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Changes are happening around COVID-19 vaccines: Here's what to know

USA Today
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FDA leaders said on May 20 that clinical trials will be required to approve annual COVID-19 boosters for healthy individuals under the age of 65 .

With this move, the FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

Other changes include the FDA 's request that both Pfizer and Moderna update their labels with a warning about the potential for vaccinated males ages 16 to 25 to develop inflammation of the heart muscle or other conditions.

Moderna ’s Spikevax was approved in late January 2022 .

Myocarditis is inflammation of the heart muscle and can reduce the heart's ability to pump blood.

Researchers looked at commercial health insurance claims data from inpatient and outpatient facilities.

The FDA noted that Moderna should replace the current label with one that reads “following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines.