CHMP Recommends Moderna's mCombriax Flu-COVID Vaccine for Adults 50+

On February 26, 2026, the EMA's CHMP recommended marketing authorization for Moderna's mCombriax (mRNA-1083), the first mRNA combination vaccine against COVID-19 and seasonal influenza for adults aged 50 and older.245

The recommendation is based on phase III trial data from ~8,000 adults showing mCombriax elicits non-inferior or superior antibody responses compared to separate Spikevax + Fluzone HD or Fluarix vaccines.234

If approved by the European Commission, mCombriax will be Moderna's fourth EU-marketed product; common side effects include injection site pain, fatigue, headache, and fever.145

No search results confirm recent CHMP recommendation for a Novartis hives (urticaria) pill; available news focuses solely on Moderna's vaccine.12345

Sources:

1. https://www.fiercepharma.com/pharma/after-chmp-nod-moderna-ceo-applauds-eus-rigorous-scientific-review

2. https://www.europeanpharmaceuticalreview.com/news/271745/first-mrna-covid-19-flu-combination-vaccine-european-approval/

3. https://www.zacks.com/stock/news/2877232/mrna-stock-gains-after-chmp-endorses-covid-19-influenza-combo-shot

4. https://www.ema.europa.eu/en/news/first-combined-covid-19-influenza-vaccine-people-50-years-older

5. https://www.ema.europa.eu/en/medicines/human/EPAR/mcombriax