FDA Vaccine Chief Vinay Prasad to Leave Agency at End of April

Dr. Vinay Prasad, the Food and Drug Administration’s top vaccine and biotech regulator, is leaving the agency for the second time in less than a year, according to NBC News and CBS News. FDA Commissioner Marty Makary announced the departure to staff in an email late Friday, saying Prasad will go at the end of April and return to his academic job at the University of California, San Francisco, CBS News reported.

Prasad directs the FDA’s Center for Biologics Evaluation and Research, a post with heavy influence over vaccines and other medical products, NBC News reported. He first left in July, after less than three months on the job, following disputes over the agency’s decision to pause shipments of a gene therapy for Duchenne muscular dystrophy. That decision drew criticism from activist Laura Loomer, who called for his removal, NBC News said. He returned about two weeks later with the backing of Health Secretary Robert F. Kennedy Jr. and Makary, according to CBS News.

The latest exit follows a run of disputes with drugmakers. According to CBS News, Prasad came under fire from pharmaceutical executives, investors and members of Congress in the past month over several decisions. In one, the FDA initially refused to review Moderna’s mRNA-based flu vaccine, an unusual step that led Moderna to go public and vow a formal challenge. A week after the rejection became public, the agency reversed course and agreed to review the shot pending an additional study, CBS News reported.

In the second dispute, CBS News said, the FDA fought publicly with UniQure, a small company developing an experimental gene therapy for Huntington’s disease, which affects about 40,000 people in the U.S. The company said Monday that the agency wanted a new trial involving sham surgery on some participants, which it said contradicted earlier FDA guidance and raised ethical concerns. On Thursday the FDA held an unusual press conference at which a senior official, speaking anonymously, called the company’s original study “stone cold negative,” according to CBS News.

NBC News also noted Prasad’s November memo to FDA staff, in which he wrote that Covid vaccines had killed at least 10 children and that “we do not have reliable data” on their benefits in healthy children. He did not provide evidence of the deaths, NBC News reported, and twelve former FDA commissioners later denounced the statements in the New England Journal of Medicine. NBC News added that the Centers for Disease Control and Prevention’s own research has consistently found that Covid vaccines and boosters protect children against severe illness.

Makary defended the record in a post on X, saying the agency reached a record number of approvals in December under Prasad, according to NBC News. The Wall Street Journal was first to report the departure, NBC News said.

The exit is the latest in a series of leadership changes at federal health agencies. NBC News listed them: 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, and O’Neill had taken over from Susan Monarez, who served 29 days as CDC director. Monarez has told senators that Kennedy fired her because she refused to approve vaccine guidance changes without scrutiny, which Kennedy has disputed.