FDA's Marks takes over vaccines office as agency prepares to part ways with 2 key officials

Amid the heated debate over COVID-19 booster shots, two key FDA vaccine experts said they'd be leaving the agency last month. In an effort to smooth over the transition, Peter Marks, M.D., Ph.D., director of the agency's Center for Biologics Evaluation and Research, has taken over the FDA's vaccines office on an acting basis.

In an email to colleagues Monday, Marks said he was immediately making himself acting director of the FDA's Office of Vaccines Research and Review (OVRR) to help "assure a smooth transition." The email came after weeks of widely reported rumors that Marks was the acting director of the vaccines office.

Late last month, OVRR Director Marion Gruber, Ph.D. and Deputy Director Phillip Krause, M.D., said they would depart the agency this fall. The officials are set to leave the FDA in late October and November, respectively. 

An FDA spokesperson said Marks' move "will facilitate a smooth transition and ensure that the important vaccine work the team is undertaking to end of this devastating pandemic can continue to move forward seamlessly."

Gruber and Krause didn't publicly disclose a reason for their departures, but, shortly after the news broke, they did join others to push back on COVID-19 boosters. In an article in The Lancet, the authors wrote that the data on COVID-19 boosters were "preliminary and difficult to interpret."

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Since then, the booster push in the U.S. has only gained steam. An FDA advisory committee panel voted unanimously in favor of Pfizer COVID-19 boosters for people 65 and older, plus those with risk factors such as diabetes and obesity. In a separate vote, the committee endorsed Pfizer boosters for healthcare workers and others in high-risk occupations. 

For their part, Centers for Disease Control and Prevention (CDC) vaccine advisers voted in favor of boosters for the elderly and high-risk individuals, but not for people who could be exposed to COVID-19 on the job. CDC Director Rochelle Walensky, M.D., later overruled them and endorsed Pfizer COVID-19 boosters based on occupation. 

Afterward, President Joe Biden said that some 60 million people who received the Pfizer shot will be eligible for boosters. The president himself received a booster dose this week.

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The FDA may be losing two important vaccine voices, but Marks has been an instrumental part of the U.S.' pandemic response and is considered to be more than qualified for the position of OVRR acting director. Early in the COVID-19 crisis, he was "very much involved in the initial push to help jump-start some of the vaccine research that needed to happen," Marks said in an interview with Fierce Pharma last October. His ideas eventually became the multibillion-dollar federal program Operation Warp Speed that yielded successful vaccines.