USA – Medgene, a leading animal health vaccine manufacturer, has announced its response to the USDA Center for Veterinary Biologics (CVB) latest directive concerning the production of vaccines to control the spread of H5N1 in dairy cattle.
This development follows the release of CVB Notice 24-13, which now allows for the testing of H5N1 vaccines outside of containment facilities, a move expected to expedite the vaccine approval process for use in the dairy industry.
The USDA’s new regulations could significantly accelerate the production timeline for the H5N1 vaccine, potentially leading to quicker agency licensure.
As Medgene’s Chief Operating Officer, Tom Halbur, emphasised, “This is great news for us, the CVB, and more importantly, the dairy industry. Our technology is founded on being able to respond to disease challenges faster. Our protocol satisfies the stated requirements, and we’re looking forward to doing our part in supporting both the necessary regulatory policies and the needs of the dairy industry.”
Since the USDA introduced its regulatory pathway in 2018, animal health companies have had a streamlined route to addressing critical disease challenges through vaccinations.
Medgene has been at the forefront of leveraging modern advances in vaccine science, developing its proprietary production model to respond rapidly to disease outbreaks.
The company specializes in the creation of vaccines under this prescription platform model, which ensures veterinarians are involved at every stage, from prescribing to supervising vaccine use.
The prescription platform technology developed by Medgene represents a new wave of disease prevention in the dairy industry. It provides an adaptable solution to emerging threats like H5N1, also known as avian influenza, which has been affecting a growing number of animal species globally.
The potential spread of H5N1 in dairy cattle could lead to devastating economic losses, making the rapid development of a vaccine all the more critical.
Medgene’s success in developing vaccines for swine, cattle, rabbits, and deer industries across the United States and internationally has positioned it as a trusted leader in the field.
Headquartered in Brookings, South Dakota, the company’s innovative platform has garnered attention for its ability to rapidly produce vaccines that address high-stakes, critical animal health concerns.
With the recent USDA notice, Medgene is poised to extend its success to dairy cattle, potentially securing either conditional or full licensure to distribute an H5N1 vaccine.
The company’s approach ensures that every critical step in the vaccine’s lifecycle, from development to application, is guided by veterinarians. This protocol ensures that the vaccine will meet the highest safety and efficacy standards necessary for widespread use.
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