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Two Top FDA Vaccine Regulators Resign After Being Frustrated With White House Pushing COVID-19 Booster Shots


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There’s major crack in the relationship between the Biden administration and the FDA.

Two top FDA vaccine regulators have resigned after they became frustrated that the Biden administration is overstepping their boundaries when it comes to vaccine booster shots.

Both Director Marion Gruber and Deputy Director Phil Krause resigned because they believe that the White House is sidelining the FDA in order to promote Pfizer’s new booster shot.

Other officials within the FDA are also frustrated with the Biden admin refusing to allow the FDA to research more about the booster shot before the White House starts pushing the general public to get jabbed for a third time.

President Trump has also been very vocal against Pfizer’s booster shot and called the third jab a “money making operation”.

Axios had more on the story:

Signs are beginning to publicly emerge that the scientists responsible for bureaucratic decision-making about drug policy are frustrated with how the White House has handled coronavirus vaccine boosters.

The Biden administration has made clear that its priority, when it comes to boosters, is to stay ahead of the virus. But in doing so, it’s also getting ahead of the process by which such decisions are usually made.

Two top FDA vaccine officials are leaving their positions this fall, the agency announced yesterday.

The officials are leaving, at least in part, because they feel like the FDA is being sidelined, Endpoints reported, and “what finally did it for them was the White House getting ahead of FDA on booster shots.”

On Monday, an independent CDC advisory committee hinted that it will only initially recommend booster shots for older Americans and health care workers — a subtle departure from the administration’s plan to offer a booster shot to most Americans eight months after their first round.
And at least one member of the committee raised concerns about the White House getting ahead of the FDA and the CDC on booster policy, STAT’s Helen Branswell tweeted.
What they’re saying: “It’s really awkward because we have to plan as if we’re going to do this before we even have the data. And sure, the scientists are thinking that isn’t the right way to do it, but there is no other way to do it,” a senior administration official told Axios.

CNBC got the scoop too:

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.

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.

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.

The White House and the FDA seem to be having a power struggle and it will be interesting to see how this all plays out.

We were told to “trust the scientists” but now the White House wants people to forego the science and trust “politicians” instead.



 

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