Vinay Prasad takes charge of FDA's biologics and vaccines division amid controversies

In March 2025, the US Food and Drug Administration appointed Dr. Vinay Prasad, a hematologist oncologist, as the director of its Center for Biologics Evaluation and Research, a division responsible for overseeing vaccines and biologic medicines. This appointment follows the resignation of Dr. Peter Marks, who had led the division for 13 years and played a significant role in the Operation Warp Speed initiative aimed at the rapid development of COVID-19 vaccines. Marks resigned citing concerns over the current leadership's approach to vaccine safety and transparency, especially regarding Health and Human Services Secretary Robert F. Kennedy Jr. This leadership change represents a shift at the FDA, especially given Prasad's critical views on the government’s pandemic response and vaccine policies. He has publicly questioned the safety and necessity of authorizing COVID-19 vaccinations for children, who generally face lower risks of severe illness compared to older demographics. The FDA's intention to implement new requirements for future vaccines, emphasizing the necessity for placebo studies, aligns with the current controversies surrounding vaccine regulation. As Prasad takes the helm, public health officials are also reconsidering vaccine recommendations for children, suggesting that the FDA is poised for significant policy review under his leadership. This situation has sparked a dialogue around the perceived safety and efficacy of vaccines, with Prasad's appointment drawing both criticism and support based on his previous outspoken criticisms of COVID-19 guidelines. Dr. Marty Makary, a prominent figure within the FDA, expressed support for Prasad’s appointment, highlighting his accomplishments in oncology research. The broader implications of Prasad's leadership may affect public trust in vaccine policies, especially as the agency navigates criticism regarding vaccine safety standards.