hypothetical vaccine could save a million lives, but
| kills 10 people who get vaccinated, are you arguing that it
| shouldn't be administered?
| slibhb wrote:
| Yes. Let justice be done, though the world perish.
| TheSpiceIsLife wrote:
| Nit pick sorry:
|
| > Now, _your risk of dying_ either from vaccination or Covid19
| depends on various _demographic factors_
|
| Your risk of dying, or other health injury, depends on _your
| personal health factors specifically_.
|
| Demographic is the statistical data of a population.
| autokad wrote:
| 0.00009% over a 30 year period means you have about a 1% chance
| of being blown up by starting your car. that's about the odds
| of catching HIV while having unprotected sex with someone who
| is HIV positive (depends on a lot of factors though).
| lupire wrote:
| Error, mismatched units. The 30 year odds of HIV due to
| unprotected sex is far higher.
| disabled wrote:
| It's not just a "blood clot" or some "rare type of blood clot".
|
| This was what I posted in this post about the European
| Medicines Agency acknowledging the AstraZeneca vaccine (which I
| was inoculated with) was linked to something never seen before:
| https://news.ycombinator.com/item?id=26725232
|
| > "Zero surprises here. Both Norwegian and German research
| teams identified the /actual specific novel antibody/ that
| causes this /new previously unclassified syndrome/ that was
| effectively unheard of before the AstraZeneca COVID-19 vaccine
| existed. Also, both teams are phenomenally talented for
| identifying this antibody so quickly. Usually it is on "finding
| a needle in a haystack" level difficulty. BTW, I am probably
| going to get downvoted but I am definitely not an antivaxxer
| and I received the AZ vaccine as innoculation for COVID-19."
| nomel wrote:
| Also, there is a clot risk for with COVID [1] that's much
| higher than the vaccine. The clot risk is the reason I've been
| indoors this whole pandemic, so I'll happily take my these
| ridiculously better chances with the vaccine.
|
| 1. https://www.cnbc.com/2021/04/13/blood-clots-more-likely-
| from...
| bitcurious wrote:
| I think this is an example of where government transparency would
| greatly aid the discourse and build trust.
|
| Where is the math that suggests that pausing the J&J vaccine is
| prudent? Inputs being risk of getting covid, risk of getting a
| blood clot, risk of injury/death from covid, risk of a new covid
| variant appearing, etc.
|
| Without that transparency we're all just guessing.
| Trasmatta wrote:
| Looks like it was 6 cases after about 7 million doses. Even if
| it were caused the vaccine, the risk there is incredibly low.
| Much lower than the risk of an adverse COVID case, I would
| think.
|
| Does pausing to investigate such an incredibly rare occurrence
| increase the public's trust in vaccines (because they see the
| government is being extra careful with safety data) or decrease
| it (because skeptics will use this as evidence that there are
| problems with the vaccines)? I feel like it's mostly the
| latter, but I dunno.
|
| Not to mention all the COVID cases that might have been
| prevented while the rollout is paused to investigate a
| potential side effect that's less than one in a million.
| bitcurious wrote:
| > Looks like it was 6 cases after about 7 million doses. Even
| if it were caused the vaccine, the risk there is incredibly
| low. Much lower than the risk of an adverse COVID case, I
| would think.
|
| Right, but the clots happened about 2 weeks after the
| vaccine, so that what portion of those ~7 million were
| administered over two weeks ago? Clots happened to a similar
| demographic, so what portion of those ~7 million were to
| women in the right age group? What about clots that cause
| damage that's not immediately obvious (and thus not spotted).
|
| I hesitate to dismiss the risk outright, but I do think that
| we should hold the CDC/FDA to the standard of "methodical."
| tzs wrote:
| The comment by Barleyman on the Ars Technica article on this
| [1] has a graphic from someplace called the Winston Centre for
| Risk Analysis that shows the benefits in COVID reduction vs the
| harms from the AZ vaccine by age group.
|
| According to that graphic, if you are in a time of medium COVID
| infection rates (60 per 100k per day), the risk from COVID
| outweighs the vaccine risks in that age group. If you in a time
| of low rates (20 per 100k per day) the vaccine risks outweigh
| the COVID risks.
|
| The vaccine risk goes down as patient age goes up, and the
| COVID risk goes up as age goes up.
|
| The J&J risks will probably follow a similar pattern and it
| also appears that the J&J clots require unusual treatment. That
| suggests a pause to at least figure out where the risk curves
| cross and to make sure that doctors and hospitals are prepared
| to recognize and treat the J&J clots.
|
| [1] https://arstechnica.com/science/2021/04/us-cdc-fda-call-
| for-...
| bitcurious wrote:
| That's excellent, thank you for sharing! The comment you
| linked to suggests that the gender disparity can be
| attributed to women being over-represented in getting the
| vaccine, but I'm not sure the logic holds. Medical
| professionals were mostly done being vaccinated prior to J&J
| being approved.
| ppf wrote:
| And not just for the vaccines, but the choices made in Covid
| policies and mandates.
| opinicus wrote:
| An analysis of the relative risks is obviously the objectively
| correct answer from a rational perspective, but most people
| aren't making decisions based on that kind of statistical
| reasoning (though we'd doubtless have better outcomes if they
| did). There's a serious risk that problems like this can spark
| a backlash against all COVID vaccines if not handled
| conservatively--there are plenty of people just waiting to have
| their anti-vaccine confirmation biases triggered. How to handle
| these events is as much a question of social behavior and
| public relations as it is of science.
| convexfunction wrote:
| One could argue (and many have, persuasively, I think) that
| Europe making a big show of being highly conservative about
| the blood clot non-issue with the AZ vaccine caused people to
| dramatically overestimate the risk of getting any kind of
| COVID vaccine. e.g., I recall an anecdote about a person in
| the US, who was going to get a different vaccine in any case,
| who decided to not get a vaccine because a family member from
| Europe assured them that blood clots were a serious risk that
| they should definitely be worried about.
| peytn wrote:
| > there are plenty of people just waiting to have their anti-
| vaccine confirmation biases triggered
|
| You're probably right, but if we keep trying to front-run
| people's reactions to events over and over again, I'm not
| sure we're going to get great results in the long run. I get
| the impression that anticipating how people will respond to
| news is engendering more extreme responses to future events.
| convexfunction wrote:
| I'll guess that you might be aware this is the reason, but just
| in case, I'm pretty sure the reason is that nobody who makes
| these decisions is actually doing any cost-benefit analysis
| (aside from the costs and benefits to them personally and their
| organization, maybe).
| supportlocal4h wrote:
| We allow people to receive no vaccination at all. But we won't
| allow them to get this vaccine if they want it?
|
| This reminds me about all those governments that allow people to
| buy and sell cigarettes, but ban the sale of raw milk.
|
| Can we just name this "Raw Milk Syndrome"?
| mumblemumble wrote:
| I think it's more an application of the principle of non-
| maleficence. (https://en.wikipedia.org/wiki/Primum_non_nocere)
| Consider this a temporary pause while they make sure they
| understand the relative risk factors.
|
| Cigarettes and raw milk are, regrettably, a specious
| comparison. In the USA, the rules concerning both are handled
| by different governing bodies. For the longest time, cigarettes
| had been explicitly excluded from the FDA's jurisdiction,
| according to a law passed by Congress, and confirmed by a
| Supreme Court decision. And rules concerning raw milk vary from
| state to state, but are generally also set by legislatures. In
| both cases, what you see there is political interests come into
| conflict with, and perhaps override, the more level-headed,
| science-driven, technocratic approach that the FDA is
| theoretically expected to take.
| hatty wrote:
| I personally had an adverse reaction to this vaccine. I had a
| fever and extreme fatigue for 2 days. I am a relatively healthy
| 30-year-old male.
| mensetmanusman wrote:
| Our entire political leadership is focused on risk mitigation,
| and it's entirely tiresome.
| marsven_422 wrote:
| Pfizers marketing department is on fire!
| mumblemumble wrote:
| Meta-comment: The ratio of downvoting to discussion in here is
| rather worrisome. The current top thread isn't really even about
| COVID vaccines; it's primarily an argument of the "this isn't an
| argument, this is contradiction" variety about birth control, of
| all things.
|
| It should be possible to have a mature, good-faith conversation
| about this, even on a pseudonymous web forum.
| throwawayboise wrote:
| It should be possible, but for many people, another person's
| opinion on these vaccines is a binary value. It's either right
| or wrong, and if it's wrong the person is summarily dismissed
| as having any relevant input to the conversation. Worrisome is
| correct.
| [deleted]
| jdhn wrote:
| Here's a question for someone smarter than me. Is there a chance
| that this number (six cases in seven million doses) will rise as
| regulators comb through previous reports of adverse effects?
| Nokinside wrote:
| Not an expert in but one of those expert drug regulators is my
| friend.
|
| 1 per million adverse effects is nothing. If that would be a
| solid fact, there would be no reason to pause vaccinations. The
| pause happens very early so that experts have time to check the
| data and methodology and verify that it's all that there is.
|
| When a new drug is given for emergency evaluation or a new side
| effect is discovered he works 14 hours per day 7 days a week
| with a team going through a massive amount of data and
| documentation to verify and check everything.
|
| The media and most commentators don't understand why decisions
| can take weeks. Why you don't have the scheduled emergency
| approval meeting just now. They fail to understand that fact-
| finding is not happening in the meeting just by people giving
| their expert opinions. Experts work around the clock without
| taking any time off to figure out what is happening. But lazy
| bureaucratic regulators, right?
| nscalf wrote:
| I have some friends in this field as well (though they are in
| small sample size things, like specific breast cancer
| trials). Some of the fact-finding looks like calling up every
| patient who has gone through their treatment, but they have
| agreed to cooperate extensively in order to get into their
| trials. I can't imagine how painful it is to do fact-finding
| on this scale.
| exyi wrote:
| I'm probably not smarter, but based on what happen with AZ I
| don't think it will rise. AZ clot cases rised after people
| became more aware of the issue so it was reported more often as
| the vaccine side effect
| bluGill wrote:
| Yes, but not from previous reports. See the other responses
| about how previous reports are handled. I would expect cases to
| rise as unreported things get reported, and as doctors start to
| ask the right questions when they see these events and report
| things that previously wouldn't have been reported but probably
| should have. Not to mention that with these reports I expect
| doctors to ask the right questions and so previously
| misdiagnosed events get diagnosed correctly (some of these
| might be unrelated to the vaccine though making the data
| messy).
| throwawaysea wrote:
| It's interesting to me seeing the direct data-based reactions to
| the pause on the J&J vaccine. For example, Nate Silver of 538
| wrote
| (https://twitter.com/NateSilver538/status/1381925025964515330):
|
| > 6 cases out of 7 million people. What a disaster. This is going
| to get people killed. And it's going to create more vaccine
| hesitancy. These people don't understand cost-benefit analysis.
| They keep making mistakes by orders of magnitude.
|
| I am seeing this argument from people of all political views this
| morning, but I am most surprised to see it from the political
| left. Why isn't the same data-driven approach used when we're
| talking about policing, or gun violence, or traffic deaths? In
| all these cases, the frequency of negative outcomes (policing
| deaths of unarmed black people, homicides committed with guns,
| traffic fatalities per mile traveled) is very low and when
| weighed with the positive outcomes, it is clear that people are
| acting irrationally when they try to defund police, or ban
| firearms, or restrict driving. And yet, the data is never brought
| up so directly in those conversations by either everyday people
| or news media.
|
| The J&J vaccine issue is frankly less alarming to me than this
| open hypocrisy or disconnect in our societal discourse.
| sbehlasp wrote:
| These vaccines have only got emergency approval . It is true that
| reliability of vaccines have caused some nervousness in society
| and that is obvious because no vaccine in history is out so early
| for use Must read https://www.weforum.org/agenda/2020/06/vaccine-
| development-b... Whole world is going through tough time. I hope
| suffering ends sooner than later
| throwaway5752 wrote:
| I trust the experts here in the FDA and the CDC. These are people
| that have been working their entire lives in vaccines and vaccine
| approval. They understand the medicine, the understand the
| policy.. if there's anything that most people here could think
| of, the odds are astronomically low that they haven't considered
| it.
|
| It is very encouraging that this appears to be a science led
| decision.
|
| Unsure why I've been downvoted, but if you've worked in FAANG
| level tech and with scientific staff of the CDC/FDA, you would
| not think that the caliber of people on either side was much
| different. There are a very, very large number of Moderna and
| Pfizer/Biontech doses going out at this point. The bigger risk is
| 501Y.V2 and company evolving to escape the vaccine, and that is
| not going to be fixed by a week long pause in J&J/Jannsen to
| identify the source and treatment for the errant platelet
| response.
| gnfargbl wrote:
| For AstraZeneca and not J&J, but these slides from the University
| of Cambridge do a better job of communicating the balance of
| risks than I possibly could:
| https://assets.publishing.service.gov.uk/government/uploads/...
| fastball wrote:
| Yeah, the problem though is that we have a Tragedy of the
| Commons situation on our hands. There is a non-negligible
| portion of the population that wants to have its cake and eat
| it too - reduce the risk that they will suffer health
| consequences from COVID-19 by letting _everyone else_ get the
| vaccine, but not getting the vax themselves, therefore putting
| their risk from vax at zero.
| Vinnl wrote:
| I think part of the thing that makes this more difficult is
| that some people already have practically no risk of
| suffering health consequences from COVID-19, and possibly
| (but also possibly not) do risk suffering health consequences
| from the vaccination.
| fastball wrote:
| This is not really true, as demonstrated by the PDF linked
| in the GC.
| ryankemper wrote:
| It is true; the PDF linked in the GC has to make a number
| of assumptions and is very obviously made from a point of
| bias (which does not invalidate its claims but warrants
| extra scrutiny).
|
| Also it's comparing raw ICU admissions, but there are a
| number of really nasty adverse reactions that don't throw
| you in the ICU. The general "second shot syndrome" that
| something like half of people getting Pfizer/Moderna
| experience is a great example of that. Yeah it's not bad
| enough to send them to the ICU, but for many people
| COVID-19 would be literally asymptomatic or would be
| minimally symptomatic, whereas the second shot syndrome
| can be quite brutal.
| mzs wrote:
| or just run PF4 for everyone concerned after adenovirus
| vector vaccinations
| josephcsible wrote:
| That seems like it'd be easy to fix: the government just
| needs to say "as soon as you're fully vaccinated, you don't
| need to social distance or wear a mask in public anymore".
| Since that isn't their position, there's basically zero
| incentive for young, healthy people to risk the vaccine side
| effects.
| bluGill wrote:
| That is one option. Which is why so many anti-vac people
| have jumped on the no vaccine passport bandwagon. If there
| is no way to prove you have been vaccinated, then they can
| lie about it and take part in non-masked public activity
| (I'm not sure why they are against the mask).
