Dr. Marion Gruber, director of the U.S. Food and Drug Administration’s vaccines office, and her deputy, Dr. Philip Krause, reportedly said they don’t believe there is data to support the Biden administration’s push to offer COVID booster shots later this month.
According to an email sent by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), to staff members Tuesday, Dr. Marion Gruber, director of the FDA’s vaccines office, will quit at the end of October, and her deputy, Dr. Philip Krause, will leave in November.
Gruber and Krause were upset about the Biden administration’s recent announcement that adults should get a COVID booster eight months after they received a second shot, people familiar with the decision told The New York Times.
Neither believed there was enough data to justify offering booster shots yet, the sources said, and both viewed the announcement, amplified by President Biden, as pressure on the FDA to quickly authorize them.
Officials within the FDA were stunned by the news, CNN reported. One source described it as a “big loss” for the FDA and noted it caught leadership off guard.
Marks said he would serve as the acting director of the vaccines office while the agency searched for its next leader.
FDA Spokeswoman Stephanie Caccomo said the agency was “confident in the expertise and ability of our staff to continue our critical public health work.”
However, a former senior FDA leader told Endpoints News, Gruber and Krause are departing because they’re frustrated the Centers for Disease Control and Prevention (CDC) and its advisory panel — the Advisory Committee on Immunizations and Practices (ACIP) — are involved in decisions they think should be up to the FDA.
The source said he heard Gruber and Krause were upset with Marks for not insisting those decisions be kept inside the FDA, and with the White House for getting ahead of FDA on booster shots.
“These two are the leaders for biologic [vaccine] review in the U.S.,” wrote Rick Bright, former director of the Biomedical Advanced Research and Development Authority, weighing in on the news. “They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Bright said.
“Dr. Gruber is much more than the director,” Bright added. “She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-CoV-2, many others.”
When asked about the departures during a briefing on Tuesday, White House COVID Response Team Coordinator Jeff Zients did not directly answer whether he was concerned the departures could affect the level of trust in the FDA’s process, CNN reported.
Zients said the White House was “grateful for the tireless work of the senior team and the whole staff at FDA.”
As The Defender reported earlier this month, the Biden administration announced a plan to begin offering a third booster dose to people who already received two doses of an mRNA vaccine beginning the week of Sept. 20.
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