[HN Gopher] The EMA Covid-19 data leak, and what it tells us abo...
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The EMA Covid-19 data leak, and what it tells us about mRNA
instability
Author : walterbell
Score : 92 points
Date : 2021-03-16 11:35 UTC (11 hours ago)
(HTM) web link (www.bmj.com)
(TXT) w3m dump (www.bmj.com)
| hannob wrote:
| I had looked at these emails when they leaked. To be clear: If
| you'd offer me one of those mRNA vaccines like right now I
| wouldn't hesitate for a second and take it.
|
| But I do think this raises some questions around transparency. If
| the EMA has concerns about the production of these vaccines then
| I think this is something that should be discussed in public - so
| the scientific community can weight in and review this issue. If
| the EMA thinks that this is a solved issue - which the emails
| imply is what they thought before they authorized the vaccine -
| then that's what they should communicate.
| hkktlgkfdn wrote:
| > _If you 'd offer me one of those mRNA vaccines like right now
| I wouldn't hesitate for a second and take it._
|
| Why do you think that means anything. Some don't hesitate to
| base jump, take crystal meth or get covid infected.
| YinglingLight wrote:
| >To be clear
|
| You know you're in a cult when you must preface your fealty
| before voicing the softest of logical hardballs. This entire
| thread is 50% prefacing. We've lost our ability for true
| discourse.
| johbjo wrote:
| It's a technical concern. Publishing will only cause fear and
| doubt.
|
| In any case, it's a matter of weighing risks. Even if there's a
| 10-6 probability of complications, giving the vaccine and
| stopping serious illness/deaths is still a better decision
| overall. Even if it means hundreds of cases of complications
| across Europe. And then, the complications might turn out to be
| statistically difficult to discern from uniform random anyway.
|
| A probability of 10-6 is difficult to conceptualize so if it is
| published with scary words, people might interpret it as "will
| probably happen to me". Then if that affects vaccine roll-out
| negatively, publishing might be a bad decision.
|
| Millions of people in the UK have received the AZ vaccine,
| which has demonstrated safety and efficacy.
|
| The efficacy metric means protection against infection, which
| is not complete. But as far as I've heard, not one person who
| has received either Pfizer or AZ has become seriously ill or
| died. In other words, it "flattens the curve" instantly.
| matwood wrote:
| > people might interpret it as
|
| Unfortunately we/they are in a damned if you do, damned if
| you don't situation. If it was published, you can be sure the
| misinformation around what it meant would be through the
| roof. Having it hidden, and now come out may end up lending
| more credence to the conspiracy theories.
| possiblelion wrote:
| Wait, so what effect does potential RNA instability really have?
| walterbell wrote:
| https://www.modernatx.com/about-us
|
| _> Welcome to Moderna. We believe mRNA is the "software of
| life. " Every cell in the body uses mRNA to provide real-time
| instructions to make the proteins necessary to drive all
| aspects of biology, including in human health and disease._
|
| What's the metaphorical software equivalent of "mRNA
| instability": undefined reference, memory corruption,
| incomplete download, installation failure, program crash, ...?
| nobrains wrote:
| https://remyhax.xyz/posts/bitsquatting-windows/
| maxerickson wrote:
| There isn't one.
|
| Mitochondria won't decode the corrupted mRNA and it will be
| broken down into constituent parts that are reused by the
| body.
|
| Edit: Oops, ribosomes, not mitochondria.
| DSingularity wrote:
| How do we guarantee that? Is there a biological equivalent
| of a checksum?
| maxerickson wrote:
| You have trillions of mitochondria. Do you think there is
| no error correction present?
|
| (The actual estimate is 10 million billion...)
|
| Edit following my other edit: each cell has something
| like 10 million ribosomes.
| serf wrote:
| NMD does similar work, but not in a checksum-like way.
|
| https://en.wikipedia.org/wiki/Nonsense-mediated_decay
| walterbell wrote:
| Any pointers to reading material on the detection process?
| A web search found this article.
|
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791314/
|
| _> Given the central role of RNA in many fundamental
| biological processes, including translation and splicing,
| changes to its chemical composition can have a detrimental
| impact on cellular fitness, with some evidence suggesting
| that RNA damage has roles in diseases such as
| neurodegenerative disorders. We are only just beginning to
| learn about how cells cope with RNA damage, with recent
| studies revealing the existence of quality-control
| processes that are capable of recognizing and degrading or
| repairing damaged RNA._
| Zancarius wrote:
| That article discusses RNA not mRNA (messenger RNA). mRNA
| is used by ribosomes to "print" proteins. Totally
| different thing.
| phkahler wrote:
| How does it recognize corruption? Certainly some could be
| processed with incomplete or incorrect results. It's really
| hard (probably impossible) to show that there will not be
| negative effects from that.
| taipan100 wrote:
| Valid mRNA has a start codon and a stop codon. Without
| these mRNA will be broken down and untranslated. However
| without translation the vaccine will be useless. So while
| unintended translation is unlikely it is possible that
| efficacy would be impacted.
| ceejayoz wrote:
| > What's the metaphorical software equivalent of "mRNA
| instability"
|
| "This shitty app doesn't work. Uninstall."
|
| That's about it here.
| maxerickson wrote:
| The mRNA is the instruction that the body follows to produce
| the viral proteins that lead to an immune response. If the mRNA
| in a batch of vaccine degrades more than they have allowed for
| in the treatment protocol, it may not work.
|
| (This is one of the reasons they have very specific handling
| rules and throw out vaccine that is improperly handled)
| topynate wrote:
| Intactness of 55% vs 75% should make no real difference to your
| view either of efficacy or of danger. Because:
|
| Efficacy: the mRNA vaccines have a large margin for error with
| respect to dose. 55% of several times more than enough is still
| more than enough.