|
| There are other options. Give everyone who has got the
| vaccine some money is one I've heard more than once. Maybe
| someone else has a different idea.
| Invictus0 wrote:
| Krispy Kreme gave vaccinated people free donuts and it
| led to an anti-vax outrage here in the States.
| throwaway8581 wrote:
| Young people shouldn't be getting the vaccine period. There
| is no reason to give every single person who will have
| children in the future an experimental vaccine for a virus
| they are at no serious risk from. The long tail risk on
| that is absolutely insane.
| fastball wrote:
| Not exactly sure what procreation has to do with
| anything.
|
| Also pretty sure risk of death outweighs literally any
| possible long-tail risk, so still seems sensible for the
| young to get the vax. Also don't think the long-tail risk
| of an mRNA vaccine can be worse then COVID's long-tail
| risk.
| ryankemper wrote:
| > Also don't think the long-tail risk of an mRNA vaccine
| can be worse then COVID's long-tail risk.
|
| It absolutely could, and that should be self-evident.
|
| > Also pretty sure risk of death outweighs literally any
| possible long-tail risk, so still seems sensible for the
| young to get the vax.
|
| This is just not true. The risk of death in children from
| COVID-19 is so low you literally should not ever worry
| about it. If you want to compare numbers in an academic
| sense go ahead, but the fact that actual adults are
| wasting valuable cognitive and emotional energy worrying
| about their kids is a great tragedy.
|
| The recorded COVID-19 deaths in children are, by the way,
| using the absurd definition of a COVID-19 case/death that
| most of the western world is using; a definition where
| having PCR-confirmed SARS-2 infection means that ANY
| death is classified as a COVID death. This is not how
| this is supposed to work; there is supposed to be a
| distinction between the virus and the disease, but we
| define the disease as merely having the virus! It's
| completely absurd. Indeed I'm writing an article about
| this concept (pathological vs physiological) right now
| [deleted]
| throwaway8581 wrote:
| We have never deployed an mRNA vaccine before. We don't
| know what effect it might have on gametes.
| fastball wrote:
| Yes we do? The mRNA vaccines cause your body to produce
| the coronavirus spike protein. That is the beauty of an
| mRNA vaccine - the cure _literally cannot_ be worse than
| the disease, because the cure is just a subset of the
| disease. Anything these mRNA vaccines do to your gametes
| would also be done (and worse) by COVID-19 itself, so...
| definitely get vaxxed with an mRNA vaccine if you 're
| worried about long-tail risk. Also this is the J&J
| vaccine which is viral vector, not mRNA (Moderna/Pfizer).
| throwaway8581 wrote:
| We don't know that it has no other effect. We don't know
| all of the circumstances where reverse transcription can
| happen in the human body. This kind of epistemic
| arrogance is dangerous and is how we ended up with
| thalidomide causing mass birth defects and other such
| disasters.
| blake1 wrote:
| We've given the mRNA vaccines to enough people to be
| highly confident that your fears are ungrounded. The mRNA
| doesn't linger more than a few hours. People received the
| vaccine a year ago.
| yumraj wrote:
| > We've given the mRNA vaccines to enough people to be
| highly confident that your fears are ungrounded.
|
| Wasn't that the case with J&J also, till they decided to
| not ignore the clots.
| fastball wrote:
| This is not, in any way, similar to thalidomide.
| Thalidomide was an issue because it is enantiomeric and
| different effects were caused by each enantiomer, only
| one of which was noticed. That is not an issue here, as
| we are talking about proteins. The primary difference
| though is that there was no treatment imperative with
| thalidomide, but there is with this.
|
| Again, we are talking about introducing something that is
| _guaranteed to be in your body anyway if you contract
| COVID-19_. SARS-CoV-2 is viral to the point where,
| without perpetual lockdowns /mask-wearing/vaccinations,
| you _will_ get it. So it is still definitely better to
| get vaccinated, at least with an mRNA vaccine - please
| stop spreading FUD. Your concerns _could_ be more
| warranted for vaccines like J &J which use modified viral
| vectors, but again, exceedingly unlikely that this could
| be any worse than the virus itself.
| throwaway8581 wrote:
| You're talking what we learned after the fact about
| thalidomide. And I'm obviously not saying thalidomide and
| the mRNA vaccines are similar in their actions in any
| way. I'm just saying we don't know what injecting a bunch
| of synthetic spike protein mRNA (a huge percent of which
| has errors) into your body might do. The same way we
| didn't know what thalidomide might do, we don't know what
| this might do. We are not at the level of knowledge about
| the human body where we can rule out unexpected effects.
| That is why we have a very stringent drug and vaccine
| testing regime.
| Pyramus wrote:
| I think the point parent is making is slightly different.
| Let me try to re-phrase it negatively: What we don't know
| about mRNA vaccines we don't know about SARS-CoV-2
| either. Our state of knowledge of the effects of SARS-
| Cov-2 will soon be eclipsed by our knowledge of the
| effects of mRNA vaccines. SARS-Cov-2 is only 6 months
| older than the mRNA vaccines. There will always be
| unknown unknowns for both mRNA vaccines and SARS-Cov-2.
| throwaway8581 wrote:
| This is a good point that is being discussed over here
| https://news.ycombinator.com/item?id=26796998
| gnfargbl wrote:
| I'm not qualified to comment on whether or not that is a
| valid concern, but the vaccine we're discussing here
| (J&J) uses a modified viral vector, as do the AstraZeneca
| and Gamaleya vaccines.
| throwaway8581 wrote:
| Correct. I meant the mRNA vaccines. The AZ & J&J vaccines
| don't have that same concern, but I'd still worry about
| an untested vaccine. There is really no good reason for
| the young and healthy to get the vaccine yet or any time
| soon.
| gnfargbl wrote:
| At the moment we're shitting on the younger generation
| even harder than usual, by denying them the opportunity
| to go out, meet people and generally enjoy their youth.
| Doing that for a year was maybe justified, but it is just
| totally unfair to carry on for an extended period.
|
| To open up again we need to bring the demand on
| healthcare services down and we need to do it
| _sustainably_ , i.e. in a way which prevents another
| exponential spike. If we can achieve that aim without
| mass vaccination of healthy young people then great, of
| course, let's do that. But: if the only way to squash
| this thing and return everyone to a somewhat normal life
| turns out to be to keep vaccinating until we get right
| down to the twenty year olds, shouldn't we do so -- for
| their sake as much as everyone else's?
| throwaway8581 wrote:
| False dichotomy. If the 20 year olds all get covid,
| almost nothing bad will happen. So just let them catch
| it. If the at-risk people are all vaccinated, then it's
| not a big deal.
| Pyramus wrote:
| > almost nothing bad will happen
|
| If we pick the 25-29 year olds and an estimated infection
| fatality rate of 0.01% [1] it's still 13.5M x 0.01% =
| 1,350 deaths. It's not a lot by any means, but it's not
| 'almost nothing' either.
|
| This is the worst case scenario of cause, sibling comment
| has already mentioned long Covid, where we don't know
| prevalence precisely.
|
| I'm aware I've picked the 'worse half' of the 20 year
| olds, 20-24 will fare better obviously.
|
| [1] https://www.nature.com/articles/s41586-020-2918-0/fig
| ures/2
| fastball wrote:
| > If the 20 year olds all get covid, almost nothing bad
| will happen.
|
| How exactly are you so confident about the long-tail
| risks of contracting COVID-19? Sounds like epistemic
| arrogance to me.
| throwaway8581 wrote:
| Very true! But that is no different than flu and cold
| mutations year to year. The only reason we are worried
| about covid is the high death rate for some populations.
| Otherwise, we would not have done any lock downs or mask
| mandates.
|
| Continuous mutation of common viruses is the background
| risk that human beings have evolved over three billion
| years to withstand as a species. That is different than a
| completely novel man-made intervention.
| allturtles wrote:
| This sounds like special pleading to me. We have two new
| possible things that could be introduced to your body - a
| vaccine or the virus.
|
| In neither case is it possible to know what hidden long-
| term effects they could have on you. But the virus is
| known to kill and maim people in the short-term at a much
| higher rate than the vaccine, which is known to protect
| you from the virus.
| throwaway8581 wrote:
| I don't think it's a special pleading. Covid is a nasty
| coronavirus but it is ultimately an incremental change in
| a very widespread kind of virus that humans have
| coexisted with forever. Human beings have evolved to
| survive this kind of thing as a species. This is the kind
| of risk that a species has to be equipped to survive to
| have made it this far. Which is not to say that a virus
| can't come around and wipe us all out, but it would be a
| truly extraordinary event.
|
| For all we know, mRNA vaccines can alter your gametes. We
| don't know because this is the first time we ever use
| them. They aren't like viruses or weakened viruses. They
| are just a massive injection of genetic material (much of
| it deformed) that encodes a single foreign protein. No
| human being has ever had such a thing done to them until
| very recently. mRNA vaccines are not part of any natural
| process that modern humans or our ancestors have had to
| withstand to get to the present day.
| allturtles wrote:
| Viruses are like super mRNA vaccines. They commandeer
| your cells not to just create a single protein, but to
| create a bunch of proteins in order to form new viruses.
| And unlike mRNA, they reproduce and can stay in your body
| for months or years. I don't see the huge new risk.
|
| I don't know why you have this special concern about the
| gametes. In any case, if there's a significant bump in
| miscarriages / infertility from the vaccine, we'll
| probably know very soon, now that lots of younger people
| are being vaccinated.
| ryankemper wrote:
| The fact that the vaccines create just a single spike
| protein and the real virus creates much more is actually
| one of the issues.
|
| First: does the rate at which the cells are made to
| artificially produce spike protein follow a different
| curve than the rate at which SARS-2 would? i.e. could
| mRNA vaccination cause a much more aggressive
| "inflammatory cliff", thus the huge percentage of "mild"
| adverse reactions (mild meaning, you feel like death for
| a day but end up fine with no detectable long-term
| issues)? It's possible.
|
| And switching to efficacy, while personally I think
| resistance to the spike protein alone will be sufficient,
| because SARS-2 does not have the same ability to
| mutate/evolve the way Influenza does (for example, I
| can't imagine SARS-2 evolving away from the spike
| protein), it's very possible that the diverse epitopes
| produced by real SARS-2 infection give a much more robust
| and enduring immunity.
| throwaway8581 wrote:
| I have special concern about gametes because it's one
| thing to risk the health of currently living people, but
| it's another to risk the gene pool going forward into
| eternity.
| krzyk wrote:
| Difference is that I know person that got COVID in
| November and now has issues with memory.
|
| I don't know a single person that has that after flue and
| cold - and those are with us much longer.
|
| As for viruses mutations etc. do we for sure know that
| this one is not man made?
| ryankemper wrote:
| > Difference is that I know person that got COVID in
| November and now has issues with memory.
|
| > I don't know a single person that has that after flue
| and cold - and those are with us much longer.
|
| Look into ME/CFS, whose existence is still contested (or
| rather I should say, whether it's a physical or
| psychogenic illness is disputed). I know you're just
| speaking anecdotally but just wanted to mention that
| post-viral issues (fatigue, memory, etc) absolutely does
| happen.
|
| > As for viruses mutations etc. do we for sure know that
| this one is not man made?
|
| At most SARS-2 is the result of extensive gain of
| function research on
| https://en.wikipedia.org/wiki/RaTG13. I don't know any
| credible individual that thinks it's fully artificial /
| manmade (and to be clear, my definition of "credible" is
| not the "anyone who agrees with the WHO/CDC and nobody
| else" definition that the establishment relies on).
|
| Personally I think it's more likely that SARS-2 was GoF'd
| into existence rather than was a purely natural zoonotic
| leap, whereas I think the probability that it was fully
| artificial is almost zero.
| blake1 wrote:
| Almost nothing bad will happen--with the current
| variants. Uncontrolled spread in a sub population will
| almost certainly lead to new variants emerging. Given the
| reduced effectiveness of current vaccines against certain
| variants, this is reckless.
| mahogany wrote:
| Do you have reason to believe that it can affect gametes?
| In other words, do you know of any hypothesized mechanism
| by which this could happen?
| throwaway8581 wrote:
| No, and no one had any reason to think that thalidomide
| would cause mass birth defects. This is why we have such
| long testing periods for vaccines and drugs in general.
| We also go through extra testing before approving things
| for pregnant women. We don't know what we don't know.
| Modern medicine is impressive, but we must maintain
| epistemic humility.
| pvarangot wrote:
| Probably none, the tricky part is how it affects an
| embryo because that's an known unknown of a lot of this
| molecular biology/medicine things. It's already counter-
| indicated for pregnant women though.
| maxerickson wrote:
| I doubt they have, but plenty enough time has passed to
| evaluate your concern by examining trial participants.
|
| The mRNA in the vaccine lasts a matter hours.
| bcrosby95 wrote:
| Total COVID deaths for people aged 0-17 in the USA are
| 246 so far.
|
| That's not that many. Despite my wife and I getting
| vaccinated, I'm not completely sure what the correct
| answer is for our kids.
|
| To put those numbers into perspective, more kids die from
| the flu in any given year (despite vaccination!). And far
| more kids die from car related accidents, and cars are a
| daily fact of life here.
|
| I'm also interested in the other longer term effects of
| COVID on kids, but there doesn't seem to be a lot of
| information out there about it.
|
| You talk as if it's a clear cut answer. Given the numbers
| involved I don't see how it can be.
| waterheater wrote:
| Here are some more relative risk assessments as well as
| stronger statistics when you're comparing to deaths by
| COVID-19:
|
| A college-enrolled 18-24 year old is 3.67x more likely to
| die of suicide [1][2][3].
|
| A college-enrolled 18-24 year old is 6.08x more likely to
| die of alcohol [3][4].
|
| A child (0-14 years) is 6.75x more likely to die by motor
| vehicles [5].
|
| A child (0-14 years) is 3.93x more likely to die of
| drowning in a pool [6].
|
| All fatalities are compared to present CDC numbers [7].
|
| [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3809451/
|
| [2] https://www.statista.com/statistics/183995/us-
| college-enroll...
|
| [3] https://nces.ed.gov/programs/digest/d18/tables/dt18_3
| 02.60.a...
|
| [4] https://www.niaaa.nih.gov/publications/brochures-and-
| fact-sh...
|
| [5] https://injuryfacts.nsc.org/motor-vehicle/historical-
| fatalit...
|
| [6] https://www.cdc.gov/homeandrecreationalsafety/water-
| safety/w...
|
| [7] https://data.cdc.gov/NCHS/Provisional-COVID-19-Death-
| Counts-...
| fastball wrote:
| Do you have a point, or?
| fastball wrote:
| It is a clear cut answer if you understand what an mRNA
| vaccine is.
| ryankemper wrote:
| (Not the one you responded to) I know what an mRNA
| vaccine is and the only clearcut answer is that "yes,
| obviously the long-tail risks of mRNA vaccines could
| outpace the long-tail risk of COVID-19". The statement is
| also true when you say "...COVID-19 could outpace...mRNA
| vaccines" as well, if that's not clear.
