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Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2

1. FDA approves updated Spikevax and mNEXSPIKE formulas for COVID-19. 2. Approval targets the LP.8.1 variant, supporting high-risk populations.

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FAQ

Why Bullish?

FDA approval enhances MRNA's market position, similar to past approvals that boosted stock prices.

How important is it?

The FDA approval is crucial for MRNA's product relevance and revenue generation.

Why Short Term?

Immediate market reaction expected due to FDA approval, although long-term effects are uncertain.

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CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older.

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