This article was originally posted at 3:26 p.m. CDT on Wednesday, Sept. 4. It was updated at 2:34 p.m. CDT on Thursday, Sept. 5, with a statement from USDA.

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REDFIELD, Iowa (DTN) -- Following U.S. Secretary of Agriculture Tom Vilsack's announcement last week that USDA has authorized the acceptance of licensure applications for an initial field study of vaccine for H5N1 for cattle, South Dakota-based animal health vaccine manufacturer Medgene has responded to the notice.

According to a USDA spokesperson, "USDA has authorized the acceptance of licensure applications for an initial field study, under specific conditions, of nonviable, non-replicating vaccine against HPAI-H5 to be administered to dairy cattle to evaluate safety, as one part of several USDA vaccine licensure requirements. Multiple vaccine manufacturers have expressed interest in beginning field safety trials. This is just one of several steps in achieving vaccine licensure. We anticipate receiving formal field study proposals for review from interested manufacturers in the coming weeks."

OUTBREAK CONTINUES, NOW IN CALIFORNIA

This also happened as California announced its first H5N1 cases at three dairies in the Central Valley. This makes for 14 states affected by the outbreak and 197 confirmed cases as of Sept. 4, 2024.

"We have been preparing for this possibility since earlier this year when HPAI (highly pathogenic avian influenza) detections were confirmed at dairy farms in other states," said California Department of Food and Agriculture Secretary Karen Ross. "Our extensive experience with HPAI in poultry has given us ample preparation and expertise to address this incident, with workers' health and public health as our top priorities. This is a tough time for our dairy farmers given the economic challenges they're facing in a dynamic market, so I want to assure them that we are approaching this incident with the utmost urgency."

SUCCESSFUL TESTING MEANS PRODUCTION FOLLOWS

Medgene has been successful in prescription platform vaccine production in the swine, cattle, rabbit and deer industries, both in the U.S. and internationally. Chief Operating Office Tom Halbur said in a news release, "This is great news for us, for the CVB (USDA Center for Veterinary Biologics) and more importantly, the dairy industry. Our technology is founded on being able to respond to disease challenges faster. Our protocol satisfies the states requirements and we're looking forward to doing our part in supporting both the necessary regulatory policies and the needs of the dairy industry."

The CVB Notice allows for vaccine studies to be conducted outside of containment facilities and has the potential to accelerate agency licensure of H5N1 vaccines in dairy cows.

Medgene's proprietary model of production was developed using modern advances in vaccine science. The expected result of this work will be conditional or full licensure by the CVB to produce and distribute an H5N1 vaccine after it has been proven safe and effective in dairy cattle.

Jennifer Carrico can be reached at jennifer.carrico@dtn.com

Follow her on social platform X @JennCattleGal

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