The U.S. government has awarded $176 million to Moderna to advance the development of its bird flu vaccine, the company announced. This funding comes amid growing concerns over a multi-state outbreak of the H5N1 virus in dairy cows and infections reported among three dairy workers since March.
The funds from the U.S. Biomedical Advanced Research and Development Authority will support the late-stage development and testing of a pre-pandemic mRNA-based vaccine against H5N1 avian influenza, Moderna stated. The agreement includes provisions to prepare for and accelerate responses to future public health threats.
In March, U.S. officials reported the first outbreak of the H5N1 virus in dairy cattle, which has since spread to more than 130 herds across 12 states. Scientists are worried that the virus's presence in poultry and dairy operations could increase the risk of it mutating to spread easily among humans, potentially triggering a pandemic.
Despite these concerns, the risk to the general public remains low, and vaccination is not currently recommended for any segment of the population, stated Dawn O'Connell, Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, during a call with reporters.
Last year, Moderna initiated a safety and immunogenicity study of its bird flu vaccine, mRNA-1018, in healthy adults aged 18 and older. This study includes both the H5 subtype currently affecting dairy cattle and the H7 bird flu subtype. Results from this study, expected later this year, will guide the vaccine's late-stage development plans, the company noted.
Late-stage trials of the vaccine are likely to begin in 2025, according to O'Connell. Moderna's vaccine utilizes mRNA technology, the same used in its COVID-19 vaccine.
"mRNA vaccine technology offers advantages in efficacy, speed of development and production, scalability, and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic," said Moderna CEO Stephane Bancel in a statement.
The manufacturing process for conventional flu vaccines using cell or egg-based technology can take four to six months. It is currently unclear how many doses Moderna will be able to produce, noted Robert Johnson, Director of the Medical Countermeasures Program at HHS, during the press call.
U.S. officials have indicated they are moving bulk vaccine from CSL Seqirus into finished shots, potentially providing 4.8 million doses if needed. These doses could be used to inoculate farm workers and others at risk of exposure to the virus.
Laboratory experiments from the U.S. Food and Drug Administration have confirmed that pasteurization inactivates the bird flu virus in dairy products, according to Don Prater, Director of the FDA's Center for Food Safety and Applied Nutrition. The FDA is also conducting ongoing tests of retail dairy products for traces of avian flu.
