FDA Changes Covid-19 Vaccine Approval, Limits Access for Healthy Adults

NEWARK, N.J. — The U.S. Food and Drug Administration (FDA) announced a significant change on May 20, 2025, regarding the approval of Covid-19 vaccines. Under the new guidelines, only those aged 65 and older, as well as individuals at high risk for severe illness, will have relatively easy access to future vaccines.

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, Director of the Center for Biologics Evaluation and Research, shared these insights in an article published in the New England Journal of Medicine. They indicated that the evidence supporting annual vaccination for healthy younger adults was insufficient, prompting this new approach.

The revised guidelines will permit updates to vaccines for adults over 65 and those six months and older with underlying health conditions that place them at higher risk of Covid-19. Based on CDC data, nearly 75% of Americans aged six months and older have conditions that heighten their risk.

“We believe this is a necessary step to align U.S. recommendations with those of other countries and restore public trust in vaccines,” Prasad stated. He expressed concern that previous broad vaccine mandates had diminished public willingness to receive vaccines.

Dr. Noel Brewer, a public health professor at the University of North Carolina, also supports the new policy, emphasizing its alignment with global public health perspectives. However, concerns persist regarding the implications for younger children, particularly those under two years old who have high hospitalization rates from Covid-19.

Vaccines will still be available to younger Americans with specific health conditions identified by the CDC. Estimates suggest 100 million to 200 million Americans will still qualify under the new guidelines.

Under the new measures, the FDA will require new clinical trials for vaccines intended for healthy adults and children under 65. This will necessitate randomized trials to demonstrate the efficacy of the vaccines for these groups, which could delay their availability.

Dr. Paul Offit, from the Children’s Hospital of Philadelphia, criticized the lack of evidence cited by the FDA regarding the decision. “We have data supporting the current vaccine regime; it’s indeed safe,” he noted.

The FDA advisory committee is set to meet this week to discuss future vaccine variants as the country prepares for the upcoming illness season.