The U.S. government has awarded $176 million to Moderna 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.
U.S. officials said on a press call that late-stage testing would begin in 2025, pending results expected in the coming weeks of Moderna's phase 1 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, on the call.
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.
BIRD FLU OUTBREAK AFFECTS OVER 24 STATES, POULTRY PRICES RISE
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.
However, "robust discussions" are occurring within government agencies about whether vaccinating farm workers would be helpful, said Nirav Shah, principal deputy director of the U.S. Centers for Disease Control and Prevention, adding that no final decisions have been made.
The government expects to have more announcements on H5N1 vaccines in the near future, O'Connell said. In a previous briefing, O'Connell said her agency was also negotiating with Pfizer for an mRNA vaccine against H5N1.
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.
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Manufacturing of conventional flu vaccines using cell or egg-based technology can take four to six months.
U.S. 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.
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 and has cautioned against consuming raw milk.
