Bombshell news that not one, but two of the Food and Drug Administration’s “most senior vaccine leaders are exiting from their positions” is “raising fresh questions about the Biden administration and the way that it’s sidelined the FDA” reports Endpoint News.
The news was first reported by BioCentury, and is a massive blow to confidence in the agency’s ability to regulate vaccines. Among the two veterans leaving the high profile positions are Marion Gruber, director of the FDA’s Office of Vaccines Research & Review. Gruber is a 32-year veteran of the agency and will leave at the end of October.
OVRR deputy director Phil Krause is also stepping down; he has been at the FDA for more than a decade and plans to leave in November.
The timing of the announcements is particularly concerning, considering the companies crucial point in time, as boosters and children’s shots are being weighed by the regulator. “The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.”
Endpoints reports they were told by a former senior FDA leader that they’re departing because they’re frustrated that the Centers for Disease Control and Prevention (CDC) and their Advisory Committee on Immunization Practices (ACIP) committee are involved in decisions that they strongly feel should be left to FDA.
The former FDAer also said he’s heard they’re upset with the Center for Biologics Evaluation and Research (CBER) director Peter Marks. Reportedly Marks did not insist that those decisions in question be kept inside FDA.
However, “what finally did it for them” writes Endpoints News, was the “White House getting ahead of FDA on booster shots.” FDA’s former acting chief scientist, Luciana Borio, wrote of the matter on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”
“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” wrote former BARDA director Rick Bright, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”