Moderna began a Phase 3 study of its experimental H5 bird‑flu vaccine on April 21, 2026, when the first participants in the United States and the United Kingdom received the first dose. The trial will enroll roughly 4,000 healthy adults across the two countries and will evaluate the vaccine’s safety, immunogenicity and efficacy.
The study is supported by the Coalition for Epidemic Preparedness Innovations, which committed up to $54.3 million in December 2025 after the U.S. government withdrew its earlier funding. CEPI’s investment restores the financial foundation for the program and highlights the importance of international collaboration in pandemic‑ready vaccine development.
Launching this trial expands Moderna’s mRNA platform beyond COVID‑19 and seasonal influenza, positioning the company as a leader in pandemic preparedness and opening potential revenue streams in the global respiratory‑vaccine market. As part of its agreement with CEPI, Moderna has pledged to allocate 20 % of its H5 vaccine manufacturing capacity to low‑ and middle‑income countries at affordable pricing if the vaccine is licensed.
Stéphane Bancel, CEO of Moderna, said, “H5 influenza, or bird flu, remains a pandemic threat. The start of our Phase 3 trial for an H5 influenza vaccine marks a significant milestone in our ongoing efforts to strengthen global pandemic preparedness.” Dr. Richard Hatchett, CEO of CEPI, added, “The first‑of‑its‑kind pivotal trial of an mRNA‑based pandemic influenza vaccine underscores the potential of this technology to reshape how we confront emerging pathogens.” Dr. Richard Pebody, Director of Epidemic and Emerging Infections at the UK Health Security Agency, noted, “Although the current risk to the human population of avian influenza remains low, the virus continues to evolve and spread in birds and various animal hosts.”
The trial’s initiation signals a strategic shift toward diversified mRNA applications and demonstrates Moderna’s resilience in securing funding after a U.S. government withdrawal. It also reflects the company’s commitment to equitable access, with a dedicated manufacturing capacity for low‑ and middle‑income markets.”],
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