FDA to limit COVID-19 vaccines

Food and Drug Administration leaders issued new guidelines in the New England Journal of Medicine for administering the COVID-19 vaccine. The agency will limit the vaccine’s availability to people aged 65 and older and those 6 months or older with one or more risk factors making them high risk for serious outcomes from the virus. FDA Commissioner Marty Makary and FDA Center for Biologics Evaluation and Research Director Vinay Prasad recommended randomized clinical trials to determine whether the vaccines are beneficial for low-risk individuals before granting full approval. Critics said the leaders should have consulted FDA’s vaccine committee in drafting the policy. The guidelines stem from the efforts of Health and Human Services Department Secretary Robert F. Kennedy Jr, to change how the FDA tests and approves vaccines. (NEJM article, 5/20/25)