Disagreement With WH Over Booster Shots Prompt Senior FDA Directors to Step Down

[TheProle]

Source: Newsweek

Two senior officials with the Food and Drug Administration will step down from their positions overseeing vaccine applications this fall, the FDA announced Tuesday.

The two officials, Marion Gruber, director of the FDA's Office of Vaccines Research & Review, will leave the administration in October and her deputy director Phil Krause will follow in November, the FDA shared in a statement shared by CNBC.

Endpoints News, a biotech industry new site, reported that a former senior FDA leader said the duo were frustrated that the CDC and Advisory Committee on Immunization Practices (ACIP) were involved in making decisions they felt should be up to the FDA.

When the White House moved to start administering COVID-19 booster shots by the week of September 20, despite not having FDA approval, the duo began the process of exiting the administration, Endpoints' source said.


Read more: https://www.newsweek.com/disagreement-wh-over-booster-shots-prompt-senior-fda-directors-step-down-1624750

[littlemissmartypants]

1. Great, the CDC and the FDA decided they want to have a turf war in the middle of a pandemic. nt

[lapfog_1]

2. In my view, good.

We need the booster shots. 5 months... especially anyone over 65 or at risk.

The vaccine's have proven to drop in efficacy in a much shorter time period that we hoped.

And we need to start with the variant vaccines much sooner.

This is a race against time. We need to free the formulation of the vaccines, push hard to manufacture, distribute, and administer billions of doses within a month or two... not years... to get ahead of the mutations coming from this virus. And we need to reach the entire planet.

[SheltieLover]

6. Absolutely!

Right. Now.

I sure hope Joe cleans house at CDC (& perhaps FDA).

[ananda]

3. A turf war? Now?

Whoa stop.

Why wouldn't the FDA respect the findings of both the CDC
and ACIP?

I'm with Biden on this. Boosters are needed for sure.

[RockRaven]

4. Why shouldn't the CDC and ACIP be involved?

[lapucelle]

5. Is there anyone besides Endpoints News reporting this? N/T

[truthisfreedom]

7. The FDA might want to wait for some data

So they can eventually approve this method. We get boosters all of our lives. I’ll be getting the flu booster this fall. If I asked my doctor whether I’d be in danger for getting it a few months early, he’d probably just shrug.

[WHITT]

8. I Don't Get The Complaint

Sure, the WH made the announcement of the rollout for Sept 20th, but the FDA approved the licensing in the interim. So?

[MichMan]

9. The FDA approved the original protocol of two shots, not a third booster

Maybe it might be a good idea to listen to their recommendations as the regulatory body entrusted with those approvals

[WHITT]

11. Actually

Fauci admitted a couple days ago that these vaccines were ALWAYS assumed from the very beginning to be a three-dose vaccine, and that most standard vaccines are three-dose vaccines.

[NH Ethylene]

20. I am not pleased about that statement.

I've always admired Dr. Fauci but this comment seems disingenuous. If it was always assumed it should have been stated from the beginning and been part of the approval process and the presentation to the public. If it is a new plan, based on new evidence (which really seems more likely) it should be stated as such.

These agencies need to be straightforward with us.

[WHITT]

23. Well

it all goes back to their concern over 'vaccine hesitancy'. They were reluctant to mention additional shots to those that were hesitant about the first.

Normally, you would get your second dose like 4 months after the first, and the third four months after the second, which would take you over the span of a year, but they weren't getting quite the consistent immunity levels just from one dose, which prompted a second dose only weeks later.

[LisaL]

25. First dose wasn't producing a lot of antibodies, which is why

Moderna and Pfizer went with a two dose regiment.
As for waiting four months for the second dose, it doesn't seem like a good idea during a pandemic, since a lot of people could become infected during those four months.

[LisaL]

24. As I recall, from the start it was expected that covid vaccine might become a yearly thing.

Nobody believed immunity from the vaccine was going to last forever. Boosters were expected from the start.

[NH Ethylene]

27. Yes, I recall that too.

Boosters were expected to be needed because of variants and/or waning immunity. But this is being called a 'third dose' now, as in a part of a three-dose series, which was not discussed at the start.

I am not opposed to the booster at all, especially after seeing the recent results from Israel showing the leveling off of new cases after a booster shot. I just bristle at any hint of manipulation of the facts. I had believed Dr. Fauci was above that.

[LisaL]

29. Yes, three dose series was not discussed.

Both Pfizer and Moderna got good results with a 2 dose regimen. So at the time there was no apparent reason to go for a 3 dose regimen.
But whether you call it a third dose or a booster-it's a third shot.

