The US FDA has approved updated 2026-2027 formulations of both Spikevax and mNexspike (COVID-19 Vaccine, mRNA) from Cambridge, Massachusetts-based Moderna (Nasdaq: MRNA), covering the JN.1-lineage XFG subvariant of SARS-CoV-2. The approvals, via supplemental Biologics License Applications (sBLA), extend Moderna's annual COVID-19 vaccine update cycle into the 2026-2027 respiratory season, with the company reporting that COVID-19 was responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the US in the prior year.
The updated Spikevax formula is approved for all adults ≥65 and people aged 5–64 with at least one underlying high-risk condition. Mnexspike — Moderna's next-generation mRNA COVID-19 vaccine — carries a narrower age indication, covering individuals aged 12 through 64 at high risk, plus all adults 65 and older. Both formulations were updated per FDA guidance specifying a monovalent JN.1-lineage XFG subvariant composition.
Both vaccines use lipid nanoparticle-delivered mRNA, but differ in their antigen design. Spikevax encodes the full-length SARS-CoV-2 spike protein, while mNexspike uses Moderna's next-generation construct encoding linked receptor-binding and N-terminal domains of spike. The press release did not report specific immunogenicity or tolerability data for the XFG formulations.