The agency announced this week that Dr. Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and her deputy, Dr. Philip Krause, would be stepping down this fall.
Employees familiar with their decision said they were upset the White House rolled out a plan to provide booster shots before the FDA had approved them. Others noted Gruber and Krause were upset that their boss, Dr. Peter Marks, was allowing the Biden administration to bypass the FDA’s oversight responsibilities.
Politico reported the two officials’ departure had triggered a “mutiny” in the FDA from employees who agreed Biden is jumping the gun. The rest of the agency is scrambling to analyze the available data supporting the use of boosters, the outlet said.
President Joe Biden announced last week that he wants fully vaccinated adults to get booster shots every five months starting Sept. 20.
However, scientists who have advised the FDA’s vaccine approval process said this push for booster shots is “premature” and “unnecessary,” since there is not enough evidence proving booster shots are effective.
It was “the administration’s booster plan; it wasn’t the FDA’s booster plan,” said Paul Offit, a University of Pennsylvania infectious disease expert who sits on FDA’s vaccine advisory committee. “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.
“The issues are complex and the days are long,” Woodcock said, “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.”