Dr. Vinay Prasad Appointed to Lead FDA's Vaccine and Biologics Division

The U.S. Food and Drug Administration (FDA) has announced the appointment of Dr. Vinay Prasad, a renowned professor at the University of California-San Francisco, as the new head of its Center for Biologics Evaluation and Research. This division is responsible for overseeing the approval and regulation of vaccines, gene therapies, and other biologic medicines.

Dr. Prasad is a hematologist-oncologist with extensive research in cancer treatments. He is also known for his critical stance on various aspects of the U.S. government's COVID-19 response, including skepticism about school closures, mask mandates, and booster shots.

He succeeds Dr. Peter Marks, who led the division for 13 years and was instrumental in the rollout of COVID-19 vaccines before resigning in March. Dr. Marks cited concerns over scientific transparency and misinformation in his departure.

FDA Commissioner Dr. Marty Makary emphasized Prasad's distinguished medical background and his contributions to oncology research, highlighting his expertise as valuable for the division's future.

Prasad's appointment comes at a time when the FDA plans to implement more stringent testing requirements for future vaccines, including the use of placebo-controlled trials. Public health policies concerning COVID-19 vaccinations for children are also being reevaluated, with some experts questioning the necessity given the lower risk for children.

The announcement has impacted biotech markets, with stocks like Sarepta Therapeutics experiencing significant declines, partly due to Prasad's previous criticisms of gene therapy approvals, including the recent approval of Elevidys.

Prasad has publicly expressed skepticism about accelerated gene therapy approvals, advocating for more effective but safely tested treatments. His leadership is expected to influence the FDA’s approach to vaccine and biologics regulation moving forward.