FDA Introduces New Restrictions for Fall COVID Shots

Approval doesn't cover younger, healthy adults
Posted Aug 27, 2025 5:17 PM CDT
FDA Introduces New Restrictions for Fall COVID Shots
This photo provided by Moderna in August 2025 shows production of the updated mNEXSPIKE COVID-19 vaccine, in Madrid.   (Moderna via AP)

The FDA has given the green light to updated COVID vaccines for this fall, but not for everybody. Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday that the agency's latest approval only covers adults 65 and up, plus anyone—child or adult—with at least one condition that raises their risk of serious COVID complications, NBC News reports.

In a post on X, Kennedy said the FDA has ended emergency use authorizations for COVID vaccines. "FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors," he said.

The new eligibility rules could also determine what insurers will cover—leaving people outside the approved groups potentially on the hook for the full cost of $140 or more. Pharmacists may also be reluctant to provide the shots to people not covered by the FDA's instructions, the AP reports. "This makes things much more complicated, and when things get complicated we see vaccine uptake go down," says Andy Pekosz, a virologist at Johns Hopkins University.

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Next up: the CDC's vaccine advisory committee, which will weigh in next month with its own recommendations on who should get the next round of jabs. Kennedy fired all 17 members of the panel in June and named replacements including well-known vaccine skeptics. The CDC previously recommended COVID shots for everyone 6 months and older.

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