FDA's top vaccine official leaves post after less than four months

The Guardian

4 days ago

The top vaccine official at the US Food and Drug Administration (FDA), Vinay Prasad, has left the federal agency less than four months after being appointed as the head of the division overseeing biological products like blood, vaccines, and cellular and gene therapies, a government spokesperson has said.
Prasad, an oncologist and a professor of epidemiology, biostatistics and medicine at the University of California, San Francisco, had previously criticized the FDA.
He was a fierce critic of US Covid-19 vaccine and mask mandates and, in the second Trump administration, he was controversially appointed as the director of the FDA's center for biologics evaluation and research in May.
'Dr Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,' a spokesperson from the Department of Health and Human Services told Reuters in an emailed statement on Tuesday evening. Endpoints News first reported Prasad's departure.
The government gave no details about the reason for his departure but he had fierce critics on both sides of the political aisle and the Washington Post reported, citing unnamed sources, that he had been ousted amid protests by conservative voices, with no response from Prasad to requests for comment.
His exit came after a number of unusual regulatory actions, including those taken recently by the agency on Sarepta Therapeutics' gene therapy, Elevidys.
'Unprecedentedly, there were multiple press leaks from the FDA, negatively impacting [the drug's] credibility,' said Kostas Bilouris, BMO Capital Markets analyst.
During Prasad's short stint in post, the FDA limited the use of Covid-19 vaccines and declined to approve therapies from biotech companies Replimune, which sought the green light for a treatment for advanced melanomas, and Capricor Therapeutics' treatment for a form of muscular dystrophy.
The regulator's decisions under Prasad raised concerns that he was anti-patient choice, Jefferies analyst Roger Song said, adding that investors will see his departure as a positive for gene therapy and vaccine makers.
Biotech stocks had plunged at the news of Prasad's appointment in May. The Nasdaq Biotechnology Index had declined 7% then, but later recovered. Shares of Replimmune rose 58%, Sarepta was up 11.2% and Capricor added 21.2% in premarket trading on Wednesday.
Prasad also held the additional role of the agency's chief medical and science officer, to which he was appointed last month, according to STAT News.
Nominating a more seasoned official to replace him could help the FDA rebuild its credibility, Bilouris said.