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Moderna Begins Phase III Trial of mRNA Bird Flu Vaccine in UK and US

The study tests a fast‑to‑update mRNA shot to boost pandemic readiness against an evolving H5N1 threat.

Overview

  • Moderna’s mRNA‑1018 vaccine, which entered phase III on Tuesday, will enroll about 4,000 adults in the two countries in the first late‑stage test of an mRNA bird flu shot.
  • The UK arm plans 3,000 volunteers at 26 sites with half over 65, and participants will get two doses three weeks apart in a seven‑month study backed by the National Institute for Health and Care Research.
  • Early‑phase results reported by Moderna found no safety concerns and showed a strong immune response that was detectable seven days after the first dose.
  • Funding from CEPI of about $54 million followed last year’s HHS cutbacks, and Moderna says that if approved during a declared pandemic it will reserve 20% of capacity for low‑ and middle‑income countries.
  • The trial focuses on H5N1 clade 2.3.4.4b, which has driven major animal outbreaks and more than 100 human cases since 2024, and it prioritizes older adults and people who work with birds because they face higher exposure.