[HN Gopher] FDA Approves First Respiratory Syncytial Virus (RSV)...
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FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
Author : ourmandave
Score : 73 points
Date : 2023-05-03 19:44 UTC (3 hours ago)
(HTM) web link (www.fda.gov)
(TXT) w3m dump (www.fda.gov)
| macinjosh wrote:
| [flagged]
| fsagx wrote:
| Moderna presentation on the vaccine from ReSViNET Conference
| (RSVVW 2023):
|
| https://s29.q4cdn.com/435878511/files/doc_presentations/2023...
|
| some commentary summarized from alexberenson.substack.com :
|
| _Nine people who received the shot got RSV. Fifty-five who
| received the placebo did. Thus the 17,500 shots prevented 46
| cases of RSV.
|
| It shows people who received the jab instead of the placebo
| reported an extra 10,156 side effects such as headache or
| fatigue. Those side effects included an extra 455 severe effects,
| rated as Grade 3 or worse.
|
| Side effects are rated on a five-point scale, with Grade 5 being
| death and Grade 4 usually requiring immediate medical treatment
| and hospitalization. Grade 3 side effects are defined as "severe
| or medically significant."
|
| For example, a Grade 3 fever is usually defined as over about 102
| degrees, while a Grade 4 is over 104.
|
| In other words, a single Grade 3 side effect is likely to be
| considerably more severe than a case of RSV for most adults.
| Again, Moderna's shot caused 10 of those side effects for every
| RSV infection it prevented._
|
| https://alexberenson.substack.com/p/how-can-modernas-rsv-jab...
| pastor_bob wrote:
| No skin in the game, but a cursory look at this article
| indicates it is bogus. Citing supposed death certifications is
| a really disingenuous tactic IMO:
|
| >A review of death certificates found that RSV kills about 35
| American adults a year
|
| National Foundation for Infectious Diseases claims it kills
| 14,000[0]:
|
| > RSV is second only to influenza as a cause of medically
| significant respiratory tract illnesses in adults7,8 and is
| estimated to cause 177,000 hospitalizations and 14,000 annual
| deaths in US adults age 65 years and older
|
| [0]https://www.nfid.org/wp-content/uploads/2019/08/rsv-
| report.p...
| evancox100 wrote:
| (I vouched for this post because I think it's important to
| actually address these issue head on with facts and not just
| shout people down.)
|
| Berenson's numbers based on the presentation you shared seem to
| check out, but the interpretation seems odd.
|
| Just looking at how many cases were averted doesn't tell you
| what types of tail risks were averted. It may be a worthwhile
| trade off to have 10x as many "severe side effects" in exchange
| for having many many fewer severe, debilitating, or fatal
| infections.
|
| Also, Berenson is looking at the ratio of severe side effects
| induced to RSV cases prevented. But the vaccine side effects
| only happen once, at the time of injection, while the vaccine
| may continue to confer long term benefits. So this ratio is
| highly dependent on the time period in question.
| detaro wrote:
| ... it's numbers about a different vaccine, how are they
| relevant here?
| breck wrote:
| > But the vaccine side effects only happen once, at the time
| of injection, while the vaccine may continue to confer long
| term benefits. So this ratio is highly dependent on the time
| period in question.
|
| One must be extremely skeptical of these kind of claims now,
| though, given what we just went through as a society. The
| side effects of the mRNA vaccines seemed to become uncapped
| (some people I know have now received 4 shots), and the long
| term benefits went to nil (if not negative), commonly thought
| due to mutation.
|
| So the question is what are the odds that it really will be
| just "once" and what are the odds that it will really provide
| protection against RSV, and future mutated strands.
|
| It seems to me the vaccine industry should be put in a severe
| category of "distrusted entities" until we have significant
| improvements in our symbolic infrastructure to the point
| where they could be trusted again.
| arcticbull wrote:
| You do know billions of doses of COVID vaccines were
| delivered and the side effects were overwhelmingly
| insignificant, right? Skepticism is good, but in the face
| of data we should be willing to pivot. The COVID vaccines
| are probably the single most studied and tested vaccine -
| heck, medical product - of all time.
|
| It's like the aspartame or MSG of the medical world. No
| matter how much data you provide people will never get over
| the idea that it must somehow be dangerous.
| breck wrote:
| I should have used a more precise term than "uncapped".