|
| BTW the "long tail" of COVID-19 in children is totally
| unproven and the whole "long haulers" phenomenom is
| likely (a) a small part normal post-viral fatigue which
| we see with basically any virus, and (b) mostly
| psychosomatic/psychogenic illness.
| mzs wrote:
| That runs contrary to good public health policy for C19
| where even the fully vaccinated should follow many
| precautions such as masking in public and limiting number
| of households in close contact.
| choward wrote:
| That's the problem.
| josephcsible wrote:
| If you believe good public health policy requires that
| there be restrictions on gatherings even where everyone
| is fully vaccinated, then what do you see as the path
| back to full normality? Or is this just how humanity has
| to live forever now?
| elihu wrote:
| I think the "return to normality" is when the number of
| new cases reported each day drops to almost nothing and
| deaths are uncommon. Currently, in the U.S. we're about
| 70 thousand new cases a day, which is about where we were
| at the height of the second wave in mid-summer. Deaths
| are around 750 a day.
|
| I think we'll get to normality eventually, but it may
| take longer than anyone has patience for, and that will
| only push it out further as people give up on social
| distancing and masking.
| mzs wrote:
| Only 22.7% of US pop is fully vaccinated as of 0600 ET
| today.
|
| https://covid.cdc.gov/covid-data-tracker/#vaccinations
|
| When that reaches +80% the recommendations will ease more
| but as of now:
|
| https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-
| vac...
| josephcsible wrote:
| Why does it matter how much of the US is vaccinated? For
| any given gathering, doesn't it only matter whether the
| people at that gathering are? Suppose 20,000 people, each
| from different households, all met at Madison Square
| Garden, and that they're all vaccinated. Why would that
| be more dangerous if nobody else in the world was
| vaccinated vs. if everybody else in the world was?
| mzs wrote:
| Look if both households are low risk and everyone has
| been vaccinated go ahead and meet under one roof without
| any masks and hug - that's fine under current
| recommendations. It's even looser than that, like if you
| unvaccinated low risk children visiting vaccinated
| grandparents ad so on.
|
| Right now across US being fully vaccinated is only 80%
| effective against infection. When you have 20k vaxed
| folks meet when the virus is endemic in the pop, some of
| those vaxed folks will be infected and some will catch it
| there.
|
| When more folks are vaxed there will be less of the virus
| circulating and then that calculation then changes. It's
| all about how prevalent the virus is in the community to
| begin with assuming no strains appear that dramatically
| reduce the effectiveness of the vax.
|
| https://www.npr.org/sections/health-
| shots/2021/04/13/9864114...
| ryankemper wrote:
| We've never taken such an attitude for any other endemic
| respiratory pathogen in existence, and for good reason.
| It's completely absurd and ignores not only the important
| health benefits of regular social contact, including
| direct physical contact, as well as the literal benefits
| of exchanging pathogens with others.
|
| You and the other commenters arguing your "side" also
| seem to completely ignore the phenomenom of natural
| immunity, which I think very obviously has been
| fallaciously denied by "experts" precisely because they
| want to convince everyone in the world to get this
| vaccine. They're already talking about yearly booster
| shots because most people's mental models are from Flu
| which has a much greater space of possible genetic
| configurations, whereas SARS-2 is relatively constrained
| in how it can evolve and thus should not need a yearly
| booster if this weren't just about making absurd amounts
| of money (which it is).
|
| In any case, you should know that there are people like
| me - very much in the minority - who refuse to submit to
| such absurdities and will keep fighting. We will continue
| to be literally as well as metaphorically discriminated
| against until your "side" stops brainwashing people into
| a completely disproportionate response to an endemic
| respiratory virus.
|
| You can stay inside with a mask on while vaccinated all
| you want. Be my guest. But please stop advocating for
| and/or supporting mandates and restrictions on the rest
| of us who have not caught your specific strain of
| agoraphobia, germaphobia, OCD and misanthropy.
| wdb wrote:
| I like how BBC calls the vaccine made in the UK the Oxford-AV
| vaccine but can't call this correctly the Janssen vaccine.
| em500 wrote:
| It probably works the same in most places. In the Netherlands
| it's usually called Janssen, while the Oxford one is called
| AstraZeneca. I'm guessing in the US they usually leave out
| BioNTech, while in Germany BioNTech comes before Pfizer.
| klebe wrote:
| I must say, the general state of discourse on HN has severely
| deteriorated over the past year (mostly in line with other online
| platforms, I suppose)
|
| COVID is the single worst thing to happen to civil discussion in
| my lifetime. The virus is obviously a risk. So are the vaccines.
| Acting any other way is just downright disingenuous.
|
| At the end of the day, any person with a working brain is free to
| calculate those risks on their own. No persuading, name-calling,
| or outright rudeness is needed. (Yes, the top 5 comments I'm
| talking about you)
|
| In times like this, I'm reminded of most historical
| calamities...in which a small minority stood on one side, another
| small minority on the other, but the vast majority simply stood
| in the middle and thought "Please let this end"
|
| Please upvote this if you're just an average person waiting in
| the middle.
| ketamine__ wrote:
| Being very conservative with vaccine rollout means more people
| will die. I think the risk-averse folks that approved of harsh
| lockdowns may want this harsh measure as well.
| shadowgovt wrote:
| The pandemic is one of those scenarios that challenges the soul
| of a nation like the US.
|
| Oh, your society believes, at a deep ethical and philosophical
| level, in individual freedoms, personal responsibility, and
| general laissez-faire attitude regarding behaviors that do no
| harm to others? Okay. Here's an invisible threat that is on
| average low-probability fatal but with wide error bars and a
| step-function if enough people decide to ignore it. If enough
| people take collective actions that are uncomfortable,
| inconvenient, and in some cases heavily disruptive (possibly
| resulting in loss of individuals' livelihoods), the odds of
| dying from it are minimized for everyone (but nonzero). If not
| enough people do these things, the odds spike up (hard to say
| by how much). In terms of personal responsibility, you don't
| know if you're spreading the disease and if someone catches it
| and dies, we only have probabilities to estimate responsibility
| regarding who it came from.
|
| Oh, and a handful of the mitigations might also have nonzero
| risk of harm or death, with some noteworthy error bars on the
| estimates.
|
| ... and all this on top of a population that barely understands
| what probability is in general, let alone error bars. Most
| citizens are, in fact, not nearly educated enough to calculate
| those risks. But they sure want to think they are, because we
| put personal responsibility for one's health on the person.
|
| It's like the crisis was hand-tuned to be everything Americans
| hate.
| narrator wrote:
| I don't think most people are looking for the truth anymore.
| They are more interested in finding out what team you're on and
| who else says what you believe and what team they're on. A
| logical argument with references means absolutely nothing to
| most people these days. Questioning certain "truths" will
| quickly get you banned on many social media platforms and the
| list of "truths" gets longer every day.
|
| I was in a zoom call with a large number of people I consider
| educated. They were talking about the California propositions
| and they didn't want to talk about what they said or to argue
| for or against, they just wanted to know who supports and
| opposes which one and if they were on the right team.
| prof-dr-ir wrote:
| As is typical for this comment thread, in this comment I will
| claim that pausing the Johnson & Johnson vaccine will lead to
| hundreds of thousands of deaths because that is how many people
| will die if we do not have a vaccine. All this to save 1 out of 7
| million lives. In passing I would like to call everybody involved
| in the decision idiotic.
| prof-dr-ir wrote:
| As is typical for this comment thread, in this top-voted [0]
| reply to this comment I will point out that pausing one vaccine
| is not the same as stopping the entire vaccination program
| forever. I would in addition like to point out that once cannot
| simply compare the risks because they can vary wildly across
| populations, and that the one out of seven million might not be
| a reliable estimate. Might it not be good to wait until we know
| the actual risk, given also the abundance of other types of
| vaccine?
|
| [0] one can hope
| prof-dr-ir wrote:
| As is typical for this comment thread, in further replies we
| can happily claim the effect that this has on the anti-vaxxing
| crowd, whose thinking we are all extremely familiar with. Of
| course, since we are all careful people we will also balance
| the effects of the decision to pause the vaccine against the
| decision _not_ to pause in the face of potential blood clotting
| issues.
| myrandomcomment wrote:
| Okay so I want to make something very clear here. The rule is to
| put it very very simply, is you can ship any drug that is
| approved but you have to list the side effects. This drug was
| approved under an emergency order and this side effect was not
| listed. This will get paused long enough for the side effects to
| be updated and then used again. The arguments about "well the
| birth control pill has a higher risk" are using a fact that while
| it is true, is not relevant as that data has no relationship to
| the rules that have to be followed. The valid argument would be,
| those that issue the emergence order for use to should amend the
| order to acknowledge the issue but not block use immediately.
| barsonme wrote:
| I don't understand why you have to pause then restart. Just
| update the side effects as you go. Or pause for the affected
| groups.
| chrisandchris wrote:
| I guess it's protocol. The same protocol that states that you
| need to list side-effects probably says if your side-effect
| list is wrong you have to re-list and get approved again.
| Until your approval is not done you don't get to sell.
|
| Otherwise you could delay your updating your side-effects
| listing because you know FDA will take your druf off-market
| (and this delay will/could cause harm to people).
| seoaeu wrote:
| The pause is to figure out exactly which groups are affected,
| and to decide if/how to update guidance. They are presumably
| working as fast as possible on that. Don't forget that the
| doses aren't going to go bad, so it is just a short delay in
| administering them
| effie wrote:
| Distributing the new document only would not be responsible.
|
| In this case, the new side effect kills people. Very rarely,
| but if you belong to some unlucky group, you're screwed. It
| is better to figure out which people are endangered. The
| recommendations and documents have to be good for everybody,
| not just for the good statistics.
| jdminhbg wrote:
| This is a vaccine for a disease that has killed over half a
| million people in the US over the past year, not a new breast
| implant.
|
| The rules are not some holy writ handed down from above, they
| are our way of trying to properly manage risk. When the
| situation changes, the rules can also change.
| cogman10 wrote:
| This is what's been frustrating for me with world health
| organizations.
|
| I get the need to make sure medicine is safe and effective,
| and we absolutely should follow those to a T when it comes to
| new medicines on the market in non-emergency situations.
|
| However, that's not the case here. vaccines are well studied
| in general and J&J is one of the more "normally developed"
| vaccines on the market. After generally ensuring that it's
| safe (Phase I/II tests), there should have been a damn good
| reason to pull it even temporarily. The "we are seeing a
| small increase in blood clots" really doesn't seem like a
| valid reason to pull a vaccine.
|
| Personally, I lay the blame primarily on anti-vaxxers.
| They've made us far too cautious around vaccinations. It has
| screwed up our risk management rules. I've no doubt that this
| pull back will result in anti-vaxxers publishing BS about the
| safety of J&J vaccinations to try and scare people away from
| it.
| dokem wrote:
| You blame the anti-vaxxers for the vaccine not being up to
| spec? Isn't this what they were saying the whole time?
| cogman10 wrote:
| No, I blame the anti-vaxxers for pushing the spec to be
| so strict that when 6 people out of 6.8 million people
| see a negative medical event, we pull the entire vaccine
| out of caution. We are pulling the vaccine because of a
| literally 1:1000000 chance that you might have a blood
| clot. Meanwhile, the risk of dying from covid is closer
| to 1:100 to 1:1000.
| arwineap wrote:
| I'm understanding that your concern is that we should be
| protecting ourselves against covid instead of worrying
| about the rare side effects of the JJ vaccine.
|
| However, keep in mind we are continuing the vaccinate
| people are a really high rate, we just are not using the
| JJ vaccine. No one is stopping all of vaccinations. A
| brief pause in JJ while they relabel is just a minor
| hiccup in our overall vaccination plans
| unanswered wrote:
| It's a neat trick, isn't it? Blaming people for being
| right.
| tgb wrote:
| I think you misread them. Anti-vaxxers were not blamed
| for the vaccine's side-effects.
| woofie11 wrote:
| Here, risk management should be a personal decision. In
| this case, the right set of actions might be to grant
| people freedom, and let market forces rule.
|
| I think some people would choose the J&J vaccine if it
| meant getting vaccinated faster. Some people would choose
| Moderna / Pfizer, later.
|
| It really depends on things like whether or not you can
| work from home, how depressing it is not interacting with
| people, or how concerned you are about the risk of long
| COVID19. That's not something we can answer for anyone
| centrally.
|
| From a public health perspective, vaccinating people now
| with Johnson is an obvious win.
| 13415 wrote:
| > _risk management should be a personal decision_
|
| I think this is unrealistic for medical application, not
| only for vaccinations but in general for anything related
| to side effects of drugs.
|
| First of all, most people don't have the data and in this
| case part of the risk management is to get more data or
| consolidate and evaluate existing data more thoroughly.
| Second, while you might be an exception, the vast
| majority of people do not have the knowledge and skills
| to properly assess risks or perform multiattribute cost-
| benefit analyses. Layman cannot even compare small
| probabilities correctly and frequently mix up risks that
| differ from each other by multiple orders of magnitude.
| Even people with fairly good knowledge of probability
| theory will have a hard time judging small risks without
| extensive comparison data and maybe some didactic tools
| like "micromort" comparisons.
| Verdex wrote:
| > there should have been a damn good reason to pull it even
| temporarily
|
| And the damn good reason was that there's a bunch of people
| out there who don't want to take the vaccine for political
| reasons. And there's a smaller amount of people who don't
| want to take the vaccine because they're uninteresting in
| taking a new vaccine. They're looking for reasons to
| validate their fears.
|
| If you just keep pushing the vaccine even though a bad
| thing happened to a small number of people, then there will
| be people who use this as an excuse to avoid all of the
| vaccines completely.
|
| Take down the vaccine and make a bunch of lab coats spend a
| hectic two weeks double checking some figures and people
| will feel listened to and they'll have less arguments to
| not get the vaccine. The vaccine that you're taking is as
| safe as it can be. After all when we saw a problem we did
| something about it.
|
| This is 100% about optics and PR AND that's 100% necessary
| right now in order to get the job done.
|
| > I lay the blame primarily on anti-vaxxers
|
| Don't even talk about anti-vaxxers right now. The only
| thing bringing up anti-vaxxers will do is grow that
| movement. The people who don't want the covid vaccine are
| not anti-vaxxers. They get the flu vaccine and they get
| their children vaccines. They're only afraid of the new
| covid vaccine. They don't like anti-vaxxers any more than
| you do, BUT if you call them that then some of them are
| going to decide they might as well join the anti-vaxxer
| movement.
|
| These are two groups of people who I do not want to join
| forces. Covid hasn't exactly been a fun time, but I'm
| really not interested in seeing polio and friends come
| back.
|
| Have rational debates, quit the name calling, go the extra
| mile to convince people who don't like your position to do
| something for the greater good. Otherwise, we're not going
| to see enough vaccinations to make a difference.