|
| Danger: suppose the danger of broken-up mRNA to increase linearly
| with the amount given. Then the increase of danger would be by a
| factor of (100-55)/(100-78) ~= 2. The substantiated near-term
| danger of Pfizer is very low. We're at 5.2 million people vaxxed
| in Israel now... Twice of very low is very low. In order to argue
| for "too much" danger you have to argue either for non-linearity
| or for long-term high danger. If you argue for the latter then
| you already think the danger to be high, so there's no real
| difference between your view now and your view before. If you
| want to argue non-linearity of danger then you are arguing for a
| very remarkable biological coincidence. You also have to explain
| why the occasional 5x overdoses, which happen when a someone is
| given a whole vial by mistake, don't seem to be doing any harm.
| Never mind that it would have come out in the animal trials.
| tobmlt wrote:
| Apologies, but I must have missed it when you said:
|
| "If you want to argue non-linearity of danger then you are
| arguing for a very remarkable biological coincidence."
|
| What do you mean here? Can you give a bit more info?
|
| Note, I am pretty well versed on nonlinearities from a
| mathematical-engineering point of view, but know very very
| little about biology. (If that's of any use to know)
| topynate wrote:
| Just that increases in risk are usually approximated pretty
| well by a linear change with dose. Radiation, poison,
| allergens, etc. Drugs too - the ones where the toxic dose is
| close to the therapeutic dose are generally pretty nasty even
| when used as intended. It's _possible_ for there to be a
| transition between "very safe" and "noticably unsafe" as the
| quantity of something increases twofold, but a priori
| unlikely. For this to happen not only in vaccines, but
| through an unknown mechanism that operates precisely in this
| particular range, would be truly rotten luck. It's also
| contradicted (a posteriori) by the evidence I referred to
| (overdoses and animal models).
| woofie11 wrote:
| This isn't right. Risk from overdoses of drugs, poison, and
| allergens is *highly* nonlinear. It'd be exceptionally
| unlikely in the case of mRNA vaccine, but that's the case
| the majority of the time.
|
| There's a specific minimum dosage most people have of
| allergen before they hit on a life-threatening reaction.
| You might be okay with trace amount of peanuts, swell up
| with one peanut, and die with five. It's pretty consistent,
| and very nonlinear.
|
| That's why you can build up a tolerance to iocane powder
| too; small doses won't do anything, while large ones are
| guaranteed to kill. If it was linear, a 1/10th lethal dose
| would have a 10% chance of killing you.
| topynate wrote:
| I mean, they're all nonlinear at some point in the range
| of possible doses. Radiation too. I should have specified
| I was focusing on the "very low" bit of the curves. Chest
| X-ray vs two chest X-rays, rather than Louis Slotin vs
| the guy at the back of the room.
| [deleted]
| woofie11 wrote:
| Let's say a piece of mRNA has a 1E-12 chance of causing you
| to grow a third arm by virtue of a defect. Two pieces of mRNA
| would have very close to a 2E-12 chance of causing you to
| grow a third arm. That's linearity. If you've doubled the
| defect rate, you've doubled the risk.
|
| This contrast with e.g. sports brain trauma, where one sports
| brain trauma might be relatively moderate risk, but two might
| be very high risk (much more than double). Or risk from
| ibuprofen, where 600mg is has close to zero risk, but an
| overdose of 60,000mg poses a significant risk of death (much
| more than 100x the risk of death of a 600mg dose). That's
| nonlinear.
|
| I'm not sure how risk from mRNA defects would be anything but
| linear. It would take an extraordinary set of coincidences.
| tobmlt wrote:
| it would appear you are sampling an unknown distribution,
| finding it mostly to be negligible in its effects, and
| calling it linear?
|
| I'm confused so let me try an analogy with DNA: most
| mutations do nothing. Every now and then, cancer. Sample a
| large number of mutations for a short duration, and you
| have proven nothing regarding nonlinearity globally.
| Roughly speaking.
|
| Another example: I can measure a the air near (but not to
| near) a shockwave, or just under (By human scale) the free
| surface of the ocean, and find pretty much linear behavior
| if no other pathologies are present. The underlying physics
| however, is not linear, it is only my approximation which
| is. Maybe it's valid over configurations of interest. But
| then I better know something about the limits of my
| approximation.
| darawk wrote:
| Is there any reason to think it's unlikely that mRNA
| defects would have the same risk profile as Ibuprofen? The
| body is full of thresholding processes, where up to X%
| blood concentration the organs filter things out fine, and
| there's no issue, but over that level danger escalates
| quickly. I don't know immunology basically at all, but is
| there some reason to think it doesn't have processes that
| behave like this?
| ppf wrote:
| It's not the percentage of intact mRNA that's the problem, it's
| what the other bits of mRNA happen to _do_.
| et2o wrote:
| Encode smaller bits of the same protein? Who cares.
|
| Otherwise, the mRNAs aren't present in high enough quantities
| to do significant signaling or silencing things, and it's
| going in the deltoid... not really a medically interesting
| place. You could inject 1mL of dilute HCl there and it
| wouldn't be a big problem.
| Tossitto wrote:
| Proteopathy is a real thing. Prion dysfunctions can cause
| self-replication, not that the makeup is necessarily there
| for that in these vaccines. Interesting starting point for
| consideration nonetheless.
| ppf wrote:
| I'd rather not be injected with bits of mRNA that encode
| random bits of proteins, thanks. The deltoid is "medically
| interesting" enough to produce Covid spike proteins.
| timy2shoes wrote:
| Won't non-intact mRNA without a stop codon get degraded
| by Non-stop decay?
| rolph wrote:
| you have the idea right , but it isnt a stop codon its a
| signal sequence on the mRNA that would give it a hall
| pass.
|
| no cytoplasmic nucleotide transport signal and it gets
| degraded quickly.
| rolph wrote:
| these fragments of mRNA will be recognized as antigens, until
| the point that the folded structure of the epitopes is
| destroyed, these smaller fragments are still recognized as
| viral PAMPs and evoke innate immune responses.
| cfu28 wrote:
| Anything particular reason you're worried about extra mRNA
| fragments? mRNA needs a initiation sequence in order to be
| translated into a protein, which only exists at the front. It
| also needs a polyA tail to maintain stability or it would
| just degrade. Random fragments don't do anything on their own
| topynate wrote:
| Didn't I cover that in "danger"? The leaks are talking about
| maybe twice as much broken bits of mRNA in early batches.
| That's assuming all the not-intact stuff is broken mRNA
| rather than simple amino acids or something else just as
| boring. That shouldn't make much difference to anyone's view.
| If you think it's "doing" stuff that makes you not want to
| get vaccinated, well you probably thought that before you
| read this report, too.
| hef19898 wrote:
| Somehow I always have to think about the articles from a while
| ago covering Russian propaganda campaigns against Covid vaccines.
| Leaking emails would fit.
| fuoqi wrote:
| Not a surprising reaction after the (mostly baseless) smear
| campaign against Sputnik V.
| program_whiz wrote:
| Hey I'm all for the vaccine, but lets be real about it. Humans
| struggle with productization. Games, phones, cars, and everything
| else we make have problems initially (and frequently after any
| small changes) because we have to come up with a repeatable and
| robust process for producing, packaging, shipping, delivery, etc,
| which may have totally different requirements from prototyping
| and development. Furthermore, these processes have a myriad of
| unknown unknowns -- with failure points we don't anticipate until
| they happen (complex systems).
|
| This is another (very very) complex system with a relatively
| untested technology in an extremely noisy deployment environment.
| Every user is running a different OS basically, and every
| deployment corrupts the deployment image to some degree (RNA
| breakdown). Problems were bound to occur, and yes, the extent of
| those challenges are likely being downplayed to avoid panic and
| to get people to take the vaccine.
|
| On the question of motivation: global pandemic, billions in R&D
| spent, pressure from people on politicians, etc. The usual set of
| unavoidable human reasons to release products before they are
| 100% tested (since 100% testing can only really happen in the
| wild anyway). Combine that with politicization of every topic,
| and the inability of the public at large to handle any nuance
| (e.g. "there may be some problems in production, but we believe
| overall it is worth the risks and won't pose a major problem
| because of X, Y, and Z.")
| [deleted]
| atleta wrote:
| You can never test "100%", especially if you don't define what
| it means. But you've set it up to be an unsatisfiable
| expectation anyway, saying that "100%" means "testing in the
| wild". Which means releasing it. So you provide a definition
| that is always true: you can't adequately test a product before
| release, because you can only test it adequately after the
| release.
|
| That's not that much different from the self deceiving mind
| trick those say who claim this is a "human experiment". Which
| is, of course it is! I mean the process for testing and
| certifying a medication _has to_ include a phase where we
| experiment on humans.
|
| And the whole process is designed with this in mind: increasing
| number of participants during phase 1-2-3 trials and then it
| gets released, without being tested "100%", if you will, and it
| enters phase 4, that is basically tracking it while being "out
| in the wild". Though you could argue that phase 3 is just as
| much out in the wild.
|
| I think what you can see from how these vaccines are being
| tested and released is that these are the most rigorously
| tested products out there.
| Pyramus wrote:
| Another way to skin the same cat: Safety is not a binary
| variable even though we have this mental model of
| safe/unsafe. In fact safety is continuous ranging from high
| risk (unsafe) to low risk (safe).
|
| With more information (more trials/subjects) we get a better
| estimate (with less uncertainty) of the associated risk. The
| properties (safety/risk) of the vaccine don't change. What
| changes is the uncertainty around our estimations.
|
| This is still a simplification (e.g. there could be unknown
| unkowns) but I find it a better heuristic than safe/unsafe.
| abfan1127 wrote:
| I agree on the simplification. No such thing as "safe",
| only "safe enough" which assumes every one's scale of
| safety is the same. That seems presumptuous.
| maxerickson wrote:
| Humans have relatively little genetic variation, you overstate
| things with the weird analogy to operating systems.
| yomly wrote:
| And you are under appreciating the myriad ways differences
| can express themselves in nature. We share 50% of the same
| DNA as a banana, and we're 98.8% the same as a chimpanzee.
|
| Spurious examples aside, the pandemic has highlighted ethnic
| differences in reactions to both pathogen and vaccine.
|
| And from personal experience in the field, seemingly "random"
| confounding factors can have drastic effects - supposedly
| safe gadolinium based contrast agents caused NSF if you
| happened to have bad kidneys.
|
| Aggregation occludes all nuance, essentially by definition.
|
| Decisions that are correct for the aggregate can often be
| wrong for the individual.
|
| But I guess that kind of thinking is why the pandemic has
| been such a crapshoot in the first place.
| Reason077 wrote:
| > _" We share 50% of the same DNA as a banana"_
|
| This is a widely repeated "internet fact" but it's not
| true. For one thing, a banana has only about 520 million
| base pairs of DNA, while the Human genome has 3.1 billion.
|
| In reality, depending on the search method used, _at most_
| about 24% of human genes have orthologous genes in the
| banana genome:
|
| https://lab.dessimoz.org/blog/2020/12/08/human-banana-
| orthol...
| maxerickson wrote:
| My point is that in the terms of the weird analogy, we are
| pretty much running the same operating system as the chimp.
| For instance, they studied the immune response to the mRNA
| vaccines in primates.
| mark_l_watson wrote:
| I agree that there is so much variation in people's reaction to
| the vaccine. My 99 year old Dad had very little negative
| reaction. I felt shitty for one day after my second
| vaccination. My Dentist has been missing about 1/3 of work
| days, periodically feeling very poorly for a few days. Most of
| my friends and family had just mild reactions.
|
| I am in general skeptical about some vaccines, especially
| loading infants up on many vaccines all at once. However, with
| COVID-19, I think the general risk is worth keeping the global
| economy from complete collapse (if that is even possible).
