USDA has authorized the first field safety study of a vaccine to prevent the H5N1 strain of bird flu in dairy cows.

The first case of the flu, called highly pathogenic avian influenza, was confirmed in a Texas dairy herd last March. As of Sept. 13, 208 cases have been confirmed in dairy herds in 14 states. The newest detections were in California, where 10 cases have been confirmed since Aug. 30.

“We have a number of companies that have been working on vaccines, and one company has now presented sufficient information to the USDA to allow me to authorize … the first field trial of a vaccine for cattle H5N1 for safety purposes,” USDA Secretary Tom Vilsack said in a recorded statement.

Next step

The field trial is the next step in vaccine development.

Information from the field trial “will allow us to determine whether we can go to the next level, next set of steps, necessary to ensure safe and effective use of the vaccine,” he said.

The Center for Veterinary Biologics in Ames, Iowa, will oversee the vaccine test.

The vaccine was developed by Medgene, an animal-health vaccine manufacturer headquartered in Brookings, S.D., using the company’s rapid-response vaccine technology.

Outside studies

An Aug. 28 notice from the Center for Veterinary Biologics now allows vaccine studies to be conducted outside containment facilities. The new notice has the potential to accelerate agency licensure of H5N1 vaccines in dairy cows, according to Medgene.

“This is great news for us, for the CVB and, more importantly, the dairy industry,” Tom Halbur, Medgene chief operating officer, said in a press release.

“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,” he said.

This is the first field safety study for a bovine-specific H5N1 vaccine and the first time a HPAI vaccine field study will be conducted outside a laboratory setting or on any type of commercial farm in the U.S., according to USDA.

USDA anticipates requests from other interested vaccine manufacturers.

The studies are limited to nonviable, non-replicating vaccines that don’t cause virus shedding. Vaccinated cattle will not transmit virus to other animals, milk, meat or into the environment. The cattle in the studies and their products do not present a risk to human health and will stay in normal production, according to USDA.