April 21 - Moderna said on Tuesday it has begun a late-stage study of its experimental bird flu vaccine in the United States and the United Kingdom, representing the first time an mRNA-based pandemic bird flu vaccine has reached late-stage clinical testing.
The vaccine, designated mRNA-1018, will be evaluated in about 4,000 healthy adults aged 18 and older. The trial is supported by a $54 million investment from the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership that funds efforts to accelerate development of vaccines for epidemic and pandemic threats.
Moderna noted that CEPI provided the funding in December. That investment followed a decision last May by U.S. Health Secretary Robert F. Kennedy Jr. to cancel more than $700 million in contracts with Moderna that had aimed to develop a bird flu vaccine intended to protect against a potential future pandemic.
The company highlighted the role of mRNA technology, which was used to develop COVID-19 vaccines, as a faster approach to making vaccines against viruses with pandemic potential. Moderna Chief Executive Stephane Bancel said bird flu remains a pandemic threat and described the start of the study as an important step in improving preparedness for future outbreaks.
Moderna also said that any future regulatory filing for mRNA-1018 would be supported by positive data from its separate seasonal influenza candidate, mRNA-1010, which is under review in the United States, the European Union, Canada and Australia. The company linked the approval pathway for the pandemic candidate to evidence gathered from that parallel program.
Under Moderna’s arrangement with CEPI, the company said that if the vaccine is approved and a flu pandemic is declared, it would reserve 20% of its manufacturing capacity for supply to low- and middle-income countries at affordable prices. That commitment is contingent on both approval and an official pandemic declaration.
Context and implications
The move places an mRNA-formulated bird flu vaccine into phase 3 testing for the first time, with public-private partnership funding backing the program. The trial size and the involvement of regulatory submissions for a related seasonal candidate are factors Moderna flagged as central to any path toward approval and global supply commitments.