Moderna’s Next-Generation COVID-19 vaccine, mNEXSPIKE, Receives Marketing Authorization in Europe
Brussels, Belgium – Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE, has received marketing authorization from the European Commission, following a positive proposal from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).This marks the third Moderna product approved in the European union, alongside spikevax and mRESVIA, bolstering the company’s respiratory vaccine portfolio in Europe.
The marketing authorization is valid across all 27 EU member states, and also Iceland, Liechtenstein, and Norway. Moderna anticipates making mNEXSPIKE available in europe pending the completion of national regulatory procedures and market access pathways.
“We welcome the European commission’s decision, which reflects the strength of the scientific data supporting mNEXSPIKE, as well as our ongoing commitment to innovative vaccines for vulnerable populations,” said stéphane Bancel, Chief Executive Officer of Moderna. “COVID-19 has become an endemic respiratory disease,and older adults continue to bear a disproportionate burden of severe complications. Europe is a key region for respiratory vaccines, and we are pleased to have a new vaccine to help protect Europeans as the EU’s COVID market begins to transition this year in select countries.”
The European Commission’s decision is based on data from a Phase 3 randomized, double-blind, active-controlled clinical trial (EudraCT: 2023-000884-30; ClinicalTrials.gov: NCT05815498) involving approximately 11,400 participants aged 12 years and older. The primary objective of the study was to demonstrate that the vaccine’s efficacy against COVID-19 was non-inferior to that of the comparator vaccine, Moderna’s original COVID-19 vaccine, Spikevax (mRNA-1273), starting 14 days after management of mNEXSPIKE.
The trial demonstrated a 9.3% relative vaccine efficacy advantage for mNEXSPIKE compared to Spikevax in individuals aged 12 years and older. A descriptive analysis of subgroups showed a 13.5% relative vaccine efficacy advantage in adults aged 65 years and older.
The Phase 3 trial also indicated that mNEXSPIKE has a similar safety profile to Spikevax,with fewer local reactions and comparable systemic reactions. The most frequently reported adverse events were pain at the injection site, fatigue, headache, and muscle aches (myalgia).
Moderna has already received regulatory approval for mNEXSPIKE in the United states, Canada, and Australia, and continues to pursue approvals in other markets globally.
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