CEPI is providing up to $54.3 million to help Moderna run a pivotal Phase 3 study of mRNA-1018, an investigational mRNA vaccine aimed at H5 pandemic influenza. The program is intended to support progression toward licensure and broaden preparedness options for a high-consequence influenza strain. The companies said the late-stage trial is expected to begin in early 2026 and will enroll participants in the United States and the United Kingdom, building on earlier immunogenicity and safety results in healthy adults. CEPI
Under the agreement, Moderna said it will reserve 20% of its H5 pandemic vaccine manufacturing capacity for supply to low- and middle-income countries if an influenza pandemic occurs. The announcement follows the earlier cancellation of a large US government contract for the same project, underscoring reliance on coalition and partner funding to sustain late-stage development. CEPI framed the investment as part of its goal to enable vaccines within 100 days of identifying a new pandemic threat, and said the Phase 3 trial will generate evidence needed for regulatory review. Moderna indicated that data from its ongoing seasonal influenza vaccine program will also support the approval pathway for mRNA-1018. mRNA platforms can be designed quickly once sequences are known, speeding production. CEPI+1
Why it matters
The funding accelerates late-stage pandemic flu vaccine development while linking regulatory evidence generation to supply and access commitments that shape global preparedness planning. CEPI
Source Attribution
Source: ACCESS Newswire | Adapted & summarized
Published on: 18 December 2025
Category: Healthcare
Region: USA
