Report: 2 FDA Regulators Resign Over Biden Vaccine Policy

Report: 2 FDA Regulators Resign Over Biden Vaccine Policy

FILE - In this Feb. 17, 2021, file photo, a health care worker receives a Johnson & Johnson vaccine at a hospital in Khayelitsha, Cape Town, South Africa. South Africa suspended the Johnson & Johnson vaccine after the FDA paused its use over rare blood clot cases. (AP Photo/Nardus Engelbrecht)

Two of the most senior vaccine officials are quitting the Food and Drug Administration, the U.S. agency tasked with releasing covid-19 shots at warp speed to fight the pandemic, raising questions about a power struggle between the FDA and the Biden administration over vaccine policy.

Marion Gruber, a 32-year FDA veteran and director of its Office of Vaccines Research & Review (OVRR) plans to leave at the end of October. OVRR deputy director Phil Krause, who’s been at FDA more than 10 years, plans to leave in November, according to Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. BioCentury first reported the news.

This is a bombshell announcement and massive blow to confidence in the agency’s ability to regulate vaccines, Zachary Brennan wrote for Endpoints News, an independent news organization that reports and analyzes top global biotech and pharmaceutical research and development news.

The departures come at a particularly crucial moment, Brennan wrote. The regulator is weighing boosters and children’s shots and 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.”

An unnamed former senior FDA leader told Endpoints that Gruber and Krause are leaving because they’re frustrated that the U.S. Centers for Disease Control and its Advisory Committee on Immunization Practices (ACIP) “are involved in decisions that they think should be up to the FDA.”

The former FDA staffer also said “he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA,” Endpoints reported. “What finally did it for them was the White House getting ahead of FDA on booster shots.”

The FDA “is losing two giants who helped bring us many safe and effective vaccines over decades of public service,” tweeted Luciana Borio, a former FDA acting chief scientist.

The FDA cleared vaccines in record time from Moderna Inc., Johnson & Johnson and Pfizer Inc. in partnership with BioNTech. Now it’s working on reviewing the administration’s booster program, which is set to roll out additional shots for most U.S. vaccinated adults Sept. 20.

“The White House announced plans to begin administering boosters … a debated decision that got ahead of the completion of the FDA’s own review,” BioPharmaDive reported.

Marks will serve as acting office director of the Office of Vaccine Research and Review. In a staff email, he said the search for the next office director will begin imminently, Bloomberg reported.

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“We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” FDA spokesperson Stephanie Caccomo said in a statement. 

Rick Bright, the former Director of the Biomedical Advanced Research and Development Authority (BARDA) described Dr. Gruber as “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,” Endpoints reported.

Together, Gruber and Karuse “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,” Bright continued.