| timr wrote:
| > Personally, I lay the blame primarily on anti-vaxxers.
| They've made us far too cautious around vaccinations. It
| has screwed up our risk management rules. I've no doubt
| that this pull back will result in anti-vaxxers publishing
| BS about the safety of J&J vaccinations to try and scare
| people away from it.
|
| This has nothing to do with "anti-vaxxers". Vaccines
| usually take years to develop _precisely because_ we give
| them to everyone, and rare, long-tail risks matter. This
| was the case well before the MMR autism scare defined
| "anti-vax" as it has come to be known today.
|
| In this case, we bypassed that standard development
| process. It was the right choice, in my opinion, but it's
| _not_ the right attitude to start claiming that our
| standard level of risk mitigation for vaccines is
| excessively cautious because "anti-vaxxers" exist. That's
| simply reactionary.
|
| If anything, we've tossed out all of our usual standards of
| evidence in 2020, and did a bunch of stuff willy nilly,
| with no supporting evidence or rational consideration of
| trade-offs. We tore off all the safety belts. We don't need
| lower bars for evidence, we need less reactionary hysteria.
| bluGill wrote:
| The only part of the safety process we bypassed was 6
| moths of phase-3 data, we decided 2 was good enough.
| Everything else was just bypassing all the time where we
| were doing nothing at all because there wasn't money to
| run the next study.
| timr wrote:
| That's not really true. The phase 1 trials were a good
| bit faster than they'd normally be. Also, even if you
| ignore that, having years of phase 2 and phase 3 trials
| gives you a lot of _additional_ safety data, in the form
| of larger trials with longer duration. Also, better
| cross-tabs, so that it 's possible to assess safety by
| age, gender, race, pregnancy, etc.
|
| The vaccine trials were limited in their power to detect
| rare events. The Pfizer trial [1], for example,
| explicitly said that events rarer than 0.01% are less
| likely to be detected:
|
| > This trial and its preliminary report have several
| limitations. With approximately 19,000 participants per
| group in the subset of participants with a median follow-
| up time of 2 months after the second dose, the study has
| more than 83% probability of detecting at least one
| adverse event, if the true incidence is 0.01%, but it is
| not large enough to detect less common adverse events
| reliably. This report includes 2 months of follow-up
| after the second dose of vaccine for half the trial
| participants and up to 14 weeks' maximum follow-up for a
| smaller subset. Therefore, both the occurrence of adverse
| events more than 2 to 3.5 months after the second dose
| and more comprehensive information on the duration of
| protection remain to be determined. Although the study
| was designed to follow participants for safety and
| efficacy for 2 years after the second dose, given the
| high vaccine efficacy, ethical and practical barriers
| prevent following placebo recipients for 2 years without
| offering active immunization, once the vaccine is
| approved by regulators and recommended by public health
| authorities. Assessment of long-term safety and efficacy
| for this vaccine will occur, but it cannot be in the
| context of maintaining a placebo group for the planned
| follow-up period of 2 years after the second dose.
|
| Even a 0.001% risk is _not small_ , when you're talking
| about giving the vaccines to billions of people.
|
| (I don't mean to single out Pfizer here. It's just the
| one I've read most recently.)
|
| [1] https://www.nejm.org/doi/full/10.1056/nejmoa2034577
| cogman10 wrote:
| > This has nothing to do with "anti-vaxxers". Vaccines
| usually take years to develop precisely because we give
| them to everyone, and rare, long-tail risks matter. This
| was the case well before the MMR autism scare defined
| "anti-vax" as it has come to be known today.
|
| Anti-vax hysteria has been around for longer than MMR and
| autism.
|
| > rare long-tail risks matter
|
| I agree, but at the same time I also think that it's an
| overblown problem with vaccinations. We aren't talking
| about medication that screws around with the metabolism
| in unusual ways. Vaccines (other than the newer mRNA
| stuff) are by and large large enough chunks of whatever
| we are vaccinating against to trigger an immune response
| when the real thing comes along + preservation/delivery
| medium.
|
| At the end of the day, the worst case for vaccination is
| that you might be infected with the disease you are
| vaccinated against (when live viruses are used).
|
| That's not the case for J&Js vaccine.
|
| So the next question is, if the worst case scenario is
| you get a disease you were attempting to prevent, then
| what is the next real biggest threat from a traditionally
| developed vaccination?
|
| > If anything, we've tossed out all of our usual
| standards of evidence in 2020, and did a bunch of stuff
| willy nilly, with no supporting evidence or rational
| consideration of trade-offs. We tore off all the safety
| belts. We don't need lower bars for evidence, we need
| less reactionary hysteria.
|
| I'd argue that pulling a vaccine over a very minor number
| of reports of increased blood clots is overly
| reactionary.
|
| Edit: And... reading this it makes it sound like I'm
| skeptical of mRNA vaxxes. Just to be clear, I'm not and
| I've gotten the pfizer vaccine myself. I do think they'd
| have more justifiable scrutiny to make sure they are safe
| as it's a new technique for mass vaccinations (even
| though it's been used in immunotherapy for a while now).
| effie wrote:
| Read the post by timr above. The studies are very limited
| and can't reliably detect problems that occur with small
| part of population. This can be hundreds of thousands of
| people.
|
| The worst case for vaccination isn't that you get the
| illness. It is that you are one of the unlucky ones that
| gets some severe reaction and gets killed.
| whymauri wrote:
| >The rules are not some holy writ handed down from above
|
| I'm sorry, but when dealing with healthcare organizations and
| policy-makers, it's more like the "holy writ" than the
| idealized system you describe later.
| peytn wrote:
| The rules do not exist to manage risk. They exist to strike a
| balance between ethics and risk in emergency situations. If
| you'd like to change them going forward, feel free to
| advocate. I think it's best we stick with our current rules
| this round.
| jdminhbg wrote:
| We've changed the rules for every single part of life and
| society because of this massive emergency, with no idea
| what the long-term consequences of doing so might be. I'm
| not sure why the FDA should be excluded.
| peytn wrote:
| The FDA has a process in place as per the Pandemic and
| All-Hazards Preparedness Reauthorization Act of 2013. If
| you find that legislation inadequate in some way, I think
| following due process to change it is the way to go. If
| how we handle pandemics should be more agile, let's get
| legislation behind that.
|
| I don't think jerking our knees over an ethics safeguard
| that led to a pause in administration of a vaccine that
| soon won't be widely available anyway is a great habit to
| get into.
| jdminhbg wrote:
| It's pretty hard to take this seriously given the total
| lack of legislative participation in business closure,
| school closure, mask mandates, etc.
| effie wrote:
| The change in life is supposedly temporary restriction of
| freedoms for emergency reasons. Maybe it is wrong but
| governments have that power and people accept it.
|
| Imposing political pressure on experts and forcing them
| to approve against their judgment would be a horrible
| corruption of these regulator institutions.
|
| Maybe the expert regulator think that the bar should be
| lowered. But then they should come forward. This should
| not be ordered by politicians or their handlers.
| __s wrote:
| Our current rules are what was done. You're the one
| advocating for more cautious rules because you consider 1
| in a million side effects too great a cost compared to the
| cost of non vaccinated covid
| peytn wrote:
| I don't understand your comment. I'm not advocating for
| more cautious rules. I'm advocating for due process. The
| rules should be what we feel is necessary.
| MuffinFlavored wrote:
| > This is a vaccine for a disease that has killed over half a
| million people in the US over the past year
|
| Serious question, how many of those people would have died in
| the past 12 months if they didn't get COVID? The number is
| most likely not 500,000, but it also probably isn't 0.
|
| Is it most likely something insignificant like 5,000?
| galangalalgol wrote:
| Initially the cdc data pointed to about 2/3rds would have
| died anyway in the same time period in the US, but that was
| a few months in. Now if you pull total deaths from the cdc,
| subtract deaths tagged as covid and fit a sinusoid with a
| 52 week period and a slope for population growth you get a
| pretty solid fit with the exception of the 2018 and 2015
| flu, _and_ last summer. But last summer the sinusoid is
| under the total daeths minus covid deaths. Integrating the
| area between I think we undereported covid deaths by about
| 50k over the summer. We are back down to predictded deaths
| now without counting covid deaths. So I think all half
| million deaths are in excess of expected value, plus
| another 50k.
| ghaff wrote:
| Probably not that low. This study [1] says about 80,000.
| (There were about 420,000 excess deaths in the US last
| year.) That number isn't perfect in that it ignores any
| death reductions from accidents, say, that didn't happen
| because people were staying home. It also doesn't account
| for any deaths resulting from untreated conditions.
|
| [1] https://www.medrxiv.org/content/10.1101/2021.01.27.2125
| 0604v...
| [deleted]
| jaegerpicker wrote:
| From the CDC: In 2019, a total of 2,854,838 resident deaths
| were registered in the United States--15,633 more deaths
| than in 2018.
|
| In 2020, approximately 3,358,814 deaths occurred in the
| United States (Table). The age-adjusted rate was 828.7
| deaths per 100,000 population, an increase of 15.9% from
| 715.2 in 2019.
|
| Assuming the rates stayed the same or roughly so from year
| to year, it appears that not many of them would have died
| sans COVID19. Certainly well over 5000. If there is a
| trend, none of the data I looked at on the CDC site
| supported this, raw deaths have been rising in the last 5
| years but death's per 100,000 have held. So if it's a small
| increase per 100,000 is "normal" given those trends 16% is
| still well outside the normal, so it's likely something
| like 300,000 or there about. I sure someone here could do
| the math to verify that but I don't feel like it. :)
|
| ref: https://www.cdc.gov/nchs/products/databriefs/db395.htm
| https://www.cdc.gov/mmwr/volumes/70/wr/mm7014e1.htm
| javagram wrote:
| > Serious question, how many of those people would have
| died in the past 12 months if they didn't get COVID? The
| number is most likely not 500,000, but it also probably
| isn't 0.
|
| This can be answered using "excess mortality" data.
|
| Studies have shown during that time period, about 600,000
| more people died than would have been expected compared to
| deaths in the previous year.
|
| The official covid death count is likely an undercount of
| deaths caused by covid, because a number of people died
| from covid related complications and got recorded as
| pneumonia, Alzheimer's, or heart disease/attack/stroke
| related deaths.
|
| https://www.nytimes.com/interactive/2021/01/14/us/covid-19-
| d...
| timr wrote:
| > The official covid death count is likely an undercount
| of deaths caused by covid, because a number of people
| died from covid related complications and got recorded as
| pneumonia, Alzheimer's, or heart disease/attack/stroke
| related deaths.
|
| That's a theory. Meanwhile, we _know_ that many places
| are classifying anyone who dies within N days of a
| positive test (N is typically 30) as a "covid death",
| regardless of actual cause.
|
| I can guarantee that not all of those people died _from_
| Covid-19. Point being: there 's likely to be overcount
| _and_ undercount, for different reasons.
| hinkley wrote:
| There are also people not experiencing death by
| misadventure because people are doing fewer outdoor
| activities and most especially not hanging out with or
| showing off for the bad influences in their lives.
|
| Also offset by excess deaths over the next few years due
| to long term effects of a sedentary lifestyle, stress,
| and all the overcompensating we are likely to see next
| year with people trying to "make up for lost time".
| panopticon wrote:
| Many national parks set monthly visitation records last
| year, campground reservations are at all-time highs, and
| SAR operations across the country are stretched thing.
| What else was there to do when other vacation and travel
| activities are closed?
|
| I'm not sure how outdoors-y fatalities will be impacted
| by all of this, but people are definitely not "doing
| fewer outdoor actives" right now.
| mym1990 wrote:
| It would depend on the age and make up of the population,
| cross reference that with a mortality table and you can get
| a pretty good idea. For a 25 year old the odds of dying in
| a given year are about .03, and this obviously moves higher
| as the population grows older.
| BurningFrog wrote:
| This is the problem with the FDA system.
|
| If thousands are dying for lack of a drug or not has, at
| best, very little impact on the decisions.
|
| The job of the FDA is to enforce regulations, not to save
| lives.
| theptip wrote:
| > This drug was approved under an emergency order and this side
| effect was not listed.
|
| Sadly, this is the case. The German regulator's FAQ explicitly
| called this out; they are not interested in determining the
| path that saves the most lives, they are simply following the
| process that checks all of the boxes that the regulations
| require. In the EU this regulatory pause of AZ has likely
| killed thousands of people.
|
| > The valid argument would be, those that issue the emergence
| order for use to should amend the order to acknowledge the
| issue but not block use immediately.
|
| Or, more generally, in the emergency-order regime, all
| decisions that can demonstrate a clear 10:1 improvement in
| expected deaths should be taken, regardless of regulatory red
| tape.
|
| The FDA and other regulators have over-fitted their process for
| "minimize likelihood of another Thalidomide, for drugs which
| have a small chance of saving a life, and a very small chance
| of causing harm". This is defensible for testing a new statin,
| where we have existing safe drugs to choose from, and we're
| looking for incremental improvements. But it's shockingly
| harmful in an emergency.
|
| One thing that has become very clear is that the FDA and other
| regulators are structurally incapable of making even
| rudimentary risk-based tradeoffs in emergency situations, and
| we need to fix this.
| effie wrote:
| > _The German regulator 's FAQ explicitly called this out;
| they are not interested in determining the path that saves
| the most lives, they are simply following the process that
| checks all of the boxes that the regulations require._
|
| A drug regulator should do its job, which is following
| established rules for approving and recommending new
| medicines. Not invent new rules, not push experimental drugs
| when new problems are being discovered on the go. Advocating
| for "greater-good" trade-offs and risks is a political
| effort, the regulator should be immune from political
| pressures.
|
| I'm glad people there prefer to err on the side of going with
| established rules and caution.
|
| If what you want is experimental drug being accessible to as
| many people as possible as soon as possible, you should
| advocate for the option to bypass the regulator and letting
| the people decide for themselves.
|
| Do not advocate for corrupting the regulator.
|
| > _In the EU this regulatory pause of AZ has likely killed
| thousands of people._
|
| I don't know how you came to that conclusion, but even if so,
| how many thousands of people would be eventually harmed or
| killed if the pause wasn't introduced? We don't know, because
| we are discovering properties and effects of the vaccines on
| the go. The data and estimates we have are based on short-
| term experience with the vaccines. They will change.
|
| In treating people for illness it is a long established rule
| that "first, do no harm". And vaccine does not even help the
| patient with any illness - it is rather to help in case the
| patient would get one in the future. For many people, getting
| vaccinated has zero to negative benefit.
|
| Nobody is entitled to get a fast-tracked rubber stamp to push
| vaccines on people. If you want to take experimental drugs, I
| support your right to do so, however I expect you let other
| people decide for themselves, including the regulators.
