Moderna Wins European Backing for First-Ever Combined Flu and COVID-19 Shot

2026-02-27 companies

Amsterdam, Friday, 27 February 2026.
As the world’s first endorsed mRNA combination shot for flu and COVID-19, Moderna’s mCOMBRIAX has secured vital European backing, promising to streamline seasonal vaccinations for adults over 50.

A Regulatory Breakthrough for Respiratory Protection

On February 26, 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for mCOMBRIAX, Moderna’s (MRNA) combination vaccine [1][2]. Announced by the biotechnology company on February 27, 2026, this development marks the first time a combined messenger RNA (mRNA) vaccine targeting both influenza and COVID-19 has received such an endorsement in the European Union [1]. The vaccine, technically identified as mRNA-1083, is specifically indicated for active immunization to prevent influenza and COVID-19 in adults aged 50 years and older [2]. This recommendation positions Moderna to potentially launch its fourth marketed product in the region, contingent upon final approval [1].

Technical Composition and Mechanism

The mCOMBRIAX vaccine utilizes mRNA technology to instruct the body’s immune system to recognize specific viral markers. It contains mRNA molecules encoding the hemagglutinin glycoproteins of three seasonal influenza strains—Influenza A (H1N1 and H3N2) and Influenza B (Victoria lineage)—alongside parts of the SARS-CoV-2 spike protein [2]. By targeting these specific proteins, the vaccine aims to elicit immune responses against both respiratory viruses through a single administration, simplifying the vaccination schedule for older adults compared to the current standard of receiving separate injections [2][4].

Clinical Efficacy and Trial Data

The CHMP’s positive opinion relies on data from a Phase 3 clinical trial (NCT06097273), which evaluated the vaccine’s safety and immunogenicity in two distinct age cohorts: adults aged 65 and older, and those aged 50 to 64 [4][5]. Each cohort included approximately 4,000 participants [4]. In the study, mCOMBRIAX was compared against simultaneous administrations of authorized seasonal influenza vaccines—specifically Fluzone HD or Efluelda for the older cohort and Fluarix for the younger group—co-administered with Moderna’s own COVID-19 vaccine, Spikevax [2][4]. The results demonstrated that mRNA-1083 elicited statistically significantly higher immune responses against SARS-CoV-2 and three influenza strains (A/H1N1, A/H3N2, and B/Victoria) in both age groups [4]. However, one exception was noted: the B/Yamagata strain did not show a statistically significantly higher immune response in adults 65 years and older compared to the comparator vaccines [4][5].

Strategic Outlook and Market Impact

This regulatory milestone is a critical step for Moderna as it seeks to expand its respiratory portfolio. Stéphane Bancel, the company’s Chief Executive Officer, described the opinion as an “important milestone” for respiratory virus vaccination, highlighting the potential for mCOMBRIAX to become the world’s first approved flu plus COVID combination vaccine [1]. Following this recommendation, the European Commission will review the opinion and is expected to make a final decision regarding marketing authorization [4]. If approved, the authorization would be valid across all European Union Member States, as well as in Iceland, Liechtenstein, and Norway, allowing Moderna to collaborate with national authorities to facilitate local access [4][5].

Sources

Biotechnology Moderna