Moderna Inc. (NASDAQ: MRNA) announced the European Commission granted marketing authorization for mCOMBRIAX, its mRNA combination vaccine for influenza and COVID-19 prevention in individuals 50 years and older.

The authorization follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and applies to all 27 European Union member states, plus Iceland, Liechtenstein and Norway. mCOMBRIAX represents Moderna's fourth authorized product.

The approval is based on results from a Phase 3 clinical trial involving approximately 8,000 adults across two age cohorts. The study compared mCOMBRIAX to co-administered licensed vaccines including high-dose and standard-dose influenza vaccines alongside Moderna's COVID-19 vaccine Spikevax.

The trial met all primary endpoints demonstrating non-inferiority of immune responses. Following a single dose, mCOMBRIAX produced statistically higher immune responses against three influenza virus strains and SARS-CoV-2 in both age groups compared to the separate vaccines given together.

The vaccine demonstrated an acceptable safety profile, with most adverse reactions being grade 1 or 2 in severity and consistent with the licensed comparator vaccines used in the trial.

"By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk," said CEO Stéphane Bancel.

mCOMBRIAX will be available across the European Union subject to national regulatory and access procedures. Moderna stated it will work with national authorities to support local access and implementation.