European regulators recommend approval of combined mRNA vaccine for flu and COVID

The European Medicines Agency recommended marketing authorization for mCombriax, Moderna's combined mRNA vaccine for people aged 50 and older, based on phase 3 trial data. The recommendation will go to the European Commission for a final decision and national authorities would decide any rollout.

European regulators have recommended marketing authorization for mCombriax, Moderna's combined mRNA vaccine intended to protect older adults against COVID-19 and seasonal influenza. The EMA's Committee for Medicinal Products for Human Use reviewed data from a phase 3 trial and issued the positive opinion. The trial involved about 8,000 participants aged 50 and older. The EMA said the vaccine would provide an option of a single shot to protect against both illnesses. Key facts: - EMA recommended granting a marketing authorization in the EU for mCombriax (mRNA-1083). - The recommendation was based on a phase 3 trial involving about 8,000 participants aged 50 and older. - Trial results were reported as showing non-inferior immune responses versus Moderna's licensed COVID-19 vaccine (Spikevax) and authorized flu vaccines (Fluzone and Fluarix). - If the European Commission adopts the recommendation, the vaccine would be authorized for use across the European Union and would offer a single-shot option for both viruses. - Moderna's CEO Stéphane Bancel said the opinion represents an important milestone and highlighted the potential of combination vaccines. Summary: If adopted by the European Commission, the authorization would permit EU-wide marketing of the combined mRNA COVID-19 and influenza vaccine and add an option for national vaccination programs. The decision now moves to the European Commission for final adoption, and national authorities will determine any rollout.