Moderna’s mNEXSPIKE Shows Strong Immune Response Against LP.8.1 Variant in Humans

Moderna, Inc. has announced promising preliminary immunogenicity results for the 2025-2026 formula of its COVID-19 vaccine, mNEXSPIKE, which targets the SARS-CoV-2 LP.8.1 variant. Data from an ongoing Phase 4 clinical trial showed that the vaccine generated, on average, more than a 16-fold increase in neutralizing antibodies against the LP.8.1 variant in individuals aged 12 to 64 with at least one underlying condition that increases their risk for severe COVID-19, as well as in all adults aged 65 and older. These results build on earlier preliminary data demonstrating that the 2025-2026 formula of Moderna’s Spikevax vaccine produced more than an eightfold increase in neutralizing antibodies against the same variant in the same populations.

The safety profile observed in this trial was consistent with previous studies, reinforcing confidence in the vaccine’s tolerability. These clinical findings align with preclinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the 2025-2026 mNEXSPIKE formula. The vaccine is now authorized for use in individuals aged 12 to 64 who have underlying conditions that increase their risk of severe COVID-19, as well as all adults aged 65 and older.