Peter Marks, director of the Center for Biologics Evaluation and Research, told staff that he would serve as the acting head of the vaccine office as the agency searches for a permanent replacement, according to an internal memo shared with The Washington Post.
The FDA — and its vaccine office — has been at the center of the government’s effort to speed coronavirus vaccines and other therapies. The agency remains under considerable pressure to approve vaccines for children under age 12, a decision that probably remains months away.
The Biden administration this month also announced a plan to roll out coronavirus booster shots in September, a public pledge that frustrated some government officials and outside scientists who warned that the White House was getting ahead of the FDA and other regulators.
White House officials sidestepped questions about whether Gruber and Krause’s departures were linked to pressure on the agency.
“As the president said last week, FDA is the gold standard, and we are all grateful for the tireless work of the senior team and the whole staff at FDA, especially during the pandemic,” White House coronavirus coordinator Jeff Zients said at a news briefing Tuesday.
Gruber has been at the FDA for more than 30 years, and Krause for more than a decade. Their planned departures were first reported by BioCentury.
FDA officials said Tuesday that the officials’ departures would not hamper the agency’s work.
“We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” FDA spokeswoman Stephanie Caccomo said in a statement.
“We have put together a plan that will allow us to continue prioritizing science, while meeting timelines that are important to ensuring the end of this devastating pandemic,” acting FDA commissioner Janet Woodcock wrote in a memo to staff shared with The Post.