FDA Vaccine Head Stepping Down

This marks Dr. Vinay Prasad's second departure from the agency in less than a year. He was previously forced out in July after clashing with biotech executives, patient advocacy groups, and conservative allies of President Donald Trump, only to be reinstated two weeks later with the support of Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. A key controversy involved his initial refusal to allow the FDA to review a new mRNA flu vaccine from drugmaker Moderna. This highly unusual move prompted a public challenge from the company, after which the FDA reversed its decision, pending an additional study. Prasad's tenure has been marked by a contentious approach to regulation, often clashing with the pharmaceutical companies the FDA oversees. He has been criticized by pharmaceutical executives and members of Congress for reversing agency decisions and requiring new trials for products that were previously greenlit. Before joining the FDA in May 2025, Prasad, a hematologist-oncologist from the University of California, San Francisco, was a vocal critic of the agency's handling of COVID-19 vaccine approvals, particularly for children. He took over from Dr. Peter Marks, who was forced to resign. Internally, Prasad has faced accusations of retaliating against subordinates and verbally berating staff, according to reports citing unnamed sources. His leadership of the Center for Biologics Evaluation and Research (CBER) also involved overruling staff in vaccine reviews. FDA Commissioner Marty Makary has stated that a successor for Dr. Prasad will be named before his departure at the end of April. Following his departure, Prasad is expected to return to his academic position at the University of California, San Francisco.