Moderna says mNEXSPIKE generates ‘strong’ immune response against LP.8.1 variant

Moderna (MRNA) announced preliminary immunogenicity data for the 2025-2026 formula of mNEXSPIKE, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The data from an ongoing Phase 4 clinical trial evaluating the safety, tolerability and immunogenicity of the 2025-2026 formula of mNEXSPIKE showed, on average, greater than a 16-fold increase in neutralizing antibodies against the LP.8.1 variant in individuals 12 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. These findings follow additional preliminary data that showed the 2025-2026 formula of Spikevax generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across the same age groups. The safety profile of the vaccine was consistent with previous studies. These clinical findings underscore the predictability of preclinical data that supported the recent U.S. Food and Drug Administration approval of the 2025-2026 formula of mNEXSPIKE, which is approved for individuals 12 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.