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Two senior FDA vaccine regulators are stepping down

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency.

Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine boosters shots to the general public.

The officials were reportedly frustrated with the White House getting ahead of the agency on booster shots.

Two senior Food and Drug Administration officials responsible for reviewing Covid-19 vaccine applications are leaving the federal agency this fall, an agency spokesperson confirmed Tuesday.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively, according to a letter shared with CNBC by FDA spokeswoman Stephanie Caccomo.

“Thank you so much to Marion and Phil for all that they have contributed and continue to contribute to the agency, and thanks so much to each of you for all that you do every day,” FDA top vaccine regulator Dr. Peter Marks said in the letter.

The news was reported earlier by the biotech website BioCentury.

Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine booster shots to the general public the week of Sept. 20. Some health experts saw the move as premature and political, especially because the FDA hasn’t finished reviewing data on boosters yet.

Endpoints News, a biotech industry publication, reported that the officials are leaving because they’re frustrated that the Centers for Disease Control and Prevention and its advisory committee are involved in decisions they think should be up to the FDA.

The final straw was when the White House got ahead of the agency on booster shots, according to Endpoints News, citing a former senior FDA leader.

When asked at a briefing later Tuesday whether the departures will affect trust in the FDA, White House Covid czar Jeff Zients said the decision to distribute boosters was made by a number of senior health officials, including acting FDA Commissioner Dr. Janet Woodcock.

“As our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” he said.

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by Anonymousreply 18September 4, 2021 1:29 PM

This doesn't seem like a good sign, does it? It sounds like the administration is Ignoring The Science.

by Anonymousreply 1September 1, 2021 12:35 PM

[quote]It sounds like the administration is Ignoring The Science.

No, it sounds like the administration is being more nimble in response to it.

If the U.S. had waited for full FDA approval on vaccines, we would have just started administering the Pfizer shot and we still wouldn't be using Moderna or J&J.

by Anonymousreply 2September 1, 2021 12:42 PM

It sounds like these two don't want to be blamed when so many people start dying from ADE that it can't be covered up.

by Anonymousreply 3September 1, 2021 12:49 PM

Oh, my! They were so infuriated and offended they’re taking 2 months to flounce.

That’s anger right there, folks.

🙄

by Anonymousreply 4September 1, 2021 12:56 PM

All these stupid vaccine threads just scream “I’m scared!”

Pathetic, obsessed Mary. Don’t get the vaccine then, loser.

by Anonymousreply 5September 1, 2021 1:02 PM

Someone in the White House should be stepping down instead. He can't do anything right.

by Anonymousreply 6September 1, 2021 1:04 PM

r6, seriously. Is he really this incompetent or is he being set up somehow? It's just mindblowing.

by Anonymousreply 7September 1, 2021 1:11 PM

I'm no fan of the FDA, but I trust them to make health decisions for the country more than Joe Biden.

by Anonymousreply 8September 1, 2021 3:44 PM

2 top FDA officials resigned over the Biden administration's booster-shot plan, saying it insisted on the policy before the agency approved it, reports say

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by Anonymousreply 9September 3, 2021 12:24 AM

Israel, who had at least 70% vaccinated is being swamped with Covid. They recommended Americans get the booster shots sooner

by Anonymousreply 10September 3, 2021 12:43 AM

No, they're quitting because the research doesn't support recommending boosters and because they don't think under 18s should be injected.

by Anonymousreply 11September 3, 2021 12:56 AM

This is concerning.

by Anonymousreply 12September 3, 2021 1:50 PM

[quote] Israel, who had at least 70% vaccinated is being swamped with Covid.

These threads are all being started by one vaxx troll and they’re just like the Markle troll threads — a handful of mentally ill posters ranting irrationally.

by Anonymousreply 13September 3, 2021 1:59 PM

They should state publicly why they left. It shouldn't be based on rumors for something this serious.

by Anonymousreply 14September 3, 2021 2:47 PM

I’d be interested to know their political leanings.,

by Anonymousreply 15September 3, 2021 3:24 PM

Maybe in those positions they weren’t making enough money to satiate their greed?

by Anonymousreply 16September 3, 2021 7:14 PM

[quote]Israel, who had at least 70% vaccinated is being swamped with Covid.

Odd shaped curve for a country that's being "swamped."

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by Anonymousreply 17September 3, 2021 7:17 PM

Is that graph accurate for the U.S., R17? I didn't realize it has gotten that bad under Biden.

by Anonymousreply 18September 4, 2021 1:29 PM
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