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Top FDA Vaccine Leaders Step Down Ahead of Decision on COVID-19 Boosters

Two of the FDA’s most senior vaccine leaders are reportedly resigning from their positions due to the Biden administration’s overreach into decisions they believe should be up to 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,” Endpoints News reported. “The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.”

The outlet added, “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.”

Gruber and Krause both played a large role in the review and authorization of three COVID-19 vaccines and the full approval of the Pfizer vaccine.

FDA’s former acting chief scientist Luciana Borio wrote 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 (Center for Biologics Evaluation and Research). A huge global loss if they both leave,” Former Biomedical Advanced Research and Development Authority director Rick Bright wrote. “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.”

Their decision comes as the FDA is weighing whether to authorize a third Pfizer shot as growing evidence shows the efficacy of COVID-19 vaccines tends to wane over time.

BioPharma Dive reported, “The White House announced plans to begin administering boosters the week of Sept. 20, a debated decision that got ahead of the completion of the FDA’s own review. The Biden administration drew criticism for the public announcement, which puts considerable pressure on the regulator to clear boosters in time for the planned rollout despite lack of definitive proof they are needed broadly for healthy adults.”

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