Two senior FDA officials resign over Biden administration booster shot plan

Two senior FDA officials resign over Biden administration booster shot plan

Two senior officials have resigned from their positions within the US Food and Drug Administration over frustrations with the Biden administration’s plans to move forward with recommending COVID-19 booster shots without their prior approval, according to a report.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause are set to leave the agency this fall, with sources telling Politico that the two officials were at odds with the FDA’s top vaccine official, Peter Marks, and were discontented over the roles of the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices in decisions that they believed should be handled by the FDA.

According to trade publication Endpoints, the officials felt they were sidelined on major decisions, that the administration’s plan for boosters was jumping the gun, and that Marks should have pushed for the FDA to have more autonomy on the matter. 

The director of the FDA’s Office of Vaccines Research & Review and its deputy director are set to leave the agency.
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Marks played a leading role in helping the administration craft its August announcement of calls for an additional vaccine for most adults after eight months. 

Marks announced the resignations in a letter to colleagues obtained by Endpoints.

“The administration’s booster plan; it wasn’t the FDA’s booster plan,” University of Pennsylvania infectious disease expert Paul Offit, who serves on the FDA’s vaccine advisory committee, told Politico. “The administration has kind of backed themselves up against the wall a little bit here.”

Acting FDA Commissioner Janet Woodcock sent a memo to regulators Tuesday standing by the booster timeline, stating, “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.”

Jeff Zients, the Biden administration’s coronavirus czar, also defended the booster timeline.  

President Joe Biden
President Biden’s administration’s plan calls for a third dose of the Pfizer or Moderna vaccine eight months after recipients’ second jab.
Chip Somodevilla/Getty Images

“The booster decision was made by and announced by the nation’s leading public health officials … and as our medical experts laid out having reviewed all the available data, it is in their clinical judgment that it’s time to prepare Americans for a booster shot. We announced our approach to stay ahead of the virus and to be transparent on latest data,” he said in a statement to Politico. 

The FDA’s former acting chief scientist Luciana Borio took to social media to praise Krause and Gruber’s work. 

@US_FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service,” she tweeted. 

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