| The comment I was responding to used the term "once". I
| was saying that in most recent vaccine history, the term
| "twice" was used, then "three times", then "four times",
| then "up to date". Uncapped was a gross exaggeration. I
| should instead said that there "once" could not be taken
| seriously and the range should be "1 to a handful of
| times", which is a significant factor increase of at
| least 2x.
|
| But anyway, in my dataset of about 1,000 acquaintances,
| the only one under 50 hospitalized related to Covid was a
| friend who was a 38 year mother of 2, in top shape, who
| had a heart attack within a month after her second dose,
| and to this day is still recovering. I do not think these
| vaccines are that dangerous--I would say they probably
| cause as much harm as one night of heavy binge drinking--
| but I saw zero evidence of any benefit, and yes I saw one
| very bad case of severe life threatening side effect.
| arcticbull wrote:
| > But anyway, in my dataset of about 1,000 acquaintances,
| the only one under 50 hospitalized related to Covid was a
| friend who was a 38 year mother of 2, in top shape, who
| had a heart attack within a month after her second dose,
| and to this day is still recovering.
|
| There's a reason we don't use anecdotes as a substitute
| for medical research. Not least because they're subject
| to the post hoc fallacy. Just because one event follows
| another doesn't mean there's a causal relationship.
|
| There's every chance that mother of 2 was going to have a
| heart attack anyways. It happens. The fact they had a
| vaccine first likely isn't relevant, clinically speaking.
| If you give a few billion people vaccines, you will find
| literally every effect that follows. Car crashes. Broken
| arms. Death by mauling. Syphilis. Turbo-cancer of the
| elbow.
|
| In that age group, a boundary group, your risk of having
| a heart attack are somewhere between 17 and 97 per
| 100,000. [1] The risk of a heart issue from the vaccine
| is about two orders of magnitude lower than that.
|
| > I do not think these vaccines are that dangerous--I
| would say they probably cause as much harm as one night
| of heavy binge drinking-- ...
|
| You have no basis to arrive at that conclusion.
|
| > ... but I saw zero evidence of any benefit ...
|
| It's in the data.
|
| > ... and yes I saw one very bad case of severe life
| threatening side effect.
|
| You saw one anecdotal report of a bad thing that happened
| to someone after they took a COVID vaccine, without any
| evidence they were connected. I'm sure more than once
| someone took a tylenol and got hit by a bus. That doesn't
| mean taking tylenol causes getting hit by a bus.
|
| > The proportions of participants who reported at least 1
| serious adverse event were 0.6% in the vaccine group and
| 0.5% in the placebo group. [2]
|
| [1] https://pubmed.ncbi.nlm.nih.gov/32111640/
|
| [2] https://www.cdc.gov/vaccines/covid-19/info-by-
| product/pfizer...
| loeg wrote:
| > If you give a few billion people vaccines, you will
| find literally every effect that follows. Car crashes.
| Broken arms. Death by mauling. Syphilis. Turbo-cancer of
| the elbow.
|
| Yeah. Lightning-induced arrhythmia was (amusingly) a
| registered side effect (Serious Adverse Event) of
| Moderna's covid vaccine.
| https://metro.co.uk/2020/12/18/covid-vaccine-volunteer-
| struc...
| Eumenes wrote:
| You could say the same thing about infections
| arcticbull wrote:
| You're going to have to explain because I can't see how
| you could.
| Eumenes wrote:
| Virus is weak and has super low mortality rate (esp. if
| you take care of yourself and are not old or fat).
| Vaccine is new and w/o years of data behind it. I pick no
| vaccine.
| arcticbull wrote:
| Well you pick wrong. But that's fine I guess, at this
| point it's personal responsibility and if you want to
| make a stupid decision, go with god.
|
| The virus has a fairly low mortality rate for healthy
| people, most people aren't healthy.
|
| The fact the vaccine is new is irrelevant because
| generally speaking you can substitute time with quantity.
| Most effects are normally distributed in time, and so if
| you have enough doses given, you can replace the fact it
| hasn't been around too long with a high number of
| administrations when making a safety assessment. And it's
| been given literally billions of times. We've seen the
| full gamut of consequences.
|
| But anyways, 'long-term side effects' don't refer to
| latent effects. It's not things that magically appear 10
| years later. They're effects that last a long time but
| usually onset almost immediately. There's no reason to
| think that 5 years of data is better than 3 years of data
| when administered billions of times.
