Moderna Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use $(CHMP)$ has adopted a positive opinion recommending marketing authorization of mNEXSPIKE (mRNA-1283), a new COVID-19 vaccine, for individuals aged 12 years and older. The vaccine has already received approval from the U.S. FDA and Health Canada. The CHMP's decision was based on results from a Phase 3 clinical trial demonstrating mNEXSPIKE's non-inferior efficacy compared to Moderna's original COVID-19 vaccine, Spikevax. Final authorization in the European Union is pending a decision from the European Commission.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moderna Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1116408) on December 15, 2025, and is solely responsible for the information contained therein.
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