The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson said Friday.
Prasad was appointed last year as director of the FDA’s Center for Biologics Evaluation and Research, a position with heavy influence over the regulation of vaccines and other medical products. But his tenure has been dogged by controversy.
Prasad briefly stepped down in July, after less than three months on the job, following disputes over the FDA’s decision to pause shipments of a gene therapy for Duchenne muscular dystrophy, a neuromuscular disorder. The decision incited backlash from right-wing activist Laura Loomer, who called for Prasad’s ouster. However, he returned to his role roughly two weeks later.
In the ensuing months, Prasad faced criticism over the FDA's delay or rejection of several treatments for rare diseases, including for a rare blood cancer. Prasad had previously pledged to create new pathways to accelerate 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 vaccines’ benefits in healthy kids. He did not provide evidence, such as documentation of the deaths, to support the claim. Twelve former FDA commissioners subsequently denounced the 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 booster shots protect against severe illness in children.
FDA Commissioner Marty Makary, who appointed Prasad to the role, said in a statement on X that the agency had hit a record number of approvals in December under Prasad’s leadership.
“He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month,” Makary said. “We will name a successor before his departure.”
The Wall Street Journal was first to report the news that Prasad is once again leaving the FDA.
Before joining the FDA, Prasad was a professor in the epidemiology and biostatistics department at the University of California, San Francisco. A critic of vaccine and mask mandates during the pandemic, he questioned whether there was sufficient data to support the authorization of Covid boosters.
Under Prasad's leadership, the FDA narrowed its approval of Covid boosters last year to adults 65 and older and people at risk of severe illness. During his time in the role, the FDA in February rejected Moderna’s application for an mRNA-based flu vaccine, though the agency later reversed course and agreed to review it.
Prasad's departure is the latest in a recent string of leadership shake-ups at federal health agencies.
Jim O’Neill stepped down last month as acting CDC director and was replaced by Dr. Jay Bhattacharya, who also directs the National Institutes of Health. O’Neill had taken over from Susan Monarez, who served as CDC director for just 29 days.
Monarez said in testimony before the Senate Committee on Health, Education, Labor and Pensions that Health Secretary Robert F. Kennedy Jr. had fired her because she refused to blindly approve vaccine guidance changes. Kennedy has disputed her account.
NIH has also experienced a wave of terminations, resignations and retirements in the 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, has 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.