[NH Ethylene]

31. That is true.

But to pretend it was planned that way all along, and that a three-shot regimen is typical, and so on, is disingenuous. I hate being manipulated, no matter who or why.

[Politicub]

30. There was nothing to admit. The vaccine cards have a blank to fill in for a booster shot.

If there is any surprise, it is how quickly booster shots may be needed.

All of the handwringing over it is just stupid. There is so much stupidity about everything that it's making my head hurt. I think I need an internet break today.

[Steelrolled]

32. Fauci seems to be a nice guy,

but anymore I don't take what he says seriously. I would rather hear it directly from the FDA or CDC.

[BlueIdaho]

10. The FDA and the CDC have not exactly covered themselves with glory

during this pandemic. They might want to find a little humility instead of throwing a tantrum.

[Lonestarblue]

12. The FDA needs some shaking up.

It recently approved a very expensive Alzheimer’s drug with virtually no proof that it works. All it will do is increase Medicare costs astronomically. Meanwhile, birth control pills have been proven safe for decades and should be available over the counter, but the FDA is following religious preferences. The same is true for the morning-after pull. In fact, birth control pills are safer than many other medications. In addition, the FDA needs to allow telemedicine consultations for the pills for medical abortions. They have proven safe, yet the FDA still requires women to see a doctor and get a prescription. Are they kowtowing to doctors who want to charge for office visits?

Edited to add: want the FDA to be effective and to do its due diligence on new drugs, but how many years does t take for birth control pills to be deemed safe!

[dalton99a]

14. +1.

[BumRushDaShow]

13. I listened to the all-day CDC ACIP meeting yesterday (from 10 am - 4:45 pm)

and it included not only the Committee members, but attendees (stakeholders) from multiple hospital/medical and industry organizations (including the vaccine makers), and reps from the various health-related OPDIVS in HHS.

And in general, there was one who expressed concern about use of the term "booster" for what is just a "3rd dose" and another who didn't think a "booster" should be a "priority" and would prefer to focus on the unvaccinated. There were others concerned about getting Janssen's data for a potential booster.

The link to the presentation slide decks is here - https://www.cdc.gov/vaccines/acip/meetings/slides-2021-08-30.html

Link to the slide deck setting out the "framework" for evaluation and consideration of additional doses - https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/09-COVID-Oliver-508.pdf

The "unvaccinated" who are still out there now know exactly what they are doing and outside of mandates, which are finally getting some of them done or strapping others of them to a chair to get a shot (which ain't happening), at this point, many of them are STILL going to refuse it - even on their deathbeds. So Dr. Sara Oliver, who did the presentation for the "framework" discussion, is, IMHO a bit naive when expressing a desire to put all the efforts on the "unvaccinated".

The two agencies generally operate in their own lanes and focus on slightly different things due to having different mandates and missions. One is more product focused (quality, efficacy, and safety, mainly only reviewing clinical data to confirm this) and the other looking at a broader picture - i.e., evaluating impactful diseases and developing strategies and policies to improve health outcomes.

[More_Cowbell]

16. Thanks for this nt

[cadoman]

19. thank you for reviewing that and sharing

It's not crazy that the agencies would have differences of opinion given how raw the info is and the differences in their missions.

All rational scientists agree the vaccine is safe and effective--the only science that isn't settled is how to best administer the limited supply of it.

[NBachers]

15. Got my booster Sunday

[orangecrush]

17. Good riddance

To likely Trump holdovers.

[MrModerate]

18. They put up with the previous administration's shenanigans and NOW they're resigning?

There has to be more to the story.

[NH Ethylene]

21. I would really like to know more about what their objection is.

Is it really as shallow as a turf war? Or do they have a substantial reason to want to consider the booster? Resigning seems pretty drastic.

[Steelrolled]

33. I've worked with people who were very sensitive to technical decisions

being made at the top. I looked at it pragmatically - it's their decision and they are responsible for the result (which they would be anyhow).

I don't know what the FDA's involvement should be in this case, but regardless I assume that ultimately the administration has the last say.

[LisaL]

22. Don't let the door hit you on the way out.

NT

[McKim]

26. Some at the FDA......

Rumor has it from my daughter the doctor that someone at the FDA believes in Herd Immunity for our children and was foot dragging on a vaccine. Hopefully this gets rid of the unscientific and cruel at the FDA.

[Steelrolled]

34. I expect there are more than a few at the FDA

who are very cautious about vaccinating children for COVID.

[Evolve Dammit]

28. Wouldn't it be nice to hear the actual truth of WHY they are leaving? Truth is all we ask.

So many millions believe truth is optional when convenient, or worse view it as a sign of weakness?? "Just the facts, M'am" needs a Big Comeback. "Make Lying Bad Again" works as well....