Dr Vinay Prasad, the leader of the US Food and Drug Administration’s (FDA) division responsible for vaccines and gene therapies, is set to leave the agency next month to return to his previous role in academia. This announcement was made by FDA Commissioner Marty Makary on Friday, local time.
Commissioner Makary noted that Dr Prasad joined the FDA with the aim of implementing four significant and enduring reforms: a 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified framework for Covid vaccines, and a new plausible mechanism framework for ultra-rare diseases, which was launched last week.
In his message, Makary expressed gratitude for Prasad’s contributions at the Center for Biologics Evaluation and Research, highlighting that his division achieved a record number of approvals in December. “He accomplished a tremendous amount during his one-year sabbatical,” he stated. “I want to thank him for his service and personal sacrifice to take time away from his family.” The FDA is expected to announce a successor prior to Prasad’s departure.
Dr Prasad previously served as an epidemiology professor at the University of California, San Francisco, and he joined the FDA in May 2025, succeeding Peter Marks. Throughout his tenure, Prasad attracted attention for his critical views on the Covid vaccine for children and for calling out companies that fail to conduct tests against placebo controls. His time at the agency was marked by controversy, particularly in relation to Sarepta Therapeutics Inc.’s gene therapy, which led to his temporary departure in late July after facing backlash from conservative commentators. However, he returned shortly thereafter with the backing of Commissioner Makary.
During his leadership at the FDA, Dr Prasad advocated for additional testing requirements for vaccines in light of safety concerns. In a memo to staff in late November, he controversially attributed the deaths of ten children to Covid shots, although he did not provide supporting evidence for this claim.
Dr Prasad also initiated new measures to expedite the approval process for drugs targeting rare diseases, including a faster approach to green-lighting customised gene-editing treatments. The announcement of his exit led to an increase in biotech shares during late trading on Friday. BMO Capital Markets analyst Evan Seigerman remarked that Prasad’s departure is perceived as a “sigh of relief” for the biotech sector.
According to a Bloomberg report, Prasad’s tenure was marked by instances where he overruled his scientific review staff, raising concerns among critics that his confrontational approach could hinder scientific innovation and delay the approval of therapies for rare diseases. Biotech companies expressed that Prasad had elevated the standards for therapy approvals, making the process more challenging.
Additionally, Prasad faced criticism for his decision not to review Moderna Inc.’s application for a new flu vaccine, a decision that was subsequently reversed by the agency.
Following the announcement of Dr Prasad’s departure, shares of UniQure NV surged by as much as 70% in post-market trading. This company has been involved in a public dispute with the FDA regarding the requirements for approval of its gene therapy for Huntington’s disease. Similarly, shares of Regenxbio Inc. rose by as much as 29%, following the FDA’s recent rejection of its gene therapy for Hunter syndrome.