Shots:
- The CHMP has recommended mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (age≥12 yrs)
- Opinion was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (age ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination
- The trial met its 1EP with mNEXSPIKE showing 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in a descriptive sub-group analysis mNEXSPIKE showed 13.5% higher rVE in participants (≥65yrs.). mRNA-1283 demonstrated a safety profile comparable to mRNA-1273
Ref: Moderna | Image: Moderna| Press Release
Related News:- Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19
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