FDA sets more limited framework for COVID-19 vaccines

Lia DeGroot, CQ-Roll Call on Aug 27, 2025

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The Food and Drug Administration on Wednesday approved COVID-19 vaccines under a more limited framework after rescinding the emergency use authorizations previously in place.

According to the manufacturers, the FDA approved the vaccines for everyone 65 and older, but limited their use to high-risk populations of a certain age for non-elderly patients. Moderna’s vaccine was approved for those at risk and age 6 months or older and Pfizer’s for those at risk aged 5 years or older.

Novavax had previously announced that its vaccine was approved for high-risk patients aged 12 and up.

In rescinding the emergency use, Health and Human Services Secretary Robert F. Kennedy Jr. said in a post on X that the prior authorizations were used to justify “broad mandates” during former President Joe Biden’s administration.

Despite the manufacturers’ clear stipulation that approval for those under 65 was for people at high risk, Kennedy said that the vaccines are available under this framework for patients who choose them in consultation with their physician. These vaccines had previously been approved more broadly.

“In a series of FDA actions today we accomplished all four goals,” he said of promises made as secretary of ending vaccine mandates, keeping vaccines available to people who want them, requiring placebo-controlled trials and ending the emergency. “The American people demanded science, safety, and common sense. This framework delivers all three.”

Earlier, the Centers for Disease Control and Prevention changed its pediatric COVID-19 recommendation to advise that healthy children receive a vaccine if the family decides in consultation with a clinician that it’s necessary. The CDC had previously recommended the vaccine for everyone ages 6 months and older.

Some epidemiological experts have argued that there is a clear benefit for vaccinating young children. The American Academy of Pediatrics issued its recommended vaccine schedule earlier this month, which countered the Trump administration’s approach.

The AAP recommends that all kids under age 2 receive an annual shot to protect them against the virus. For children older than 2, the organization recommends a vaccine if they or someone in their household is at high risk of developing severe COVID-19, the child lives in a long-term care facility or other congregate setting, or the child has never received the vaccine.

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