Dr. Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, will serve as the vaccine office's acting director.

Dr. Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, will serve as the vaccine office's acting director. Jim Lo Scalzo/Pool via AP

FDA's Two Top Career Vaccine Officials to Step Down

The employees reportedly had disagreements over the Biden administration's approach to COVID-19 booster shots.

The two top officials in the Food and Drug Administration’s vaccine office will step down in the coming months, leaving gaps as the Biden administration looks to finalize key decisions in its battle against COVID-19. 

Marion Gruber will retire at the end of October from her role as director of Office of Vaccines Research and Review with FDA’s Center for Biologics Evaluation and Research, while Philip Krause, Gruber's deputy, will retire in November. Gruber and Krause, both long-time career FDA employees, stepped down at least in part due to disagreements over the Biden administration’s rush to approve COVID-19 vaccine booster shots, according to several media reports. The resignations were first reported by BioCentury and confirmed in emails sent to staff and provided to Government Executive by FDA. 

President Biden has pushed for the boosters, suggesting anyone who is at least eight months out from his or her original vaccination would be able to get another shot starting Sept. 20. Some reports have said the administration is pushing that timeline up to as little as six months. Gruber and Krause disagreed with the aggressive approach, as reported by The New York Times and others, instead arguing there is not yet enough evidence to support the widespread distribution of the boosters. 

Peter Marks, head of the larger Center for Biologics Evaluation and Research, will serve as the vaccine office's acting director. Marks made no mention of any disagreements in a message to employees announcing the retirement, instead thanking Gruber and Krause for their service and calling their departures a "huge loss" for the agency. 

Gruber's “contributions throughout her career have been immeasurable, but never more so than during the COVID-19 pandemic," Marks said. He added that Krause's “keen insight and experience in addressing a wide variety of challenges will truly be missed."

Janet Woodcock, FDA’s acting director, sent an email to staff Tuesday evening thanking Gruber and Krause and expressing her “full support and complete confidence" in the FDA's staff on its vaccine work. She noted her belief in the team still at the vaccine office and promised to prioritize science while "meeting timelines" that will ensure the end of the pandemic. 

“These are difficult times, requiring extraordinary effort, and I want to take the opportunity to once again thank you for your perseverance and dedication,” Woodcock said. “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.”

Biden has yet to nominate a permanent FDA director. 

The president has repeatedly vowed to listen to career scientists and never interfere in their work, saying he would turn the page on an era in which the Trump administration faced many high-profile allegations of political manipulation of scientific work. President Trump was specifically seen as pressuring FDA to approve a COVID-19 vaccine more quickly, causing FDA officials—such as Center for Biologics Evaluation and Research’s Marks—to threaten resignations. While Biden has vowed to install more rigorous scientific integrity policies at agencies throughout government, he has faced some criticism for pushing the booster shots ahead of FDA authorization. The agency is also facing pressure to authorize COVID-19 vaccines for children under the age of 12.