| saurik wrote:
| Why is the correct solution not to support people enough that
| the only reason anyone has to interact is to do "essential"
| work--for which the they should be paid hazard-level pay--and
| then do this slowly and carefully? We can offer the vaccine
| to people who would then feel better taking it--particularly
| if it means they get to make hazard-level pay--but it
| wouldn't matter if people didn't: the main risk of getting
| covid should be "I decided to interact with people, knowing
| the risks", and it isn't our job to prevent them from getting
| ill any more than it is our job to police peoples' home
| lives. This whole "the sky is falling" emergency scenario is
| a false dichotomy we have constructed to avoid actually
| staring at the problem of wage slavery :(.
| santiagobasulto wrote:
| But is it really a side effect? If 6 people vaccinated are hit
| by a car, is that included as a side effect?
|
| Are those side effects lists just a catch it all sort of
| exception where they throw anything there just in case? Honest
| question.
| bluGill wrote:
| We will ask if the vaccine somehow cause those 6 people to be
| hit by a car, if we decide the vaccine caused that would be
| listed. (I don't see how a vaccine could cause people to be
| hit by a car, but I'm open to suggestions)
| skykooler wrote:
| could cause some sort of mental change that causes one to
| be drawn towards fast-moving objects?
| pvarangot wrote:
| That would probably be listed as drowsiness, depression,
| dementia or something like that. They already tell you
| not to drive heavy manchinery after the J&J vaccine
| though.
| myrandomcomment wrote:
| The answer is yes, "as determined by the experts" that made
| the recommendation after looking at the data on this and also
| the data from what has happened in the UK/EU with the AZ
| vaccine which uses a very similar method. Are the experts
| correct here - no one knows at this exact second. It will
| take time and future studies to see if they made the correct
| call. One point that people are missing in the reported data
| is that this type of blood clot is not the usual kind where
| the normal treatment that I doctor would follow would fix it.
| The pause here is about getting the information out to the
| doctors and the public that says "Hey Public, if you get J&J
| and feel this way X,Y,Z with in X weeks of getting it go to
| the doctor. Hey Doctor, if someone comes in in X time of
| getting the J&J and feels this way X,Y,Z be aware that it
| could not be the NORMAL thing you think and look for XXX and
| treat it this different way to make sure you have a good
| outcome."
| softwaredoug wrote:
| It's not about the rules, it's about the optics.
|
| How many people will point to this or feel a bit hesitant about
| getting J&J vaccine now?
| rebuilder wrote:
| It's really not clear at all that the incidence of this type of
| blood clots is actually higher in the vaccinated. So it seems
| early to call this a side-effect.
|
| I wish the health agencies were a bit more open about their
| thought processes. OTOH, the rate of incidence doesn't seem
| higher than baseline AFAIK, which seems absurd. It also seems
| absurd that the various health authorities around the world
| would all make such a big deal of if if there wasn't some
| elevated risk. So I don't really know what to make of it, but
| privately, I'm leaning towards the interpretation that the idea
| is to avoid backlash against the vaccines by being irrationally
| strict about any potential hazards.
| effie wrote:
| > _So it seems early to call this a side-effect._
|
| Yes, causation is hard to show with certainty.
|
| However, regulator have to follow rules, and those rules
| probably err on the side of caution. Similarly to "first, do
| no harm".
|
| I agree that the matter of public trust is also relevant
| here. In some countries large part of the population already
| does not want to get vaccinated. So the vaccinator is
| naturally motivated to prevent any PR screw-ups even at the
| cost of slowing down.
| kaczordon wrote:
| Umm maybe because the blood clot issue is being underreported
| because no one is looking for it? We're essentially doing mass
| experimentation with gene-based vaccines on the US population,
| all the vaccines use either mRNA or DNA insertion. Caution here
| is the logical and ethical thing.
|
| Also: the side effect profile for the moderna and pfizer
| vaccines in the clinical trials was far WORSE than the jnj
| vaccine.
|
| Edit: gene-based not gene-therapy
| simple_phrases wrote:
| Gene therapy and mRNA vaccines are two very different things.
| kaczordon wrote:
| True corrected it to "gene-based", both jnj and astra use
| DNA encoding btw.
| tylerhou wrote:
| But neither have the ability to alter your DNA, so they
| are unlikely to be able to cause long-term symptoms
| though a gene-expression mechanism.
| kaczordon wrote:
| Right but they are still gene-based. No gene-based
| vaccine has ever received approval for human use, and the
| present coronavirus vaccines have not undergone
| preclinical testing as normally required by international
| regulations.
|
| A potential danger of DNA-based vaccines is the
| integration of plasmid DNA into the cell genome (1).
| Insertional mutagenesis occurs rarely but can become a
| realistic danger when the number of events is very large,
| i.e. as in mass vaccination of a population.
|
| (1) https://www.nature.com/articles/3302213
| [deleted]
| tylerhou wrote:
| I'm not a biologist, so I could be completely wrong here,
| but I disagree with you.
|
| First of all, plasmid != viral vector. That's why the
| Nature paper you cited had to use electroporation to
| introduce the payload. As J&J is a viral vector vaccine,
| I would not be confident in using this paper to make the
| argument that an adenovirus-based vaccine could modify a
| host's DNA.
|
| Second, your article does not make the claim you think it
| does. Specifically, the discussion says:
|
| > Using simple intramuscular injection, the vast majority
| of plasmid DNA that persists is extrachromosomal, and the
| frequency of integration, if it occurs at all, is
| negligible.
|
| > However, even if the residual plasmid in the gel-
| purified genomic DNA did represent integrated plasmid,
| one copy... would be at least three orders of magnitude
| below the frequency of spontaneous gene-inactivating
| mutations...
|
| That is, the delivered gene does not integrate directly
| into the genome itself, but rather stays in the cell. To
| detect whether the gene stays in the host cell, the
| article compares molecular weight and uses a PCR test.
| Both methods do not tell us whether the gene inserts
| itself into the host DNA; one way to detect that would be
| to sequence the subsequent DNA, which would be
| monstrously expensive (because the modification incidence
| is extremely low).
|
| The only way that a gene _might_ integrate itself into
| the chromosome is if during DNA transcription, an error
| occurs and the foreign DNA is merged onto the host DNA.
| But this would be incredibly rare because it would
| require most base pairs to match up between the host &
| foreign DNA; otherwise, the cell would attempt to repair
| itself or induce apoptosis.
|
| And even if the resulting base pairs match up, the
| resulting DNA might not have any behavioral differences
| because it's (approximately) the same sequence of
| characters. (And you would need _another_ transcription
| error later on that happens to reduce the non-modified
| strand by approximately the same length. That 's also
| extremely unlikely.)
|
| Fourth, the Pfizer and Moderna vaccines use a mRNA-based
| vector, which (in my limited knowledge) is very difficult
| to integrate into the genome. The most plausible
| mechanism I could imagine would be:
|
| 1. (Optional) an enzyme which converts a modified
| nucleoside mRNA strand into one that mimics the mRNA
| chemical structure that is compatible with a reverse
| transcription enzyme [1].
|
| 2. A reverse transcriptase to convert the mRNA strand
| into a (foreign) DNA strand.
|
| 3. A restriction enzyme that cleaves the host DNA
| suitably so that the foreign DNA can be inserted.
|
| 4. A matching ligation enzyme which actually inserts the
| foreign DNA into the the host DNA.
|
| All these above enzymes do not naturally occur in humans,
| so DNA modification through this mechanism would be
| incredibly rare.
|
| [1] https://link.springer.com/protocol/10.1007/978-1-4939
| -6481-9...
| kaczordon wrote:
| Ermm, the jnj uses an adenovirus to _deliver_ the plasmid
| DNA(1). I 'm only referring to the jnj/astra here not the
| mRNA ones. And I think that article I linked represents a
| real risk it's not like we've tested for this danger
| before going ahead with a mass vaccination campaign where
| even rare events can become a real danger.
|
| Additional dangers of DNA vaccines include production of
| anti-DNA antibodies and autoimmune reactions(2). I think
| we should be communicating these dangers to the public so
| that healthy individuals at no risk can make a proper
| benefit-risk decision, instead of just saying "vaccines
| good" and brushing over concerns.
|
| (1) https://coronavirus.medium.com/decoding-johnson-
| johnsons-cov...
|
| (2) https://link.springer.com/protocol/10.1007/978-1-6270
| 3-110-3...
| tylerhou wrote:
| > I think that article I linked represents a real risk
|
| The article you linked estimates the risk of DNA
| integration is three orders of magnitude times lower than
| gene deactivation through regular mutations. I think
| we're safe.
|
| > Additional dangers of DNA vaccines include production
| of anti-DNA antibodies and autoimmune reactions
|
| Any documented cases in clinical trials?
| kaczordon wrote:
| Sigh yes this is a well recognized risk which even the
| FDA has guidelines for: _" The administration of a DNA
| vaccine exposes the patient to foreign DNA or its
| fragments that could be inserted into the host's
| chromosomal DNA [70]. In the case of incorporation into
| an exon, an insertional mutation or a frameshift mutation
| occurs. Such mutations can cause a gene to malfunction or
| inactivate (i.e., a tumor suppressor gene). The insertion
| of foreign genes into the host genome could also lead to
| constituent expression of previously silent
| bacterial/parasite genes that have been inserted."_(1)
|
| To date, there is no licensed DNA vaccine for use in
| humans, which is my _whole point_ we aren 't testing for
| this and instead just using the whole US population as
| test subjects without informing them of the risk.
|
| (1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105045/
| maxerickson wrote:
| That's a different technology than the Adenovirus
| vectors.
|
| There's no plasmids in the Covid vaccines, a virus has
| been modified to include instructions for the target
| proteins.
|
| Edit: plasmids are used to encode the virus for
| production, they aren't part of the delivery mechanism:
| https://www.addgene.org/viral-vectors/
| tylerhou wrote:
| Also,
|
| > and the present coronavirus vaccines have not undergone
| preclinical testing as normally required by international
| regulations.
|
| Citation needed.
| kaczordon wrote:
| https://www.fda.gov/vaccines-blood-
| biologics/vaccines/emerge... there's a reason it's
| emergency authorization, we don't have long term data
| yet.
| tylerhou wrote:
| You said vaccines haven't undergone preclinical testing;
| where is the evidence of that? All EUA vaccines have
| undergone animal tests.
| strikhedonia wrote:
| We don't have "long term data" for the next week or two,
| anyway. Phizer and Moderna's chances of winning full use
| authorization this spring look quite good.
| amalcon wrote:
| This is the J&J vaccine, which is not mRNA-based. It's an
| adenovirus vector vaccine, which is also not gene therapy
| but is a (tiny) bit closer than an mRNA vaccine.
| serial_dev wrote:
| Yes, as a non medical/statistician person, I'd be really
| surprised if we had the same quality and quantity of data on
| the birth pills and this new vaccination.
|
| The risks could be higher, but maybe our data is not yet
| there.
|
| Just as a side note, the risks (and gains) are different,
| maybe I really don't want a child accidentally, but I don't
| consider the coronavirus too dangerous to me (it's just a
| hypothetical, this hypothetical person could be wrong, but in
| the end we all operate on incomplete data)
| theptip wrote:
| > Caution here is the logical and ethical thing.
|
| In this pandemic, inaction costs lives. The logical and
| ethical thing to do is evaluate the cost/benefit and choose
| the path that kills fewer people. You wouldn't say "we should
| exit the burning house one at a time in case we get hit by a
| meteor outside, caution here is the logical and ethical
| thing"; you're making the same kind of logical error, just
| with a less-absurd difference between the risk of the two
| options we need to choose between.
| ABeeSea wrote:
| This is sensationalism and fear mongering.
|
| The type of blood clots (low platelet) the J&J causes gets
| worse with the standard treatment of blood thinners. This was
| on the CDC call this morning.
| fastball wrote:
| I don't think causality has been demonstrated, no?
| loeg wrote:
| Definitely not _under_ reported. I 've heard about it,
| despite an incidence rate of ~10^-6.
| kaczordon wrote:
| Underreported means how many cases of this have been
| caught. _Not_ how much news agencies report on this.
| zests wrote:
| Whether or not this is true, that is not what the messaging is.
| jonplackett wrote:
| I just made this website to show you how really, really small the
| risks are, and how they compare to risks we happily take every
| single day.
|
| whatoneinamillionmeans.com
|
| If you're not willing to take 1 in a million chances, it's gonna
| be pretty hard for you to get out of bed today.
|
| This vaccine seems to have about the same rate, which makes sense
| as I think it uses the same technology.
| thedrbrian wrote:
| I appreciate what you're doing but I'm still avoiding the
| vaccine as long as I can. I've got a class 1 medical , a PPL
| and I hope [ha] one day to get paid to fly planes. I really
| don't want another Pandemrix because with my luck I'd end up
| with the side effect. Also I'm MASSIVELY allergic to certain
| drugs and I get the NHS third choice for antibiotics and anti
| inflammatories.
| jonplackett wrote:
| Everyone should make their own decisions. I'm just trying to
| put out some truth about the risks so people can make
| informed choices.
|
| TBH I've made this site for myself as much as anyone - I'm
| just under 40 so the risk/benefit is tight for me personally,
| but I want to do my bit for everyone else and stop the spread
| so I'll take any vaccine they'll give me.
|
| Good luck with you flying dreams and say safe!
| SomeHacker44 wrote:
| FAA mandates only a two day wait after vaccination. I suggest
| the risks from "long covid" should you recover from an
| initial infection are worse than most problems a vaccine
| could cause. I waited too, but after millions of okay doses
| of Pfizer I took one. I did suffer two days of 2nd shot
| malaise (fevers and lethargy) which is expected as my immune
| system ramped up to fight the mRNA "invasion" of the spike
| protein.
| mike_red5hift wrote:
| Thanks! Now I'm never leaving the house again.
| jonplackett wrote:
| Haha! This was not my intention! I deliberately tried to find
| things that you could not worry about. I'd already seen a lot
| of comparisons like 'don't worry about a 1/1,000,000 blood
| clot, you have a 1/100 chance of getting a brain tumour in
| your lifetime' and thought _that_ would freak you out more.
|
| (It's true though by the way, go enjoy the sun while you
| still can...)
| captainredbeard wrote:
| I'll gladly accept additional micromorts (I do dangerous things
| often) but it must come with an appreciably worthwhile reward.
| My chances of dying from COVID (if you include the risk of
| catching it weighted by dying from it) isn't large enough to
| make the "gap" worth it. It may not be pro-social but there's
| no requirement in society to be pro-social.
| pithon wrote:
| "That's the same risk as driving London to Liverpool"
|
| This was the first one your website presented and I have no
| idea what it means.
| shawabawa3 wrote:
| They are 2 cities in the UK that are ~220 miles apart, so 1
| in a million people die every 220 miles driven
| happytoexplain wrote:
| Not to be rude, but are you aware that Liverpool (like
| London) is a city? I guess I'm unsure what the confusion is.
| alistairSH wrote:
| London and Liverpool are major cities in England. 200 miles,
| 4 hours drive time, roughly.
