Spikevax and mNEXSPIKE - (LP.8.1 variant)

August 27, 2026: Moderna, Inc. (NASDAQ: MRNA) said the FDA approved supplemental BLAs for the 2026-2027 formulas of Spikevax and mNEXSPIKE, both updated to contain the JN.1-lineage XFG SARS-CoV-2 subvariant for COVID-19 prevention.

Spikevax is approved for people age 6 months through 64 years with at least one underlying condition that increases risk of severe COVID-19, and for all adults 65 and older. mNEXSPIKE is approved for people age 12 through 64 years with at least one underlying high-risk condition, and for all adults 65 and older.

The company said the updated vaccines were developed in line with FDA guidance for a monovalent JN.1-lineage XFG composition and are expected to be available in the coming days for the respiratory virus season.

Outside the U.S., the 2026-2027 Spikevax formula has already been approved in Europe, South Korea, Singapore, Switzerland, the United Kingdom, and other countries; the 2026-2027 mNEXSPIKE formula has been approved in Japan. Moderna said additional regulatory applications are under review globally.