Two top U.S. Food and Drug Administration regulators in charge of evaluating COVID-19 vaccine applications are quitting their posts from the federal agency this fall.
Marion Gruber, chief of the FDA's Office of Vaccines Research and Review, and deputy chief Phil Krause will leave the FDA in October and November, respectively, according to CNBC. Biotech website BioCentury first reported the news.
The announcement comes as the agency is examining the evidence for COVID-19 vaccine booster shots.
The news also comes in the wake of intense contention and criticism over whether the Biden administration is pushing ahead of the medical analysis process in disclosing booster shots for the masses that could be available by Sept. 20.
"Thank you so much to Phil and Marion for all they've contributed and continue to contribute to the agency," CNBC quoted FDA top vaccine regulator Dr. Peter Marks as saying in a letter.
On Twitter, former top FDA scientist Luciana Borio commented the FDA is "losing two giants" who helped bring many effective and safe vaccines over many years in their public service.
Some health experts view the departure as premature and political, especially because the agency has not completed evaluating data on boosters yet.
Endpoints News disclosed a former top FDA regulator said Krause and Gruber were dismayed the Centers for Disease Control (CDC) had too much involvement in making the decision on booster shots, something they believed should be left up to the agency.
When asked during a briefing whether the Gruber and Krause's exit will impact trust in the agency, White House COVID-19 czar Jeff Zients said the decision to roll out booster shots was carried out by multiple top health officials, including acting FDA Commissioner Dr. Janet Woodcock.
In an emailed statement, FDA spokesperson Stephanie Caccomo said the agency is "confident in the expertise and ability" of its personnel to continue their critical public health efforts, including reviewing COVID-19 vaccines.
Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, said he will serve as acting chief of the vaccines division while the agency searches for a new director.