|
| Similar distance/time as DC to NYC.
| Y_Y wrote:
| > I have no idea what it means
|
| You have the whole internet available. I bet you can work it
| out without too much effort.
| pithon wrote:
| Risk of... dying? Being injured? Being hospitalized?
| Developing a life-threatening clot? Also it's missing a
| word "from" but I worked that out. Thanks for your
| contribution.
| majewsky wrote:
| I guess you may be confused by the missing "from". It should
| be "driving _from_ London to Liverpool ", whereas the present
| phrasing suggests we move a city with millions of
| inhabitants.
| happytoexplain wrote:
| That might actually be the problem - however, it's kind of
| a stretch to say it "should" be expressed that way.
| "Driving A to B" is a common phrase (as for whether it's
| _technically_ correct, despite the ambiguity of meaning, I
| actually am not sure).
| jonplackett wrote:
| Good point! I was focussing on the UK since that's where the
| majority of AZ vaccine users are, but you're right. I'll swap
| in a more international first risk!
|
| Maybe tonight I can work out do an IP address lookup and
| personalise it for your locality ;)
| nicbou wrote:
| That's a good website. I had a chuckle at some of those.
| jonplackett wrote:
| Thanks. It's been quite fun to research all the unlikely ways
| of dying!
| quercusa wrote:
| From the article:
|
| "I think this is a very low risk issue, even if causally linked
| to the vaccine: 6 cases with about 7 million doses (lower than
| the risk of clots with oral contraceptives) is not something to
| panic about," Dr. Amesh Adalja, an infectious disease expert at
| the Johns Hopkins Center for Health Security in Baltimore, said
| in an email.
| ravenstine wrote:
| I'm trying to understand why this isn't ridiculous, and I'm not
| sure what that reason could be.
|
| The disease left to its own accord has the potential to kill
| millions (someone please correct me on this). Why would we pause
| a vaccine because 6 people in 7 million got blood clots? Why
| would we do that and risk fueling anti-vaccine viewpoints?
|
| I'm baffled, but perhaps I'm a fool.
| ed_balls wrote:
| I suppose they don't know what is the cause and what's gonna
| happen in the future(6 now, 10 000 in a few years).
|
| The communication that public gets is outrageously bad.
| ravenstine wrote:
| Isn't that as true, if not greater, for the mRNA based
| vaccines, despite them not having that observed side effect?
| For all we know, everyone's butts might fall off because of
| them in the future. (yes, I'm being somewhat facetious)
| ed_balls wrote:
| My understanding is the that AstraZeneca and J&J are also
| new tech. Vector-based and mRNA are different than
| attenuated (weakened) form of the virus which is used in
| most vaccines.
|
| (I'd be good if someone with more knowledge could comment)
| ravenstine wrote:
| Yes, you are right. Both are experimental / new tech.
| tzs wrote:
| What you may be overlooking is that this is a biology problem,
| not a physics problem, so you cannot assume a uniform
| population of spherical humans with identical characteristics.
| :-)
|
| COVID risk goes up with age. In the other COVID vaccine with a
| clotting issue (the AZ vaccine) clotting risk goes down with
| age. If that turns out to also be the case with J&J, then for a
| lot of people in the US (up to 20% or so) at the current levels
| of COVID the vaccine has a good chance of being more of a
| danger to them than COVID.
|
| A short pause to determine if they should add a minimum age
| (possibly a variable minimum age that depends on the overall
| COVID rates) for J&J is prudent.
| [deleted]
| krastanov wrote:
| For many people the risk of serious complications from COVID is
| similar. I am a young, healthy introvert working from home and
| enjoying the social isolation in a location that does not have
| explosive spread right now. The product of "probability of
| getting COVID" * "having serious long term effects or death" is
| in the same ballpark for me.
|
| I would still get this vaccine (or the AZ one) if offered
| because I consider it my duty to be part of the herd immunity.
| But not everyone will do that, and the moment you have people
| in privileged position refusing one of the vaccines, you start
| (1) exacerbating inequalities (2) fueling conspiracy theories,
| mistrust, and vaccine hesitancy.
|
| If you assume that the world is perfectly rational, then you
| are right, but it is a running joke on HN to point out how
| economists used to make that same mistake and derive silly
| conclusions.
| CannisterFlux wrote:
| The risk of a vaccine is very low. But emotionally it is hard
| to accept.
|
| It is my actual choice to have the vaccine and go from 0
| chance of vaccine-related blood clots to some non-zero value.
| Whereas catching covid feels more like I'm in control of not
| catching it by not leaving the flat, and even if I did catch
| it, chances are it'd not affect me that much.
|
| I know this is not totally logical, but it is difficult to
| get past emotionally. Imagine if I _did_ get blood clots from
| the vaccine - I 'd go from safe in my flat and healthy, to
| dead, and for what? To protect me from a virus that has an
| even lower chance of causing long-term problems, and from
| which I can protect myself by being careful.
| dragonwriter wrote:
| > Why would we pause a vaccine because 6 people in 7 million
| got blood clots?
|
| Because J&J isn't the only vaccine in the inventory, and the
| others don't have that problem (or, IIRC, the same level of
| other adverse reactions), and because:
|
| > Why would we do that and risk fueling anti-vaccine
| viewpoints?
|
| What risks fueling anti-vaccine viewpoints is ignoring adverse
| impacts which are known and plowing forward, especially giveb
| that people often don't have a choice of which vaccine they are
| administered.
| ravenstine wrote:
| > What risks fueling anti-vaccine viewpoints is ignoring
| adverse impacts which are known and plowing forward,
| especially giveb that people often don't have a choice of
| which vaccine they are administered.
|
| Your point about other vaccines being available is totally
| valid and sound, but... what is our standard here, then? For
| absolute-zero people to die of any vaccine we produce? What
| if it was 1 person who got a blood clot? It probably sounds
| like I'm being pedantic, but I'm serious in that I want to
| know why people find it reasonable to pull an otherwise
| effective vaccine because of this. It just doesn't seem worth
| it to tell everyone that the vaccine is dangerous enough that
| it had to be pulled entirely.
|
| Ignoring adverse impacts definitely fuels anti-vaccine
| sentiment, but so does giving people _concrete_ evidence that
| the vaccine can possibly kill people, possibly leading them
| to be resistant to getting any COVID vaccine at all until
| they 're forced to get it. I mean, if I were at all skeptical
| of getting a COVID vaccine, and I was told the J&J vaccine
| was so dangerous they had to pause it, why would I get any of
| the more experimental vaccines knowing that they also have
| the potential to kill me but we don't even know yet because
| they're experimental?
|
| I don't think people on HN realize the full magnitude to
| which the public can be timid and irrational. It just doesn't
| seem worth it to me for us to possibly fuck up the rollout of
| vaccinations when we are facing a possible 4th wave of COVID
| and more virulent variants.
|
| Let's compare some numbers here.
|
| The number of known blood clot cases with the J&J vaccine
| seems to be 6 in 7 million. That's a ~0.00000085% chance of
| getting a blood clot caused by the vaccine, give or take a
| zero since I suck at math and calculators refuse to not use
| scientific notation. According to the CDC, around 100,000
| people die of blood clots in the United States every year,
| and the US population is 308,401,808, meaning that Americans
| have a ~0.0003% chance of dying of a blood clot in their
| lifetime. The only concerning factor as far as I can tell is
| that the people who got the blood clots were women under 50.
|
| I mean, fine, if that's a risk profile we are averse to, then
| so be it. I don't really understand that.
| dragonwriter wrote:
| > Your point about other vaccines being available is
| totally valid and sound, but... what is our standard here,
| then?
|
| The standard is not to distribute a vaccine with a known
| side effect that standard treatment protocols will
| catastrophically fail for without pausing to get
| information about it to healthcare poviders needed to
| implement protocols to identify and properly treat it.
|
| That's explicitly what the pause is for per the article.
|
| > The number of known blood clot cases with the J&J vaccine
| seems to be 6 in 7 million.
|
| It's not, because the effect is seen 6-13 days after
| vaccination, and much of the 7 million (per the article,
| 6.45 million is the most recent cumulative figure I can
| find elsewhere but its two days old, if both are accurate
| that's over 0.5 million doses in the last two days...) J&J
| doses that have been delivered are within 13 (and even 6)
| days. And the clots have all been in women 18-48, who
| aren't the only people getting the vaccine, so, unless
| that's a fluke (and the numbers are small enough that
| that's merely unlikely but not implausible) the prevalence
| in that demographic is even higher.
| mikem170 wrote:
| I agree with your numbers above. But wondered about
| factoring the below into these calculations [0]:
|
| > During Johnson & Johnson's clinical trial, there were
| reports of other types of blood clots, too. Some are
| relatively common, such as deep vein thrombosis, so it
| wasn't surprising that among roughly 20,000 participants
| who received the vaccine, some would experience those
| clots.
|
| > What made FDA scientists take note, however, is that in
| the trial, about the same number of people received a
| placebo -- a shot of saline that does nothing -- as
| received the vaccine. However, when comparing the two
| groups, more study participants developed clots after
| receiving the vaccine than the placebo.
|
| > Calling it a "slight numerical imbalance," the FDA noted
| that there were 15 events in 14 participants who received
| the vaccine, compared to 10 events in 10 participants who
| received the placebo.
|
| I think the 6 in 7 million people are the serious and
| unusual blood clots, but would not include the +50%
| increase in blood clots of any type noted above. However I
| appreciate that you did include the extra data about
| 100,000 people dying per blood clots per year.
|
| I also like to pay attention to the numbers for this stuff.
| I was scheduled for a J&J shot today, which was cancelled.
| It wasn't my first vaccine choice. I'll be trying to get an
| appointment for one of the other vaccines, I guess.
|
| [0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-
| blood-...
| jsight wrote:
| Yes, but the risk is death and there are alternatives that do
| not appear to have this risk. Why not pause until it is more
| well understood?
|
| In the US, the other vaccines are starting to become really
| readily available.
| lisper wrote:
| Because the rate of vaccination is still supply-limited at
| the moment. If everyone who would have received the J&J
| vaccine could get a safer alternative in the same time frame
| this might make sense. But they can't, so it doesn't. Do the
| math. It is all but certain that more people will die as a
| result of this pause than without it, even if you assume a
| worst-case clotting risk scenario under the current data.
| jsight wrote:
| I only know my corner of the globe well. In this area,
| vaccine appointments are pretty easy to get and everyone
| 16+ is eligible. It certainly looks like any delay caused
| by this would be minimal.
|
| Maybe other parts of the country are different.
| lisper wrote:
| What part of the country are you in? And what counts as
| "pretty easy to get"? In California, the most populous
| state, people under 50 are not generally even eligible to
| _try_ to get an appointment for another two days. I don
| 't know how it is in other states, but I don't think this
| is unusual.
|
| That the vaccination rate is supply-limited is manifest
| in the fact that less than a third of the U.S. population
| has been vaccinated _at all_.
|
| Yes, there are places where there are vaccine surpluses,
| but this is not because the supply isn't the limiting
| factor. It's because in some rural areas there are large
| numbers of vaccine denialists who are choosing to forego
| the vaccine altogether. That leaves some localized
| surpluses. But overall supply is still the limiting
| factor, and it will continue to be until _everyone_ who
| wants a vaccine can get one without having to wait.
| jsight wrote:
| South Carolina -- availability varies, but most parts of
| the state have at least some appointments and they seem
| to be becoming more readily available.
|
| > there are large numbers of vaccine denialists who are
| choosing to forego the vaccine altogether. That leaves
| some localized surpluses.
|
| The people that do not want the vaccine are a part of
| why. There are different reasons for this, with some just
| wanting others to get a chance first. But noone is going
| to force people to take it.
|
| Its also really unfair to characterize this as "rural
| areas" with "large numbers of vaccine denialists". We
| have urban areas with vaccines available and rural areas
| with full appointment books.
| lisper wrote:
| > We have urban areas with vaccines available
|
| Really? Where?
| jsight wrote:
| https://vaccinefinder.org/ - This site is halfway decent.
|
| Be careful to click through to the actual pharmacies,
| though. It is often out of date with actual availability
| being lower than indicated. Our state has also been
| running mobile events that have generally not been fully
| booked.
|
| I'm in no hurry personally, but I'm not seeing where it
| would be difficult to get for me.
| lisper wrote:
| > It is often out of date with actual availability being
| lower than indicated
|
| My experience with VF was the exact opposite: it was
| showing lots of availability where in fact there was
| none.
|
| But the burden of proof is still on you: what urban areas
| in the U.S. has good vaccine availability? By which I
| mean: anyone who wants one can get one same-or-next day.
| jsight wrote:
| > My experience with VF was the exact opposite: it was
| showing lots of availability where in fact there was
| none.
|
| That's exactly what I said, actually. Though it wasn't
| none, just low. Be sure to check back after a day or so.
| Availability swings pretty quickly.
| randomfool wrote:
| All of these vaccines are approved under emergency
| authorization- the long-term effects are still unknown. At
| this same rate (6 in 6 million+), there could easily be
| unnoticed issues lurking in the alternatives as well.
|
| What we do know is that the alternative to not being
| vaccinated is much worse.
| jsight wrote:
| That's possible, but this isn't "unnoticed" and the others
| have far longer track records in the US at this point.
| newacct583 wrote:
| It's bad policy. But it's important to get the analysis right:
| the choice here isn't between a very safe vaccine and an
| unvaccinated world population facing a pandemic to completion
| (which matches "the potential to kill millions").
|
| It's between "continued rapid vaccination with all three
| approved US vaccines" and "somewhat delayed vaccination with
| one of the three approved US vaccines". That's not remotely a
| million-person delta, though the number is surely much higher
| than the 1/1M case rate on these blood clots.
|
| Honestly the worst effect isn't with the vaccinations per se,
| it's the potential that this may delay vaccine acceptance rates
| among people sitting on the edge, due simply to fear.
| umanwizard wrote:
| We've completely transformed human civilization in a desperate
| attempt to slow down the spread of this virus that kills 1 in 200
| people, and now we don't want to use one of the miracle cures
| because of a literal one in a million chance of issues.
|
| People are absolute garbage at thinking about scale.
| rel2thr wrote:
| It's not a sim city decision. In young healthy people the risk
| of covid death is much lower than 1/200 , so you gotta see why
| this would make people hesitate.
| SpicyLemonZest wrote:
| As a young healthy people myself, I'm not tremendously
| concerned about either risk on a personal level, but I'm very
| concerned about getting vaccinated as fast as possible so I
| can do what I'd like without spreading disease. (To their
| credit, the agencies seem to have evaluated this and
| concluded the pause won't have a huge impact on vaccination
| timelines - but that won't do much for the people who were
| hoping to get it today!)
| mft_ wrote:
| Deaths from COVID aren't seen as the direct 'fault' of the
| regulatory bodies. Deaths from a vaccine will be... and
| fundamentally, regulatory bodies aren't really incentivised to
| take risks anyway.
