FDA will restrict future COVID-19 vaccines based on age, risk factors

 FDA officials outlined new restrictions for COVID-19 vaccine approvals in the United States that could limit their use among healthy people.

The policy shift was announced Tuesday in a New England Journal of Medicine article written by FDA Commissioner Martin Makary, MD, MPH, and Vinay Prasad, MD, MPH, who leads the Center for Biologics Evaluation and Research and is the agency’s top vaccine regulator.

In the article, Makary and Prasad indicated that adults aged 65 years or older and anyone aged 6 months to 64 years who has one of dozens of conditions that place them at a high risk for severe disease will have access to future COVID-19 vaccines, such as fall boosters, as long as a study showed the vaccines induce an immune response, as has been standard for COVID-19 vaccines.

For anyone aged 6 months to 64 years without a risk factor, however, Makary and Prasad indicated that the FDA will now require data from randomized placebo-controlled controlled trials that evaluate clinical outcomes before the agency will approve COVID-19 vaccines in this age group.

Most other countries have switched to risk-based recommendations for COVID-19 vaccination. The issue was discussed by CDC vaccine advisors last year before they ultimately recommended sticking with a universal vaccine recommendation for people aged 6 months and older.

https://www.healio.com/news/infectious-disease/20250520/fda-will-restrict-future-covid19-vaccines-based-on-age-risk-factors