FDA Announces New Rules For COVID Shot

Someone getting a shot.

Someone getting a shot.

On Tuesday, May 20, 2025, the U.S. Food and Drug Administration announced new rules to approve COVID-19 shots. They are no longer a school requirement. Additionally, the FDA said it will require more research before approving yearly COVID-19 boosters for young, healthy Americans.

Who Gets It?

The shots will still be approved for adults over 65 and for people with health problems that put them at higher risk.

Boosters

Over the past two seasons, uptake of the annual COVID-19 booster has been poor. Less than 25% of Americans received boosters yearly, ranging from less than 10% of children younger than 12 in the 2024–2025 season to 50% of adults over 75. Even health care workers are slow in getting the boosters, with less than one-third participating in the 2023–2024 fall booster program. Also, public trust in vaccination in general has declined. Citizens are reluctant to vaccinate,  even vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which have been used for years. The surge of illegal immigrants over the border with no vaccination process or separation time has brought about disillusionment with the healthcare system. Also, the mandatory COVID-19 vaccine did not stop recipients from getting the virus.

The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.

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