Key Takeaways:
- Pivotal Trial Launch: Moderna has dosed the first participants in a Phase 3 study for mRNA-1018, involving 4,000 adults in the U.S. and UK to evaluate safety and immune response.
- Funding and Support: The trial is backed by a $54.3 million investment from CEPI, specifically targeting the H5N1 strain, which continues to spread in wild birds and farm animals.
- Global Access Commitment: Moderna has pledged to reserve 20% of its manufacturing capacity for low- and middle-income countries at affordable prices if a pandemic occurs.
Moderna has begun a Phase 3 clinical trial of its investigational mRNA-based Bird Flu Vaccine after dosing the first participants in the United States and United Kingdom, the company announced Tuesday.
The trial, supported by the Coalition for Epidemic Preparedness Innovations, or CEPI, is designed to test the safety and immune response of Moderna’s vaccine candidate, mRNA-1018, in about 4,000 healthy adults age 18 and older. The study comes as health officials continue to monitor the spread of avian influenza, commonly known as bird flu, in birds and other animals.
Moderna said CEPI agreed in December 2025 to invest up to $54.3 million to help advance the vaccine candidate toward possible regulatory approval.
“H5 influenza, or bird flu, remains a pandemic threat,” Moderna Chief Executive Officer Stephane Bancel said in a statement. “The start of our Phase 3 trial for a Bird Flu Vaccine marks a significant milestone in our ongoing efforts to strengthen global pandemic preparedness.”
Bancel said Moderna’s mRNA platform can help support global health security because it allows vaccines to be developed and produced more quickly than traditional methods.
CEPI Backs Trial to Improve Pandemic Preparedness
CEPI officials said the late-stage study could help determine whether mRNA technology can play a larger role in responding to future disease outbreaks.
“The first-of-its-kind pivotal trial of an mRNA-based Bird Flu Vaccine underscores the potential of this technology to reshape how we confront emerging pathogens,” CEPI Chief Executive Officer Dr. Richard Hatchett said.
Hatchett said successful trial results could improve the world’s ability to respond more quickly and fairly to a future influenza pandemic.
The Phase 3 study could also support future regulatory filings if Moderna’s seasonal influenza vaccine candidate, mRNA-1010, continues to advance. Moderna said mRNA-1010 is already under review in the United States, the European Union, Canada and Australia.
Health officials have warned that bird flu viruses continue to evolve, even though the immediate risk to humans remains low.
UK Officials Warn Bird Flu Threat Remains
Dr. Richard Pebody, director of epidemic and emerging infections at the UK Health Security Agency, said authorities remain concerned that avian influenza could eventually gain the ability to spread more easily between people.
“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 in the UK and elsewhere,” Pebody said.
Pebody said the Bird Flu Vaccine study is an important step in improving readiness for future influenza outbreaks.
Under its agreement with CEPI, Moderna said it will reserve 20% of its H5 pandemic vaccine manufacturing capacity for low- and middle-income countries if the vaccine is approved and a pandemic occurs.
The company said the doses would be offered at affordable prices to help ensure broader global access during a health emergency.
Moderna, based in Cambridge, Massachusetts, became one of the leading vaccine makers during the COVID-19 pandemic through its use of mRNA technology. The company has since expanded its work into vaccines and treatments for infectious diseases, cancer, rare disorders, and most recently, the development of a Bird Flu Vaccine.
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