[HN Gopher] FDA Approves First Respiratory Syncytial Virus (RSV)... ___________________________________________________________________ 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] ___________________________________________________________________ (page generated 2023-05-03 23:00 UTC)