US EditionAs 2025 COVID vaccines become available, FDA guidance has changed. Here's what to know
The FDA updated vaccine guidance focuses on adults 65 and older and high-risk individuals, while coverage by insurers remains uncertain as CDC advisory schedules are pending.
- On Aug. 27, the U.S. Food and Drug Administration approved the 2025 COVID vaccines for adults age 65 and older, and manufacturers began shipping updated doses immediately, including Pfizer, Moderna, and Novavax.
- Federal guidance has recently shifted, prompting medical associations, including the American Academy of Pediatrics, to sue after Health and Human Services Secretary Robert F. Kennedy Jr. bypassed CDC processes in May.
- The FDA's approval targets people age 65 and older and individuals with underlying conditions like asthma and diabetes; experts say vaccines protect up to six months but don't prevent infection 100%.
- Uncertainty about insurance coverage means vaccine providers can't confirm billing, and pharmacies in over a dozen states require prescriptions until the Advisory Committee on Immunization Practices issues guidance.
- Leading medical groups like the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists maintain vaccination recommendations, while experts warn recent changes could reduce uptake and manufacturers shipped doses immediately after approval.
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As 2025 COVID vaccines become available, FDA guidance has changed. Here's what to know
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