FDA Vaccine Chief Vinay Prasad Set to Leave Post Next Month

(Bloomberg) — The head of the US Food and Drug Administration’s division of vaccines and gene therapies is leaving the agency after a tumultuous tenure, sending biotech shares higher in late trading on Friday.

Vinay Prasad will depart the Center for Biologics Evaluation and Research next month to return to his prior career in academia. Prasad sparked controversy for overruling his own scientific review staff at times and taking a confrontational approach that critics said would stymie scientific innovation and slow approvals for rare disease drugs.

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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, adding that him leaving the FDA improves the chances of several companies getting their drugs approved and may alleviate the uncertainty facing vaccine makers.

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 his 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.

FDA Commissioner Marty Makary thanked Prasad for his service in a post on X late Friday, noting his division hit a record number of approvals in December. The FDA plans to name a successor before Prasad departs, Makary said.

A former epidemiology professor at the University of California at San Francisco, Prasad made a name for himself by criticizing the Covid vaccine for children and companies that don’t test their treatments against placebo controls.

He joined the FDA in May 2025, replacing Peter Marks, who was pushed out after disagreeing with Health Secretary Robert F. Kennedy Jr. about the importance of vaccines. Prasad briefly left the agency in late July after conservative pundits including Laura Loomer and Rick Santorum led a crusade 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.

He also spearheaded some new initiatives to support rare disease drugs, like unveiling a faster approach to approving customized gene-editing treatments. But behind the scenes, biotech companies said 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.

Late last month, Makary defended Prasad against accusations that he was unfairly rejecting promising drugs. In a CNBC interview, Makary called Prasad a “genius” who is facing a “fatwa” and a “smear campaign” by certain media outlets. A recent editorial in the Wall Street Journal accused Prasad of insisting on clinical trials that are too difficult and expensive to pull off.

News of Prasad’s departure was first reported by the Journal.

–With assistance from Nyah Phengsitthy and John Tozzi.

(Updates with analyst comment in third paragraph.)

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