EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's mNEXSPIKE (COVID-19 Vaccine, mRNA)

mNEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and mRESVIA (Respiratory Syncytial Virus Vaccine)

mNEXSPIKE will be available in the European Union, subject to authorization by the European Commission

CAMBRIDGE, MA / ACCESS Newswire / December 15, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization of mNEXSPIKE (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. Following the CHMP's positive opinion, the European Commission will make a marketing authorization decision.

The CHMP's positive opinion for mNEXSPIKE reflects Moderna's continued commitment to advancing innovative vaccines that protect the most vulnerable," said Stéphane Bancel, Chief Executive Officer of Moderna. "Across Europe, adults aged 65 and older remain disproportionately affected by severe COVID outcomes, and if authorized, mNEXSPIKE will be another important tool in addressing this ongoing public health need. Europe represents a significant market for respiratory virus vaccines, and we are excited about the opportunity to drive sales growth in 2026 and 2027 through this potential new product launch and geographic diversification. I want to thank our teams for their exceptional work and the EMA for its thorough assessment."

Across Europe, COVID-19 continues to persist year-round, with periodic case increases driven by waning immunity and the emergence of new Omicron-lineage variants, as demonstrated through the European Centre for Disease Prevention and Control's (ECDC) respiratory virus surveillance system.^[1] These trends confirm that COVID-19 has become an established, endemic respiratory pathogen in the region, requiring targeted protection for vulnerable populations.

The CHMP's positive opinion for mNEXSPIKE is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.

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