| AndrewBissell wrote:
| > _However, with COVID-19, I think the general risk is worth
| keeping the global economy from complete collapse (if that is
| even possible)._
|
| We could simply reopen the economy at any point. There are
| more than enough counterexamples around to demonstrate that
| lockdowns do not eliminate Covid-19, and that a lack of
| lockdowns does not lead to endless piles of dead bodies in
| the streets. Lack of sufficient vaccination is not what is
| keeping the economy closed -- its usefulness in driving
| forward certain agendas is. The vaccines aren't even
| promising anything close to 100% effectiveness, particularly
| not among the highest risk groups (who were excluded from the
| clinical trials).
|
| "We can go back to normal soon if everyone just does this one
| thing" has been the carrot dangled in front of people's noses
| to get them agreeing to measures of dubious effectiveness
| since the start of the pandemic. If the virus mutates in the
| fall and winter and boosters have to be rolled out again,
| we'll either "have to" shut the economy back down until
| everyone gets shots in their arms again (in which case these
| vaccines are a poor preventative against economic damage) or
| we'll accept the need to live with some amount of endemic
| Covid spread (in which case it was certainly not lack of
| vaccines keeping us from reopening).
| renaudg wrote:
| > There are more than enough counterexamples around
|
| Citation needed.
| prithee wrote:
| My understanding is that this "reaction" is just immune
| response, and since you likely have a strong immune system
| than your father you saw a stronger reaction, both of which
| would likely be less deleterious than if your father
| contracted COVID directly.
| pacman2 wrote:
| Where can I download the leak? I am very interested in the
| production methods since I have some ideas how to improve them.
| Would appreciate a link.
| ArkanExplorer wrote:
| The risk profile for vaccines overlaps almost perfectly with the
| risk profile for COVID.
|
| That is, the age groups most at-risk from the virus (ages 70+,
| with comorbidities) are also going to live the shortest, and so
| suffer from fewer side-effects as well as not reproducing.
|
| So why aren't the rollouts focused on vaccinating the elderly
| first? By the time this is done the kinks will be ironed out.
| maxerickson wrote:
| On a per country basis, the roll outs are focusing on the
| elderly.
| usrusr wrote:
| Are there rollouts that don't focus on the elderly?
| EdwardDiego wrote:
| Well, in NZ the elderly come third, but that's because we're
| trying to keep it out, rather than contain an existing
| infection. (MIQ = "Managed Isolation/Quarantine")
|
| > Group 1 - Border and MIQ workers and the people they live
| with
|
| > Group 2 - Frontline workers and people living in high-risk
| settings
|
| > Group 3 - People at higher risk of serious outcomes or
| illness
|
| > Group 4 - General population
|
| https://www.health.govt.nz/our-work/diseases-and-
| conditions/...
| purple-again wrote:
| In the US at least they absolute have been doing the oldest
| first and then lowering the age bracket slowly as more vaccines
| have ramped up.
| bronco21016 wrote:
| There certainly was a large effort to reach the elderly first.
| For a host of reasons though the population was not vaccinated
| 100%. Issues with scheduling appointments, getting people to
| clinics, doubts over safety, etc. At some point the number of
| doses still coming in is increasing but the number of those for
| example 70+ began to dwindle and so it has to opened up so
| these doses can be put in people's arms.
| firebird84 wrote:
| ...Aren't they, though? At least in my country/state they are.
| raverbashing wrote:
| Not a "Data leak", it's a cyberattack plus
| editorialization/manipulation
|
| Of course the details of drug approval are not "discussed in the
| open" because a) trade secrets b) the public doesn't know how
| sausages are made and can (and do) make a mountain out of a
| molehill
|
| mRNA instability is probably not such a big deal. Sure you want a
| high number because that's going to cause the immune reaction, if
| you have a lower number it's potentially less targets. But having
| imperfect mRNA strands are not a big deal.
|
| The vaccine does not have to be 100% "perfect", it has to be
| safer than the virus. I know where to take my chances.
| molticrystal wrote:
| > the agency told The BMJ that the levels of truncated mRNA "and
| the amounts of a potential protein produced by the truncated mRNA
| would be too low to constitute a safety risk."
|
| I still plan on getting vaccinated, but I always wondered about
| the failure modes of the mRNA as it decays and what materials it
| could produce. I'm hoping prions are not possible, but are they?
|
| The story also asks what happens to the lipid nanoparticles, but
| I am wondering about another aspect of these crafted mRNA
| sequences. The "U" in the mRNA has been replaced
| 1-methyl-3'-pseudouridylyl, denoted by Ps in their sequences.
| What happens to the Ps and its byproducts as it decays or is
| metabolized?
| hkktlgkfdn wrote:
| > _What happens to the Ps and its byproducts as it decays or is
| metabolized?_
|
| I had the same question. What I found in a long paper about
| mRNA vaccines is that they do not really know, but they assume
| you'll be fine, since they didn't see any immediate effects and
| because the quantities are tiny.
| cfu28 wrote:
| > Ps
|
| Ps is naturally found in tRNA, so its not really something to
| be concerned about.
|
| Edit: scratch that, confusing pseudouridine with
| 1-methyl-3'-pseudouridylyl
| baxtr wrote:
| Why would you assume prions? Isn't mRNA a standard cell
| product, which can be found in any of your body's cell at any
| time?
| Izkata wrote:
| mRNA encodes instructions for creating proteins, and prions
| are mis-folded proteins. I think the concern is more, our
| bodies' natural mRNA is unlikely to create prions or it would
| be a common occurrence, but lab-created mRNA isn't made of
| the same parts and doesn't have that millennia of evidence
| behind it.
| wrycoder wrote:
| Prions are mis-folded proteins which cause a cascade of
| mis-folding in proteins of the same structure which are
| already present in the body. The mis-folding affects their
| biological activity.
| maxerickson wrote:
| This lab created mRNA creates a protein from a highly
| infectious virus, so it's probably not a big additional
| risk over the medium term (body probably gonna be folding
| some of them either by vaccination or infection).
