Moderna is set to receive $176 million in federal funding to develop a human vaccine against bird flu following outbreaks of the virus in dairy cows across several states, the Department of Health and Human Services announced Tuesday.
The U.S. has documented three cases of humans with bird flu in 2024. All had regular contact with dairy cows. As of July, more than 130 herds across 12 states have seen infected cows.
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The HHS award to the American vaccine manufacturer will go toward developing an mRNA-based pandemic influenza vaccine. Moderna’s candidate for the vaccine draws from mRNA technology used successfully during the COVID-19 response, resulting in one of the first Food and Drug Administration-authorized COVID-19 vaccines ultimately licensed by the FDA, HHS said.
Vaccines from mRNA can complement traditional vaccine technologies during a pandemic influenza emergency response. This is a concern with H5N1 avian influenza, even if the current risk to human health remains low.
“We have successfully taken lessons learned during the COVID-19 pandemic and used them to better prepare for future public health crises,” HHS Secretary Xavier Becerra said in a statement. “As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities.”
The funding, made through the federal Rapid Response Partnership Vehicle, allows Moderna to enhance vaccine response capability, an HHS news release said. This includes using large-scale commercial mRNA manufacturing and ongoing seasonal flu vaccine development. HHS secured a fair pricing agreement to ensure cost savings access to vaccines.
Moderna will prepare materials and conduct clinical trials to collect safety and immune response data to support FDA approval and, eventually, potentially scale response with commercial production in a public health emergency.
The award also enables rapid development of mRNA vaccine targeted to various influenza virus subtypes, or strains, with pandemic potential. Development and manufacturing can pivot quickly, if needed to address other emerging infectious diseases, HHS said.
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If successfully developed, Moderna’s mRNA-based pandemic flu vaccine could improve response times if a new virus strain emerges. HHS pointed to the swine flu pandemic in 2009.
In 2023, the federal Biomedical Advanced Research and Development Authority, part of HHS, requested proposals from Moderna and other companies to develop mRNA vaccines for potential public health emergencies caused by influenza viruses, including H5N1.
In a news release, Moderna said it initiated a study to look at vaccine safety and immunogenicity for pandemic influenza in people 18 and older. This included vaccine candidates against H5 and H7 bird flu viruses. Results are expected in 2024 to inform further study development plans, Moderna said.
In the U.S., there have been four human cases of bird flu, including three in 2024. Health officials said the risk to the general population remains low, although dairy workers and others working near infected cows face heightened risk.
Beyond the announcement for Moderna, federal health officials have already begun emergency preparedness against bird flu.
The Administration for Strategic Preparedness and Response, within HHS, already has 4.8 million doses of bird flu vaccine being poured into vials that could be used pending FDA approval, the agency’s director Dawn O’Connell said in a call with reporters Tuesday morning. Those first doses could be ready by mid-July through August.
Still, vaccines may not be the best solution to address bird flu should the outbreak spread further into humans, said Dr. Nirav Shah, principal deputy director at the Centers for Disease Control and Prevention.
Other options to contain bird flu may be used, particularly if more farm workers get sick. These could include widespread use of antivirals to fight the virus, for example. No decision has been made on what the best response is, Shah added.
