Europe Approves Moderna's First Combination mRNA Vaccine for Flu and COVID-19
Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine
Ars Technica
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Moderna's combination vaccine, mRNA-1083 (mCOMBRIAX), has been authorized for use in Europe, marking it as the world's first approved shot targeting both flu and COVID-19. This vaccine aims to simplify immunization for high-risk adults, while the U.S. has yet to approve it.
- 01mCOMBRIAX is the first authorized combination vaccine for flu and COVID-19.
- 02The European Commission approved the vaccine following a positive review from the European Medicines Agency.
- 03The vaccine aims to simplify immunization for adults, especially those at high risk.
- 04Clinical trials showed mCOMBRIAX produced higher immune responses against common flu strains and SARS-CoV-2.
- 05The vaccine is still pending approval in the U.S., where it was developed.
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Moderna's mRNA-1083, branded as mCOMBRIAX, has received authorization from the European Commission, becoming the first combination vaccine approved for both influenza and COVID-19. This decision follows a favorable review from a committee of the European Medicines Agency in February. Moderna's CEO, Stéphane Bancel, highlighted the vaccine's potential to simplify immunization for adults, particularly those at high risk. mCOMBRIAX combines Moderna's existing COVID-19 vaccine with an investigational flu vaccine, mRNA-1010, which is still under review. The approval is based on a Phase III clinical trial involving about 4,000 adults, demonstrating statistically significant immune responses against prevalent flu strains (A/H1N1, A/H3N2, and B/Victoria) and SARS-CoV-2, with no safety concerns reported. While Europe moves forward with this innovative vaccine, it remains unapproved in the U.S.
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The approval of mCOMBRIAX could enhance immunization efforts in Europe, particularly benefiting high-risk adults by providing a single-dose option against two viruses.
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