The European Medicines Agency (EMA) has recommended granting marketing authorization to the combined influenza and COVID-19 messenger RNA (mRNA) vaccine, mCombriax (Moderna), for people aged 50 years and older. It is the first of its kind to be approved in Europe. The opinion will now be sent to the European Commission to decide upon EU-wide marketing authorization. 

According to the World Health Organization, there have been close to 282 million cases of COVID-19 in Europe as of February 8, 2026. Deaths from COVID-19, however, have fallen sharply since the pandemic: from a peak of more than 42,000 in January 2021 to less than 100 per week across the continent since February 2025. 

Meanwhile, there are up to 50 million symptomatic cases of seasonal influenza each year in the European Economic Area and between 15,000 and 70,000 influenza-related deaths.

While most cases of COVID-19 and influenza are mild to moderate, severe cases can happen, especially among older people and those with compromised immune systems. Co-infection of influenza virus and SARS-CoV-2 can lead to more severe disease than infection of either alone. 

mCombriax contains mRNA that encode parts of the SARS-CoV-2 spike protein as well as the full-length, membrane-bound hemagglutinin glycoproteins of seasonal influenza virus types A (H1N1 and H3N2) and B (Victoria lineage). 

The EMA recommendation comes after a phase 3 randomized trial involving 8015 participants aged 50 years and older who either received mCombriax plus placebo or were co-administered two usual-care flu and COVID vaccines. 

Twenty-nine days after vaccination, those vaccinated with mCombriax exhibited antibody levels against influenza and SARS-CoV-2 that were statistically noninferior to those who received the co-administered vaccines. The study also found that mCombriax induced higher immune responses than alternative treatments. 

Overall, no safety concerns were identified for mCombriax, and it was found to have acceptable tolerability and safety profile. Although adverse reactions were slightly higher in frequency and severity in those who took mCombriax, most were mild to moderate and short in duration. Reactions included injection site pain, fatigue, myalgia, headache, arthralgia, chills, lymphadenopathy, nausea/vomiting, and pyrexia.

mCombriax will be available as a dispersion for injection in pre-filled syringes. Use of the vaccine should happen in accordance with official recommendations. 

Detailed recommendations for using mCombriax will be published in the summary of product characteristics, which will be available on the EMA website in all official European Union languages once the European Commission has granted the drug marketing authorization. 

Annie Lennon is a medical journalist. Her writing appears on Medscape, WebMD, and Medical News Today, among other outlets.