Moderna Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorisation for mCOMBRIAX (mRNA-1083) in the European Union.

mCOMBRIAX is a combination vaccine designed for active immunisation against influenza and Covid-19 caused by SARS-CoV-2 in adults aged 50 years and older. It is the first flu and Covid-19 combination vaccine globally to receive a positive CHMP opinion and marks Moderna’s fourth vaccine to achieve this milestone in Europe.

The vaccine builds on the company’s existing mRNA platform, including its authorised Covid-19 vaccine Spikevax and its investigational seasonal influenza vaccine candidate, mRNA-1010, which is under regulatory review in multiple regions.

The CHMP recommendation is supported by data from a pivotal Phase 3 clinical trial involving approximately 8,000 participants across two age cohorts. One group included adults aged 65 years and older, while the second included individuals aged 50 to 64 years. The study evaluated the safety, reactogenicity and immunogenicity of mRNA-1083 compared to co-administered licensed influenza vaccines and Spikevax.

All primary endpoints demonstrating non-inferiority of immune responses were met. Following a single dose, mRNA-1083 generated statistically significantly higher immune responses against three influenza strains—A/H1N1, A/H3N2 and B/Victoria—as well as against SARS-CoV-2 in both age groups. The only exception was the B/Yamagata strain in adults aged 65 years and older; however, this strain is no longer recommended for inclusion in seasonal influenza vaccines.

The vaccine demonstrated an acceptable safety and tolerability profile, with most reported adverse reactions classified as mild to moderate and consistent with those observed for licensed comparator vaccines.

Following the positive CHMP opinion, the European Commission will review the recommendation and is expected to issue a final decision on marketing authorisation. If approved, the authorisation will be valid across all EU Member States and European Economic Area countries, including Iceland, Liechtenstein and Norway. Moderna will subsequently engage with national authorities to support local access and implementation.

Moderna continues to expand its mRNA-based vaccine portfolio, aiming to simplify immunisation strategies and enhance protection against respiratory viruses through combination vaccine approaches.