Moderna initiates Phase 3 study of mRNA Pandemic influenza vaccine

The company states: “Moderna (MRNA) announced that the first participants in the U.S. and UK have been dosed in a Phase 3 study of the Company’s investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018. In December 2025, the Coalition for Epidemic Preparedness Innovations and Moderna announced that CEPI will invest up to $54.3 million to help advance mRNA-1018 to licensure. The Phase 3 study will evaluate the safety and immunogenicity of mRNA-1018 in healthy adults ages 18 years and older and is expected to enroll approximately 4,000 adults in the U.S. and UK. If successful, global regulatory submissions for mRNA-1018 will be further supported by positive data from the pivotal Phase 3 trial of Moderna’s investigational seasonal influenza vaccine, mRNA-1010, which has been accepted for review in the U.S., the European Union, Canada and Australia.”