FDA panel recommends Pfizer's Covid booster doses for people 65 and older
cnbc.com
cnbc.com
1. We still haven't been able to correlate antibody titers to protection.
2. The vaccine's effects on transmission are not clear.
3. It seems there is virtually no meaningful data on memory B and T cell responses even though we know this is a critical part of immunity.
Even more striking to me was how weak Pfizer's presentation/argument for a 3rd booster was.
https://www.fda.gov/news-events/press-announcements/coronavi...
Clearly a booster would reduce infections but that effect probably is dwarfed by vaccinating the un-vaccinated. Rolling out a booster across a large population takes resources (and the health sector is running very, very low on resources - Idaho gave up on normal standards of care now).
The question is also what is the impact of the booster on medium term development, medium term options and vaccination discipline of the general population. We also lack understanding of Pfizer vs. Moderna stats. Then the is the lack of understanding what repeated short term boosting does - it is not typically done. And last but not least the question is what is the best strategy to deal with the threat of new variants emerging. Reducing infections in the US will help reduce the chance for a concerning variant to emerge but possibly these resources are better spent fighting the virus globally as these variants tend not to stay in one place only.
Pushing for a quick approval and rollout for the first vaccine was a relatively clear cut risk - benefit trade-off. There are risks with the booster (small but there are with any medicine) and the benefit is vastly smaller. The trade-off is different and we should not pressure experts to come to conclusions on a shortened timeline.
More money only allows us to conduct more parallel research to answer questions in parallel. It doesn't mean that we iterate any faster in the "question -> answer -> think of new question" bottleneck.
We've got research on Pfizer, Moderna, Johnson and Johnson, Novavax (and other vaccines) coming in. We got research on corticosteroids (dexamethasone, Prednisone, Methylprednisolone ), IVM, hydroxychloroquine, etc. etc. (even if we have no reason to believe that Ivermectin or hydroxychloroquine will work, we'll conduct the research anyway so that some loud people out there can finally shut up about it). There's monoclonal antibodies (REGN10933 and REGN10987), with probably more in the works. Etc. etc.
There is research on Vitamin C, Vitamin D, Blood type, etc. etc. So much research, and many of that research is getting replicated over-and-over again, to ensure accuracy.
And of course: there's research about _how long does the vaccine last_, which is fundamental to this entire FDA question. There's a myriad of measurements going on, and it seems like the scientists aren't agreeing upon the research yet.
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That's fine. CDC has one set of research. FDA has another. White House will make a decision. When agencies disagree, we take it up to the higher-levels of discussion to make a decision through other means.
This is one of the stupidest stock examples ever invented. The idea is that one of the most parallelizable processes known to mankind, characterized by its rapid growth and perfect scaling, is the paradigmatic example of a process that bottlenecks itself.
It takes one woman more than 30 months to have two babies. Two women can do it in 9 months.
When someone says "9 mothers can't have a baby in one month", you have to wonder whether the lesson they want you to draw -- that some other process can't be parallelized -- applies to that other process any better than it applies to the process of population growth.
downvote this all you want and tremble in your basement with the blinds closed but this is how we move past this.
Presumably this has already occurred. COVID daily death rates in the US are on track to meet or exceed the previous all time high. It is undeniable at this point that the vaccine effectively eliminates the possibility of death from COVID-19, so there are presumably still many Americans without protective immunity. Government should do everything to get people vaccinated and prevent needless death.
>heard [sic] immunity builds and repeat exposure keeps peoples immune system responsive to it in perpetuity
This does not seem to be an accurate understanding. I know of many people who contracted COVID-19 during the alpha wave, declined vaccination thinking they had protective immunity, and then contracted Delta with severe symptoms a year later.
>this is how we move past this.
How do you figure? If we don't get more people vaccinated, deaths will continue to accelerate. There is also no known protective immunity better than vaccine + infection.
