The FDA has approved supplemental biologics license applications for three updated 2026-27 COVID-19 vaccines from Pfizer and BioNTech and Moderna, according to Aug. 27 news releases from the companies.
Here are five things to know:
- Pfizer and BioNTech’s Comirnaty XFG formula is approved for adults 65 and older, as well as people ages 5 through 64 with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes.
- Moderna’s updated Spikevax is approved for people ages 6 months through 64 with a high-risk underlying condition, plus all adults 65 and older. Its mNEXSPIKE shot is approved for people ages 12 through 64 with a qualifying condition, plus all adults 65 and older.
- All three updated vaccines target the JN.1-lineage XFG subvariant, in line with FDA guidance calling for formulas that more closely match currently circulating strains. The FDA’s Vaccines and Related Biological Products Advisory Committee recommended the XFG update in May, citing the fast-spreading omicron hybrid — nicknamed “stratus” — and its ability to partially evade COVID-19 antibodies. XFG.1.1, the most prevalent U.S. lineage at the time, carries 12 spike protein substitutions compared with LP.8.1, the strain in last season’s shots. This marks the second straight year the agency’s advisory committee has centered its strain recommendation on a JN.1-lineage target.
- The high-risk-only eligibility continues the narrowed approval framework the FDA laid out in May 2025, which maintained the existing approval pathway for older and high-risk Americans while requiring stronger trial data before clearing shots for healthy people under 65. The framework was one of several vaccine policy changes in 2025 under HHS Secretary Robert Kennedy Jr.
- Both companies expect the vaccines to be available in pharmacies, hospitals and clinics within days. Pfizer and BioNTech said shipments began immediately.
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