The new policy ‘balances competing values,’ agency leaders said.
The Food and Drug Administration (FDA) will not approve COVID-19 vaccines for many Americans absent trial data showing that the benefits outweigh the risks, top agency officials said on May 20.
“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titers in people—the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes,” such as asthma or cancer, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, wrote in a New England Journal of Medicine article.
“For all healthy persons—those with no risk factors for severe Covid-19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.”
Pfizer, Moderna, and Novavax, which have received licenses for their COVID-19 vaccines, did not immediately respond to requests for comment.
Several medical groups that have commented on FDA steps concerning COVID-19 vaccines, such as the American Academy of Family Physicians, did not return inquiries.
The FDA in 2024, in its most recent action concerning the Pfizer and Moderna vaccines, approved updated versions for most Americans and extended emergency authorization for others, despite there being no trial data available for those formulations.
Makary and Prasad planned to talk about the policy update at 1 p.m. on Tuesday.
The regulatory agency on May 16 approved Novavax’s COVID-19 vaccine for the first time. The approval was for adults aged 65 and up. The agency said that people aged 12 to 64 could receive a Novavax shot, but only if they have one of the conditions that puts them at higher risk for severe COVID-19 outcomes.
