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FDA Approves Targeted 2025–26 COVID Vaccines, Limits Access to Seniors and High-Risk Groups

The risk‑based shift leaves coverage and rollout uncertain pending CDC guidance.

Overview

  • Pfizer, Moderna and Novavax won approvals for updated shots that are broadly available to adults 65 and older and restricted to younger people with at least one qualifying condition, with age bands of Moderna 6 months+, Pfizer 5+, and Novavax 12+ for high‑risk use.
  • FDA rescinded multiple emergency authorizations, including Pfizer’s under‑5 clearance, leaving Moderna as the only option for high‑risk children 6 months to 4 years.
  • The vaccines are formulated against the LP.8.1 subvariant within the JN.1 lineage, and manufacturers say shipments begin immediately or within days.
  • Practical access remains uncertain as eligibility verification, pharmacy workflows and insurer coverage are unresolved, and some under‑65 patients may face out‑of‑pocket costs.
  • Medical societies including the American Academy of Pediatrics and the Infectious Diseases Society of America are urging broader access as a newly reconstituted CDC advisory panel is expected to meet in September.