|
| And frankly if you think 3 years and billions of data
| points are insufficient nothing's going to change your
| mind. So you may as well stop pretending it's a data
| issue.
|
| As I said, irrationality is your prerogative. But you are
| wrong.
| Eumenes wrote:
| Yeah I'm speaking for myself, and I'm very healthy and
| fit. If I were not, I'd probably be on other prescription
| drugs, so what's one more thing? I don't think I've taken
| an OTC or prescription drug in 10-15 years. My medicine
| cabinet is empty. I've smoked some weed though. Agreed on
| the personal responsibility piece.
|
| The long-term side effects piece is still undecided and
| that's undebatable, simply because not enough time has
| gone by. Maybe I'll be open to changing my mind in 5-10
| years. Even then, I'd win, no?
| arcticbull wrote:
| > The long-term side effects piece is still undecided and
| that's undebatable, simply because not enough time has
| gone by. Maybe I'll be open to changing my mind in 5-10
| years. Even then, I'd win, no?
|
| Like I said long-term side effects doesn't mean latent
| effects. It doesn't mean things that show up years after
| administration. It means things that happen right after
| administration but last a long time. If getting the COVID
| vaccine caused your arm to fall off 30 seconds after
| administration, that's a long-term side-effect because
| last I checked arms don't re-grow.
|
| Yes, we do know what the long-term side effects are.
| You've confused 'long-term' and 'latent'.
|
| Yes, it's decided. No, it's not debatable.
|
| > ... simply because not enough time has gone by.
|
| Again that (a) doesn't matter and (b) unless you're a
| vaccineologist then your opinion about whether sufficient
| time has passed is totally meaningless.
| burnished wrote:
| Are you suggesting that the limited duration of protection
| and hence the need for followups (like flu shots) is.. the
| result of a conspiracy? Its not clear why you think they
| should be 'distrusted' which calls your judgement into
| question.
| breck wrote:
| No I am saying that there was no protection and the
| follow ups provided none either.
|
| Yes, with 99% odds I am saying there was a conspiracy to
| end the randomized placebo control group early to bury
| any chance that someone could ever conclusively prove
| these vaccines were ineffective.
|
| The claim was they decided it was unethical to withhold a
| "life-saving" vaccine from control participants and
| that's why they ended it. I would bet with 99% odds that
| if there was a funded investigation with subpoena power
| you would find strong evidence that the primary reason
| that control group was ended because of extreme financial
| incentive to end it. If the control group were allowed to
| continue and it were shown that the vaccines were
| ineffective (which is what ended up being the case), tens
| of billions would have been lost. I am counting on
| someone being sloppy and letting the truth spill
| somewhere internally.
|
| Now if you are saying that I am showing bad judgement for
| speaking truth to power, for caring about honesty, I
| could see a valid argument there. But to me truth and
| honesty is more important than money.
|
| There is _zero_ scientific evidence that this thing saved
| a single life. The _only_ randomized control group
| experiment showed _zero_ lives saved.
| stevehawk wrote:
| the common argument I heard from the anti-vaxxers was
| that the mRNA COVID vaccine was obviously
| bad/fake/contrived because it required a booster and "no
| other vaccine requires a booster!" And if you mention
| tetanus, hepatitis or meningococcal, or other vaccines
| that required a booster/multiple shots then you just get
| ignored. Ignorant gonna ignorant.
| breck wrote:
| https://en.wikipedia.org/wiki/Straw_man
| version_five wrote:
| Like it or not, these sort of not-very-effective-vaccines-for-
| mostly-mild-diseases are going to be a very tough sell for a
| lot of people post-covid. I assume there will be ongoing
| attempts to ride of covid's coattails to get them pushed or
| mandated wherever possible.
|
| The real concern is that if we ever get new effective vaccines
| for bad diseases, there are going to be lots of people not
| taking them after all the abuse of trust that's happened. At
| this point, how do you even know who to belive?
| Eumenes wrote:
| 100%. I am in my late 30s and have not received a vaccine
| since I was in middle school ... literally never sick, never
| got covid. There'd have to be zombies or bubonic plague to
| convince me, and even then, there'd be bigger fish to fry.
| Spooky23 wrote:
| Honestly, who cares.
