-Moderna said on Tuesday its updated COVID-19 vaccine formulation elicited a strong immune response in all adults aged 65 and older, as well as in individuals aged 12 to 64 with at least one underlying risk condition.
Preliminary data from an ongoing post-marketing study indicated that the vaccine, mNEXSPIKE, on average, showed greater than a 16-fold increase in neutralizing antibodies against the LP.8.1 variant — currently one of the Sars-CoV-2 variants under monitoring with increasing prevalence globally.
The trial was evaluating safety, tolerability and immunogenicity of the 2025-2026 formula of mNEXSPIKE. The safety profile of the vaccine was consistent with previous studies, the company said.
Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID-19 shot, Spikevax, and lower-than-expected uptake of its respiratory syncytial virus vaccine.
The U.S. Food and Drug Administration had approved mNEXSPIKE in May, the first endorsement since the regulator tightened requirements for COVID-19 vaccines and said it plans to require new clinical trials for approval of annual boosters for healthy Americans under age 65.
Spikevax is approved for individuals aged 65 and older, and for those aged six months to 64 who are at risk for severe disease.
The data for mNEXSPIKE follows additional preliminary immunogenicity results for the 2025-2026 formula of Spikevax, Moderna said.
Both vaccines for the 2025-2026 season “have demonstrated strong immune responses against today’s top circulating COVID-19 strains”, the company said.
