India Pharma Outlook Team | Monday, 29 September 2025
Moderna has conveyed that the primary immunogenicity data for the 2025-2026 formula of mNEXSPIKE, the mRNA COVID-19 vaccine of their choice to the LP.8.1 variant of SARS-CoV-2, is in the positive range. The results stem from a Phase 4 clinical trial, which is still ongoing, that evaluates the safety, the vaccine's tolerability, and the immune response of the updated formula.
The trial numbers show that the vaccine, on average, led to more than a 16-fold increase in neutralizing antibodies against the LP.8.1 variant in the 12-64 years age group with at least one underlying condition that predisposes to severe COVID-19, and all healthy adults 65 years and older. This goes along with the preliminary data of the Spikevax 2025-2026 formula, which indicated an 8-fold increase in neutralizing antibodies in all the mentioned age groups.
The safety profile of the updated mNEXSPIKE formulation was essentially the same as in previous studies, thus the vaccine’s tolerability continues to be reassuring.
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These clinical outcomes match the preclinical data that was the basis for the USFDA’s endorsement of the 2025-2026 formula. The vaccine is now available for administration to the 12–64 years old group with at least one high-risk condition and all adults aged 65 and above.
The results show that Moderna is still committed to modifying its vaccine formulations to the new variants of SARS-CoV-2. This strategy ensures that the immune system of high-risk populations and older adults remains strong as COVID-19 spreads worldwide.
