FDA Authorizes Updated COVID-19 Vaccines for High-Risk Groups

WASHINGTON, Aug. 27, 2025 - U.S. regulators on Wednesday approved a new formulation of COVID-19 vaccines for the 2025-26 season but narrowed eligibility to individuals aged 65 and older and persons aged 5-64 with at least one underlying health condition. This marks a departure from prior recommendations for annual vaccination of all Americans 6 months and older.

The Food and Drug Administration granted supplemental approval to monovalent vaccines from Pfizer-BioNTech, Moderna, and Novavax, each reformulated to target the emerging LP.8.1 sublineage of SARS-CoV-2. Distribution to pharmacies, hospitals, and clinics will begin immediately, with shipments expected to arrive nationwide in the coming days.

Health and Human Services Secretary Robert F. Kennedy Jr. announced the authorization on social media platform X, stating, “FDA has now provided marketing authorization for those at increased risk” and noted that vaccines will be available to any patient who opts in after consultation with a healthcare provider.

Under the new framework:

  • Pfizer-BioNTech’s COMIRNATY® LP.8.1 is approved for adults 65+ and for individuals ages 5-64 with high-risk conditions, including asthma and obesity.
  • Moderna’s Spikevax® LP.8.1 holds the same age and risk-based restrictions, with full approval down to age 6 months granted in July 2025.
  • Novavax’s protein-based vaccine is authorized for ages 12 and older under identical high-risk criteria, continuing to offer an alternative for those averse to mRNA platforms.

Several medical organizations, notably the American Academy of Pediatrics, have criticized the tighter eligibility, warning that requiring proof of a qualifying health condition could impede access for families wishing to protect healthy children. The Centers for Disease Control and Prevention’s advisory committee is scheduled to convene in September to issue formal recommendations on vaccine use and insurance coverage.

Industry experts note that private insurers typically align coverage decisions with CDC advice. However, under the updated authorization, patients lacking high-risk status may face out-of-pocket costs exceeding $150 or must seek off-label administration through physicians willing to document risk factors.

This authorization arrives amid a midsummer resurgence of COVID-19 cases driven by evolving variants, prompting renewed calls for targeted protection of the most vulnerable populations. Health officials continue to monitor infection trends and vaccine uptake, urging eligible individuals to receive the updated formulations promptly.

Key Points

  • FDA approval restricted to adults 65+ and individuals 5-64 with underlying conditions.
  • Vaccines from Pfizer, Moderna, and Novavax reformulated for LP.8.1 strain; shipping begins immediately.
  • Critics warn new restrictions may limit access and complicate insurance coverage.
  • CDC advisory committee to review and guide implementation in September.