Two senior officials officially resigned from their positions within the U.S Food & Drug Administration, citing frustrations with the Biden Administration’s plan to move forward with COVID-19 booster shots without their prior approval.
The director of the FDA’s Office of Vaccines Research & Review, Marion Gruber, as well as deputy director Phil Krause both announced that they would be leaving the agency this fall. Gruber has served at the FDA for 32 years and will leave at the end of October. Krause has served at the FDA for over ten years and will step down in November. They said they had been “at odds” with FDA top vaccine official Peter Marks, as well as the roles of the Centers for Disease Control and Prevention and the Advisory Committee on Immunization Practices.
Gruber and Krause claimed that they were making decisions that they believed should’ve been handled by the FDA. They felt that the administration was “jumping the gun” on the booster shots, especially Marks. Marks played a leading role in announcing additional vaccines for adults after eight months.
U.S Surgeon General Vivek Murthy defended the Biden Administration’s booster timeline, adding that booster shots could lead to slowing the spread. They said that the pattern of decline in vaccines could lead to “reduced protection against severe disease, hospitalization, and death.”
Third doses are currently authorized for immunocompromised people including organ-transplant patients. Others have not been given the green light by the FDA to go ahead and include themselves into that category.
Acting FDA Commissioner Janet Woodcock also shared a memo standing by the booster timeline. “The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges,” she wrote.
But Infectious disease expert Paul Offit, who serves on the FDA’s vaccine advisory committee, shares that it was the administration’s booster plan, not the FDA’s booster plan. He said that the administration “kind of backed themselves up against the wall a bit here.”
Some believed Gruber and Krause’s resignations were motivated by anger and over the FDA’s lack of autonomy in the decision-making process. They left over their differences with Marks, along with other vaccine makers who were not making decisions with key data.
A CNBC reporter asked White House COVID-19 response coordinator Jeff Zients if he was concerned about the resignations affecting the trust in the FDA and the vaccine process, especially since the review for the kids is coming up.
Zients went on to say that the FDA is the “gold standard” and that they are grateful for the tireless work their senior team and staff put in. He said it is the leading medical experts’ “clinical judgment” with all of the available data to prepare Americans for booster shots.
