US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older

Moderna (NASDAQ:MRNA) has received FDA approval for mNEXSPIKE (mRNA-1283), its third approved product and new COVID-19 vaccine for adults 65+ and high-risk individuals aged 12-64. The approval is based on a Phase 3 trial with 11,400 participants, where mNEXSPIKE demonstrated 9.3% higher relative vaccine efficacy compared to Moderna's original Spikevax vaccine, with a 13.5% improvement in those 65 and older. The vaccine showed a similar safety profile to Spikevax with fewer local reactions. Common side effects include injection site pain, fatigue, headache, and myalgia. Moderna plans to make mNEXSPIKE available for the 2025-2026 respiratory virus season alongside Spikevax and mRESVIA.

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