HQ Staff Reporter
March 8. 2026: Dr. Vinay Prasad, the vaccine head of the US Food and Drug Administration, will be stepping down from his post in April, according to a staff email sent by FDA commissioner Mary Makary. This is the second time within a year that his departure has been announced after a review of his decisions regarding vaccinations and specialty drugs for rare diseases.
Prasad is expected to rejoin academics at the University of California. Makary said in a post on X, “He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month.”
Prasad has been involved in some contradictory and inconsistent decisions regarding vaccines, gene therapies, and biotech drugs during his tenure at the regulatory body. He has called for new trials of products that have been previously greenlighted by the organization.
Previous Departure
Last July, Prasad was forced to step down after displeasing certain biotech executives, patient groups, and conservative allies of the government. He was reinstated within two weeks at the insistence of health secretary Robert F Kennedy Jr and Makary.
The latest firing has been caused by Prasad’s refusal to consider Moderna’s application for a new, potentially more effective flu shot based on messenger RNA (mRNA) technology, which medical experts say stems from his “anti-vaccine stance.”
Prasad wrote in his rejection note that it did not have an “adequate and well-controlled” trial, with the control group lacking “the best-available standard of care in the United States at the time of the study.”
The FDA quickly changed course after it faced pressure from the White House. Andrew Nixon, a spokesperson for the Department of Health and Human Services (HHS), said in a statement: “As authorized under PDUFA (Prescription Drug User Fee Act) and defined in FDA guidance documents, FDA held a Type A meeting with Moderna. Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted. FDA will maintain its high standards during review and potential licensure stages as it does with all products.”
Moderna, on its part, has modified its approach to satisfy the government’s concerns. Under the newly accepted application, Moderna is seeking full approval for adults aged 50 to 64. For those aged 65 and older, it is seeking “accelerated approval,” which allows a product to reach the market faster based on early data while more research continues. The FDA is expected to make its final decision on the vaccine by Aug. 5.
During his brief career at the FDA, Dr. Prasad has threatened executives and employees who disagreed with his diktats with expulsions and resignations. He issued a series of rejections for treatments of rare diseases, upsetting patients who have few options and biotech companies invested in developing cures. He refused any kind of review meetings, advisory panels, and any decision transparency.
