Moderna Inc (NASDAQ:MRNA, ETR:0QF) shares edged higher after the US Food and Drug Administration (FDA) approved its newest COVID-19 vaccine mNEXSPIKE (mRNA-1283).
The vaccine was approved for use in adults aged 65 and older and individuals aged 12 to 64 who have at least one underlying health risk factor as defined by the Centers for Disease Control and Prevention (CDC), Moderna said on Monday.
The FDA approval was based on a Phase 3 clinical trial involving approximately 11,400 participants, which showed that mNEXSPIKE had a 9.3% higher relative vaccine efficacy compared to Moderna's original COVID-19 vaccine, Spikevax (mRNA-1273), with a 13.5% higher efficacy in adults 65 and older.
"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," Moderna CEO Stéphane Bancel said in a statement.
"COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health."
It is expected that mNEXSPIKE will be available for eligible populations in the US for the 2025 to 2026 respiratory virus season, alongside Spikevax and mRESVIA, its respiratory syncytial virus (RSV) vaccine.
Shares of Moderna added 1.9% at $27 late morning on Monday.