Two senior officials from the Food and Drug Administration (FDA) are leaving the agency. Dr. Marion Gruber, head of the FDA’s Office of Vaccines Research and Review (OVRR), will leave on Oct. 31; deputy director Phil Krause will exit in November. The OVRR is the department responsible for regulating all vaccines in the United States, including COVID-19 shots.
“Thank you so much to Marion and Phil for all that they have contributed and continue to contribute to the agency, and thanks so much to each of you for all that you do every day,” FDA top vaccine official Dr. Peter Marks said in a letter. Marks will serve as the acting director until another qualified person is found to lead the division. The letter did not mention why Gruber and Krause were leaving.
“@US_FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service,” Luciana Borio, a former acting chief scientist at the FDA, tweeted.
According to a report by Politico, Gruber and Krause were apparently angry at the agency’s lack of autonomy in planning the nation’s booster shot campaign. They were discontent that the CDC and the Advisory Committee on Immunization Practices were making decisions that should have been taken by the FDA.
An anonymous health official told Politico that Krause and Gruber left the agency due to differences in opinion with Marks. A key factor that triggered the resignations is believed to be Joe Biden’s declaration that booster shots will be rolled out starting the week of Sept. 20. His announcement took many health experts by surprise. Biden said that the plan was to get every adult vaccinated with a booster shot eight months after they received their second dose.
The FDA is facing “a potential mutiny among its staff and outside vaccine advisers,” since many believe that COVID-19 booster shots to all adults are unnecessary, states Politico. The exit of two top officials from the FDA’s vaccine department has reportedly shaken several current and former officials.
The agency’s morale is already low due to the workload created by the pandemic. Many are concerned that the Biden administration is prejudging FDA determination even before the agency has reviewed all data related to the safety and efficacy of a third COVID-19 vaccine shot.
The White House Covid-19 Response Team Coordinator Jeff Zients defended the administration’s decision. He stated that the booster decision was made only after reviewing “all available data.”
“We’ve 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… So, bottom line, this virus has proven to be unpredictable, and we want to stay ahead of it, and plan for every scenario, and that’s been our approach from day one and will continue to be our approach,” Zients said.
Some feel that jumping the gun on booster shots has been an irresponsible move from Washington. Helen Talbot, a member of the CDC’s Advisory Committee on Immunization Practices, explained during a recent panel meeting that many healthcare providers in southern states that are seeing a surge in COVID-19 infections are injecting their workers and patients with a third dose. This is happening even though the FDA had not approved the third shot. She blamed it on the confusion created by Biden’s remarks on booster vaccines.
“This highlights, critically, the need for any vaccine recommendations to go through the normal avenues and not come out from outside… It is very frightening to me that healthcare providers, trying to do the best job that they can, are taking guidance from HHS and White House, and now have put themselves at risk,” Talbot said at the meeting. In an interview with The Atlantic, John Wherry, immunologist at the University of Pennsylvania, warned about the dangers of vaccinating people too often. After many doses, the cells might potentially stop learning from the vaccine materials it is exposed to. That essentially causes the cells to “burn out” from information overload.