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Listening to the panel, I was struck by how big the gaps are in our knowledge of the vaccine. For instance, members of the panel raised the following issues:

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.

In March 2021 the FDA authorized the Adaptive Biotechnologies T-Detect test which assays one aspect of memory T cell responses. It's disappointing that most recent studies still aren't routinely using that test in combination with PCR and antibody tests. It could give us a more complete picture of population immunity levels and changes following infection or vaccination.

https://www.fda.gov/news-events/press-announcements/coronavi...

The immune system is a curious thing. There is e.g. a vaccine against pneumonia but you my doctor explained to me that you can only get it once in your life. There is another one which is not as good so you may get that some years later. The recommendation is - at least here in Germany - to take the vaccine only once you are older and have a higher hospitalization (and with it associated infection) risk.

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.

I find it really saddening that we aren't ramping the spending on these questions and issues. We should spend on the order of 100-200 billion globally to research and fights the pandemic. That would be a drop in the bucket compared to the economic impact of the pandemic.
This is just getting ridiculous. Get everyone who wants it the vaccine and then drop the distancing measures and masks so heard immunity builds and repeat exposure keeps peoples immune system responsive to it in perpetuity. Pharma companies are going to push boosters forever as they make money on it.

downvote this all you want and tremble in your basement with the blinds closed but this is how we move past this.

Sometimes I wish the experts would not just talk about their desire to know more, but also considering the consequences of taking or not taking chances.

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.

> 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...

This is the psychology of prison reform. You don't want to be the elected official who's responsible for one released prisoner killing someone so you lock up all the prisoners forever.

[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.

> I was struck by how big the gaps are in our knowledge of the vaccine.

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.

It also seems patently obvious that in order for the vaccinated immune system to destroy the virus, one must first have the virus in the body, i.e. be infected with 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.

I'm not expert is any of this, but what worries me is that political pressures, conflicts of interest, profit motives, rushed timelines, experts who have misled to get a reaction, and many studies with either short terms or small sample sizes are making it so that the average person has no idea what to believe.
I never thought that the various governments would be the scariest part of a pandemic but it’s pretty obvious now in hindsight.
This is why the average person should have choice what to eventually believe (if anything). Mandating a belief, like what we generally see today, is harmful.
>the average person has no idea what to believe.

as usual one can just follow the money [and power].

They then approved it for people with 25+bmi, which is 73% of the adult pop
I watched from the first vote, discussion of how to change the question, second vote, and post vote discussion. They didn't seem to want to wade into details of what "higher risk of severe covid-19" means (though bmi 35+ was mentioned) and figured the FDA and CDC would be more specific (panel vote, as I understand it, is non-binding and FDA can do whatever they want to it).
Using BMI to measure obesity is like relying purely on line coverage to measure the quality of software testing. Why is this still the go to measure? Is it just the cost of other measurements?
This is a really important point which is being missed by virtually all commentators on this topic.
As with most other studied diseases, the real risk factor comes not from high BMI per se but rather from excess visceral fat. This is linked to metabolic diseases like diabetes. Subcutaneous fat is much less dangerous.

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.

And what percent of those are six months after their second dose? I expect Pfizer to have phase three booster trial data on hand before any significant portion of those people become eligible under the coming EUA.
I'm trying to find that somewhere. I see obesity listed a possible comorbidity, but nowhere can I find a 25+ BMI (which is overweight not obese ~30BMI). Obesity would still cover 30-40% of Americans.
it's really interesting seeing the "follow the science" crowd's reaction to this

somehow they know better than the scientists that they really need these boosters

Sciencism? Scientism? Something like that.
If you got a bit over one hour, spend it and hear the section on the experience in Israel with boosting:

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.

Aside from the specifics of the case, the contrast of headlines is interesting. CNBC says "FDA panel rejects ...". Bloomberg says: "FDA Advisers Back a Narrower Authorization for Pfizer Booster"

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".

Maybe it's A/B tested? I'm getting a headline which seems more fair and less clickbaity: "FDA panel recommends Pfizer’s Covid booster doses for people 65 and older after rejecting third shots for general population"
Meanwhile CBS' headline is "FDA advisers unanimously endorse Pfizer booster shots for some Americans."
Felt like political pressure meant Marks could not leave that room without some positive vote, and they would make up questions until it happened.

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.

Headline needs to be updated to “FDA panel recommends Pfizer’s Covid booster doses for people 65 and older after rejecting third shots for general population”
Changed now. Submitted title was "FDA panel rejects plan to administer Pfizer’s booster doses to general public". I'm not sure if that was the article's previous headline (legit) or an editorialized submission (not legit per https://news.ycombinator.com/newsguidelines.html).

edit: according to other commenters, the article's own headline was changed (https://news.ycombinator.com/item?id=28570880)

People can easily get a booster by just telling cvs or Walgreens that they haven’t been vaccinated yet. When I talk to the pro-booster folks and tell them this they shudder and say, “well I’d never!”

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?

because everything just gets folded into the culture war. but why?
I know some guy that took the booster in a similar way in Europe; he took the first shot in his native country, the second in the country where he lives and works and the third back in his native country 5-6 months later.
That feels like lying and possible stealing that dose from someone that has not been vaccinated yet.
Why isn't the public allowed to make its own determination about what medical care they want to receive or reject? I would like the freedom to be able to purchase a booster shot at the market price if I so choose. That's a voluntary transaction between me and the manufacturer and I do not agree with the FDA standing in the way. Is safety really a concern? Or is this more of a political decision to reserve vaccine doses for other countries per the WHO's request?
Personal choices that have the ability to significantly negatively impact many other people have something of a tendency to get regulated and controlled in some manner.

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.

Same argument against letting the general public administer care of their choice-Health Insurance does not want to pay for mistakes. Doctors are entrusted with making these decisions.
Is anyone stopping you? Can't you just make an appointment at a vaccine site? They aren't even checking ID. I know people who have already gotten boosters.
There are 2 reasons:

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.

I think that's still possible - there just wasn't data that it is necessary for the under 65 yet.
As long as there isn’t a surplus, I doubt that will happen.
by that logic i should be able to go buy myself a big box of fentanyl for the medical care i've decided that i need
For now, the market price for individuals is infinity. All the doses are being sold to governments.