“FDA: No Full Licenses for COVID-19 Vaccines for Most Americans Without Clinical Trial Data”

In a notable policy shift, the U.S. Food and Drug Administration (FDA) announced that it will no longer approve COVID-19 vaccines for the majority of healthy Americans without new randomized, controlled clinical trial data demonstrating that the benefits outweigh the risks.

The updated guidance was outlined in a policy statement published Tuesday in the New England Journal of Medicine by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, Director of the FDA’s Center for Biologics Evaluation and Research. The statement reflects a significant recalibration of the agency’s licensing framework and signals a more rigorous standard for future vaccine approvals.

According to the new policy, the FDA will continue to approve vaccines for adults over the age of 65 and individuals over six months old who have risk factors for severe COVID-19—such as cancer, asthma, or immunosuppression—based on immunogenicity data alone (i.e., evidence that the vaccine produces an immune response). However, for most individuals between six months and 64 years of age who do not have such risk factors, manufacturers will now be required to provide clinical trial data showing improved health outcomes, not just immune response markers, before being granted full approval under a Biologics License Application (BLA).

This represents a substantial tightening of the standards used in earlier pandemic years, when many vaccines were approved based primarily on short-term safety data and antibody levels under Emergency Use Authorizations or expedited licensure pathways.

The policy change is likely to affect major pharmaceutical companies, including Pfizer, Moderna, and Novavax, all of which have previously received authorization for multiple COVID-19 vaccine formulations. None have publicly commented yet on how the new requirements may affect their development or approval timelines.

FDA officials are expected to elaborate further during a scheduled press briefing later today. The agency’s decision comes amid growing public and expert debate over the long-term necessity and benefit of continued vaccination in low-risk populations, particularly as COVID-19 transitions into an endemic phase.

This policy shift may also influence future booster campaigns and could affect insurance coverage policies tied to FDA approval status. For many, the move signals a return to more traditional evidentiary standards for vaccines and biologics—prioritizing demonstrated clinical benefit over surrogate endpoints like antibody levels.

Rewritten. Source article posted here: https://yournews.com/2025/05/20/3454843/fda-no-full-licenses-for-covid-19-vaccines-for-most-americans/