Dr Vinay Prasad, the top vaccine official at the US Food and Drug Administration (FDA), is leaving the agency for the second time in less than a year. FDA Commissioner Marty Makary announced the news in an email to staff on Friday, stating that Prasad would depart at the end of April and return to his academic post at the University of California, San Francisco (UCSF).
Prasad's departure follows a series of high-profile controversies surrounding FDA reviews of vaccines, gene therapies, and biotech drugs. Companies have criticised the agency for reversing decisions, sometimes demanding new trials for previously approved products. In July, Prasad was briefly forced out after clashing with biotech executives, patient groups, and conservative allies of Donald Trump, but was reinstated less than two weeks later with backing from Health Secretary Robert F Kennedy Jr and Makary.
Since joining the FDA last May, Prasad has taken a seemingly contradictory approach. He has supported faster drug reviews while also imposing new warnings and study requirements for certain biotech drugs and vaccines, particularly Covid-19 shots. Last month, he refused to consider Moderna's application for a new mRNA-based flu shot, citing inadequate trial controls. The decision sparked backlash from medical experts, who described it as part of a broader 'anti-vaccine agenda'. The FDA later reversed course after White House pressure.
Prasad replaced Dr Peter Marks, who resigned in March after being given the choice to resign or be fired. Marks had been a key figure in Operation Warp Speed, which developed and distributed Covid-19 vaccines. Before his FDA role, Prasad was a professor at UCSF and worked at the National Cancer Institute and the National Institutes of Health.
