US EditionEuropean health agency recommends approving Moderna’s combined flu, COVID vaccine
Moderna’s mCombriax vaccine showed higher antibody levels than separate shots in trials with 8,000 participants, targeting protection for those 50 and older against COVID-19 and flu.
- Europe's medicines regulator recommended approval of Moderna's mCombriax for people aged 50 and older on Friday, advancing it toward EU authorization.
- Moderna filed in 2024 after late-stage results showed immune responses, and the EMA reviewed data showing mCombriax triggered adequate antibodies plus WHO-selected variant guidance.
- The pivotal trial directly compared mCombriax with Spikevax plus flu vaccines from GSK and Sanofi, showing recipients produced more antibodies than those given separate shots in an 8,000‑participant study.
- The CHMP's endorsement positions mCombriax for EU review as the first combined flu/COVID shot, with Moderna saying it could be available in certain EU markets for the 2026-2027 season pending European Commission ratification.
- Moderna says the combination shot is crucial for its future revenue, as U.S. regulators have asked for large‑scale efficacy data after withdrawing and refiling its application.
19 Articles
19 Articles
Europe Pushes Moderna COVID-Flu Jab
Europe’s medical regulator, the European Medicines Agency (EMA), recommended the approval of Moderna’s COVID-19-flu vaccine. According to the agency, the vaccine, called mCombriax, “triggered the production of adequate amounts of antibodies” against both COVID-19 and influenza. The mRNA vaccine is designed for those aged 50 and older against both viruses. The agency’s recommendation stems from a study involving 8,000 people age 50 and older that…
European Regulator Recommends Approving Moderna’s COVID-Flu Vaccine
Europe’s medical regulator on Feb. 27 recommended approval of Moderna’s COVID-19-influenza vaccine. Data show the vaccine, known as mCombriax, “triggered the production of adequate amounts of antibodies against both viruses,” the European Medicines Agency said in a statement. Moderna’s COVID-19 vaccine has been available in many countries since early in the COVID-19 pandemic. The company’s influenza and combination COVID-flu shots, which also ut…
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