FDA approves updated 2026-2027 Spikevax and mNEXSPIKE COVID-19 vaccines

The FDA approved Moderna's updated 2026-2027 COVID-19 vaccines, Spikevax and mNEXSPIKE, which both target the JN.1-lineage XFG subvariant. Spikevax is approved for adults 65 and older and for people aged 6 months to 64 with a high-risk condition. mNEXSPIKE covers adults 65 and older and people aged 12 to 64 with a high-risk condition. The approval sets up the 2026-2027 season, when COVID-19 vaccine sales are seasonal and drive most of Moderna's revenue.

• Both vaccines updated to the JN.1-lineage XFG subvariant, a single-strain formula
• Spikevax: adults 65 and older, plus people aged 6 months to 64 with a high-risk condition
• mNEXSPIKE: adults 65 and older, plus people aged 12 to 64 with a high-risk condition
• Availability expected in the coming days after the decision