Produced by South Dakota-based Medgene, the vaccine is awaiting conditional approval by the USDA before it goes to market. The USDA previously approved Medgene’s vaccine platform technology in cattle.
A company spokesperson said: “Medgene has completed safety and efficacy trials of its H5N1 vaccine in cattle. This data will be evaluated by the USDA Center for Veterinary Biologics (CVB). Based on Notice No. 24-11, we are confident the data will meet the expectations for conditional licensure.”
Last year, company CEO Mark Luecke told Politico that the company could produce ‘hundreds of millions of doses’ if it gained approval, because the firm was the only one using platform technology – which allows multiple vaccines to be produced from a single system – to develop such a vaccine. The company told us that it has ‘more than enough manufacturing capacity to provide the necessary doses to annually vaccinate the US dairy herd’.
As for how long the vaccine would protect cattle from the virus, there isn’t a definitive answer yet, but a company spokesperson told us the following: “Duration of immunity studies require extended observation of vaccinated animals that is not feasible to meet the urgent need of this specific vaccine in the field.
“However, Medgene has approved data using a similar platform technology vaccine on file with the USDA demonstrating duration of immunity greater than 6 months. Internal data suggests duration of immunity up to 12 months.”
It should also work against different strains of the virus, we learned.
“Although new strains (D1.1, etc.) have changes in some viral proteins, the target protein in the virus (H5 - 2.3.4.4b) has been remarkably stable since the original outbreak in dairy cattle,” the company spokesperson said.
“Medgene is confident in the vaccine’s ability to protect against current H5N1 viruses in dairy cattle, which can be directly measured using laboratory assays. Our platform technology can be used to rapidly update the vaccine should the need arise.”
This week, US Agriculture Secretary Rollins announced the USDA would invest $1bn to combat bird flu and tackle rising egg prices in the US; the package includes $100 million for vaccine research.
There are two vaccine candidates in limited quantities in the US stockpile currently, with Moderna having also received funding to develop an mRNA vaccine targeting the trains currently in circulation among wild birds, poultry and dairy cows.
Jeff Simmons, President and CEO of Elanco Animal Health, commented: “Elanco is pleased to partner with Medgene to bring customers options to fight this devastating disease and believes this product will become part of a routine vaccination protocol for the U.S. dairy industry. This partnership further strengthens our diverse dairy portfolio and advances our One Health platform of animal health solutions, not only benefitting our dairy customers, but helping curb disease spread for our poultry customers, and working to improve egg prices for consumers.”
