News/Regulation/May 28, 2026

FDA advisers back a monovalent XFG COVID-19 vaccine formula for fall 2026

The FDA's vaccine advisory committee recommended a monovalent JN.1-lineage XFG strain for US COVID-19 vaccines for the 2026-2027 season, and the FDA told manufacturers to make that formula. The change affects all US-licensed COVID-19 shots, which is the revenue base of Moderna's Spikevax and mNEXSPIKE. Fall 2026 sales will depend on timing of approvals of the updated formula.

  • Committee recommended XFG, a JN.1-lineage variant, as the preferred antigen
  • FDA recommends a monovalent JN.1-lineage XFG formula for use in the US from fall 2026
  • Applies to US-licensed COVID-19 vaccines, including Spikevax and mNEXSPIKE
Source
US Food and Drug Administration
May 28, 2026
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