| [deleted]
| [deleted]
| fuoqi wrote:
| Is there a good way to test that an mRNA vaccine batch was stored
| improperly and in result has reduced efficiency? In the US supply
| chain may not be a problem, but if exported, in some countries
| it's possible that people will get near useless vaccine shots,
| thus hurting reputation of mRNA vaccines in general.
| passerby1 wrote:
| The question is why the leaked information was classified if it's
| so important for the public good.
| londons_explore wrote:
| The question is why we allow information about a patented
| innovation to be kept secret, when the very point of a patent
| is that the inventor gets exclusivity in return for disclosure.
| quantumwoke wrote:
| So Pfizer is not transparent with the contents/stability of their
| mRNA envelope and AstraZeneca causes blood clots.
|
| Who can we trust?
| vmception wrote:
| I trust the lady that spent her whole life on mRNA, gives a
| dose with >3x more mg than Pfizer's and requires less
| refrigeration than Pfizer's
|
| But thats at the top of the list, I would take any of the
| vaccines on the market except the one touted by China.
|
| I would take the Sputnik V, for example.
|
| I've researched them all and am comfortable with the
| methodology of each, except the one touted by China.
|
| I've talked with people bothered by the vaccination and there
| isnt much nuance or awareness of geopolitics or many times even
| awareness that there are like 5 vaccines, some using different
| technology. Makes it easier to keep with my convictions.
| eric-hu wrote:
| What makes the China vaccine untrustworthy? I haven't looked
| into it since it likely wouldn't be an option for me anyway.
| vmception wrote:
| for me it's the data collection methods not being
| transparent enough, coupled with the behavior of the state
| being even less about an individual but more about
| reputation performance metrics
|
| other governing systems could have the same result, but the
| current vaccines on my shortlist have data collection thats
| tolerable for me and the mRNA ones are at the top of my
| list by along shot.
|
| Feel free to correct anything inaccurate if there is good
| data on the China one (or if there are multiple vaccines
| from organizations in china)
| atleta wrote:
| You should trust the system and the process. No, AZ does not
| _cause_ blood clots. It 's being investigated for it. And even
| if it _does_ cause, you should take into account the
| probability. Which seems to be extremely low compared to your
| chances of succumbing to covid. (Of course, the latter is a
| function of a lot of things, but if someone makes a claim that
| "AZ cuases bloog clots", I'm not sure if they ever looked into
| estimating and then comparing the said probabilities.)
| jMyles wrote:
| > You should trust the system and the process.
|
| I don't know which system and process you mean specifically,
| but I don't think that the system of approval under the FDA
| in the United States generally deserves our admiration or
| support.
|
| The current opioid crisis is a great case study in the
| tragedy of trust, profit, and death.
|
| As a scientifically literate society, we can do much better.
| atleta wrote:
| I mean the scientific system and the vaccine/medication
| authorization process in general in the western world. (I
| don't know about the other parts, so can't comment.) Yes, I
| completely beleive that process of the FDA and/or the EMA
| can be improved and if so, it should. Still:
|
| - your best bet is trusting the current system as of now
|
| - improving the system is part of the system. That's what's
| hard for e.g. science denialists to understand. (Don't get
| me wrong, I'm not hinting you are one of them, just came to
| mind.)
| jMyles wrote:
| > I mean the scientific system
|
| I have great confidence in the scientific _method_ ,
| precisely because it doesn't ask for my trust. The
| "scientific system" seems to be largely designed to
| obfuscate the implementation of that method.
|
| I can't help but notice that, even amidst social pressure
| for people to use these vaccines, the underlying data
| used to produce the reports remains unavailable, and will
| remain unavailable until the conclusion of the monitoring
| of phase III of the trials. I'm not sure I understand the
| reasons for that, and I'm quite sure that this is the
| first time in my life that mainstream scientists and
| medical journal editors have expressed such consternation
| about a vaccine approval process.
|
| > and the vaccine/medication authorization process in
| general in the western world
|
| I think it's not unfair to say that this process has
| failed and is no longer relevant in an internet-connected
| society. Countless cases demonstrate this, such as the
| capricious and scientifically unsound reject of cannabis
| happening contemporaneously with the approval of opioid
| preparations touted as non-habit forming, when even a
| single dose (of the drug and of common sense) easily
| refutes that claim.
|
| > - your best bet is trusting the current system as of
| now
|
| Why? When I can do my own research, access experts fairly
| directly, and make my own health care decisions?
|
| > - improving the system is part of the system. That's
| what's hard for e.g. science denialists to understand.
| (Don't get me wrong, I'm not hinting you are one of them,
| just came to mind.)
|
| I think everyone is interested in improvement. The
| question is which parts of "the system" have shown
| promise worth keeping. It seems to me that involvement of
| the state as a gatekeeper will necessarily result in this
| system being used for regulatory capture and profiteering
| first, and public health second or worse.
| donovanian wrote:
| > You should trust the system and the process.
|
| If I'm supposed to be ok with small risks, why aren't any of
| the pharmaceuticals ok with the small risk that they've made
| a mistake and should be held liable?
|
| Why did they seek indemnity if there's no chance the vaccine
| could risk my health?
|
| I don't oppose the vaccine but this has never sat right with
| me.
| chki wrote:
| This is not completely correct, at least in the EU there
| have not been any emergency vaccine authorisations by the
| EMA which means that pharmaceutical companies will be
| liable for mistakes that cause adverse health effects.
|
| In the UK there was an emergency authorisation which means
| that they will not be liable to the same degree.
|
| As for why they do this: There is always a small chance
| that the vaccine will cause adverse health effects because
| pharmaceutical stuff is very complex. Minimizing legal
| risks is a completely normal thing in all industries and
| part of the negotiation process. I would not draw the
| conclusion that they aren't 100% convinced of their vaccine
| but instead that their team of highly paid lawyers told
| them what was a good business decision.
