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Two top FDA vaccine regulators to depart in the fall

Aug. 31 (UPI) -- Two top vaccine regulators at the Food and Drug Administration announced plans to depart this fall as the Biden administration attempts to roll out booster shots for vulnerable Americans next month.

Dr. Marion Gruber, director of the FDA's vaccine office, will retire at the end of October, while her deputy, Dr. Philip Krause, will depart in November, according to an email sent to staff by Dr. Peter Marks that was obtained by The New York Times and Politico.

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The outlets reported that the pair's departure was brought on by their opposition to the Biden administration's announcement earlier this month that it will make booster shots available to people more than eight months removed from receiving their second dose of the Pfizer or Moderna vaccine beginning Sept. 20.

Neither Gruber nor Krause reportedly believed there was significant data to justify offering booster shots and viewed the announcement as pressure for the FDA to quickly authorize the additional shots.

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Dr. Jeffrey Zients, the White House's COVID-19 response coordinator, hailed the FDA as the regulatory "gold standard" in a Tuesday press briefing.

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"As our medical experts laid out, having reviewed all the available data, it is in their clinical judgement that it is time to prepare Americans for a booster shot," Zients said. "We announced our approach in order to stay ahead of the virus, give states and pharmacies time to plan and to be transparent with the American people."

The White House has also stressed that the plan for booster shots was endorsed by the most senior federal health officials, including acting FDA commissioner Dr. Janet Woodcock.

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Woodcock on Tuesday reiterated her support in a memo to vaccine regulators on Tuesday, Politico reported.

"The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put COVID-19 behind us and better prepare us for future challenges," she wrote.

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