Moderna Receives U.S. FDA Approval for Updated 2026-2027 COVID-19 Vaccines

CAMBRIDGE, MA / ACCESS Newswire / August 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant of SARS-CoV-2 to help prevent COVID-19.

The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition placing them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. mNEXSPIKE, Moderna's latest COVID-19 vaccine, is approved for individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older.