Moderna moves higher on FDA approval of new COVID-19 vaccine

Moderna shares rose 1.9% to $27 following FDA approval of its new COVID-19 vaccine, mNEXSPIKE (mRNA-1283), for adults 65 and older and those aged 12-64 with underlying health risk factors. Phase 3 trial data showed mNEXSPIKE had 9.3% higher relative vaccine efficacy than Moderna's original vaccine, Spikevax, and 13.5% higher efficacy in adults 65 and older, with the vaccine expected to be available for the 2025-2026 respiratory virus season.

Analysis

Moderna (MRNA) shares experienced a modest 1.9% increase to $27 following the U.S. Food and Drug Administration (FDA) approval of its latest COVID-19 vaccine, mNEXSPIKE (mRNA-1283). This approval, significant as it marks Moderna's third commercial product, covers adults aged 65 and older, and individuals aged 12 to 64 with specific underlying health risk factors as defined by the CDC. The FDA's decision was underpinned by Phase 3 clinical trial data from approximately 11,400 participants, which indicated mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy compared to Moderna's original Spikevax (mRNA-1273), with this advantage increasing to 13.5% in the 65 and older demographic. CEO Stéphane Bancel highlighted the ongoing public health concern, referencing over 47,000 COVID-19 related deaths in the U.S. in the preceding year, positioning mNEXSPIKE as an important new protective measure. The vaccine is anticipated to be available for the 2025-2026 respiratory virus season, joining Spikevax and the company's RSV vaccine, mRESVIA, potentially diversifying and strengthening Moderna's revenue streams from its infectious disease portfolio.

Key Decisions for Investors

• Investors should view the FDA approval of mNEXSPIKE as a positive development for Moderna, potentially enhancing its market share in the COVID-19 vaccine segment due to improved efficacy, particularly for high-risk populations.
• Consider monitoring the commercial uptake and market penetration of mNEXSPIKE upon its launch for the 2025-2026 respiratory season, as its success will be crucial for revenue contribution alongside existing products like Spikevax and mRESVIA.
• Evaluate the evolving demand for COVID-19 vaccines and Moderna's ability to capitalize on its expanding product line to sustain growth, factoring in the continued, albeit potentially moderating, public health need.