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FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
- deleted 3y ago[deleted]
- fsagx 3y agoModerna presentation on the vaccine from ReSViNET Conference (RSVVW 2023): https://s29.q4cdn.com/435878511/files/doc_presentations/2023/02/rsvvw-p301-ia-oral-presentation_final-update.pdf 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-be-approvable https://alexberenson.substack.com/p/how-can-modernas-rsv-jab...
- markus92 3y agoNote: OP posted about the GSK vaccine, not the Moderna one.
- philjohn 3y agoThis 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 3y agoI 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 3y agoThe 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.
- evancox100 3y ago(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.
- breck 3y ago> 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.
- burnished 3y agoAre 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.
- stevehawk 3y agothe 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.
- version_five 3y agoLike 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?
- Spooky23 3y agoHonestly, 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 3y agoIf you want to base your medical decisions on wildly average data that's your problem.
- burnished 3y agoI 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 3y agoThen 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!
- tikkun 3y agoDoes someone have the same stats re side effects for the approved vaccine?
- Spooky23 3y agoIf you look at the actual data ( https://s29.q4cdn.com/435878511/files/doc_presentations/2023/02/rsvvw-p301-ia-oral-presentation_final-update.pdf 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.
- pastor_bob 3y agoNo 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.pdf https://www.nfid.org/wp-content/uploads/2019/08/rsv-report.p...
- peteradio 3y ago[flagged]
- tikkun 3y ago*Approved for individuals age 60 and older.
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- hammock 3y agoWhy is it approved only for 60 years and older? Is it because of the fatal brain swelling and Guillain Barre syndrome side effects? I would like to give this to my expectant wife and 2 year old child
- icegreentea2 3y agoGSK only registered for 60+ in their trial. Most likely because the clinical endpoints are more significant/easier to measure, and also because the safety trade-off is more weighted towards intervention.
- dgacmu 3y agoTo GP, I'm sorry your family isn't eligible yet. Pfizer has an in-progress vaccine for which they had good phase 3 results in both older adults and expectant mothers (looking at the outcomes for the infants once born). Their FDA application is in progress and miiiight be done by summer: https://www.health.com/rsv-vaccine-for-pregnant-moms-approval-7185422 https://www.health.com/rsv-vaccine-for-pregnant-moms-approva... Fingers crossed for y'all. It would be awesome to remove RSV from the things you have to worry about as a new parent. (We had a pretty nasty case with our first. Didn't end up in the hospital but it was really close.)
- treeman79 3y agoWife still hasn’t recovered from Covid shot. Injection Arm double the size of other arm.
- amanaplanacanal 3y ago
- XorNot 3y agoLooking 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 3y ago> 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.
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- XorNot 3y agoYou can get COVID so mildly you don't know you actually have it. Which has been a problem for dealing with pandemic spread, but if my son can not spend 3 weeks trying to clear the cough he gets from RSV (and being upset the whole time) then that's an absolute win (had our first bout 2 months ago, preceded by rhinovirus, then followed by rhinovirus again).
- NDizzle 3y ago[flagged]
- macinjosh 3y ago[flagged]
- jwineinger 3y agoMy preemie daughter got 3 rounds (monthly, IIRC) of injections to prevent RSV ten years ago. Was that some sort of antibody then?
- icegreentea2 3y agoYes, looks to be the case: https://en.wikipedia.org/wiki/Palivizumab https://en.wikipedia.org/wiki/Palivizumab
- ceejayoz 3y agoYep. My kids got that a bit over a decade ago.
- xattt 3y agoSynagis was described as a passive vaccine to parents in the mid-2000s.
- version_five 3y ago[flagged]
- detaro 3y agoYou really think trying to argue about safety data for a different vaccine, while pretending you are talking about the submission topic (the article is about approval for GSKs, the comment links to stuff about Modernas candidate while saying "presentation on the vaccine") is an important substantive post and not horribly derailing the discussion? Or what substantive flagged post do you mean?
