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Dr. Vinay Prasad, the top vaccine official at the U.S. Food and Drug Administration (FDA), is leaving the agency, his second departure from the role after briefly resigning last year.
Prasad, the FDA’s chief medical and scientific officer and director of the Center for Biologics Evaluation and Research, will leave the agency and return to his academic role at the University of California, San Francisco, in April, FDA Commissioner Marty Makary said in a social media post.
The agency will appoint a successor before his departure, Makary said. He thanked Prasad for his work at the FDA, saying Prasad got “a tremendous amount accomplished” while serving the agency.
“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, & the new plausible mechanism framework for ultra rare diseases which we launched last week,” Makary said.
“Also, under his leadership, his center hit a record number of approvals in Dec,” he said. “I want to thank him for his service and personal sacrifice to take time away from his family.”
Prasad was named head of the FDA’s Center for Biologics Evaluation and Research in May 2025 but later stepped down from the role in July. The Department of Health and Human Services said at the time that Prasad wanted to return to California to spend more time with his family. He subsequently rejoined the agency two weeks later at the FDA’s request.
In his role as director of the Center for Biologics Evaluation and Research, Prasad oversaw the FDA’s regulation of biological products designed for human use under applicable federal law.
Prasad made several significant changes during his tenure at the FDA, including jointly with Makary, unveiling a new policy on COVID-19 vaccines. The two-pronged approach had continued letting companies provide antibody data to receive clearance for updated vaccines for the elderly and other people with a risk condition, but also required companies to provide clinical trial data to receive clearance for tens of millions of other Americans.
In addition, Prasad overruled FDA staffers on three COVID-19 vaccines, including two from Moderna. The FDA approved the vaccines for the elderly as well as younger people with an underlying condition, who are at higher risk of severe COVID-19 outcomes, but not for the rest of the U.S. population.
Before joining the FDA, Prasad was a professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco, a position he has held since 2020.
