Two Senior FDA Officials Stepping Down Over Reported Disagreements With White House Over Booster Shots

Two of the FDA’s senior vaccine officials are leaving their positions as the agency mulls new rules and regulations over booster shots and Covid-19 vaccinations for children, according to Bloomberg and Endpoints News.

Marion Gruber, head of the regulator’s Office of Vaccines Research and Review, plans to retire on Oct. 31 and Philip Krause, deputy director for the FDA’s Center for Biologics Evaluation and Research, will be leaving the following month, according to an email to staff that was viewed by Bloomberg.

U.S. health officials have been working to evaluate Covid vaccines and treatments at top speed, with shots from Moderna Inc., Johnson & Johnson and the partnership of Pfizer Inc. and BioNTech SE cleared in record time. Now the agency is charged with considering the administration’s booster program, which is set to roll out additional shots for most U.S. vaccinated adults Sept. 20. -Bloomberg

As Endpoints News notes, “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.”

More via Endpoints‘ Zachary Brennan:

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.”

In a letter from Marks to staff, he explained:

Janet Woodcock told Endpoints that she wishes Gruber and Krause well and thanks them for their significant service.