On Tuesday, two of the FDA’s top vaccine reviewers announced their resignations in protest of administrative intrusions from the CDC and the Biden White House.
“Marion Gruber, director of the FDA’s Office of Vaccines Research and Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November,” according to EndPoints News.
The senior officials expressed frustration over the CDC and their Advisory Committee on Immunization Practices (ACIP) intruding into the decisions that should be made by the FDA. The final straw was the White House decision to begin administering booster shots the week of September 20, an announcement that was made before the FDA had time to complete its review process.
The sidelining of the FDA by the Biden administration in order to fast-track approval of Covid booster shots is being compared to similar pressure put on the FDA during the Trump administration. Politico reports:
FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team's top-down booster plan and former President Donald Trump's attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.
According to Paul Offit who sits on the FDA’s vaccine advisory committee, the abrupt announcement of Covid booster shots was “the administration's booster plan; it wasn't the FDA's booster plan,” adding that, “the administration has kind of backed themselves up against the wall a little bit here.”
The latest departures follow the previous departures of Nancy Messonnier and Anne Schuchat at the CDC. “Such departures are not unusual when they occur over months or years in the normal pitter-patter of government,” writes Dr. Kavita Patel over at MSNBC. “But when four scientists and physicians at two of the most important United States agencies leave during the middle of a pandemic with no ready transition plan or heirs apparent, there is clearly a need to look to the agencies’ leadership.”
Within the agency, a potential mutiny is forming, with several key advisors claiming they’ve been cut out of the decision process because they’ve expressed concerns over the necessity of a booster program at this time. Sources have told Politico that there has been very little coordination between the federal health agencies. And the key decision on whether the goal should be preventing serious illness and hospitalization, or preventing all infections including mild ones, has yet to be officially made.
A week ago, President Biden made an off-the-cuff remark suggesting boosters could be given only 5 months after the second shot. His remark directly contradicted the eight-month window that his administration had just recently proposed. This confusion may have led some to assume that the FDA had already given its approval on booster shots. Many providers around the country have already started giving third shots to health care workers and patients. Currently, boosters are only authorized for the immunocompromised, but nearly a million doses have already been administered.