It’s a bit tough to follow the logic of this comment. If we have more vaccinated than ever, but there are more cases and deaths than ever, how does it therefore follow that it is “undeniable” that the vaccines are doing exactly what we want? Maybe and perhaps that can be partially explained through mutations, but with more than half the population fully vaccinated by now, you’d think that infection rates would be declining, not increasing. It’s very easy to see how vaccine skeptics would continue to think that everything doesn’t fully add up here.
PS: What tests did your friends use to differentiate between alpha and delta infection?
In my area, most people are vaccinated. If the vaccine wasn't very effective, you'd expect that most people dying of COVID would be vaccinated. In reality, something like 98% of deaths are among the unvaccinated
I vaguely recall seeing it had dropped to 95% a month or two ago, but that was still counting from the beginning of the year and not weighting by percent vaccinated.
Since September 1, there have been 435 COVID deaths. 70% of people in my county are vaccinated, so you'd expect that if vaccines were useless then 304 of those deaths would be amongst fully vaccinated people. But the real number is actually 81. However the 81 includes anyone who died with an active COVID infection, so I wouldn't be surprised if the real number was much lower. But assuming that 81 is it, it looks like the effect is more like a ~75% reduction in death odds
I was referring to the US in my last comment, it's the only one I'd seen so far that was so skewed to >95%.
They didn’t get a test but they got symptomatic covid at the height of both waves.
As far as I can tell, the data shows that the Covid vaccines, on an individual level, do seem to dramatically minimize symptoms. As far as science can tell, the vaccines usually turn a severe Covid outcome (which is still very rare if you're not geriatric, fat, or otherwise unhealthy) into something far less severe. We're basically in agreement with that, right?
Let's stop there for a second and analyze the current social situation up to here.
At least 50% of people in the US are fully vaccinated. And more people have at least 1 injection and at least some protection from symptoms. And many more have natural immunity from past cases too. If the vaccines were having the exact social effect we expected, it would be reasonable to assume that cases and deaths would be falling in light of increased vaccination. Cases and deaths are not falling though, right? So what gives? Something doesn't add up with the vaccines' overall impact. If there's a reasonable theory why this is, please explain.
This isn't just an issue with stubborn Americans. I believe that no democracy has been more aggressive about vaccinations than Israel, and they're having significant problems right now too. If the vaccines will work on a societal level as intended, what gives?
There's more than one theory here, but I'd suggest that the properties of the vaccines (minimizing symptoms) makes it so that vaccinated people don't quickly realize that they're sick and go about their business normally and some can act as unwitting super-spreaders. This wouldn't happen as readily with unvaccinated people who feel that they're sick and would be more likely to stay at home. Ironically, the mass vaccinations may be driving the spread.
Another scarier theory is that these leaky vaccines are creating a Marek's Disease type of situation in humans where the vaccinated are creating the mutations that are killing the unvaccinated.
Another possibility is of course that mutations are being driven by the unvaccinated. (it's a possibility worth mentioning, but I'd discount it as unlikely given how viruses tend to mutate towards being less lethal in order to spread more)
Am I trying to have a discussion in good faith or not? I think I am and am bringing up some reasonable points. Just my $0.02.
The % of Americans fully vaccinated is too low to achieve herd immunity against the more transmissible delta variant.
> no democracy has been more aggressive about vaccinations than Israel
Israel is no longer even in the top 30 countries in terms of % of population fully vaccinated. Where they are having success is controlling breakthrough infections after a 3rd dose.
> I'd suggest that the properties of the vaccines (minimizing symptoms) makes it so that vaccinated people don't quickly realize that they're sick and go about their business normally and some can act as unwitting super-spreaders.
There is no evidence the vaccine delays symptom onset. It reduces the chances of severe symptoms and death.
> I'd discount it as unlikely given how viruses tend to mutate towards being less lethal in order to spread more
The delta variant originated in India, which was at the time the world’s largest population of unvaccinated people. No variants have emerged from highly vaccinated populations.
For example there wasn't enough data to support giving AZ to elderly people, which made Germany not give it to elderly people, which turned out doubly bad: AZ works in older people, but is more dangerous in younger ones (well 1 in 100.000 dead dangerous). This likely cost us something like 5.000 to 10.000 of our 90.000 deaths.
