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FDA Approves 2025–26 COVID Vaccines, Restricts Use to Seniors and High-Risk Groups

Access will largely depend on CDC recommendations that have not yet been issued.

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Four vials with the "Nuvaxovid" COVID-19 vaccine from Novavax are pictured in Saabruecken, Germany, February 26, 2022. REUTERS/Frank Simon/File Photo

Overview

  • Pfizer, Moderna and Novavax won FDA approval for LP.8.1-targeted shots, with broad access for adults 65+ and limited use for younger people who have at least one qualifying condition.
  • Manufacturer rules differ: Moderna is cleared for high-risk patients 6 months–64 years, Pfizer for high-risk 5–64, and Novavax for high-risk 12–64, with all three available to those 65 and older.
  • Pfizer’s emergency authorization for children under 5 was rescinded, leaving Moderna as the only mRNA option for the youngest children and only for those with serious health problems.
  • Insurance coverage is uncertain without CDC guidance; Kaiser Permanente says it will fully cover the shots, while other major insurers offered limited or no commitments.
  • Major medical groups including the American Academy of Pediatrics and ACOG issued broader recommendations for children and pregnant patients, as pharmacies and clinics face documentation and state-authorization hurdles during rollout.