FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
fda.gov
fda.gov
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...
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.
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.
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.
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.
I have never seen a trustworthy dataset that showed this. I was the Senior Software Engineer at Our World in Data who built the Covid Data Explorer so it was literally my job for a year to work with Covid data.
A big reason I was so upset that they killed the control group was because this was finally going to be the trustworthy dataset where we could see the true danger of Covid, which was grossly exaggerated (10x or more), by government and the media. I was really focused on that study, and it was showing very little mortality from Covid. And then they killed the control group. Looking back it was a smoking gun that this was a "Scamdemic". Sure, a bad virus, and 2x-4x worse than the typical flu. But not even close to the Doomsday scenario it was made out to be. The real pandemic was fear.
> for ethical reasons
I 100% dispute this. I do not see how you can make the case that it is ethical to abandon the scientific process and risk the health and safety of hundreds of millions, and destroy any slam dunk evidence that could put blame on the vaccine makers. It was extremely unethical to cancel that control group. They said they did it to "save lives", and yet, at the time they did it, all the data showed zero lives saved from the vaccine. "It hasn't saved any lives yet, but trust us it will, we have a hunch". That is not scientific. That is not ethical.
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.
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.
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...
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...
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.
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.
> unless you're a vaccineologist then your opinion about whether sufficient time has passed is totally meaningle Also, outright dismissal of an argument based on appeal to authority is not productive.
Most people conflate latent with long-term. They believe when researchers are looking for 'long-term' effects they're looking for things that magically show up somewhere down the line, and therefore 'we haven't waited long enough!!' and 'there's not enough data!!' - but that's not what they're doing, although they're open to being surprised.
We've studied mRNA for like 50 years now, we understand how it works enough to know that what you're suggesting just isn't a real outcome.
You are right it doesn't matter per se because outcomes are normally distributed in severity and time and if you give enough people the vaccine you can substitute that for waiting. And by vaccinating 70% of the world, we can be utterly, completely, 100% sure it's safe.
It's safe, end of story.
> Also, outright dismissal of an argument based on appeal to authority is not productive.
To invoke appeal to authority there would have to be an attempt to invalidate evidence on the basis that someone is or isn't an expert. The parent didn't provide any evidence whatsoever. If they had either evidence or experience in the area I'd take their claim more seriously (but still inconclusively). However at this point it's just some random person on the internet saying "we need more time!" without explaining why or why I should believe them in absence of data.
Sorry bud, it's MSG all over again. But like I said it's a personal responsibility thing now and if you want to be wrong you're free to do so.
What an utterly fortunate universal truth of vaccines!
The reality is most drugs and vaccines that you get are tested on a few hundred or a few thousand people over a long period of time. But mostly because it's very difficult to measure the efficacy of something with statistical significance if the prevalence rate is low.
So you can either give a bunch of people Ebola to check if the Ebola vaccine works, or you can wait a long time. Ethics boards frown on the former.
However with COVID like 1% of the population had it when we were ready to test vaccines so showing efficacy was very quick and very easy.
What reason do you or anyone else on earth have to think there would be a mechanism that yields latent issues? We have studied mRNA for about 50 years now. And the adenoviral vector vaccines are a completely different mechanism studied for about 50 years too.
What exactly bad thing do you think would miraculously appear 3 years later showing zero signs, symptoms or evidence in 6 billion people? And why would that be different after 5, 10 or even 15 years? There's no law that says Tylenol doesn't cause your arm to fall off 110 years later either, but that's not the standard of proof. Nothing in life has zero risk.
That aside I think if your n is large enough, I think even issues that are ordinarily latent would be at least detectable. Certainly 3 years later. The normal development cycle is as short as 5 years, 2 of which are in regulatory approval.
At some point we have to be guided by our past experience. You can't ever prove a negative, but you don't have to prove a negative to move forward.
mRNA and the adenoviral vector vaccine delivery mechanisms have been studied for 50+ years and are vetted.
> Did you know its rare but accepted that some dogs get injection site tumors and we don't really know why?
Did you know dogs aren't humans, and there's no evidence of this kind of thing in humans at all?
btw it's also extremely extremely rare in dogs, to the extent it's hard to find any kind of data on it. It wasn't thought to occur except in cats until the 70s, so I've written up the rest of this generously assuming cats.
Most study headlines you read are fun achievements that only work on the animals under study and they don't have the same effects in humans. You can significantly increase the life of worms by not feeding them, but humans not so much. Weird huh.
Again this brings us back to our 'substitution of T with N' conversation. It's always a normal distribution. While these VAS tumors develop a few years in, in some cases they develop within a few months. So if you give 6 billion people vaccines over 3 years, you would have definitely seen this kind of latent thing by now, even if its peak effect is a few years later.
> That would surely be a latent effect in dogs, why do we think it could never happen in humans who live much longer?
That's not a thing. Again you're asking to prove a negative, which is not how we do anything because it's impossible. The burden of proof is on you to explain why you think it could happen, not on me to prove why it couldn't.
Prove to me that eating a tomato won't cause turbo-cancer of the elbow. You can't.
I'm also saying that beyond that reasonable estimate based on the 300+ years of vaccine development behind us (and 50+ years of development of mRNA and viral vector vaccines) you are asking scientists to prove a negative which nobody can do.