|
| If you think reducing likelihood of getting really sick by
| 80%, especially if you're vulnerable is no big deal, and you
| want to suffer or spend your life savings on unnecessary
| medical care because some YouTuber told you so, that's your
| problem.
| peteradio wrote:
| If you want to base your medical decisions on wildly
| average data that's your problem.
| burnished wrote:
| I don't think I would agree broadly with the person you are
| responding to (riding the coattails of covid is a phrase
| that paints a picture), but this narrow point has merit due
| to the way herd immunity works. It is genuinely a matter of
| community health.
|
| No idea what to do about it given all the absolutely
| unhinged perspectives on the topic, but still, I care.
| peteradio wrote:
| Then one time, I believe it was July ... no August, there's a
| knock on the door. Open the door and there's this cute little
| girl scout. Ah she was so adorable with her little pigtails
| and all. And she says to me "how would you like to buy some
| cookies?" I said "well what kind do you have?" She had thin
| mints, graham crunchy thins, oatmeal raisin... I said "we'll
| take a graham crunchy. How much will that be?" She looks at
| me says "I'll need about three fitty." WELL! IT WAS ABOUT
| THAT TIME I NOTICED THIS LITTLE GIRL SCOUT WAS ABOUT 8
| STORIES TALL CRUSTACEAN FROM THE PALEDOZOLIC ERA! THE
| LOCHNESS MONSTER!
| version_five wrote:
| Is this a reference to something?
| peteradio wrote:
| Yes it's south park probably very random.
| shrimp_emoji wrote:
| The last panel of: https://www.qwantz.com/index.php?comic=14
| markus92 wrote:
| Note: OP posted about the GSK vaccine, not the Moderna one.
| philjohn wrote:
| This feels like something that will be of benefit to the
| immunocompromised, or with conditions such as Asthma (RSV can
| be super non fun with Asthma)
| peteradio wrote:
| I wish there was a way to determine more stratified outcomes
| according to potential correlates... without having to
| perform high statistics human trials. I imagine that kind of
| detail is released after some time, I wonder how long that
| usually is.
| icegreentea2 wrote:
| The approved vaccine (Arexvy) is a GSK vaccine. It's also not
| an mRNA vaccine - it's recombinant subunit vaccine (ie, you
| tinker with microbes to spew out relevant pieces of the virus
| which you harvest and purify).
|
| Edit: Also your linked commentary basically completely hinges
| on what we believe the risk of RSV to actually be (fair). The
| lower bound estimate provided by tallying up actual death
| certificates is just that - a lower bound. The linked study for
| that number dedicates a huge pile of its discussion section to
| the very weakness of just using death certificates. I'm not
| saying that the 14k number must be true, but it's also quite
| unlikely that the 35 per year number is the right order of
| magnitude as well.
| tikkun wrote:
| Does someone have the same stats re side effects for the
| approved vaccine?
| Spooky23 wrote:
| If you look at the actual data (
| https://s29.q4cdn.com/435878511/files/doc_presentations/2023...
| ), 0.6% with the vaccine had a grade 3 fever, compared to 0.4%
| of placebo.
|
| The population in question is 60+ or 70+. RSV can be very
| significant in that population, even in young kids, it is a
| virus that shuts down schools. The author is a well known anti-
| vax guy, so I'd assume he's presenting the most negative
| scenario possible.
| version_five wrote:
| Turn on showdead or you're missing the actual conversation. This
| is one of the most egregious examples of people using flagging to
| shut down a discussion that I've seen here. Either the whole
| thread should be closed as off-topic or the substantive flagged
| posts should stand.
| RC_ITR wrote:
| I did exactly that and I saw was anecdotes and unsupported
| claims.
|
| This is supposed to be a data-driven discussion forum - people
| correctly flagging content you like != censorship.
| version_five wrote:
| You got to decide for yourself, that sounds like a win
| RC_ITR wrote:
| No - why participate in a forum if you fundamentally
| disagree with the way it's run.
|
| There's plenty of places online to do _whatever_ you want,
| people like it _here_ because we at least sort of try to
| follow some rules to encourage a fragile thing (informed
| debate).
|
| Like I said, happy to look at _data_ about this, but not
| random stray stories.
| RoyGBivCap wrote:
| > _No - why participate in a forum if you fundamentally
| disagree with the way it 's run._
|
| The forum is useful _because of_ its users _in spite of_
| how it 's run. Just like reddit.
