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Two FDA Vaccine Officials to Leave After Covid Clearances

Bloomberg logoBloomberg 8/31/2021 Fiona Rutherford
a sign in front of a building: Food And Drug Administration Headquarters In Maryland-GETTY Sub © Photographer: Sarah Silbiger/Getty Images Food And Drug Administration Headquarters In Maryland-GETTY Sub

(Bloomberg) -- Two key vaccine officials are preparing to step down from the U.S. Food and Drug Administration, which raced to clear Covid shots to fight the pandemic and is now considering President Joe Biden’s booster plan.

Marion Gruber, head of the regulator’s Office of Vaccines Research and Review, plans to retire on Oct. 31 and Philip Krause, deputy director for the FDA’s Center for Biologics Evaluation and Research, will be leaving the following month, according to an email to staff that was viewed by Bloomberg. 

U.S. health officials have been working to evaluate Covid vaccines and treatments at top speed, with shots from Moderna Inc., Johnson & Johnson and the partnership of Pfizer Inc. and BioNTech SE cleared in record time. Now the agency is charged with considering the administration’s booster program, which is set to roll out additional shots for most U.S. vaccinated adults Sept. 20.

“We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” FDA spokesperson Stephanie Caccomo said in a statement. 

Gruber and Krause were two of a group of FDA staff who last year pushed back against pressure by the Trump administration to speed up the authorization of the Covid vaccines, according to a person familiar with the matter.

Video: New poll shows majority support for businesses mandating vaccines: Pro (CNBC)


Trump publicly called for the FDA to clear use of the vaccines before Election Day in the U.S., and called the FDA part of the “deep state” — an unsubstantiated allegation that members of the agency were trying to politically undermine him.

The search for the next office director will begin imminently, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the email to staff. He will serve as acting office director of the Office of Vaccine Research and Review.

The departures were reported earlier by Biocentury

(Updates with Trump pushback in fifth paragraph)

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