FDA approves Moderna's COVID vaccines sBLA
US mRNA specialist Moderna (Nasdaq: MRNA) yesterday announced that the US 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 company’s shares moved up as much as 3.6% on the news, but slipped back by close of trading.
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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