Who will be able to get COVID-19 shots this fall in the United States? The answer is far from clear following the publication this week of a new framework by U.S. Food and Drug Administration Commissioner Martin Makary and Vinayak “Vinay” Prasad, director of FDA’s Center for Biologics Evaluation and Research.
In a commentary published in The New England Journal of Medicine (NEJM), Makary and Prasad wrote that going forward, the vaccines will generally be approved only for use in people ages 65 and older and those who have medical conditions that leave them at higher risk for severe COVID-19. That is a major departure from the current recommendation from the U.S. Centers for Disease Control and Prevention (CDC), which says everyone above the age of 6 months should receive a dose of the latest COVID-19 vaccine, which has generally been updated each year.
If manufacturers want their vaccines to be available to healthy people under age 65, “FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes” before it would approve a license for those groups, Makary and Prasad wrote. Previously, companies had their updated vaccines licensed on the basis of so-called immunogenicity data, showing only that a vaccine can generate antibodies in people. That standard will remain for licensing new vaccines for older and at-risk populations.