| donovanian wrote:
| You're being pretty generous, and I think it sounds
| reasonable but placed within the broader picture (and
| given how liberals generally consider profit-driven
| healthcare systems and industry in other
| circumstances...) it seems like people are looking to
| paper over some dastardly stuff and dismiss legitimate
| concerns so as to not "rock the boat."
|
| For instance:
|
| > Officials from Argentina and the other Latin American
| country, which cannot be named as it has signed a
| confidentiality agreement with Pfizer, said the company's
| negotiators demanded more than the usual indemnity
| against civil claims filed by citizens who suffer serious
| adverse events after being inoculated. They said Pfizer
| also insisted the governments cover the potential costs
| of civil cases brought as a result of Pfizer's own acts
| of negligence, fraud, or malice. In Argentina and Brazil,
| Pfizer asked for sovereign assets to be put up as
| collateral for any future legal costs.
|
| https://www.statnews.com/2021/02/23/pfizer-plays-
| hardball-in...
|
| It'd be one thing if they were looking to defend against
| unforeseen damages. But this looks like they're trying to
| evade liability for crimes.
| chki wrote:
| Interesting points, I did not know about these actions in
| South America. I don't want to be too generous to
| Pfizer/Biontech and you rightly point out the need to be
| cautious with these companies especially if they are in
| such an influential position. However my guess would be
| that legal risks in countries with weaker rule of law
| protections (for reference see this report
| https://worldjusticeproject.org/rule-of-law-index/) is a
| lot higher. You might find yourself in a position where a
| court rules against you although you did not commit any
| crime - or you might presume that there is a possibility
| that you will be in such a position. If you want to
| protect yourself and have an extremely strong negotiation
| position, you might write very far-reaching liability
| clauses.
|
| This in itself could - imo rightfully - be seen as a
| deplorable strategy because you are dictating these rules
| for a life saving vaccine. But it does not imply that you
| are committing any crimes at the moment.
| atleta wrote:
| This is an interesting question and has several responses
| beyond the knee-jerk one. First of all, the process was
| expedited at the request of the authorities, so it's
| natural that they try to reduce their risks. Also, even if
| we disregard the expedited process, the _release_ (the rate
| of production and administering it) is faster than you 'd
| expect normally, which in itself imposes a greater
| financial/business risk by exposing more people quicker to
| the same amount of risk.
|
| To say it in a less abstract way: given the normal/expected
| risk levels (say it's 1:100000), they'd get say a 100
| complaints a year for a new vaccine that gets administered
| to 10 million people. Say they may get brought to the court
| in one out of those 100 and lose with a 50% chance. And, of
| course it turns out that something's not right (and say
| 1:100000 actually _dies_ because of the vaccine, they can
| still stop it at the 1M or 10M mark).
|
| Now if they roll out the vaccine to 1B people a year, that
| means 100x more exposure. And it may not worth it business
| wise. Especially since at least some of the companies forgo
| (at least some of) the profit. So you have increased risk
| with decreased profit but increased demand. Perfectly
| logical move.
|
| If we are talking about us, then let's not forget that
| while the vaccine definitely poses a higher risk than one
| that's been on the market for say a decade or more, the
| choice is not between:
|
| a) I take the vaccine and accept the (small) risk
|
| b) I don't take the vaccine and I don't expose myself to
| any additional risk
|
| Because dying of covid has a pretty f*&^ high risk when
| compared to dying from the vaccine. (And covid also seems
| to cause long term health damage to way more people than it
| kills.)
|
| But even if we add all this: the EU (and rightly so) did
| not give indemnity to the pharmaceuticals. (Because while
| there is logic for them to seek it, there is also logic in
| not giving it to them.)
| AndrewBissell wrote:
| I look at the vaccine vs. virus risk profile quite
| differently.
|
| I am in my mid-30s, with good levels of vitamin D, and
| I'm prepared to treat any Covid infection I do get with a
| protocol including ivermectin and various vitamins which
| has proven effective where it has been tried in India in
| Mexico. I'm not going to die from it (certainly don't
| have a "pretty f*&^ high risk"). The long haul risk is a
| little bit more substantial, but having a treatment lined
| up reduces my risk a lot there too, and in the vast
| majority of cases it is not debilitating and I'm
| optimistic that treatment methods will be found.
|
| So the "risk of ruin" from the virus is basically
| nonexistent. What's my risk of ruin from the vaccines? We
| really have no idea because they're new and almost
| completely untested (in some cases this is even true of
| the _techniques_ used). If there 's even a 0.1% chance of
| the vaccine causing some sort of debilitating,
| significant harm, that's a far worse bargain for me than
| taking my chances with the virus. The chances of
| something like antibody dependent enhancement are
| essentially impossible to predict until the vaccine's
| interaction with the circulating virus has been observed
| for many more months (ideally through another winter
| season). It will probably take at least a couple of years
| of seeing the vaccine in widespread use for this risk
| calculus to tilt the other way for me.
| donovanian wrote:
| I'm in the same boat, I'm not against vaccination either.
| I've taken every vaccine offered, I get the yearly flu
| vaccine and even went out of my way for the HPV vaccine.
| AndrewBissell wrote:
| Same, I and my family have all our routine shots,
| although we're not all that consistent about the flu.
| m4rtink wrote:
| Even if you migh not have you health ruined by covid,
| getting infected still makes it possible for you to
| infect others who might not be so lucky.
|
| While vaccination apparently doesn't completely prevent
| you from infecting others, all studies as far as I can
| tell say that they reduce the risk quite substantially.
| AndrewBissell wrote:
| I don't believe I am obligated to take an experimental
| vaccine in order to reduce the risk that I will transmit
| a virus with a 99.95% survival rate for people under 70.
| And while I'm optimistic about the prospect for these
| vaccines to reduce transmission in the short run, it
| remains to be seen how well they will work over the long
| term against the evolving virus.
| [deleted]
| donovanian wrote:
| So it stands to reason that if the vaccine were
| effective, after the vaccine blitzkrieg that's going on
| now, the vulnerable should be ok.
