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FDA Approves Updated COVID-19 Vaccines for Fall 2026 Season

The FDA has approved updated COVID-19 vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech, all targeting the JN.1-lineage XFG subvariant now driving the majority of cases. The companies announced approval yesterday, with eligibility limited to adults 65 and older and younger individuals with an underlying condition that raises their risk of severe disease.
Approved age ranges vary by product:
  • Pfizer (Comirnaty XFG): ages 65+, and 5–64 with an underlying condition. Distribution to pharmacies is already underway.
  • Moderna (Spikevax): ages 65+, and 6 months–64 with an underlying condition. Its lower-dose formulation, mNEXSPIKE, is approved for ages 65+ and 12–64 with an underlying condition.
  • Sanofi (Nuvaxovid, non-mRNA, originally licensed by Novavax): ages 65+, and 12–64 at high risk for severe COVID-19.
The CDC lists a range of qualifying conditions, including asthma, cancer, chronic lung or kidney disease, obesity, pregnancy, and mental illness. Facilities may want to flag this update for residents and staff now, particularly as the CDC reports COVID-19 activity is growing or likely growing in 48 states.
 
 
Staff contact: mcarland[at]mehca.org