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.
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.”
Jeff Zients, the Biden administration’s coronavirus czar, defended the booster timeline. “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 [New York Post].