| donovanian wrote:
| > Also, even if we disregard the expedited process, the
| release (the rate of production and administering it) is
| faster than you'd expect normally, which in itself
| imposes a greater financial/business risk by exposing
| more people quicker to the same amount of risk.
|
| All this seems to dance around the fact that it's the
| first vaccine of its kind. It induces side effects that
| are not normal. And the process has been greatly
| expedited far beyond the usual liberal sentiment that the
| FDA is indispensable and we should be taking
| extraordinary amounts of time to approve medicines, etc.
|
| Perhaps there is an asymmetric aggregated risk "exposure"
| for pharmaceuticals. But I still don't see a huge upside
| to someone like me who's relatively young, fit and who's
| had tons of relatives, friends, etc. who've gotten the
| virus and not only survived but really didn't notice any
| lasting effects.
| atleta wrote:
| > it's the first vaccine of its kind. It induces side
| effects that are not normal.
|
| It wasn't clear that you were specifically talking about
| the mRNA vaccines (or maybe just the Pfizer vaccine) as
| the comment I was replying to mentioned both this and the
| AstraZeneca one. Also, I'm not sure what non-normal side
| effects you are talking about WRT the mRNA vaccines.
| Israel basically ran a huge trial for Pfizer with several
| million people. I'm pretty sure we know (or will have the
| data very soon) for all the possible side effects.
|
| > But I still don't see a huge upside to someone like me
| who's relatively young, fit and who's had tons of
| relatives,
|
| That's a different question. As I said (maybe in a
| different comment) you should calculate the probabilities
| yourself. What you _feel_ doesn 't matter. Also, what you
| see around yourself doesn't matter. What you call a huge
| upside is up to you, but it's hard to imagine that there
| is _anyone_ who doesn 't get at least a 10x upside. But
| again, look at the statistics, there are some that tell
| you how likely you are to die from covid based on your
| age.
|
| I don't know how old you are, I don't remember all the
| numbers, but e.g. with the AstraZeneca vaccine in the UK
| they estimate that 40 out of 17M people had blood
| clotting problems. ( _And_ it 's being investigated,
| which is good.) I don't think there is a single age group
| with lower COVID mortality than that. Definitely not
| among adults. So it's worth checking the numbers.
|
| A second thing is that since the vaccines don't provide a
| 100% immunity, it's never just about yourself, of course,
| and the circulating virus can (and does) mutate and it
| may do so in the wrong direction. (It may also mutate
| towards a simple common cold.)
|
| But since older people have a higher risk of dying from
| covid, the younger you are the longer you can wait, which
| means the better you will know the safety because the
| more people will get it before you. So your best strategy
| is convincing older people to take the vaccine, because
| it's what's best for _them_ and _you_. And then if a few
| months you 'll know better. (I'm pretty sure it will take
| months until you can get a vaccine if you are that young
| and healthy. Wherever you live.)
| donovanian wrote:
| I guess I've been of the opinion that the largest at-risk
| segment of the population are the chronically ill and
| frail and that includes the overweight and obese. They
| should take the vaccine. The elderly should definitely
| take the vaccine.
|
| But once they're taken care of - I cannot really fathom
| most people accepting draconian measures in the absence
| of extraordinary deaths.
|
| For me though the idea that the vaccine is the _only_
| option brings to mind the question: why does the public
| health establishment prefer advanced technology over
| something that 's immediately actionable and dead simple
| like advising people to lose weight?
|
| To me it seems like a system that's caught in a death
| spiral, sustaining an illusion that people can completely
| disregard their health and still be healthy.
| toshk wrote:
| It's not hard to imagine that rushed trials, rushed
| production and pressured approvals might not lead to the best
| process.
|
| Next to that: Over the last 50-60 years approved medicines
| with the backing of more extensive clinical trials have been
| withdrawn. So the whole process in itself isn't flawless.
|
| I'm not saying the vaccines are unsafe or all the processes
| are wrong, but many people who are wary are often put in a
| corner of conspiracy theorists and I don't think this is
| fair.
| treesprite82 wrote:
| > rushed trials, rushed production
|
| Fast doesn't mean rushed. The trials were fast because it
| was easy to gather huge numbers of participants, and the
| phases were carried out in parallel rather than
| sequentially (normally, to save money/resources, phase II
| would only start after a successful phase I).
|
| > and pressured approvals
|
| Immense pressure to make sure it's safe, too. Like this
| precautionary pause for what seems like a lower blood-clot
| rate than would be expected just by chance in that size of
| population.
| atleta wrote:
| It's not flawless. But the point is not that it is flawless
| or that it should be (because, I don't think such a complex
| process can ever be). The point is that it gives you the
| best possible result as of now. Meaning, you have the
| highest chance for survival/avoiding a permanent health
| damage (which COVID _can_ cause too) is taking an EMA /FDA
| approved vaccine.
|
| > but many people who are wary are often put in a corner of
| conspiracy theorists and I don't think this is fair.
|
| I think think this happens for at least two reasons. First,
| they are often simply conspiracy theorists who just try to
| phrase their thoughts in a way that doesn't seem like
| conspiracy theory at first. I've talked to a _lot_ of
| people (mostly online) and I can tell you that it happens a
| lot. And the same people will start the same conversations
| again and again along the same patterns, pretending they
| are not conspiracy theorists or anti-vaxxers for that
| matter but go down the same path and show themselves if you
| engage in a discussion.
|
| Second, because of the above phenomenon, some people will
| just jump to the conclusion that anyone who raises concerns
| are indeed conspiracy theorists. (Again, because a lot of
| them will pretend that they are indeed sane people having
| sane questions.) It's not ideal, but not surprising either.
| Pyramus wrote:
| > Who can we trust?
|
| I've spent the last couple of weeks working my way through the
| spectrum from healthy skepticism to conspiracy theory with
| regards to Covid-19 (on Twitter mostly).
