Moderna Secures FDA Approval for 2026 Vaccines, Targeting XFG Variant

The U.S. Food and Drug Administration (FDA) approved Moderna’s Spikevax and mNEXSPIKE vaccines on August 27, 2026. These updated formulations target the dominant XFG variant of the JN.1 lineage following FDA advisory panel recommendations. The FDA also authorized concurrent shots from Pfizer-BioNTech and Novavax-Sanofi for the 2026-2027 season.

Spikevax is approved for high-risk individuals aged six months and older and all adults over 65. The mNEXSPIKE vaccine is cleared for high-risk individuals aged 12 to 64 and all adults 65 and older. Moderna expects the vaccines to be available within days for the fall and winter respiratory season.