The European Commission has approved Moderna’s mCOMBRIAX, the first combined mRNA vaccine for influenza and COVID-19 in adults aged 50 and older, supported by Phase 3 data.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
The European Commission has granted marketing authorization for mCOMBRIAX® (mRNA-1083), a combination mRNA vaccine developed by Moderna, Inc. for the prevention of influenza and COVID-19 in individuals aged 50 years and older.
The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is valid across all European Union member states as well as Iceland, Liechtenstein, and Norway.
The authorization is supported by results from a Phase 3 randomized, observer-blind trial involving approximately 8,000 participants across two age groups (50–64 years and ≥65 years), where mRNA-1083 was compared with co-administered influenza and COVID-19 vaccines, including Fluzone HD®/Efluelda®, Fluarix®, and Spikevax®.
The vaccine met all primary endpoints, demonstrating non-inferior immune responses, with significantly higher responses observed against influenza strains A/H1N1, A/H3N2, and B/Victoria, as well as SARS-CoV-2 in both cohorts; no higher response was seen for the B/Yamagata strain in older adults, which is no longer included in seasonal vaccines.
The safety profile was acceptable, with most adverse events reported as mild to moderate and consistent with existing licensed vaccines.
mCOMBRIAX is Moderna’s fourth authorized product and builds on prior programs including mNEXSPIKE® and the investigational influenza vaccine mRNA-1010, currently under review in multiple regions.
The company stated that the combination approach is intended to simplify immunization, particularly for higher-risk populations, by offering protection against two respiratory viruses in a single dose.
Stéphane Bancel, Chief Executive Officer of Moderna stated that the approval of mCOMBRIAX marks the introduction of the first combined influenza and COVID-19 vaccine, designed to simplify immunization for adults particularly high-risk groups by providing dual protection in a single dose, while supporting healthcare system resilience in Europe.
The vaccine will be rolled out across the European Union in line with national regulatory and access procedures, with coordination between the company and local health authorities.
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About the Writer
Karthik Teja, Pharm.D is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.