The US government has awarded $US176 million ($A264 million) to Moderna to advance development of its bird flu vaccine 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 US 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.
US officials said late-stage testing would begin in 2025, pending results expected in the coming weeks of Moderna’s phase one trial. The late-stage trial would likely focus on safety and immune response.
The contract includes options to accelerate the development timeline if needed, based on an increase in human cases, the severity of cases or human-to-human transmission of the virus.
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.
In March, US 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 US Department of Health and Human Services, told reporters.
However, “robust discussions” are occurring within government agencies about whether vaccinating farm workers would be helpful, said Nirav Shah, principal deputy director of the US Centres for Disease Control and Prevention.
Shah added that no final decisions have been made.
The government expects to have more announcements on H5N1 vaccines in the near future, O’Connell said.
Both the Moderna and Pfizer vaccines use messenger RNA, the technology used in their COVID-19 vaccines.
“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.
US officials previously announced they were moving bulk vaccine from CSL Seqirus that closely matches the current virus into finished shots that could provide 4.8 million doses if needed.
Some of those doses could be available as early as this month, O’Connell said. Those shots could potentially be used to inoculate farm workers and others at risk of exposure to the virus.
Moderna began early tests of its mRNA bird-flu vaccine in 2023, with healthy adult volunteers.
