The FDA is guilty of one of the worst crimes in science/medicine- inconsistency

[RAB910]

I am a bit disturbed by the poor showing of the FDA in terms of their Pfizer booster shot. They voted 16-2 against boosters for people 16 and up saying there wasn't enough evidence that boosters work. Then they turn around and vote to approve the booster shot for those over 65.

Here's the critical heart of the matter. Either data shows that the booster works or the data don't show/prove the booster work. You can't claim in one vote you don't know if the booster works then turn around and claim well it does work and we think people over 65 should get it.

I reviewed the Lancet Op-Ed (which had members of this panel sign on to the editorial). That opinion piece strayed from medicine and the efficacy of a booster (which is what these boards should be focusing on) and get involved in issues about boosters versus getting the first shot in unvaccinated people in other parts of the world. While that is an issue for politicians to consider, it's not what this FDA board should have been considering.

We already have enough science deniers and critics. The FDA should have stayed in its lane and voted strickly on the effectiveness of a booster shot. I have little doubt if they did, they would have followed Israeli's lead

[unblock]

1. In a global pandemic, getting first vaccines to unvaccinated people in other countries is important

Vaccination rates in India and China and Africa and else west here ultimately have an impact on my personal health risks as an American because it's a contagious disease.

For non-contagious diseases, arguably it's just politics; but for a global pandemic, prioritizing foreign first vaccines over American third vaccines is well worth considering, and certainly well worth studying and having experts opine on the relative merits.

[Scrivener7]

2. I totally agree with you but I think RAB910 is right. These are two different issues, and the

FDA only has jurisdiction over one of those issues.

The first issue is: Does the vaccine improve the immunity, or prevent loss of immunity, as we go out in time from the second shot. The FDA was supposed to tell us that.

The second issue is: Should we vaccinate the rest of the world before we give boosters to Americans. The FDA is not in a position to weigh in on that.

I totally support giving vaccines to the rest of the world before we get boosters. It's the right thing to do, but it's also the self-serving thing to do. The worst thing that could happen now would be for a variant to develop that would thwart the existing vaccines, and the more people spreading Covid around the greater the chances of that happening. So the more people we get vaxxed around the world, the better it is for us.

BUT the FDA is not in the business of saying whether we should be helping out other countries. That is for Biden and other heads of state to work out. The FDAs only task here was to tell us if the booster is a safe thing to do, and if it is an effective thing to do.

And RAB910 is also right about the issue of consistency. When an organization like the FDA is inconsistent, any authority they have is seriously undermined.

[democrattotheend]

3. Agreed 100%

As long as less wealthy countries don't have access to the vaccines, the virus would continue to mutate and potentially evade the vaccines in those countries and then come back here, even if we got everyone in the US vaccinated. So I think it does make sense for the FDA to consider whether the doses are put to better use in other countries in terms of what will ultimately keep us the safest.

[Demsrule86]

16. I do not agree. We can do both..

[Tomconroy]

4. The FDA advisory committee was not allowed to consider

The issue of the need for vaccines by the rest of the world. They only considered issues related to the US.

[Sabrielo]

5. There's no inconsistency

Your argument is that young people and older people need to be treatee the same with regard to boosters.
But the immuno-compromised are older. Those are the ones in need of a booster. Not younger people.

[Demsrule86]

17. There is no need to wait when rhere is vaccine available.

[Sabrielo]

19. Scientists disagree with you

You, a nickname in a message board, say there's no need to wait. Scientists say there is need to wait, for certain people.
I think I'll go with the scientists.

[USALiberal]

23. Lol, So many here are making up their own excuses.

[marble falls]

21. That seems to me to be CDC's thinking, too. Like on airplanes: when the masks drop ...

... who gets the mask first? Adults then kids.

[StarfishSaver]

6. Where's the line between inconsistency and adjustment to new info/circumstances?

[JanMichael]

8. You mean like their idiotic May mask freedom event? They screwed the states and cities. nt

[CrackityJones75]

25. And here we go...

This is how people on the left will delegitimize the scientists at the CDC and the FDA because they were wrong once. While people on the right do the same.

