Highlights

FDA Rebels Against Biden Regime
 
Two senior FDA officials are in disagreement with the Biden administration over COVID booster shots. They plan on leaving the FDA later this Fall and announced their departure last month after reported frustration with the Biden administration.
 
Endpoints News, a biotech industry outlet, reported that Gruber and Krause were frustrated that the CDC was making decisions that should be made by the FDA. The final straw was reportedly the Biden administration’s announcement that COVID booster shots would be made available—before the FDA had finished evaluating data on the need for a third jab.
 
The resignation of the two senior officials at the FDA is a huge loss according to the FDA’s former acting chief scientist Luciana Borio:  “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service. These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave.” 
 
Now an international group of scientists, including the two senior FDA officials, are saying the COVID booster isn’t necessary.
 
The two FDA officials, Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, published an opinion piece in The Lancet with other experts.
 
Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA.
 
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.
 
The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.
 
A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.
 
FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”
 
“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”
 
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2021-08-17_12-55-18

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