Animal health vaccine manufacturer Medgene has responded to notice from the USDA Center for Veterinary Biologics (CVB) on testing of vaccines to address H5N1 incidence in dairy cattle. The CVB Notice, 24-13, now allows for vaccine studies to be conducted outside of containment facilities. The new notice has potential to accelerate agency licensure of H5N1 vaccines in dairy cows.

“This is great news for us, for the CVB and more importantly, the dairy industry,” stated Medgene Chief Operating Officer Tom Halbur. “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.”

In 2018, the USDA created a regulatory pathway for animal health companies to address critical disease challenges through vaccination. Medgene’s proprietary model of production was developed to take advantage of modern advances in vaccine science. The category of vaccines created under USDA’s regulatory pathway is called “prescription platform.”

The expected result of Medgene’s development work will be conditional or full licensure by the CVB to produce and distribute an H5N1 vaccine that has been proven safe and effective in dairy cattle. Medgene’s prescription platform technology requires that veterinarians are involved in every critical step, including prescribing and supervising the use of the H5N1 vaccine.

Headquartered in Brookings, South Dakota, Medgene has been successful in prescription platform vaccine production in the swine, cattle, rabbit and deer industries, both in the United States and internationally.