Who is Vinay Prasad? US FDA vaccine chief to step down next month

Dr Vinay Prasad, the head of the US Food and Drug Administration’s division of vaccines and gene therapies, is quitting the agency next month to return to his prior career in academia, FDA Commissioner Marty Makary shared on Friday, local time.

In an X post, Makary said, a year ago, Dr Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, and the new plausible mechanism framework for ultra-rare diseases “which we launched last week”.

Thanking Prasad for his service at the Center for Biologics Evaluation and Research, the FDA commissioner said his division hit a record number of approvals in December. “He got a tremendous amount accomplished within his one-year sabbatical,” he said. “I want to thank him for his service and personal sacrifice to take time away from his family.”

The FDA plans to name a successor before Prasad departs, Makary said.

Who is Dr Vinay Prasad?

Dr Vinay Prasad is a former epidemiology professor at the University of California at San Francisco. Prasad joined the FDA in May 2025, replacing Peter Marks.

Prasad made headlines for his criticism of the Covid vaccine for children and companies that don’t test their treatments against placebo controls. He also had to leave the agency in late July after the conservative pundits crusaded against him over his handling of Sarepta Therapeutics Inc.’s gene therapy.

But he returned just a few weeks later with the support of Makary.

During his time at the FDA, Prasad said the agency would require additional testing for vaccines as a result of safety concerns.

In a memo to staff in late November, he blamed Covid shots for contributing to the deaths of 10 children, without providing evidence.

Prasad also spearheaded some new initiatives to support rare disease drugs, like unveiling a faster approach to approving customised gene-editing treatments.

End of Prasad’s tenure is ‘a sigh of relief’ for biotech industry

The news of Dr Vinay Prasad's exit sent biotech shares higher in late trading on Friday. The end of Prasad’s tenure is “a sigh of relief” for the biotech industry, BMO Capital Markets analyst Evan Seigerman said in a note to clients.

According to a Bloomberg report, during his time, Prasad sparked controversy for overruling his own scientific review staff at times. He also reportedly took a confrontational approach, which the critics said would stymie scientific innovation and slow approvals for rare disease drugs.

Bloomberg quoted biotech companies as saying that Prasad was raising the bar and making it more difficult to get new therapies approved. He also faced backlash over a decision not to review Moderna Inc.’s application for a new flu vaccine. The agency soon reversed itself.

UniQure NV jumped as much as 70% in postmarket trading after the news of Prasad’s departure. The company has been engaged in a public feud with its division over the requirements for seeking approval of its gene therapy for Huntington’s disease. Shares of Regenxbio Inc. rose as much as 29%. Last month, the FDA rejected its gene therapy for Hunter syndrome.

(With Bloomberg inputs)