[Voltaire2]

27. They weren't wrong.

Vaccinated people remain at very low risk. What changed was new data regarding transmission of in particular the delta variant by vaccinated people. When that data was confirmed, the recommendations changed.

I really enjoyed my three months of masklessness.

[JanMichael]

28. Masks are the easiest tool to stop spread but they couldn't help themselves

It was premature because at the time in India Delta was already a big ass issue and unfortunately Americans can't see past their own f****** borders. It was premature it was premature it was premature and we are all paying for it. The biggest issue is by the CDC saying masks are not necessary for vaccinated people that made most states give up. Now in North Carolina for instance relatively liberal cities have masked mandates but the rest of the state is basically a covid soup.

While it wasn't technically wrong in the middle of May it was premature because we had/have a pandemic going on which the giddy Walinsky didn't particularly give a s*** about. Look just because Biden appointed her doesn't make her right for the job.

her message of saying vaccinated people were okay to mosh pit away made states give up their mandates. then you couldn't tell who was vaccinated who wasn't at the grocery store. They were using the CDC as their backing for making these mandates. When they lost that we lost. It's a big deal.

[pwb]

7. I think anyone high risk can get it now. With proof of need.

If the rest of us don't need it what is the rush?

[muriel_volestrangler]

9. There's evidence the drop-off in efficacy is only significant in the over 65s

Link to tweet

https://threadreaderapp.com/thread/1438100712441974786.html

[Tomconroy]

10. At least one doctor on the FDA panel was quite explicit:

Last edited Fri Sep 17, 2021, 09:05 PM - Edit history (1)

The goal of the vaccines is to prevent serious illness and death.
If you believe that is the goal then you are going to make different decisions on a whole host of issues as opposed to believieng the goal of the vaccines is to prevent infection.

[LisaL]

12. Yep, they seem to think that infection is not a big deal unless

one ends in the hospital.
I don't necessarily agree with that idea.

[Demsrule86]

18. Yup, we cant afford to be out of work .

[LisaL]

24. We also don't want to infect others.

NT

[CrackityJones75]

26. I have always understood

I have always understood that vaccines do not prevent infection. Is that not true?

[LisaL]

29. They do prevent infections, just not a 100 %.

NT

[CrackityJones75]

30. Either you are infected or you aren't.

Vaccines stop the infection from spreading.

[Caliman73]

11. Disagree.

First. Science, as most human activity, is inherently political. That is very different that saying it is Partisan. Science informs public policy and therefore, it needs to take into account the needs of various constituency groups.

The science shows that in younger, healthy subjects, the effectiveness drop off is significantly less than in older more compromised people. That would dictate different public health policy approaches to the different populations. If the need is greater in other areas of the world with regards to at risk populations, than that is where the limited resources should be used, not in practices that while not necessarily harmful to youth in the US, are not necessarily any more beneficial either.

Science is complex and public policy is complex. International cooperation is complex. If we did everything based on what the most ignorant, partisan hacks would or would not scream about, we'd all be dead by now.

[milestogo]

20. Exactly.

[Ms. Toad]

13. 16 and up includes over 65, but as to vaccinations over 65 has frequently been treated differently.

As to the flu vaccine, peopel 65 and older are often given a high does version. I don't see any reason that over 65+ would be more efficient at building immunity to COVID, relative to youngers, than they are at building immunity to influenza.

Inconsistency, and being slow on the uptake of new information really bothers me - but I don't see inconsistency here.

[wanderer54]

14. Fluzone High-Dose for Seniors

Fluzone High-Dose for Seniors has 4 times the antigen as a regular flu shot.

[Hugin]

15. They're practicing reactive science...

instead of proactive.

Which cumulatively over time can lead to things like global warming.

It bothers me, too.

[fescuerescue]

22. I don't understand the FDA didn't consult DU before voting.

hard to say.

It's almost as if that group of 16 highly regarded doctors think they understand the issue better than us chat board chatters.

Crazy times.