Two top officials from the US Food and Drug Administration resigned Tuesday. Reports said they were angry at the Biden administration’s plans to distribute COVID-19 booster shot before official approval.
Dr. Marion Gruber and Dr. Philip Krause are leaving the FDA’s Office of Vaccines Research and Review in October and November. BioCentury reported the news first on Tuesday.
Dr. Peter Marks (director of the FDA’s Center for Biologics Evaluation and Research) praised the two for their efforts during the COVID-19 pandemic. He did not give any reason for their departures.
Endpoints and Politico were told by sources that Gruber was upset about the Biden administration’s booster shot plan. Last month, the administration announced that most people would receive a COVID-19 booster vaccine approximately eight months after their last vaccination.
Endpoints was told by a former top FDA leader that Gruber and Krause had left because the Centers for Disease Control and Prevention made vaccine decisions that should be left to the FDA. They were angry at Marks, their leader, for failing to insist on oversight.
According to a source, the FDA had not officially approved the booster-shot plan until the Biden administration announced it.
Politico was told by a former FDA official that resignations were due to anger at the FDA’s inability to plan boosters autonomously. A current official said that the two were leaving because of differences with Marks.
When asked about the reports, Jeff Zients the White House’s coronavirus czar said that the decision to begin booster shots was made and announced by “the nation’s leading public health officials”, including the acting FDA Commissioner, the CDC director and the surgeon general.
Zients stated, “Having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”
He said the administration had “also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”
Insider reached out to Gruber, Krause, and FDA for further information.