The US Department of Health and Human Services (HHS), through its Biomedical Advanced Research and Development Authority (BARDA), today announced that it has awarded Moderna $176 million to develop a prepandemic vaccine against H5 avian influenza. [Kaiser Health News & Univ. of MN]
In its announcement, HHS said the award helps bolster the nation's pandemic flu vaccine capacity, which currently relies on an older traditional vaccine platform. Moderna will leverage its domestic large-scale commercial mRNA vaccine manufacturing platforms and ongoing development of mRNA-based seasonal flu vaccines.
The award comes as officials confirm more H5N1 avian flu in US cattle and poultry.
Phase 3 trials could begin next year
Dawn O'Connell, JD, assistant secretary for preparedness and response at HHS, said the $176 million represents the base award and the agreement contains other options that allow the government to quickly pivot funding to other mRNA vaccines when new flu strains or other disease threats emerge. She said the H5 vaccine is in clinical development and that phase 3 trials could begin in 2025.
The award also includes an option for large-scale production and pandemic response. At today's briefing, Robert Johnson, PhD, director of medical countermeasures at BARDA, said it's too early to project production capacity. He said the number will depend on dosing information, which should be available later this year.
Moderna said in a statement today that in 2023 it launched a phase 1/2 clinical trial of an investigational pandemic flu vaccine in healthy adults, which included candidates against H5 and H7 viruses, and results are expected this year.
Meanwhile, fill-and-finish activity continues on vaccine from bulk stocks of candidate cell-based adjuvanted H5 vaccine made by CSL Seqirus, and O'Connell said the first of 4.8 million doses will be available in the middle of July, with production continuing through August. This is faster than the government had anticipated.
Officials weigh early vaccine use for high-risk groups
As vaccine production and planning continues, federal officials are in ongoing discussions about how to best protect farm workers and others exposed to cattle.
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