In hindsight waiting for phase 3 trials on the vaccines similarly cost so many lives around the world it seems crazy now. Could we have prevented some of the last fall wave?
Boosters seem to be in a similar position. If you have the guts (like Israel) to take a chance as a society you might save another 1 life per 2.000 to 10.000 this fall.
Screw testing let's deploy to prod cause we need to seem like we are doing something!
65+ (Who are almost 80% of deaths in the US) and At risk groups are still advised to get it & everyone else will still have significant protection from the first shots. Not that the young and the healthy were at high risk to begin with...
[edit] it's also the psychology of investing in infrastructure for your software project. It's impossible to count the set of things that didn't happen because of your work. It's much easier to count the set of negative things that did happen as a result of your not doing that work.
Investing software quality is a goos example because we all know the trade-off between perfect software and launching with bugs. The conversation with vaccines in the epidemic has been too much looking for perfection.
I still hear people talk about how they don't want the vaccine "because it hasn't been studied enough" when it's literally been given almost six billion times.
You are putting all of your eggs in one basket AND counting them before they've hatched. That's a pretty serious double whammy.
I'm only half serious but I think the above is pretty representative of some common concerns.
A quibble: Phase IV "post-marketing" is where you find the really rare adverse effects that you can't find in Phase III trials, which for the FDA authorized and approved vaccines were as big as they get, but still have a maximum of 23,000 people getting the vaccine. So that rare brain blood clotting problem with Janssen's vaccine actually had one case of it in its clinical trial, but that wasn't enough signal to detect it as a problem. But after 6 million or so people got it in the US there were enough cases reported to the CDC's Vaccine Adverse Event Reporting System (VAERS), a handful or so it could be detected and addressed. Same sort of thing happened with the heart and heart lining inflammation for the mRNA vaccines.
But as you say, these are the standard approaches, no extra length pre-marketing testing would have discovered them based on how vaccines work, and for drugs roughly the same thing happens as you discover there are some people who just don't tolerate them. For more on this, look into "black box" warnings that are regularly added to the prescribing information for doctors from Phase IV surveillance.
(1) Very similar coronaviridae have been researched for years, since the first SARS and MERS outbreaks in the early 2000s. And of course some nontrivial quantity of common colds are caused by coronaviridae.
(2) A lot of time was spent attempting to create MERS and SARS vaccines that was leveraged for COVID.
(3) mRNA has been researched for like 30 years.
(4) Viral vector vaccines have been researched for about 50 years.
(5) Vaccines are a fairly well understood quantity that won't mess with your germ line.
(6) The clinical trials used to confirm efficacy of the COVID vaccines were roughly in line with the sample size of any other clinical trial.
(7) At this point after 6 billion doses administered it's about as safe as aspartame.
Whether you quibble with any specific points, do you have any reason to believe a COVID vaccine is unsafe other than some nebulous gut feeling? Would anything change your mind?
Most of what you describe is not just "knowledge of the vaccine", it's "knowledge about how immune systems actually work". For example, we still have no certain knowledge about how measles manages to wipe out your immune system.
Most of medicine is (although often very good!) guesswork.
> 2. The vaccine's effects on transmission are not clear.
Indeed, but the vaccine's effects on infection are clear. Less infected people automatically means less people transmitting the virus.
This will take a non-zero amount of time. Hence, a vaccinated person can in the interim test positive for the virus, even if the vaccine protection is working perfectly fine.
Otherwise you're correct as far as I know, the other mechanisms of the adaptive immune system only come into play once cells get infected. But there might not be very many of them, perhaps not enough for a RT-PCR test to find.
The vast majority of people are completely unqualified to evaluate the data, even if they had access to all of it. And they too have to correct for all the same biases that might be affecting the FDA.
as usual one can just follow the money [and power].
https://finance.yahoo.com/news/fda-panel-votes-against-pfize...
