2 FDA Officials Resign Over Biden’s COVID Booster Plan

2 FDA Officials Resign Over Biden's COVID Booster Plan 2 FDA Officials Resign Over Biden's COVID Booster Plan A patient receives his booster dose of the Pfizer-BioNTech coronavirus (COVID-19) vaccine during an Oakland County Health Department vaccination clinic at the Southfield Pavilion on August 24, 2021 in Southfield, Michigan. (Emily Elconin/Getty)

By Charlie McCarthy | Wednesday, 01 September 2021 10:14 AM

Two top Food and Drug Administration officials resigned Tuesday over the Biden administration's announced plans to roll out COVID-19 booster shots before the agency had approved the inoculations, Politico reports.

Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, plan to leave the FDA within the next three months, BioCentury first reported.

The FDA announced the resignations Tuesday.

One former senior FDA leader told Politico that Gruber and Krause were leaving because they felt that the Centers for Disease Control and Prevention had been making vaccine decisions that should have been left to the FDA.

They were also upset with top FDA vaccine official Peter Marks for not insisting that these decision be made by the agency, Politico said.

The Biden administration announced last month that most people will be offered a COVID-19 booster shot about eight months after vaccination – the final straw for Gruber and Krause, the Politico source said.

Former Trump administration officials are also angry over Biden's approach to boosters after being criticized for pressuring the agency on drug and vaccine decisions.

Politico, which spoke to 11 current and former health officials, said the FDA "is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary."

The news outlet, based on its sources, said there is little coordination between federal health agencies, even as two top FDA officials try to guide the booster rollout.

"We understand the importance of additional vaccine doses for control of this pandemic and will move as rapidly as possible to evaluate all submissions," an FDA spokesperson told Politico.

"Responding to this pandemic requires an all of government approach. FDA has and will continue to make regulatory decisions. And the [Centers for Disease Control and Prevention’s vaccine advisory committee] will continue to make clinical recommendations."

White House coronavirus czar Jeff Zients said Tuesday the decision to start booster shots "was made by and announced by the nation's leading public health officials" including the acting FDA commissioner, the CDC director, the surgeon general, the director of the National Institutes of Health, and others.

A senior health official with direct knowledge of the situation told Politico that political appointees within the White House largely steered Biden's booster announcement.

Pfizer completed its initial booster application on Aug. 27, but it was unclear when Moderna and Johnson & Johnson might do likewise.

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