Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19

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• The US FDA has approved mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals (≥12yrs.) with ≥1 underlying risk factor as defined by Centers for Disease Control and Prevention; regulatory review is ongoing in other regions
• Approval was based on P-III (NextCOVE) trial assessing mNEXSPIKE (10 or 50μg) vs Spikevax (mRNA-1273) in ~11,400 subjects (≥12yrs.), starting 14 days post-vaccination
• 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.)

Ref: Moderna | Image: Moderna| Press Release

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