FDA Limits COVID-19 Boosters to Seniors, Other High-Risk Groups

Key Takeaways

• Federal regulators will only approve COVID-19 boosters for seniors and high-risk groups

• Officials want more data before recommending shots for healthy individuals

• More than 100 million Americans would still qualify under the new plan

WEDNESDAY May 21, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has decided that only seniors and people at high risk should get the latest COVID-19 booster shots this fall.

The new framework, announced Tuesday, says adults 65 and older, and people with certain health conditions, can still get updated COVID-19 vaccines, The Associated Press reported.

These changes are meant to limit the use of the shots while experts collect more data on how well they work for healthy people.

Dr. Vinay Prasad, the FDA’s top vaccine official, said more than 100 million Americans would still qualify for the boosters.

“For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster,” Prasad said.

The FDA laid out its new framework in the New England Journal of Medicine and during a live webcast. This is a shift from the agency’s previous approach, which made COVID-19 boosters available to nearly all adults, just like the flu shot.

Going forward, vaccine makers like Pfizer and Moderna must run large, long-term studies in healthy people before those shots can be approved for broader use.

“Is the pharmacist going to determine if you’re in a high-risk group?” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

“The only thing that can come of this will make vaccines less insurable and less available," he said in a report from AP.

The American Academy of Pediatrics (AAP) also raised concerns.

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“If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” said Dr. Sean O’Leary, chair of the AAP Committee on Infectious Diseases.

In 2023, 231 children died from COVID-related causes, which is similar to a typical flu season, according to AP.

The move is part of a broader effort by the Trump administration to review how COVID vaccines are handled. Last week, the FDA gave full approval to Novavax’s COVID shot but also limited it to certain groups.

FDA Commissioner Dr. Marty Makary, co-author of the new guidance, said the U.S. needs to move away from a "one-size-fits-all" approach to vaccines, AP reported. 

The FDA plans a new trial to see how well boosters work in healthy adults.

This new guidance comes just ahead of a June meeting in which advisors to the U.S. Centers for Disease Control and Prevention are to discuss who should get COVID-19 shots going forward.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccination.

SOURCE: The Associated Press, May 20, 2025

What This Means For You

If you're 65 or older or have a high-risk health condition, you can still get a COVID booster. Others may have to wait, however.