| version_five wrote:
| Thanks for using italics to drive home how much you value
| data. Unfortunately, this is is a discussion forum,
| thankfully not a citation-fest, so some people will give
| opinions, some will refer to other sites, etc. Everyone
| doesn't have to agree.
| mustacheemperor wrote:
| And showdead is a feature available to everyone who wants
| to decide for themselves. I leave it on, and I'd agree
| people should be made aware of it. But for me this was just
| another example that what gets downvoted to grey here often
| is speculative, conspiratorial, and/or hostile to the
| detriment of making a meaningful point.
|
| As pointed out in its replies, the article linked in that
| comment includes some basic mistakes like attributing to
| death certificates that RSV kills 35 American adults every
| year, when NFID claims 14k. Launching a conspiratorial
| discussion from the platform of an article with such
| rudimentary errors is always going to result in downvotes
| on this community, so nothing seems unusual about this
| instance to me.
|
| And it's not like they linked a review of the paper by any
| kind of medical doctor. Anyone who recognizes the name Alex
| Berenson would reasonably assume the article is bogus,
| especially in the context of infectious diseases.
| https://en.wikipedia.org/wiki/Alex_Berenson
| JumpCrisscross wrote:
| > _supposed to be a data-driven discussion forum_
|
| Anecdotes are fine. Flags should really be for violations of
| the guidelines [1] or stuff that's blatantly illegal that the
| mods should know about, though that's just my opinion.
|
| [1] https://news.ycombinator.com/newsguidelines.html
| m463 wrote:
| thank you for helping me understand how showdead works.
|
| If you enable it in your profile, dead articles appear, which
| means
|
| "The post was killed by software, user flags, or moderators."
|
| In this case, a downvoted(?) thread appears at the bottom with
| 28 replies.
| detaro wrote:
| your comment made me double-check if this changed: the thread
| is still be there with showdead off, just its (flagged) top
| comment is replaced with the [flagged] placeholder.
| detaro wrote:
| You really think trying to argue about safety data _for a
| different vaccine_ , while pretending you are talking about the
| submission topic is an important substantive post and not
| horribly derailing the discussion? Or what substantive flagged
| post do you mean?
| JumpCrisscross wrote:
| > _trying to argue about safety data for a different vaccine_
|
| I turned on showdead and promptly reenabled it. Referencing
| Covid and mRNA vaccines in response to a non-Covid non-MRNA
| vaccine seems like using "Hacker News for political or
| ideological battle" and pursuing "generic tangents" [1].
|
| [1] https://news.ycombinator.com/newsguidelines.html
| [deleted]
| teslabox wrote:
| [flagged]
| phkahler wrote:
| >> What's the point in vaccinating for RSV when effective
| treatments already exist?
|
| Standard answer: your 1 case is an anecdote, not data. I would
| argue that it is actually 1 data point, but that you can't even
| say it didn't clear up on its own.
|
| The next problem is that nobody will fund clinical trials of
| anything they can't patent and milk for money.
|
| I cured my asthma with non-accepted stuff. I have before and
| after test data to prove it too. Can't say it will work for
| everyone though ;-)
| [deleted]
| ceejayoz wrote:
| Most RSV infections last a week or two. 10-12 days is right
| where it goes away on its own.
|
| Time is more likely your "effective treatment" in this case.
| XorNot wrote:
| Looking forward to this landing in Australia and widening it's
| approved usage.
|
| Giving my son a chance of not catching RSV from daycare would be
| be great.
| nvahalik wrote:
| > not catching RSV
|
| These only lessen the effects. To my knowledge, there is not
| (nor ever has been) any respiratory "vaccine" that prevents you
| from getting it. It just makes your body better at fighting it.
| [deleted]
| jwineinger wrote:
| My preemie daughter got 3 rounds (monthly, IIRC) of injections to
| prevent RSV ten years ago. Was that some sort of antibody then?
| icegreentea2 wrote:
| Yes, looks to be the case:
| https://en.wikipedia.org/wiki/Palivizumab
| ceejayoz wrote:
| Yep. My kids got that a bit over a decade ago.
| NDizzle wrote:
| [flagged]
| tikkun wrote:
| *Approved for individuals age 60 and older.
| [deleted]
| [deleted]
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