|
| One of the patterns I find really interesting is that the more
| towards conspiracy theory, the more extreme the allocation of
| trust becomes. At the end of the spectrum people will fully
| distrust large parts of society (government, big pharma,
| general scientists, WHO, CDC), but at the same time they will
| fully trust a small group of 'independent scientists'.
| atomashpolskiy wrote:
| Our instincts.
| eddieroger wrote:
| Maybe, but I'm concerned about the sample size. Guess I'll
| stick to the science.
| atomashpolskiy wrote:
| I'm all for science, but as one of the other comments
| points out, you can't ignore other factors at play and just
| exclude the humans from the equation. It's not like science
| is brought upon us from the heavens above. If some product
| cost billions in R&D and still does not work quite as
| planned, you may rest assured that the owners will go to
| all lengths to cover the losses and persuade buyers to
| ignore the facts as long as possible. This is simple logic,
| isn't it?
| YinglingLight wrote:
| Scientists got mortgages, too.
| SketchySeaBeast wrote:
| My instincts still raise the hair on the back of my neck
| every time I go up the basement stairs. What was once a good
| survival mechanism millennia ago is now a vestigial
| distraction.
| junon wrote:
| Anti-vaxxers.
|
| (/s)
| meepmorp wrote:
| > EMA says the leaked information was partially doctored,
| explaining in a statement that "whilst individual emails are
| authentic, data from different users were selected and
| aggregated, screenshots from multiple folders and mailboxes have
| been created, and additional titles were added by the
| perpetrators."3
|
| Worth noting
| lhnz wrote:
| The article by the BMJ is responding to the leak as if the
| information within it is believed to be correct.
|
| Is the EMA suggesting that this isn't the case or are they just
| telling us that it was editorialised by whoever disseminated
| it?
|
| Doctored is the word you'd use if the contents have been
| changed in order to deceive people. However this could be an
| attempt at damage control if they want people to dispute the
| veracity of the leak.
|
| Edit: Since I'm questioning the EMA here I'll add that
| "Vaccines are Good" and that we should await expert opinion
| before making idle speculation.
| the-dude wrote:
| Sounds like journalism to me.
| srj wrote:
| I find this part highly suspicious and it calls into question
| the motives of the "leaker" and wisdom of publishing this
| article. If someone wanted to discredit the vaccine finding
| some internal document around a process failure (even a
| temporary one), doctoring parts of it to make it more dramatic,
| and finding someone who will write about it is a good way to go
| about it.
|
| By the time the correction is published for the doctored
| material, or the matter is contextualized, the fear will have
| already spread.
| fuoqi wrote:
| They can easily show discrepancies by publishing everything
| without hiding the important information. But for some reason
| they don't. AFAIK they even haven't bothered to specifically
| indicate which parts exactly are not authentic.
| throwaway4good wrote:
| Did they (ema) publish exactly what was doctored?
| isitdopamine wrote:
| Anyone would say that a leak is doctored...
|
| Even the Clinton team tried to say the Wikileaks were doctored,
| despite the vast majority of them having a DKIM signature
| confirming their authenticity.
|
| The ball is in EMA's field now: they have to demonstrate the
| leaks are doctored.
|
| There's pretty damning information in there, it's in their
| interest to demonstrate it's false.
| raverbashing wrote:
| > they have to demonstrate the leaks are doctored.
|
| So the victims of a cyberattack have to prove their data has
| not been manipulated? Cool
|
| > There's pretty damning information in there
|
| No, there isn't, unless you're buying manipulated information
| and believe in 5G vaccines.
|
| The data presented sounds like a regulator doing its job and
| not rubberstamping every decision ( _cough_ _cough_ 737Max)
| itchyjunk wrote:
| The question wasn't if they were victims or not though.
| They are. The question is about the validity of data and
| questioning is just fine.
|
| You might not have seen anything useful in what was
| presented but it doesn't mean someone else can't. Comparing
| it to "5G vaccines" to discredit the parents point isn't
| the right way to challenge their interpretation.
| raverbashing wrote:
| > The question is about the validity of data and
| questioning is just fine.
|
| Are you going to question every "data leak" and smear
| campaign that comes from questionable sources (I think
| this leak was first published on Rutor - not the first
| time Russia does something like that)?
|
| > it doesn't mean someone else can't
|
| True, that's what the article addresses. And as you see
| it's making technical questions not implying they're
| hiding something.
| rediguanayum wrote:
| Hey guys- This data leak looks like the work of a misinformation
| campaign. The very first thing this article says is the data is
| from a cyberattack on European Medicines Agency (EMA), and the
| data was sent anonymously to journalists. A Reuters article
| claims that the Russian and Chinese are behind this:
| https://www.reuters.com/article/us-eu-cyber/russian-chinese-....
| May be it's true that there is mRNA instability, but the efficacy
| data says the Moderna vaccine works extremely well. mRNA in
| intrinsic in your cellular biology with all of its instability,
| and your body manages to deal with it just fine.
| crocodiletears wrote:
| Everything looks like a misinformation campaign perpetrated by
| 'them' anymore. This well could be. It also might not be. The
| data could have been manipulated. It might not have been.
|
| We do what we can with what information is offered to us. Lies,
| half-truths, and all.
| renaudg wrote:
| > May be it's true that there is mRNA instability, but the
| efficacy data says the Moderna vaccine works extremely well
|
| The efficacy data was based on clinical trial batches though,
| and the challenge seemed to be with lower manufacturing quality
| in the large scale commercial batches : "changes were made in
| their processes to ensure that the integrity was improved and
| brought in line with what was seen for clinical trial batches."
|
| To be honest, we do also have real world data now (Israel
| mainly) that confirms the benefit/risk balance to be extremely
| good.
| rolph wrote:
| instability of mRNA is not an issue under the following
| proviso, the truncated fragments of the whole mRNA must not
| destroy the structure of the epitope regions; and beyond this
| level there are still PAMPs [pathogen associated molecular
| patterns] that will trigger an immune response pathway as well.
| https://en.wikipedia.org/wiki/Innate_immune_system
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