- JumpCrisscross 3y ago> trying to argue about safety data for a different vaccine I turned on showdead and promptly reënabled 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 https://news.ycombinator.com/newsguidelines.html
- deleted 3y ago[deleted]
- RC_ITR 3y agoI 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 3y agoYou got to decide for yourself, that sounds like a win
- RC_ITR 3y agoNo - 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.
- teslabox 3y ago[flagged]
- phkahler 3y ago>> 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 3y ago[deleted]
- ceejayoz 3y agoMost 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.
- curmudgeon22 3y ago> In this study, approximately 12,500 participants have received Arexvy and 12,500 participants have received a placebo. Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.
- devmor 3y agoOh man this would be great! Wife and I had RSV this past winter and it was horrid. We thought it might be covid at first but tested negative every time - ended up just having nearly a month of torn up throats and sore diaphragms.
- lukeschlather 3y agoI wonder how far away we are from an affordable and relatively universal antigen test. Lately the Covid testing is starting to feel not unnecessary but more inadequate. It would be nice if we could say "oh I have Rhinovirus A, I'm going to sit this out." Or "I checked and it's just Rhinovirus A, is that a problem?" RSV I assume people get it and recover all the time and are none the wiser. Seems like comprehensive tests that can at least tell you about the stuff of concern (Flu, RSV, Covid-19) would make people take the vaccines more seriously.
- detaro 3y agoThey already exist. Cost about 5€ online here in Germany. (EDIT: removed info about them not being sold anymore, apparently that was resolved?)
- n8henrie 3y agoWe use a flu A / flu B / RSV / COVID test (PCR) for virtually every respiratory patient in our rural ED (US). EDIT: We've only had it for the last 18 months or so. I was really shocked to discover how many older folks actually have RSV that I would previously have admitted as "probably a community acquired pneumonia" for mild hypoxia and maybe a highly questionable infiltrate on X-ray (read: probably no infiltrate but I need a diagnosis). Nice to now have a better excuse to consider holding back on antibiotics.
- deleted 3y ago[deleted]
- inferiorhuman 3y agoInteresting. Here in San Francisco I went in to Kaiser for a PCR COVID test and they checked for flu A+B, but not RSV. I wonder how widespread the use of RSV tests is.
- 6nf 3y agoDoes it change the treatment regime?
- nahnahg 3y ago[dead]
- henriquez 3y ago[flagged]
- fshr 3y agoIt feels like HN is turning into Reddit. I’m noticing more and more comments like yours in the last week or so. Like jokey redditor comments. Not sure what to chalk it up to. Maybe it’s just me. I wonder if there’s a clear way to run an analysis to find out.
- henriquez 3y agoShould I be worried?
- perihelions 3y ago- "According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older." Those are respectively 0.1 – 0.2%, and 0.01% – 0.02%, annual risks for this subgroup (55 million persons). The OP discusses three studies, with a combined N of about 17,500 (12,500 + 2,500 + 2,500) (the non-placebo groups). They apparently attribute one death to this vaccine (in combination with an influenza vaccine), which is 0.006% of the participants of the three studies. I don't know how to interpret this. The FDA's endpoints are "RSV-associated [lower respiratory-tract disease]" and "severe RSV-associated LRTD". Okay. I guess they're ignoring mortality because its small-number statistics aren't meaningful to interpret. But then why endorse a vaccine at all, if the mortality rate is so low? You'd need a vastly larger study to answer the question "does this therapy increase or decrease the risk of death", because the probabilities are microscopic on both sides.
- 6nf 3y agoOmicron covid for young people (under 50) has similar stats iirc
- elif 3y agoThe covid vaccine has not been linked to any deaths under 50, and has been administered far more than 17K times.
- t0bia_s 3y agoYou should inform yourself more, because your statement is false. There are plenty studies monitoring covid vaccine injuries and deaths among youth. Numbers are high.
- heliostatic 3y agoFeel free to cite studies supporting your claims (genuinely, not sarcasm, but making positive claims about factual matters can and should be supported by evidence).
- throwaway4220 3y agoSo not to get meta but a lot of presumably brilliant people here are showing their ignorance on a topic they have no clue about. I went through medical school and still don’t feel as confident about my beliefs. Is this what’s the Dunning-Kruger effect?