COVID-19 vaccine
COVID-19 vaccine iStock

Two top vaccine regulators at the US Food and Drug Administration announced their resignations from the agency, an FDA spokesperson said Tuesday night.

According to a letter shared by the FDA with CNBC, Marion Gruber, the director of the FDA’s Office of Vaccines Research & Review, has resigned from the agency, effective next month.

Deputy director Phil Krause has also quit the agency, effective in November.

According to a report by the biotechnology publication Endpoints News, Gruber and Krause resigned in protest of pressure they faced from the White House and the Centers for Disease Control in connection to approval for use of COVID vaccines.

In particular, the two were frustrated over pressure to clear the use of COVID booster shots, Endpoints News reported, citing a former senior FDA official.

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

“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.”

The departures come after the Biden administration announced that booster shots could be available as early as the week of September 20th, despite the FDA not having yet completed its review of the use of COVID boosters.