Two FDA Senior Members Resign Over Booster Shots

The US Food and Drug Administration announced the resignations of two top vaccine officials on Tuesday, and reports said the two were leaving in anger over the Biden administration’s plan to roll out COVID-19 booster shots before officials had a chance to approve it.

Dr. Marion Gruber, the director of the FDA’s Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, plan to leave the FDA in October and November. BioCentury first reported the news on Tuesday. Both are senior regulators and are responsible for oversight of vaccines.

Both FDA officials, Marion Gruber and Phil Krause, wrote an article in a medical journal stating that there is no evidence the general population should get boosters. The FDA unanimously determined boosters are not necessary for those under 65.

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 worked at the FDA for more than a decade, will leave in November. The news, first reported by BioCentury, has already begun to impact vaccine trust in the general population, as well as those who regulate vaccinations.

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 FDA leader also stated 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, adding “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.”