Marion Gruber, director of the FDA’s Office of Vaccines Research and Review; and her deputy director, Phil Krause, said they plan to leave the agency in October and November respectively after failing to reach an agreement with the White House on its booster strategy.
“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” Gruber and Krause, joined by several other health experts, wrote in The Lancet on Monday.
The experts suggested there is no evidence to support booster shots and warned that Biden administration officials were primarily relying on “confounding and selective reporting” to justify booster shots.
“Widespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the authors wrote, arguing that vaccines should be allocated to unvaccinated populations instead.
Jeff Zients, a member of Biden’s coronavirus team, defended the booster timeline, claiming it is widely supported “by the nation’s leading public health officials.”
“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.
FDA employees familiar with Gruber’s and Krause’s decisions to step down said Biden’s booster strategy has triggered a “mutiny” in the agency from employees who agree that Biden is jumping the gun.
“[This is] 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.”