FDA vaccine chief to leave the agency for a second time
The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will leave the agency next month, an FDA spokesperson said Friday.
Prasad was named director of the FDA’s Center for Biologics Evaluation and Research last year, a position that has strong influence over the regulation of vaccines and other medical products. But his tenure was marred by controversy.
Prasad briefly resigned in July, after less than three months on the job, following disputes over the FDA’s decision to suspend shipments of a gene therapy for Duchenne muscular dystrophy, a neuromuscular disease. The decision drew backlash from right-wing activist Laura Loomer, who called for Prasad’s ouster. However, he reprized his role approximately two weeks later.
In the months that followed, Prasad was criticized for the FDA’s delay or rejection of several rare disease treatments, including for a rare blood cancer. Prasad had previously pledged to create new pathways to speed up drug approvals.
Then, in November, Prasad sent a memo to FDA staff in which he wrote that Covid shots had killed at least 10 children and that “we do not have reliable data” on the benefits of vaccines in healthy children. He did not provide any evidence, such as documentation of the deaths, to support this claim. Twelve former FDA commissioners later denounced these statements in the New England Journal of Medicine.
The Centers for Disease Control and Prevention’s own research has consistently found that Covid vaccines and boosters protect against serious illness in children.
FDA Commissioner Marty Makary, who appointed Prasad to the position, said in a statement on X that the agency reached a record number of approvals in December under Prasad’s leadership.
“He has accomplished an enormous amount during his gap year at UCSF and will return to his university home later next month,” Makary said. “We will appoint a successor before he leaves.”
The Wall Street Journal was the first to report that Prasad was leaving the FDA again.
Before joining the FDA, Prasad was a professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco. A critic of vaccine and mask mandates during the pandemic, he questioned whether there was enough data to support authorizing Covid boosters.
Under Prasad’s leadership, the FDA last year restricted its approval of Covid boosters to adults 65 and older and people at risk of severe illness. During his tenure, the FDA in February rejected Moderna’s application for an mRNA-based flu vaccine, although the agency later reversed course and agreed to review it.
Prasad’s departure is the latest in a recent series of leadership shakeups at federal health agencies.
Jim O’Neill resigned as acting director of the CDC last month and was replaced by Dr. Jay Bhattacharya, who also heads the National Institutes of Health. O’Neill had succeeded Susan Monarez, who served as CDC director for only 29 days.
Monarez said in testimony before the Senate Health, Education, Labor and Pensions Committee that Health Secretary Robert F. Kennedy Jr. fired her because she refused to blindly endorse changes to vaccine guidelines. Kennedy disputed his account.
The NIH also saw a wave of layoffs, resignations and retirements last year, leaving more than half of the agency’s 27 institutes and centers without permanent directors. Dr. Jeanne Marrazzo, who succeeded Dr. Anthony Fauci as director of the National Institute of Allergy and Infectious Diseases, claimed in a lawsuit and whistleblower complaint that Kennedy fired her in September for defending vaccines and speaking out against the cancellation of NIH research.
