This marketing authorization follows the positive opinion adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and marks Moderna's third product authorized in the European Union, alongside Spikevax® and mRESVIA®, further strengthening the Company's respiratory vaccine portfolio in Europe. The marketing authorization is valid in all 27 European Union Member States, as well as Iceland, Liechtenstein and Norway. Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local market access pathways.

"We welcome the European Commission's decision, which reflects the strength of the scientific data supporting mNEXSPIKE and our continued commitment to advancing innovative vaccines for populations most at risk," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 has become an endemic respiratory disease, with older adults continuing to bear a disproportionate burden of severe outcomes. Europe represents a key region for respiratory vaccines, and we are pleased to have a new vaccine available to help protect Europeans when the EU COVID market reopens starting this year in some markets."

The EC decision is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (EudraCT: 2023-000884-30; ClinicalTrials.gov: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective of the study was to demonstrate 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. In the trial, participants received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax. mNEXSPIKE showed a 9.3% higher relative vaccine efficacy compared to Spikevax in individuals aged 12 years and older, and in a descriptive subgroup analysis, a 13.5% higher relative vaccine efficacy in adults aged 65 years and older.

In the Phase 3 trial, mNEXSPIKE was found to have a similar safety profile to Spikevax, with fewer local reactions and comparable systemic reactions. The most commonly solicited adverse reactions were injection pain, fatigue, headache and myalgia.

Moderna has already received regulatory approval for mNEXSPIKE in the U.S., Canada and Australia, and continues to pursue approvals in additional markets worldwide.