EU regulator backs Moderna’s first combined COVID-19 and flu shot for older adults

Europe’s drug regulator has endorsed the world’s first vaccine designed to protect older adults against both COVID-19 and seasonal influenza with a single shot, a move that could reshape autumn vaccination campaigns across the continent.

EMA recommendation and what comes next

On Feb. 27, the European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use (CHMP) recommended granting a European Union-wide marketing authorization for mCombriax, a combined mRNA vaccine developed by Moderna Biotech Spain S.L. The product is intended for people 50 and older.

“EMA has recommended granting a marketing authorisation in the European Union (EU) for mCombriax, a messenger RNA vaccine for protecting people aged 50 years and older against COVID-19 and seasonal influenza (flu),” the agency said in a statement.

The CHMP opinion now goes to the European Commission, which will decide in the coming weeks whether to grant a legally binding EU marketing authorization. National governments would then determine how, and for whom, to use the shot.

If cleared, the vaccine would be offered as a single injection to replace separate COVID-19 and flu jabs in eligible adults, potentially simplifying immunization campaigns and making it easier for older people to stay up to date on both vaccines.

EMA emphasized the step is not the final decision. The Commission almost always follows CHMP recommendations, but it is not formally bound to do so.

Trial results and side effects

The recommendation follows a Phase 3 clinical trial in roughly 8,000 adults aged 50 and over. Participants were randomly assigned to receive either the combination shot or separate doses of Moderna’s Spikevax COVID-19 booster and an approved seasonal flu vaccine.

Regulators focused on immunogenicity—the strength of the immune response—as a proxy for real-world protection. EMA said antibody levels against both influenza strains and SARS‑CoV‑2 in people who received mCombriax were at least as strong as those in people who received the two vaccines separately, meeting pre-set criteria for non-inferiority.

Moderna said the combination vaccine produced “statistically significantly higher immune responses” against three seasonal flu strains and SARS‑CoV‑2 than the licensed flu and COVID vaccines given together.

Common side effects were similar to those seen with existing mRNA vaccines. More than one in 10 recipients experienced injection-site pain, fatigue, muscle aches, joint pain, headache, chills, swollen lymph nodes, nausea or vomiting, and fever. Most symptoms began within two days and resolved within about three days, according to EMA.

EMA’s public summary did not highlight new major safety concerns, describing the safety profile as consistent with known mRNA flu or COVID-19 vaccines.

How the combination shot works

The vaccine delivers strands of messenger RNA inside lipid particles. Once injected, the mRNA instructs human cells to briefly produce parts of two viruses: a portion of the SARS‑CoV‑2 spike protein and the hemagglutinin surface protein from three influenza strains—A(H1N1), A(H3N2) and B/Victoria. The immune system then mounts a response so it can recognize and fight off the viruses later.

EMA said the components are expected to be updated periodically, similar to how seasonal flu shots and updated COVID-19 boosters are revised to match circulating viruses.

Public health impact and rollout questions

The decision marks the first time a major regulator has backed a single vaccine to prevent both viruses, which together account for tens of millions of symptomatic infections in Europe each year and place heavy pressure on hospitals every winter.

COVID-19 has caused more than 281 million reported cases in Europe as of Feb. 1, and continues to generate waves of infections. Seasonal influenza leads to as many as 50 million symptomatic cases each year in the European Economic Area. Older adults and people with weakened immune systems face the highest risk of hospitalization and death from both diseases.

For health systems, a combination vaccine could ease logistics by allowing clinics and pharmacies to offer a single appointment and injection—an attractive prospect as “vaccine fatigue” has dampened enthusiasm for repeat COVID-19 boosters in many countries.

EMA framed the product as an additional tool rather than a replacement for existing options, calling it “one more option for national authorities to consider for vaccination campaigns against COVID‑19 and influenza.”

Regulatory divergence and Moderna’s strategy

The European recommendation also comes amid differing regulatory approaches to next-generation mRNA vaccines. Earlier in February, the U.S. Food and Drug Administration initially refused to file Moderna’s application for a standalone mRNA flu vaccine, seeking more data in older adults, before later agreeing to move forward after additional commitments from the company.

Moderna has invested heavily in combination products as it looks to broaden its portfolio beyond its pandemic-era Spikevax vaccine.

“The CHMP’s positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine,” Chief Executive Stéphane Bancel said.

What happens if it’s approved

Even with European Commission authorization, major decisions would still fall to individual EU and European Economic Area countries: whether to incorporate mCombriax into national schedules, which age bands or risk groups to prioritize, and how to fund purchases. Pricing and supply agreements could determine whether the vaccine becomes a default option or a niche product.

Still, the recommendation signals how quickly mRNA technology has moved—from emergency pandemic vaccines to the threshold of a seasonal combination shot aimed at two of the main respiratory threats facing Europe’s aging population. How governments, clinicians and patients respond will help determine whether a “one shot for winter” model becomes routine.