Moderna has announced in a statement that the European Commission (EC) has granted marketing authorisation for the company's new COVID vaccine, mNEXSPIKE (mRNA-1283), for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older.
The news follows the positive opinion adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). It is Moderna's third product in its respiratory vaccine portfolio to be authorised in the European Union, following the approval of Spikevax and mRESVIA.
The marketing authorisation is valid across all 27 European Union Member States, as well as in Iceland, Liechtenstein and Norway. Moderna has stated that it anticipates making 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, CEO 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."
Supporting evidence from clinical trials
The European Commission's decision is backed by results from a randomised, observer-blind, active-controlled Phase III clinical trial (EudraCT: 2023-000884-30; ClinicalTrials.gov: NCT05815498), which included approximately 11,400 participants aged 12 years and older.
The primary objective of the study was to demonstrate that the mNEXSPIKE vaccine was noninferior to the comparator, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine.
Efficacy was measured 14 days after administration of the mNEXSPIKE vaccine. Participants in the trial 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 with 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 III trial, mNEXSPIKE demonstrated a safety profile comparable to Spikevax, with fewer local reactions and similar systemic reaction rates. The most frequently reported adverse reactions included injection site pain, fatigue, headache and myalgia.
Moderna has already obtained regulatory approval for mNEXSPIKE in the United States, Canada and Australia and is actively seeking approvals in additional markets worldwide.