Federal health officials say the Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials first, a major shift in the agency’s approach to preventive measures for the disease.
The move, announced Tuesday in the New England Journal of Medicine by FDA Commissioner Martin Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research, and other actions this week challenge conventional thinking on the effectiveness and risks for such vaccines.
The FDA’s change comes ahead of the agency’s Vaccines and Related Biological Products Advisory Committee meeting on Thursday, at which the panel will make recommendations for the strain selection for the 2025-26 COVID-19 vaccine rollout. The panel routinely makes such decisions in the spring to prepare for the fall, on a similar timeline as the annual flu vaccine program.
