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FDA Approves 2025–26 COVID Boosters, Limits Routine Use to Seniors and High‑Risk Patients

CDC has not issued recommendations, leaving insurance coverage unclear.

Overview

  • Shots from Pfizer-BioNTech, Moderna and Novavax are cleared for all adults 65 and older, with younger people eligible only if they have at least one qualifying condition, with age cutoffs of 6 months for Moderna, 5 years for Pfizer and 12 years for Novavax.
  • The FDA revoked Pfizer’s emergency authorization for children under 5, leaving Moderna as the only option for that age group and only for kids with high‑risk conditions.
  • Insurers are not uniformly committing to coverage without CDC guidance, with Kaiser Permanente saying it will fully cover the shots as others signal they will follow applicable law; patients could face costs of about $150 or more if not covered.
  • Access may require a physician visit or documentation of risk, and pharmacists often cannot verify eligibility, even as Pfizer begins shipping immediately and Moderna says doses will be available within days.
  • The vaccines target the LP.8.1 lineage within JN.1, and professional groups including the American Academy of Pediatrics and the Infectious Diseases Society of America are urging broader vaccination than the FDA labels allow.