The European Commission granted marketing authorization for mCombriax (messenger RNA [mRNA]-1083), a combined influenza and COVID vaccine developed by Moderna. This decision marks the first global approval of a single vaccine designed to protect against both seasonal influenza and COVID.

The decision issued on April 22, 2026, followed a positive opinion issued in February 2026 from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

mCombriax is an mRNA vaccine indicated for adults aged 50 years or older for active immunization against influenza and COVID. mCombriax is available in the form of a suspension in a prefilled syringe.

Vaccine Design

The vaccine contains mRNA sequences encoding hemagglutinin glycoproteins from influenza A strains H1N1 and H3N2 and the influenza B/Victoria lineage, together with components of the SARS-CoV-2 spike protein. The mechanism of action is based on inducing an immune response against these viral antigens, enabling protection against both influenza and SARS-CoV-2 infections with a single formulation.

Phase 3 Data

The European authorization is based on a pivotal phase 3 randomized, double-blind trial that compared mRNA-1083 with coadministration of standard- and high-dose influenza vaccines and a reference COVID vaccine.

Two cohorts were included: 4017 adults aged 65 years or older and 3998 adults aged 50-64 years. The median ages were 70 years and 58 years, respectively.

The combined vaccine met the primary endpoints of immunologic noninferiority compared with the individual administration of the vaccines. It also generated higher immune responses than those generated by:

• A standard-dose quadrivalent influenza vaccine in adults aged 50-64 years across all four influenza strains
• A high-dose quadrivalent influenza vaccine in adults aged 65 years or older across three strains: A/H1N1, A/H3N2, and B/Victoria
• A SARS-CoV-2 vaccine across both age groups

No superiority was observed for the influenza B/Yamagata strain, which is no longer included in the current seasonal vaccine formulations.

Safety Profile

The safety profile of mCombriax was acceptable. The most commonly reported adverse events included pain at the injection site, fatigue, myalgia, headache, arthralgia, chills, lymphadenopathy, nausea, vomiting, and fever.

The median time to onset was 2 days, with a median duration of 3 days. Events that were mostly mild to moderate were more frequent and generally more severe than in comparators in both age groups (≥ 65 years: 83.5% vs 78.1%; 50-64 years: 85.2% vs 81.8%).

Public Health Impact

The composition of mCombriax will be updated regularly to reflect circulating viral strains.

The use of the mCombriax vaccine must align with national and EU recommendations, which will be specified in the summary of product characteristics.

Availability will vary depending on country-specific pricing and reimbursement decisions.

Regulatory development is ongoing in the US. Moderna previously withdrew its authorization application and is awaiting additional efficacy data for its influenza vaccine candidate, mRNA-1010.

This story was translated from Univadis France, part of the Medscape Professional Network.