This Phase 3 study would be the first mRNA-based vaccine targeting pandemic influenza to enter a pivotal trial. By contrast, an mRNA vaccine can be designed in hours or days as soon as the virus’s genetic sequence is known and swiftly manufactured at scale. The Phase 3 trial, set to begin early in 2026, will evaluate the safety and immunogenicity of Moderna’s H5 vaccine candidate in populations in the UK and U.S. Potential licensure of the vaccine will also leverage data from a pivotal Phase 3 trial of Moderna’s investigational seasonal influenza vaccine, mRNA-1010. This project is part of CEPI and Moderna’s strategic partnership, which aims to harness Moderna’s mRNA platform to accelerate epidemic and pandemic vaccine development.

Source: The Herald December 20, 2025 21:49 UTC