CHMP Recommends Moderna’s LP.8.1-Targeting COVID-19 mRNA Vaccine for 2025-2026 Season
CAMBRIDGE, MA – July 28, 2025 – Moderna, Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for its updated mRNA COVID-19 vaccine. The vaccine is specifically designed to target the SARS-CoV-2 variant LP.8.1, aligning with global health authority guidance for the upcoming 2025-2026 vaccination season.
The recommendation supports the vaccine’s use in individuals aged six months and older. A final decision on marketing authorization from the European Commission is now pending.
Stéphane Bancel, Chief Executive Officer of Moderna, emphasized the importance of the milestone: “The CHMP’s positive opinion on our updated mRNA COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1 is an important step in our ongoing effort to protect people across the European Union. COVID-19 continues to place a significant burden on vulnerable populations and healthcare systems. Updated vaccines can be an important tool for protecting individuals and societies.”
The CHMP’s decision was based on a comprehensive review of manufacturing and preclinical data, supplemented by extensive prior clinical, non-clinical, and real-world evidence supporting the safety and efficacy of Moderna’s COVID-19 vaccines.
Moderna, founded in Cambridge, Massachusetts, has been a pioneer in mRNA technology for over a decade. The company, which developed one of the earliest COVID-19 vaccines, continues to pursue mRNA-based medicines across various infectious diseases and other therapeutic areas. The company confirmed that additional regulatory applications for the LP.8.1-targeting vaccine are currently under review in other regions.
Source:
https://pharmatimes.com/news/modernas-updated-covid-19-vaccine-receives-positive-ema-opinion/
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