The U.S. government has awarded $176 million to Moderna (MRNA.O) to advance development of its bird flu vaccine, the company said on Tuesday, as concerns rise over a multi-state outbreak of H5N1 virus in dairy cows and infections of three dairy workers since March.
Funds from the U.S. Biomedical Advanced Research and Development Authority will be used to complete late-stage development and testing of a pre-pandemic mRNA-based vaccine against H5N1 avian influenza, the company said in a statement.
The agreement also includes additional options to prepare and accelerate a response to future public health threats, the company said.
In March, U.S. officials reported the first outbreak of the H5N1 virus in dairy cattle, which has since infected more than 130 herds in 12 states.
Scientists are concerned that exposure to the virus in poultry and dairy operations could increase the risk that the virus will mutate and gain the ability to spread easily among people, touching off a pandemic.
The risk to the general public from bird flu remains low, and vaccination is not currently recommended for any segment of the population, Dawn O'Connell, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, said on a call with reporters.
Last year, Moderna started a safety and immunogenicity study of its bird flu vaccine called mRNA-1018 in healthy adults aged 18 and older. That study included both the H5 subtype of bird flu that is currently circulating in dairy cattle, as well as the H7 bird flu subtype.
Results of that study are expected this year and will be used to map out late-stage development plans, the company said.
Late-stage trials of the vaccine will likely begin in 2025, O'Connell said.
Moderna's vaccine uses mRNA, or messenger RNA, the technology in its COVID-19 shot.
"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," Moderna CEO Stephane Bancel said in a statement.
Manufacturing of conventional flu vaccines using cell or egg-based technology can take four to six months. It is too early to tell how many doses Moderna will be able to manufacture, said Robert Johnson, director of the medical countermeasures program at HHS, on the press call.
U.S. officials have said they were moving bulk vaccine from CSL Seqirus (CSL.AX) that closely matches the current virus into finished shots that could provide 4.8 million doses if needed.
Those doses would potentially be used to inoculate farm workers and others at risk of exposure to the virus.
Lab experiments from the U.S. Food and Drug Administration continue to confirm that pasteurization inactivates the bird flu virus in dairy products, said Don Prater, director of the agency's Center for Food Safety and Applied Nutrition.
The FDA is conducting ongoing tests of retail dairy products for traces of avian flu.
