According to a report, two senior officials have resigned from the U.S. Food and Drug Administration due to frustrations with the Biden administration’s plans to move forward on the recommendation of COVID-19 booster shots without the its prior approval.
Marion Gruber, director of the FDA’s Office of Vaccine Research and Review, and deputy director Phil Krause are due to leave the agency this fall, with sources telling Politico that the two officials disagreed with the top official. of FDA vaccines, Peter Marks, and were unhappy with the role of the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices in the decisions they believed should be managed by the FDA.
According to the trade publication Endpoints, officials felt they were on the sidelines of important decisions, that the administration’s plan for the boosters was jumping the gun, and that Marks should have pushed for the FDA to have more autonomy in this regard.
Marks played a major role in helping the administration work out 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 plan to strengthen the administration; it was not the FDA’s reinforcement plan, “University of Pennsylvania infectious disease expert Paul Offit, who is part of the FDA’s vaccine advisory committee, told Politico.” The administration has supported a little against the wall here. “
FDA Acting Commissioner Janet Woodcock on Tuesday sent a note to regulators alongside the timeline of the reinforcement, stating: “The problems are complex and the days are long, but please know the work you all have. done so far and will continue to do so in the coming days.weeks and months in advance, we hope that one day it will allow us to leave Covid-19 behind and better prepare for future challenges. “
Jeff Zients, the tsar’s coronavirus tsar of the Biden administration, also defended the chronology of the reinforcement.
“The decision to reinforce was made and announced by the country’s leading public health officials … and, according to our medical experts, after reviewing all available data, it is according to their clinical judgment that it is time to “preparing the Americans for a booster shot. We announced our approach to stay ahead of the virus and be transparent in the latest data,” he said in a statement to Politico.
Former FDA acting scientist Luciana Borio went to social media to praise the work of Krause and Gruber.
“@US_FDA it is losing two giants that helped us get many safe and effective vaccines during decades of public service, ”he tweeted.