Moderna (NASDAQ:MRNA) secured a landmark regulatory victory on Friday as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for mCOMBRIAX (mRNA-1083).
If authorized by the European Commission, the vaccine will become the first messenger RNA combination shot in the world to protect against both seasonal influenza and COVID-19 in a single injection.
The recommendation is specifically for adults aged 50 and older.
The committee’s decision was underpinned by data from a pivotal Phase 3 clinical trial involving approximately 8,000 participants.
In the study, mCOMBRIAX demonstrated statistically significantly higher immune responses against three seasonal influenza strains and SARS-CoV-2 compared to currently licensed vaccines administered separately.
The safety profile was reported as acceptable, with the most common reactions—such as injection site pain and fatigue—consistent with established vaccines.
The endorsement marks a strategic milestone for the Cambridge, Massachusetts-based biotech as it seeks to offset declining pandemic-era revenue with a recurring seasonal portfolio.
mCOMBRIAX is poised to become Moderna’s fourth marketed product in Europe, joining its original COVID-19 vaccine Spikevax, its respiratory syncytial virus (RSV) shot mRESVIA, and its next-generation COVID-19 vaccine mNEXSPIKE, which received European Commission authorization on February 17, 2026.
Final marketing authorization now rests with the European Commission, a decision typically rendered within two months of a CHMP recommendation.