Europe—not US—first to authorize Moderna’s combo mRNA flu-COVID vaccine

Moderna has received approval in Europe for its groundbreaking mRNA-based vaccine that targets both COVID-19 and influenza, while the United States has yet to grant similar authorization. This week, the European Commission officially allowed Moderna to market the combination vaccine, known as mRNA-1083 or mCOMBRIAX, marking a significant milestone as it becomes the first authorized dual vaccine for these respiratory illnesses worldwide. The approval follows a favorable review in February by a critical committee of the European Medicines Agency, which set the stage for this historic decision. Stéphane Bancel, CEO of Moderna, expressed enthusiasm over the development, stating, "By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk." He emphasized that mCOMBRIAX presents a vital new option for Europeans and aims to bolster the healthcare systems across the continent. mCOMBRIAX merges Moderna’s existing COVID-19 vaccine with an investigational flu vaccine, mRNA-1010, which is still under review in Europe. The authorization was based on results from a Phase III clinical trial involving approximately 4,000 adults. This trial included two groups: one consisting of participants aged 50 to 64, which compared mCOMBRIAX to a standard flu vaccine, and another group of individuals aged 65 and older, which compared it to a high-dose flu vaccine. Notably, mCOMBRIAX demonstrated statistically significant immune responses against prevalent flu strains—A/H1N1, A/H3N2, and B/Victoria—as well as against SARS-CoV-2, outperforming the comparator vaccines in both age groups. Importantly, the trial raised no safety concerns or adverse event reports, further solidifying the vaccine's promising profile.