It's easier to just let the bodybuilders not take the shot - given that's their right anyway - than to use bodyfat % or some other measure as the prerequisite for boosters, even if those measures more specific they end up less accurate (hope I'm getting those terms right)
https://www.researchsquare.com/article/rs-880193/v1
But it's expensive to measure visceral fat accurately. So from a public health standpoint BMI is a good enough proxy.
somehow they know better than the scientists that they really need these boosters
https://youtu.be/rsEGC38rhII?t=5063
(starts around 1:25h)
I can't grasp that we don't heed their warning that waning immunity needs to be countered to prevent a 4th wave. Fall and winter will be tough in Europe and the US.
Reminds me of an old Soviet-era joke. Ronald Reagan and Leonid Brezhnev race the 100 meters, and Reagan, being much younger, wins the race. Headline in the Pravda: "Brezhnev places second, Reagan second-to-last".
The panel initially voted to reject the booster. Afterwards, they held a second vote in which the panel approved the booster for 65+.
AP’s
US panel backs COVID-19 boosters only for elderly, high-risk
https://apnews.com/article/fda-panel-rejects-widespread-pfiz...
Sad day for science. No one on earth can tell a 65 yo or HCW with confidence that they will be better off after the booster than before. No good efficacy data, no good safety data on boosters.
This comment shows how peoples’ unwitting exposure to political propaganda shapes their view of reality via an implicit bias which they interpret as “gut feelings”.
Not to mention:
accidental vote
made up new voting question on the fly
10 minutes to deliberate the evidence
used very vague terms in the vote
You obviously didn’t watch the meeting.
edit: according to other commenters, the article's own headline was changed (https://news.ycombinator.com/item?id=28570880)
But they want the decision forced on the general public by the current political administration. Am I the only one to sense a sort of cognitive disconnect on this?
That's reality and it's not unreasonable. The thing we need to sort out is where to draw those lines to optimize for best outcomes for both individuals and society.
1. Most don't have the knowledge to make an informed choice (how many people have enough medical knowledge?)
2. It is generally accepted that seat belts are mandatory, helmets on motorcycles are mandatory in most of the world (except a few states in US), but that is not seen as lack of own determination. What is the difference? All these are preventive actions.
You could say this about anything: camera lenses, frozen food, airline flights. How much do you really know about how these things operate/are made? Prices externalize that information that allows people to decide whether it’s worth it. Also most people are far smarter (especially when it regards their own bodies) than the assumption you’re making here…
250,000 people a year. Nearly 10% of all deaths. A 0.7% chance of dying (from a mistake) per hospital visit.
You know why it goes under the radar? Because there is no billing code for f-ups.
I realize of course this doesn't mean self-medication is safer; legitimate medical treatment might cause more deaths just because there is more of it.
[https://hub.jhu.edu/2016/05/03/medical-errors-third-leading-...]
"The researchers caution that most medical errors aren't due to inherently bad doctors, and that reporting these errors shouldn't be addressed by punishment or legal action. Rather, they say, most errors represent systemic problems, including poorly coordinated care, fragmented insurance networks, the absence or underuse of safety nets, and other protocols, in addition to unwarranted variation in physician practice patterns that lack accountability."
I would be inclined to wear a helmet or a seatbelt regardless of the law, so it doesn't make a practical difference to me if they are mandated.
On the other hand, it seems arbitrarily inconsistent to me, to say it's ok for motorcyclists to take a lot of risk, even with a helmet, and yet not allow car drivers to choose whether to wear a seatbelt or have an airbag.
I can drive any old pre-airbag car that's nearly as dangerous as a motorcycle, but there's little accommodation for selling new cars without every bell and whistle.
Not that I would want someone to say "ok, then we'll outlaw motorcycles and scrap all the old cars".
But I'm not sure these regulations are really necessary. If people have different risk tolerances, then they can pay an appropriate amount in insurance.
On the other hand, I do strongly believe in safety regulations where the risk is not obvious and people can't judge it. I can't see if food or drugs are potentially lethal, it has to be certified and monitored by experts.
With cars, the question of whether the seatbelts will work correctly in a crash is something that regulations need to cover, even if we were to say it's ok to not have them at all.