South Dakota company signs agreement to support the dairy industry; Accelerates vaccine testing for turkeys, egg-laying hens, and companion animals

February 25, 2025:

A Brookings, SD, based animal health company has reported (Feb. 25, 2025) successes in making H5N1 vaccines commercially available to animal owners and veterinarians.

Medgene has entered into a distribution agreement with Elanco Animal Health to accelerate the company’s support of the U.S. dairy industry, pending a final decision by the U.S. Department of Agriculture to vaccinate dairy cattle. Medgene’s H5N1 vaccine for dairy cattle has met all requirements of USDA’s platform technology guidelines and is in the final stages of review for conditional license approval. H5N1-infected dairies have experienced mortality, milk production loss with limited recovery, and abortion storms in pregnant heifers.

Medgene has previously worked with USDA’s Center for Veterinary Biologics to develop platform technology vaccines for emerging and foreign animal diseases, such as rabbit hemorrhagic disease, under specific regulatory guidelines for platform technologies.

As Medgene’s H5N1 vaccine for dairy cattle awaits USDA-CVB completion of departmental review, the company has made progress in essential testing for poultry and companion animal applications. USDA’s Agricultural Research Service is currently testing Medgene’s H5N1 vaccine in turkeys and egg-laying hens. Medgene has also recently completed its field safety study in turkeys.

Additionally, Medgene is collaborating with Cornell University to test its H5N1 vaccine in cats, which according to the American Veterinary Medical Association, have experienced mortality from consuming H5N1-infected products. Initial antibody titers from Medgene’s H5N1 vaccine in cats have surpassed the company’s expectations.

OCTOBER 23, 2024:

Medgene, a South Dakota based animal health company, has begun a field trial on their H5N1 vaccine in cattle. The trial began earlier this month (Oct. 2024) at a contract research facility. The goal of the field trial is to demonstrate a reasonable expectation of eﬃcacy and preliminary safety in animals specific to the company’s H5N1 vaccine, data to support a conditional license by the U.S. Department of Agriculture.

Dr. Alan Young, co-founder and Chief Technology Oﬃcer for Medgene stated, “As unfortunate as the H5N1 spread is, this is exactly the kind of situation that our technology was created to address. Our goal from the very beginning of this outbreak was to be ready for our cattle customers whenever the USDA gave us the green light.”

Medgene’s H5N1 cattle vaccine study is expected to be complete in five weeks, with results then shared with the USDA.

SEPTEMBER 11, 2024:

Prescription platform vaccine manufacturer Medgene announces that it will be expanding its vaccine offerings to help keep sheep and goats healthy in partnership with Iowa State University.

“Partnering with Medgene offers many benefits to university researchers, allowing them to continue to serve the needs of animal agriculture,” says Dr. Alan Young, Medgene co-founder and Chief Technology Officer. “A collaboration of this type is also a benefit for Medgene, where the expertise of grant principal Dr. Jodi McGill can be used to solve tough problems for the animal health industry that can be rapidly implemented.”

The two-year grant that makes these sheep and goat vaccines possible is from the USDA Animal & Plant Health Inspection Service (APHIS) National Animal Disease Preparedness Response Program.

“Iowa State University is routinely contacted by goat producers who submit diagnostics for diseases and are looking for biologic solutions. Currently, they are forced to use tools developed for cattle with few products developed specifically for goats,” says Dr. Michael Roof, Chief Technology Officer, Immunovac, Iowa State University. “Because of the variety of different diseases that need solutions, Medgene’s prescription vaccine platform is very appealing, as it can be applied quickly across numerous diseases, including bacterial and viral diseases.”

The grant has three objectives, all based around pursuing vaccine solutions for diseases affecting sheep and goats, including bluetongue virus (BTV), Cache Valley Fever and respiratory syncytial virus (RSV).

“I’m grateful for the opportunity to work with the team at Medgene,” says Dr. McGill. “I think this will be a really productive partnership. I’m also really excited to address this important need for our sheep and goat producers and am looking forward to seeing these vaccines used on farms that need them.”

Pneumonia caused by respiratory infections such as RSV cause production losses and even death in young lambs and kids. Currently, most RSV and other respiratory viral pathogens that are recommended annually for cattle, but there are currently no vaccines available for sheep and/or goats.

In sheep and goats, Cache Valley Fever can cause abortions, malformed fetuses, infertility and congenital abnormalities. Mosquitoes transmit the disease, which is endemic in many parts of the U.S. Developing vaccines to prevent this disease will benefit producers and improve animal welfare for small ruminants.

SEPTEMBER 6, 2024:

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 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.

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

ABOUT MEDGENE:

Medgene is an American animal health company headquartered in Brookings, South Dakota. Medgene received the first USDA license to produce Platform Vaccines for the cattle industry, allowing veterinarians to safely respond to diseases faster and more efficiently. Medgene’s prescription platform vaccine technology is also licensed in swine and companion animals (rabbits), and is used in white-tailed deer.

Medgene’s prescription platform system ensures that all the ingredients that go into our vaccines are animal origin free.

South Dakota company signs agreement to support the dairy industry; Accelerates vaccine testing for turkeys, egg-laying hens, and companion animals

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