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FDA Is Losing 2 of Its Vaccine Leaders

Head of the Office of Vaccines Research and Review and her deputy say they're out
By Kate Seamons,  Newser Staff
Posted Sep 1, 2021 8:46 AM CDT
2 of the FDA's Vaccine Leaders Are Exiting
In this March 2021 photo provided by Pfizer, vials of the Pfizer-BioNTech COVID-19 vaccine are prepared for packaging at the company's facility in Puurs, Belgium.   (Pfizer via AP)

Job openings have been at record levels this summer. Add two more openings to the tally. Two high-profile FDA vaccine regulators will depart the agency this fall, and the New York Times gives two points of context: One, that their exit could throw a wrench into the process of deciding whether to recommend COVID vaccines for kids under 12. Two, its sources say the move was in part due to frustration over the Biden administration's announcement about vaccine boosters, which they reportedly saw as premature. Who "they" are: Dr. Marion Gruber, director of the Office of Vaccines Research and Review, and Dr. Philip Krause, deputy director of the office.

Gruber will retire Oct. 31, and Krause will exit in November, per an internal email sent Tuesday. In announcing in mid-August that Americans should receive a booster shot eight months after being fully vaccinated, the administration did state that the plan would first need to be OKed by the FDA, which is still reviewing booster shots' safety and effectiveness. The Times reports some saw that as "undermin[ing] the agency’s responsibility to make that assessment on its own schedule, led by career scientists."

CNBC cites reporting in biotech industry publication Endpoints News that Gruber and Krause were also irritated that the CDC and its advisory committee were being looped into decisions they felt were under the FDA's purview. CNN reports the news came as a shock to many within the FDA, and it cites its own prior reporting that morale isn't the strongest right now due in part to the stress and demands of the job during the pandemic. (More FDA stories.)

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