08:02 AM EDT, 09/23/2025 (MT Newswires) -- Moderna ( MRNA ) said Tuesday its 2025-26 mNEXSPIKE Covid-19 vaccine has demonstrated positive preliminary immunogenicity data, targeting the LP.8.1 variant of SARS-Cov2 to help prevent Covid-19.

Data from an ongoing phase 4 clinical trial evaluating the safety, tolerability and immunogenicity of the new vaccine formula demonstrated, on average, a greater than 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.

Moderna ( MRNA ) said the results underscore the predictability of preclinical data that supported the US Food and Drug Administration's approval in August of mNEXSPIKE.