That's not the standard we hold literally anything else to, nor should we.
That's alarmingly high for such an infectious virus. It's why CoVID-19 caused such a spike in mortality around the world over the last three years, and why life expectancy in the US declined by two years.
Given how infectious SARS-CoV-2 is, it is a very deadly virus. It's nearly a worst case for public health. It's not Ebola, but almost no one gets Ebola. It's far deadlier than other viruses that people get seasonally.
In the US, the median age of people who died of CoVID is around 75 years. The average person who died lost about 10 years of life.
CoVID is a significant contribution to mortality for most age groups. 10% of all deaths among 40-something-year-olds are due to CoVID. There are around 40k confirmed CoVID deaths in this age group alone.
The stats are here: https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#Se...
It only killed millions of people...
Also
the cumulative COVID-19 mortality rate in the 15-24 year age group was 0.03%
The mortality rate of covid for your undocumented friend is higher than the target group mortality of RSV.
I also know dead persons after covid vaccination, serious injuries also in family. How many healthly people dead from covid do you know?
There were 3 deaths on my block, including a renowned weight lifter who was a daily staple at the gym.
Deaths and harm occur in some limited cases in vaccination. They occur in some limited cases without. That's why we have data.
One person being harmed cannot stop a program that reduces harm in aggregate.
I guarantee you the riskiest thing that child did on a regular basis was get into a car. There's a 1% lifetime risk of death in a car accident in America.
I guess this is the trolley problem in action but do we actually think all humans are the same? Would you divert the trolley from 2 90 year olds to 1 16 year old?
Among children? Name data and studies that supporting your claim, please.
Did you read those studies about negative side effects? https://news.ycombinator.com/item?id=35094410 Those are not anecdotes.
> There's a 1% lifetime risk of death in a car accident in America.
Should we ban cars because of this data?
It [feels] to me the vaccine industry should be ...
FTFY
I hate being controlled by 'the man' just as much as anybody, but I think you have to ask yourself why you are so fixated on this issue?
What's your position on gun ownership? If you really want to keep mothers of two, or their children for that matter, from dying; then maybe focusing your outrage there would save more lives.
It had better! Otherwise (in my opinion) it has little claim to the label “vaccine”.
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?
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.
No idea what to do about it given all the absolutely unhinged perspectives on the topic, but still, I care.
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.
>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...
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.
(EDIT: removed info about them not being sold anymore, apparently that was resolved?)
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.
I got a 5-virus test for a study recently (Influenza A+B, Adenovirus, RSV, Covid). I haven't seen them to be sold for end customers. There are a few 4-virus tests on the market here, yet the legality is currently questionable here in Germany. (It seems there's an interpretation of the law that Influenza testing shall only be done by doctors.)
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.
Trust is fragile and loose when anecdotal evidence is differnet with official agenda.
> Trust is fragile
You already answered your own question.
After the 2016 election, I became super interested in epistemology and how we learn things (including effects of trust and influence). In practice, we know almost nothing from first principles and we “know” almost everything because we heard/read it from sources we trust.
The difficulty with COVID is that people who either trust or distrust the vaccines have strong priors and discussions like this thread don’t spend the time to understand each others priors, hence the reasons they trust different sources.
Example: a pro-vaccine arguer probably understands that VAERS entries are not necessarily vetted, may represent post hoc ergo promoter hoc fallacies, and should be taken with a grain of salt. An arguer on the other side may assume that all VAERS entries represent a floor (perhaps many other side effects were somehow prevented from being reported). The truth is most likely somewhere in between the positions of the two arguers.
> Trust is fragile and loose when anecdotal evidence is differnet with official agenda.
Trust has little bearing on the objective truth. Most people trust other people who haven’t proven to be trustworthy. Your statement could be about fraud in the 2020 election. Despite low trust in the election (initially among Republicans, but that distrust has spread to independents and Democrats), no election fraud claims have withstood scrutiny. Repeatedly stating distrust has created more distrust, despite no more evidence that we should distrust it (since early 2021).
https://fortune.com/2023/02/15/trust-in-media-low-misinform-...
https://axios.com/media-trust-crisis-2bf0ec1c-00c0-4901-9069...
(2) The more you use the word “agenda”, the more you sound like you have political motives as opposed to curious + minimally biased. If your goal is to spread factual information, use the language of facts. If it is to be political, then continue using the language of politics / those who spread conspiranoia.
Please, name those best avalible media.
- If your goal is to spread factual information, use the language of facts.
How can I do that on internet?
Also... Official news about covid was unfortunately more political, than anyone would like to have it. Opposite opinions and discussion was not present and those who disagreed was discriminated and censored. Those signs are discribed in terms of propaganda - official and only one allowed agenda.
These death totals do not substantially pass the baseline for expected deaths in that population. In none of these cases has spike protein been observed on heart tissue, which is the potential vector for vaccine induced myocarditis and can be performed visually under standard microscopy.
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.)
Also, you can pretty much anticipate pregnant women will be the last two be approved for anything. Pregnancy complications are common enough that no one wants to mess with that whole situation until you're certain you won't have cross antigen reactivity in the host
Giving my son a chance of not catching RSV from daycare would be be great.
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.