A group of twelve seasoned former FDA commissioners has publicly condemned a recent memo issued by the agency’s top vaccine official, Vinay Prasad. The memo, which quickly leaked to the media, contained unsubstantiated claims linking COVID-19 vaccines to the deaths of 10 children in the US. It also proposed radical changes to how the FDA approves and updates vaccines, including seasonal flu shots.

With over 35 years of collective experience, these former leaders expressed serious concerns about the memo’s implications. Publishing their critique in the New England Journal of Medicine, they described Prasad’s approach as a dangerous departure from evidence-based practices that could undermine public trust and safety.

Prasad’s proposal involves replacing the current immunobridging studies—used to efficiently update vaccines based on immune response data—with lengthy and costly randomized trials. Experts warn that such a shift could delay crucial vaccine updates, weakening our response to flu seasons and emerging COVID variants.

According to healthcare analyst Dr. Lisa Carter, “This kind of policy shift risks prioritizing bureaucracy over proven science, which could have serious consequences for public health.” The consensus among experts emphasizes that evidence-based, adaptive strategies remain essential for effective immunization programs.

David Nield

Dave is a freelance tech journalist with over 20 years covering gadgets, apps, and the web. From Stockport, England, he covers news, features, and reviews for TechRadar, focusing on phones, tablets, and wearables. He ensures top weekend breaking news and has bylines at Gizmodo, T3, PopSci, and others. He edited PC Explorer and The Hardware Handbook for years. Read me on x.com or linkedin.