|
| If they follow your line of thinking and it's all fine... no-
| one's going to be writing articles praising them.
|
| If they follow your line of thinking and more people die form
| blood clots... people will write articles attacking them.
| Questions will be asked, and careers may be harmed. Etc.
| jjcon wrote:
| > kills 1 in 200 people
|
| It kills less than that in the demographic in question, not to
| mention that is only of those who contract the virus.
|
| > People are absolute garbage at thinking about scale.
|
| I don't think it is that, I think it is that for better or
| worse humans tend to view wrongs through inaction as less
| atrocious than wrongs through action. Additionally - they
| already have better alternatives and plenty of supply in the US
| (Moderna and Pfizer vaccines) so they are opting to just use
| those at the moment.
| tombert wrote:
| First, it's closer to 4 in 200 [1]
|
| Second, there's evidence that even if people don't die, there
| can be long term neurological effects [2].
|
| Third, even if we accept your number, 1 in 200 would still be
| 1.5 million Americans dead, not even considering the rest of
| the world. I am personally not comfortable doing nothing to
| stop that number.
|
| I agree that being super worried about a 1 in a million blood
| clot might be short sighted, especially since the death rate
| from catching the virus is 2 in 100.
|
| [1] https://coronavirus.jhu.edu/data/mortality
|
| [2] https://www.reuters.com/article/idUSKBN2BT2ZI
| mizzack wrote:
| It's absolutely disingenuous to use CFR to drive home a point
| about absolute deaths rates in a population.
|
| People with asymptomatic infections (which are the majority
| of them) do not have any reason to get tested, so they do not
| count as "cases".
| tremon wrote:
| It's also similarly absolutely disingenuous to use any
| other number that's not based on measured (or measurable)
| facts. CFR is the only one we have right now, what else do
| you suggest?
| tombert wrote:
| That's probably true, so maybe the 2% death rate is too
| high, again, let's assume that the OP's point of 0.5% is
| accurate.
|
| As I said, that still implies that if everyone in the
| United States got it, 1.5 million of them would die
| (320,000,000 * .005). That's a lot of people.
|
| If a government did nothing to prevent a terrorist attack
| that killed 1.5 million people, most people would (rightly)
| be pretty upset.
|
| EDIT: Also, forgot to mention, it's totally disingenuous to
| only look at "deaths". We do not fully know the long term
| health effects, but as I stated there's potential
| neurological effects, potential risks of type 1 diabetes,
| and people permanently losing smell.
| lax4ever wrote:
| While I can appreciate where you are coming from,
| countering a terrorist attack typically has something
| that we don't have with COVID and that is information.
| The world was introduced and expected to react to this
| disease without any sort of "tactical" knowledge. Even if
| you include the other four variants of coronavirus, the
| availability of information can still be considered
| sorely lacking. Discounting government-provided
| information, even medical sources had a harder time
| providing a consensus on how the disease was transmitted
| during the first few months. That the larger questions
| like why we have such a large population that appears to
| be asymptomatic remains unanswered while we are still
| being pushed to "one-size-fits-all" remedy (and a remedy
| that appears to only be there to debase the severity of
| symptoms) doesn't help. Unfortunately, we need
| information, and information is going to take time. The
| long term arguments for health side effects are on both
| sides of the coin here.
| temp667 wrote:
| This is absolute and total BS. 2% death rate? Who comes up
| with this total garbage?
|
| You have 100M infected in US as the estimate. A 2% death rate
| is 2M deaths from COVID alone. I've not seen anything like
| that as credible death rates - it's at least half if not a
| quarter of this rate - more like 0.5% or less. Do the same
| thing in countries with 70% infected rates - if fatality was
| really 2%+ death counts would be insane.
|
| You really start to understand how people start to doubt the
| crap COVID "experts" put out when basic math shows it is
| garbage.
| tombert wrote:
| > Who comes up with this total garbage?
|
| Johns Hopkins University. I don't feel like that's
| typically considered a bad source. Maybe it's a bit high or
| they're looking at different data sets.
|
| But again, and I cannot overstate this enough, even if I
| accept the 0.5% number, that's still a lot of deaths, about
| 1.5 million if everyone in the US gets it.
|
| According to the NYTimes [1], there's been about half a
| million deaths from COVID. If your provided number of 100M
| infected people is correct, then that would be consistent
| with 1.5M dying if everyone gets infected (US population ~=
| 3 * 100M, 3 * 500,000 = 1.5M).
|
| [1]
| https://www.nytimes.com/interactive/2020/us/coronavirus-
| us-c...
| jdhn wrote:
| 1 in 200 people? Maybe if you're above the age of 75 and have
| significant comorbities. If it was 1 in 200 for all age groups
| you wouldn't have to convince people that lockdowns and
| maskwearing isn't all theater, they'd be so scared you wouldn't
| have to convince them of anything.
| umanwizard wrote:
| > If it was 1 in 200 for all age groups you wouldn't have to
| convince people that lockdowns and maskwearing isn't all
| theater, they'd be so scared you wouldn't have to convince
| them of anything.
|
| Not really. 1 in 200 is fewer than how many die a year anyway
| of all causes.
| exyi wrote:
| 1 in 200 is a low estimate of the average. If you are above
| 75 with significant comorbities it will more like 1 in 10 :/
|
| Surprisingly, even the elderly and sick people often do not
| understand the risks.
| novaRom wrote:
| > now we don't want to use one of the miracle cures
|
| We want if there are safer options. Not all vaccines are equal.
| Important question is why we unable to scale up production of
| mRNA vaccines?
| ceejayoz wrote:
| > Important question is why we unable to scale up production
| of mRNA vaccines?
|
| Where are you getting the idea that we can't?
|
| Hundreds of millions of doses of the Pfizer and Moderna
| vaccines have already been made. Pfizer expects to make 2
| billion doses this year.
| novaRom wrote:
| Why only this 2 companies? Why don't we mobilize all pharma
| of the world to produce more mRNA vaccines quickly?
| Intellectual property? I think it's an extraordinary time
| so we should all agree to vaccinate all earthlings quicker
| is much higher priority than commercial interests.
| ceejayoz wrote:
| Again, where are you getting the idea that this isn't
| being done?
|
| https://www.novartis.com/news/media-releases/novartis-
| signs-...
|
| > Novartis announced today that it has signed an initial
| agreement to leverage its manufacturing capacity and
| capabilities in order to address the COVID-19 pandemic by
| supporting the production of the Pfizer-BioNTech COVID-19
| Vaccine. The agreement will see Novartis utilizing its
| aseptic manufacturing facilities at its site in Stein,
| Switzerland.
|
| https://www.merck.com/stories/why-were-excited-to-
| partner-on...
|
| > On March 2, we announced a partnership with Johnson &
| Johnson to expand manufacturing capacity and supply of
| its COVID-19 vaccine. Under the Biomedical Advanced
| Research and Development Authority (BARDA) agreement, our
| company is adapting and making available some of our
| existing manufacturing sites to accelerate manufacturing
| efforts for the vaccine and enable more timely delivery
| and administration.
|
| https://investors.modernatx.com/news-releases/news-
| release-d...
|
| > Under the terms of the agreement, the companies plan to
| establish manufacturing suites at Lonza's facilities in
| the United States and Switzerland for the manufacture of
| mRNA-1273 at both sites. Technology transfer is expected
| to begin in June 2020, and the companies intend to
| manufacture the first batches of mRNA-1273 at Lonza U.S.
| in July 2020.
|
| https://www.astrazeneca.com/media-centre/press-
| releases/2021...
|
| > AstraZeneca and IDT Biologika also intend to strengthen
| Europe's vaccine manufacturing capability with a joint
| investment to build large additional drug substance
| capacity for the future. Details of the agreement are to
| be finalised. Both companies plan to invest in capacity
| expansion at IDT Biologika's production site in Dessau,
| Germany to build up to five 2,000-litre bioreactors
| capable of making tens of millions of doses per month of
| AstraZeneca's COVID-19 vaccine. The new assets are
| estimated to be operational by the end of 2022.
| shlant wrote:
| intellectual property is one reason[1] but for the mRNA
| vaccines, the technology/machinery required to mass
| produce them is also part of the bottleneck along with
| raw materials[2]
|
| 1. https://theconversation.com/how-patent-laws-get-in-
| the-way-o...
|
| 2. https://www.thedailybeast.com/heres-why-it-will-be-
| hard-to-r...
| nicbou wrote:
| Despite our attempts at containing it, it has killed roughly 3
| million people worldwide. I'd say it's cause for concern.
| enumjorge wrote:
| I don't think the parent comment meant to downplay the virus.
| I read it more like "we had to make great sacrifices to
| contain a 1 in 200 death problem but now we're turning our
| noses at a cure that has a 1 in 1M serious side effect rate".
| _Microft wrote:
| The section I have italicized here stood out in the statement
| from the FDA/CDC, in my opinion. This is not about putting
| vaccinations with the Johnson & Johnson vaccine on hold
| _infinitely_. For a good part, it seems to be about being _aware
| of and prepared for_ this serious adverse effect, not to avoid it
| at all costs.
|
| "Until that process is complete, we are recommending a pause in
| the use of this vaccine out of an abundance of caution. _This is
| important, in part, to ensure that the health care provider
| community is aware of the potential for these adverse events and
| can plan for proper recognition and management due to the unique
| treatment required with this type of blood clot._ ", from
| https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.htm...
| rantwasp wrote:
| so, let me get this straight. you have vaccines that use a new
| tech (mrna) that are awesome and vaccines that use "old tech" and
| at least 2 of then produce blood clots?
|
| something is weird here. i'm not saying this is due to mass
| hysteria generated by people that don't want the vaccine but this
| does sure look like a case where we don't understand relative
| risk.
|
| i may be ignorant and not understand all the factors but I don't
| see the data that allows me to understand if suspending this
| vaccine is a good thing or nkt.
| opinicus wrote:
| The J&J and AstraZeneca vaccines are both based on adenovirus
| vectors. This platform has a little more history, having been
| used in a recent ebola vaccine, but the number of doses
| administered has been relatively tiny. I'd say both vector-
| based and mRNA very new, pioneering tech.
| lsllc wrote:
| Massachusetts DPH has now shutdown administering J&J vaccines (of
| which MA got a large batch last week) and have been cancelling
| J&J appointments:
|
| https://twitter.com/MassDPH/status/1381947053287354368?s=20
| sjg007 wrote:
| Why are women adversely affected?
| graeme wrote:
| If it's an autoimmune reaction, autoimmune diseases generally
| are more common in women.
|
| That's not an explanation, of course, I don't know the reason.
| But it places this in a larger category.
| novaRom wrote:
| Yes, new analysis of those deadly issues with AstraZeneca
| shows it's autoimmunity:
|
| https://covid19-sciencetable.ca/sciencebrief/vaccine-
| induced...
| thornjm wrote:
| Med Student here so possibly wrong but...
|
| There is a well established link between oestrogen and
| increased blood coagulability. Whilst it is possible females
| are more affected by the vaccine I suspect one factor is that
| their baseline coagulation risk increases their likelihood of
| thrombus due "reaction induced coagulability" compared to
| males.
| jjk166 wrote:
| CVST normally affects women at significantly higher rates than
| men.
|
| > Cerebral venous sinus thrombosis is rare, with an estimated
| 3-4 cases per million annual incidence in adults. While it may
| occur in all age groups, it is most common in the third decade.
| 75% are female. [0]
|
| [0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombo
| s....
| ideamotor wrote:
| I read there is a bias in the data due to young women being the
| moat common demographic for nursing jobs.
| washedup wrote:
| The 9 day median length to development of the condition leads me
| to believe that this number will grow, and that they are smart to
| pause for a week or two to see what the real numbers are.
| jsight wrote:
| They also need to make sure the information is out there on how
| to identify and treat the condition if it does occur. Proper
| warnings and information are pretty important.
| cblconfederate wrote:
| Is there an understanding of why the vaccines cause the clots?
| clon wrote:
| As for the AZ vaccine, we are still learning:
| https://www.nejm.org/doi/full/10.1056/NEJMoa2104840
|
| The paper details several cases (and index case in more detail)
| as well as a plausible mechanism behind the thrombotic events.
| Even better, there are some therapeutic possibilities as well
| arising from the heparin induced analogue condition.
| stevenwoo wrote:
| The theory is that it is the same reaction that a tiny
| percentage of people have to heparin (AZ vaccine in this study
| but mechanism presumably the same) There is a treatment but
| imperative that doctor knows that this is the cause for
| appropriate response.
| https://www.nejm.org/doi/full/10.1056/NEJMoa2104840
| jkingsbery wrote:
| I haven't seen any news articles provide a point of comparison of
| how the number of people receiving the J&J vaccine and
| experiencing this particular kind of clotting. The first
| academic-ish article on the subject I could find indicated a
| typical baseline of 15.7 cases per million (https://www.ahajourna
| ls.org/doi/full/10.1161/STROKEAHA.116.0...). If that's true, I
| don't get it - why would we stop roll out of any vaccine when the
| baseline (15.7) is higher than the problem that is being claimed
| (1 per million)?
| _wldu wrote:
| Covid itself causes blood clotting in many seriously ill
| patients. A friend, who was in ICU in March 2020, was given
| Herparin (due to clotting concerns), and was told to take aspirin
| at home after release.
|
| Is it surprising that the vaccines cause clotting too? Isn't this
| sort of obvious?
| kian wrote:
| Vaccines for tetanus don't cause lockjaw. Vaccines for measles
| don't give you bumps all over your body. Most vaccines, except
| for those that used to work by actually infecting you with a
| related virus, do not cause the same symptoms as the diseases
| they treat.
| m-ee wrote:
| No this is a very different form of clotting caused by auto
| antibodies that causes both clotting and low platelet counts.
| It's similar to HIT. Giving heparin in this situation would
| make things worse.
|
| https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopen...
| wonminute wrote:
| aspirin != heparin. Question, would taking aspirin prior to
| and after Janssen vaccination lower this risk?
| m-ee wrote:
| No it would not. There have been a couple papers focused on
| the AZ vaccine that get into possible treatments.
| CivBase wrote:
| > The US has by far the most confirmed cases of Covid-19 - more
| than 31 million - with more than 562,000 deaths, another world
| high.
|
| The BBC is usually pretty good about sticking to relevant
| information (at least compared to US media), so I was a bit
| disappointed to see this blurb - especially since it's only the
| fourth sentence in the article. What does it add? It has nothing
| to do with the subject (ie the safety of the J&J vaccine) and
| isn't even particularly useful data in almost any other context
| aside from half-baked political jabs between nations.
| mdavidn wrote:
| It also ignores differences in population. Several European
| countries have more deaths per capita than the United States.
| So far, the UK had 200 more deaths per million (11% more). The
| Czech Republic had 900 more per million (53% more).
