MRNA · 10-Q · 2026Q2 · Full report

Regulatory Approval Milestones

Moderna, Inc. · 2026-07-31 · Importance 38 · Surprise 60 · In source text

The European Commission authorized mCOMBRIAX, Moderna’s influenza-plus-COVID vaccine, for individuals aged 50 and older in April 2026. The authorization is valid across all 27 European Union member states, Iceland, Liechtenstein and Norway, subject to national regulatory and access procedures; the product had not yet been commercialized as of June 30, 2026. Moderna’s mRNA-1010 seasonal flu vaccine received a unanimous positive recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee for adults aged 50 through 64 and adults 65 and older. Regulatory filings for mRNA-1083 are under review in Japan, Canada and Australia, while mRNA-1010 filings are under review in Europe, Canada and Australia.

Key facts

• In June 2026 the FDA VRBPAC voted unanimously that the benefits of mRNA-1010 outweigh its risks for prevention of influenza disease in adults 50 through 64 and 65 and older, and the FDA assigned a PDUFA goal date of August 5, 2026 for Moderna, Inc.'s BLA for mRNA-1010. source
• In April 2026 Moderna, Inc. received marketing authorization from the European Commission for mCOMBRIAX (mRNA-1083) for prevention of influenza disease and COVID-19 in individuals 50 years of age and older, valid in all 27 EU member states, Iceland, Liechtenstein and Norway. source
• mRESVIA was approved by the FDA in May 2024 for adults aged 60 years and older. source
• mRESVIA's approved use was expanded in June 2025 to include adults aged 18 through 59 years who are at increased risk for lower respiratory tract disease caused by RSV. source
• mNEXSPIKE was approved in May 2025 for use in adults aged 65 years and older and individuals aged 12 through 64 years with at least one underlying risk factor. source
• mCOMBRIAX was approved by the European Commission in April 2026 for prevention of influenza disease and COVID-19 in adults 50 years of age and older. source
• As of June 30, 2026, Moderna had four approved products: Spikevax, mNEXSPIKE, mRESVIA and mCOMBRIAX. source

Impact estimates