EU backs Moderna COVID-flu combo shot

BRUSSELS, March 3, 2026 — Europe’s medicines regulator has recommended approval of Moderna’s combined COVID‑19 and influenza vaccine, mCombriax, for adults 50 and older, a move that would make a single shot available for two seasonal respiratory threats if the European Commission signs off. Reuters and the European Medicines Agency said the recommendation came from the EMA’s human medicines committee.

The endorsement positions mCombriax as the first combined COVID‑19/flu vaccine in Europe, and Moderna said availability could begin in some EU markets for the 2026–27 season, with broader access once current procurement contracts lapse in 2027, according to Reuters.

Evidence behind the recommendation

The EMA said its recommendation relied on a phase 3 trial involving about 8,000 participants aged 50 and older, showing non‑inferior immune responses compared with separate COVID‑19 and flu shots. The EMA and CIDRAP reported the study compared mCombriax against Moderna’s authorized COVID‑19 vaccine and standard or high‑dose influenza vaccines.

According to the EMA, the vaccine uses mRNA instructions for SARS‑CoV‑2 and seasonal influenza strains, and the composition is expected to be updated regularly to track circulating variants, as is standard for flu shots.

Why it matters for Moderna

Moderna called the recommendation a milestone for respiratory virus vaccination, saying combination vaccines could simplify immunization for older adults. The company’s statement, carried by PharmiWeb, said the shot would be the company’s fourth vaccine product in Europe if approved.

The U.S. pathway has been more complicated. BioPharma Dive noted Moderna withdrew its U.S. application to gather additional data for the flu component, while Reuters reported the company is still seeking guidance on refiling after FDA concerns.

What comes next

The EMA emphasized that older adults face higher risks from severe respiratory illness and that co‑infection can worsen outcomes, a key rationale for a combined shot. Details on that risk profile and the agency’s clinical rationale were outlined in the EMA release.

For Moderna, the decision offers a potential new growth line as COVID‑19 vaccine demand has cooled. Both Reuters and BioPharma Dive described the company’s reliance on international markets to stabilize revenues.

The recommendation now moves to the European Commission for a final decision, and national authorities will determine how and for whom the vaccine is rolled out. The EMA and CIDRAP said that approval would open the door for country‑level immunization planning ahead of future seasons.

How we report: We select the day’s most important stories, confirm facts across multiple reputable sources, and avoid anonymous sourcing. Our goal is clear, balanced coverage you can trust—because transparency and verification matter for informed readers.