| daemoens wrote:
| A pause on vaccines will cause far more deaths than a 1 in 1
| million chance of blood clots.
| ars wrote:
| It's unethical to give people a vaccines that can cause a blood
| clot without informing them first of the risk.
|
| It doesn't matter that globally it could cause more deaths.
| It's not the job of the FDA or CDC to act as your parent and
| decide for you what risk is and isn't acceptable.
|
| Informed consent is a cornerstone of medical policy.
|
| What will happen is they will modify the consent form to let
| people know about the risk, and let them decide for themselves.
| dragonwriter wrote:
| > A pause on vaccines will cause far more deaths than a 1 in 1
| million chance of blood clots.
|
| Its not "a pause on vaccines" it's a pause on one vaccine. And
| its not 1 in 1 million, because many of the 6.45 million doses
| administered of J&J are still, or even not yet, within the 1-2
| week window after administration where this complication has
| been observed. And the pause is to get information to
| healthcare providers and permit them to establish appropriate
| protocols for handling the clots, not for open ended study. And
| it coincides with the timing of a short-term supply drop (-80%
| from prior week) in J&J vaccines that was going to force a
| sharp drop in the rate of adninistration at some point in the
| very near future anyway.
| jjk166 wrote:
| 6 cases in 7 million doses over 3 months is exactly the rate that
| CVST would normally be expected at. While that doesn't mean we
| shouldn't investigate, it does mean there is no reason to be
| alarmed at this time.
|
| > Cerebral venous sinus thrombosis is rare, with an estimated 3-4
| cases per million annual incidence in adults. While it may occur
| in all age groups, it is most common in the third decade. 75% are
| female. [0]
|
| [0]
| https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
| wallacoloo wrote:
| > All six cases were in women aged between 18 and 48, with
| symptoms appearing six to 13 days after vaccination.
|
| All the observed cases occurred shortly after vaccination, so
| I'm not sure 3 months is the right divisor to use in your
| comparison.
| jjk166 wrote:
| You are only looking at people a short time after
| vaccination. Anyone in the population who had a clot prior to
| being vaccinated or who will get a clot later this year have
| not been counted.
| fspeech wrote:
| That is exactly the point. Using the background rate you
| quoted from Wikipedia within a two week window you are
| expected to see around one case. So most of the cases can
| not be explained by the background.
| vincentmarle wrote:
| > While that doesn't mean we shouldn't investigate, it does
| mean there is no reason to be alarmed at this time.
|
| Except to the general public this overcautious behavior and
| resulting media hype raises vaccine suspicions, and will
| decrease public trust in J&J (and even vaccines in general) as
| a result. It's already happening.
| mStreamTeam wrote:
| Public trust in J&J has been low ever since they got caught
| putting asbestos in baby powder
|
| https://www.reuters.com/investigates/special-
| report/johnsona...
| fspeech wrote:
| There's the question of timing too. It's not clear if the
| number includes all CVST incidences or only those ocurring in a
| time window after vaccination. (Update: according to NYT these
| cases are 1-3 weeks after vaccination, so the background rate
| is too low to matter here). If there is a strong correlation in
| timing you can not simply use frequency data to rule out
| causation.
| jjk166 wrote:
| Of course the cases are shortly after vaccination, the data
| is symptoms reported shortly after vaccination which might be
| side effects. You're not going to have anyone who got a clot
| before the vaccine or long afterwards in the dataset, but
| those cases still did/will exist. There is no evidence yet of
| a correlation in timing.
| fspeech wrote:
| The background rate you quoted are expected to be spread
| out independent of vaccination. If you pick a two-week
| window after vaccination you should only expect 1/6 of the
| cases that are expected in 3 month, which is the number you
| calculated.
| jjk166 wrote:
| But we're not observing people for 3 months and picking
| an arbitrary two week window. People do not get added to
| the population until they have taken the vaccine, and
| they are all observed for different lengths of time. We
| did not hypothesize a 2 week period beforehand and
| compare how many landed within to how many were outside
| that range, the 2 weeks is just a circle drawn around the
| datapoints after the fact.
| fspeech wrote:
| Here is the chain of logic:
|
| 1. First assume independence, that CVST is unrelated to
| vaccination.
|
| 2. Take any two weeks, you can calculate the expected
| cases using population background rate because we assume
| independence.
|
| 3. The number is around 1 using Wikipedia data.
|
| 4. The observed case number 6 greatly exceeds the
| expected number based on independence assumption.
|
| 5. We conclude that with high probability that our
| independence assumption is wrong, i.e. there's
| correlation with high confidence.
| jjk166 wrote:
| Your logic breaks down at step 2. As a counter example,
| what are the odds that in the other 7 weeks you would
| have zero cases? Of course the answer is that this isn't
| how the data works.
|
| You are not sampling a random, normally distributed event
| over a fixed interval, you are sampling the spacing
| between two different events where one of them is
| systemically linked to how you define the population and
| the interval.
| thehappypm wrote:
| People need to accept that this is a real effect. Denying it
| isn't helping anyone. It's happening, it's rare, but it's
| happening.
| jjk166 wrote:
| If it's statistically significant, the evidence showing so
| will emerge quickly and we can decide at that time how the
| increase in risk compares to that of remaining unvaccinated.
|
| Otherwise, there isn't a whole lot of difference between "not
| real" and "real but so rare as not to matter."
| greenwich26 wrote:
| Over the past 2 weeks, the reported rate of these events
| associated with the AZ vaccine has gone from 1 in a million, to
| 1 in 30,000 [0].
|
| [0] https://www.nejm.org/doi/full/10.1056/NEJMoa2104882
| kokx wrote:
| The source you mention does not explicitly give a one in
| 30.000 figure, and it is not something that can be safely
| concluded from the data in the paper. The authors state that
| at the time 132,686 people had received their first AZ shot
| in Norway, of which five had developed thrombosis.
|
| This is definitely not enough data to conclude a 1 in 30,000
| figure. And neither does the cited paper conclude this.
| greenwich26 wrote:
| 5 developed the disease 7 or 8 days after the vaccination.
| Not sure what you're getting at...sampling error? It's a
| binomial distribution, right? Back of the fag packet maths,
| we can easily reject 1 in a million, and put a reasonable
| upper bound below 1 in 100,000.
| jjk166 wrote:
| The clots associated with the AZ vaccine aren't CVST.
| mzs wrote:
| Though there have been SVTs and DVTs the vast majority have
| been CVSTs with thrombocytopenia:
|
| https://www.theguardian.com/world/2021/apr/13/astrazeneca-
| bl...
| endisneigh wrote:
| Makes sense.
|
| Given there are some organizations that are forcing you to get a
| vaccination. 1 in a million chance of dying from something you
| were forced to do is different than 1 in a million chance of a
| pseudo-random event. Makes no sense to continue with J&J given
| the other two don't have this issue at the moment.
|
| Of course, the utilitarian approach is to simply continue
| vaccinating with J&J since surely more people are helped than
| harmed. I'm sure they'll reverse this decision soon enough.
| stickfigure wrote:
| > different than 1 in 150 chance of contracting and dying from
| COVID
|
| Fixed that for you.
| endisneigh wrote:
| What? I never claimed that contracting and dying was a 1 in a
| million chance?
| [deleted]
| bentlegen wrote:
| As of today about 560,000 people in the US have died of COVID,
| or roughly 1 in 574. I think it's safe to say the odds are
| higher than "1 in a million".
| endisneigh wrote:
| My point isn't to say that 1 in a million die of COVID, my
| point is that psychologically the decision makes sense.
| stickfigure wrote:
| We don't need to have abstract philosophical conversations
| about hypothetical numbers. We know the real ones.
| endisneigh wrote:
| Again, that is not my point to begin with. My point is
| that it makes sense to pause given the poor optics of the
| clotting/dying until we investigate.
|
| If the article was saying J&J was permanently
| discontinued perhaps I'd agree with you.
| space_fountain wrote:
| What organizations are forcing you to get vaccinated. I've
| heard a lot of speculation and honestly there should be more
| forceful, but I'm not aware of any. Plenty of jobs force you to
| drive which is absurdly risky
| endisneigh wrote:
| https://www.npr.org/2021/04/11/984787779/should-colleges-
| req...
|
| There are also jobs. I don't disagree with the forced
| vaccinations, but it is what it is.
| JohnWhigham wrote:
| You're already required to have a list of other vaccines
| before entering most colleges. This is nothing new. Try
| harder.
| jhoechtl wrote:
| The others are way more expensive though. Allegedly
| artificially expensive to milk those in despair.
| baggy_trough wrote:
| Awful decision. Everyone involved should be fired or removed from
| office for grotesque lack of judgement leading to a significant
| net increase in mortality.
| yboris wrote:
| Related: The J&J Vaccine Is Safer Than the Birth Control Millions
| of Women Take Every Day
|
| https://www.vice.com/en/article/z3xbk9/johnson-and-johnson-c...
| xiphias2 wrote:
| Why didn't they stop the vaccinations in women under age of
| 60/65?
|
| I'm a 40 year old man, if I were a woman I wouldn't take J&J or
| AstraZeneca, but as I'm a man, I think it's worth to take the
| risk of the side effects of the vaccination.
| _wldu wrote:
| I wonder why all the clot victims are 100% female with J&J?
|
| Also, only 1/3 of Astra Zeneca clot victims are male:
|
| https://news.yahoo.com/astra-zeneca-vaccine-blood-clot-risk-...
| Pyramus wrote:
| They aren't - at least one out of nine patients with blood
| clots from AZ vaccine was male [1].
|
| [1] https://www.researchsquare.com/article/rs-362354/v1
| sudosteph wrote:
| I'm only speculating, but serious blood clots are also known
| to be possible side effects of some forms of hormonal birth
| control. Given the relatively young ages of the women who had
| side effects on J&J, I would be really interested in learning
| if there could be a connection there.
| xyzzyz wrote:
| Many more people will die as a result of stopping vaccination
| than they will of alleged side effects to some vaccines.
| xiphias2 wrote:
| They are not alleged at this point, they are real, and we
| have enough data that proves it. Using a language that
| pretends that vaccines can't have lethal side effects is just
| dividing people farther. It's all about the risk-reward
| calculation, which is still on the vaccine's side for most
| people.
|
| For a 18 year girl though it may be better to wait 2 weeks
| more for the Moderna / Pfizer vaccine in lockdown at home
| than to take the J&J or AstraZeneca. As an example my parents
| did the same thing (watching TV and using the elliptic
| machine for training, waiting 2-3 weeks more than their
| friends who got the Chinese vaccine).
| Igelau wrote:
| > They are not alleged at this point, they are real, and we
| have enough data that proves it.
|
| What was it? 6 cases out of 7 million doses? That doesn't
| even look like a correlation, let alone a side effect.
| mikem170 wrote:
| This article [0] mentions 50% more blood clots observed
| during vaccine trials, which at the time was
| characterized as a slight numerical imbalance (15 blood
| clots versus 10 in the placebo group, in a trial of 20k
| people)
|
| The 6 cases out of 7 million would appear to be the most
| serious/unusual/cerebral blood clots, but that number
| does not include all blood clots.
|
| I don't mean to advocate against the vaccine with these
| numbers, just add data. I see the 6 out of 7 million
| number batted around a lot and that's not a complete
| picture.
|
| [0] https://www.cnn.com/2021/04/13/health/johnson-
| vaccine-blood-...
| Baeocystin wrote:
| From what I understand, we have data that shows a few
| people per million have a serious health condition that
| appears to be similar in order of magnitude as the normal
| background rate of the same condition without the vaccine.
|
| As someone else in this thread said, isn't that
| (potentially) like someone getting hit by a car, then
| calling that a side-effect? When dealing with very large
| numbers of people, there's going to be deaths at all ages
| due to the normal vagaries of life.
|
| Do we have enough information to be certain that these
| clots are genuinely above the background rate?
| xiphias2 wrote:
| What is the background rate of CVST / 2 weeks? I think
| it's significantky less that 1/million people
| bilbo0s wrote:
| Now you have the logistical challenges of shipping 2 vaccines
| to some small town. One for the men, another for the women.
| Additionally, that town needs the not insubstantial
| refrigeration capabilities anyway.
|
| So what's the point if you're a public health admin? Just get
| the moderna or Pfizer and save yourself and your staff a lot of
| headache.
|
| The logistical benefits of J&J mean that it's only logistically
| beneficial if it can be used for everyone.
| [deleted]
| bluGill wrote:
| The towns small enough to only need one shipment are easy,
| just thaw some mRNA in the nearest big city and someone
| drives it out the morning of the vaccine clinic.
|
| The big enough cities to need many shipments can handle these
| logistic.
| hedora wrote:
| Better to write the town off to the pandemic. I mean, we're
| in the middle of a fourth surge, so realistically, double
| digit percentages of the town are likely to get covid if we
| delay even a few weeks, but 10% of 0.5% the population dying
| from covid and increased spreading of the new variants are
| reasonable prices to pay to avoid 1 in a million side
| effects.
|
| We can make a statue for the people that die in the following
| weeks protecting the rest of us from the J&J vaccine. They'll
| be heroes.
|
| Sorry. Really pissed off about this.
| robrenaud wrote:
| The informed old people are vaccinated already. The IFR is
| way down from around .5 percent.
|
| Still agree that covid is a way bigger threat than the J&J
| vaccine though.
| t_sawyer wrote:
| You think 10% of a towns population will die from COVID in
| a couple weeks?
|
| Has that percentage of people in any county in the USA
| actually died from COVID in over a year?
|
| Florida who has been pretty laissez-faire about COVID has
| 5,980 deaths in Miami-Dade County (their highest amount of
| deaths in a county). 2.717M population in 2019.
|
| 0.22% of their population.
| robrenaud wrote:
| He estimates an additional 10% (increased spread of covid
| infection due to change in vaccine policy) of .5% (death
| rate given covid infection) of a towns population will
| die from covid due to vaccine hesistancy.
| bilbo0s wrote:
| Only there is no vaccine hesitancy. Only public health
| admins saving themselves headaches by just using moderna
| or Pfizer in the first place. Since using J&J would
| require them to use moderna or Pfizer anyway.
| throwaway0a5e wrote:
| Using a machete when you should be using a scalpel (though to
| be fair at the time it looked like a filet knife was the tool
| for the job) has been more or less how this pandemic has been
| handled since day 1. Why would that change now?
| rainyMammoth wrote:
| Nobody seem to discuss that this issue appears around 10 days
| after getting the vaccine. And I believe most of the doses have
| been given over the last 10 days. So we actually don't know yet
| the real incidence of this issue. It makes sense for the FDA to
| be cautious here, there are other vaccines which are fully
| available.
| williesleg wrote:
| No big deal, just get out and get some sunshine. Also, the
| vaccination only lasts about 6 months, you'll need another shot
| in the fall.
___________________________________________________________________
(page generated 2021-04-13 23:01 UTC)