MRNA · 10-Q · 2026Q3 · Full report

Product Launch and Transition

Moderna, Inc. · 2026-11-06 · Importance 33 · Surprise 42

Moderna launched mFLUSIVA, its seasonal influenza vaccine, in the United States in September 2026 for the 2026–2027 respiratory virus season after FDA approval for adults aged 50 and older. The vaccine was also approved in Canada and remained under regulatory review in the European Union, Australia, and Taiwan. U.S. sales were immaterial in the quarter because the launch followed the start of the influenza contracting season, and uptake for the season remained uncertain. Moderna also received Canadian approval for mCOFLU, its flu-plus-COVID combination vaccine, which is marketed as mCOMBRIAX in the EU; it had not yet been commercialized as of September 30, 2026.

Key facts

• Moderna launched commercial sales of mNEXSPIKE in the third quarter of 2025. source
• The European Commission approved mCOMBRIAX in April 2026 for prevention of influenza disease and COVID-19 in adults 50 years and older. source
• The FDA approved mFLUSIVA in August 2026 for prevention of influenza disease in adults 50 years and older, and Moderna launched commercial sales in September 2026. source
• In August 2026, the FDA approved mFLUSIVA for adults 50 years of age and older. source
• Moderna launched mFLUSIVA commercial sales in the United States in September 2026 for the 2026–2027 respiratory virus season. source
• As of September 30, 2026, mCOMBRIAX had not been commercialized; mFLUSIVA net product sales were immaterial for the quarter, reflecting launch timing and uncertainty about seasonal uptake. source
• As of September 30, 2026, mCOMBRIAX had not been commercialized. source
• As of September 30, 2026, Moderna had five approved products: Spikevax, mNEXSPIKE, mRESVIA, mCOMBRIAX and mFLUSIVA. source