Moderna Wins EU Approval for 10 mcg mNEXSPIKE, Shows 13.5 percent Higher Efficacy in Seniors
Moderna received European Commission marketing authorization for its 10 mcg mNEXSPIKE COVID-19 vaccine for ages 12 and older, covering all 27 EU states plus Iceland, Liechtenstein and Norway. Phase 3 data from ~11,400 participants showed mNEXSPIKE achieved 9.3 percent higher efficacy overall and 13.5 percent higher efficacy in adults 65+ versus Spikevax.
1. EU Marketing Approval
Moderna has secured European Commission marketing authorization for its mNEXSPIKE COVID-19 vaccine (mRNA-1283), a 10 mcg formulation indicated for individuals aged 12 and older. This approval covers all 27 EU member states as well as Iceland, Liechtenstein and Norway, marking Moderna’s third authorized product in the region alongside Spikevax and mRESVIA.
2. Phase 3 Clinical Trial Results
mNEXSPIKE’s authorization was based on a randomized, observer-blind, active-controlled Phase 3 trial enrolling approximately 11,400 participants aged 12 years and older. The study demonstrated mNEXSPIKE achieved 9.3% higher vaccine efficacy overall and 13.5% higher efficacy in adults aged 65+ compared to the 50 mcg Spikevax regimen.
3. Safety and Dosage Advantages
Participants received a 10 mcg dose of mNEXSPIKE versus a 50 mcg dose of Spikevax, with mNEXSPIKE showing a safety profile similar to Spikevax but fewer local reactions. Common adverse events included injection site pain, fatigue, headache and myalgia, aligning with expectations for mRNA-based vaccines.
4. Global Expansion and Analyst Outlook
Moderna has already secured mNEXSPIKE approvals in the US, Canada and Australia and is pursuing additional regulatory decisions globally. Evercore ISI maintained an In-Line rating on Moderna shares while raising the price target from $28 to $35 following the EU approval.