The European Commission has authorized Moderna's mRNA-based combination vaccine against flu and COVID-19, making it the world's first approved shot for both respiratory viruses. The vaccine, called mCOMBRIAX (mRNA-1083), received regulatory approval this week following a positive review from the European Medicines Agency's committee in February.

The combination vaccine merges Moderna's existing COVID-19 vaccine with an investigational influenza vaccine (mRNA-1010) still under European review. Phase III trial data from around 4,000 adults showed statistically significant stronger immune responses against common flu strains (A/H1N1, A/H3N2, and B/Victoria) and SARS-CoV-2 compared to standard and high-dose flu vaccines, with no safety concerns.

The approval starkly contrasts with the US situation, where Moderna withdrew its FDA application last year amid the political landscape shaped by Health and Human Services Secretary Robert F. Kennedy Jr.'s anti-vaccine agenda. CEO Stéphane Bancel noted the vaccine simplifies immunization for high-risk adults while offering "an important new option for Europeans."