U.S. Biologic announced it had received conditional licensure from the United States Department of Agriculture (USDA) for its novel oral vaccine against the wildlife spread of Borrelia burgdorferi, the bacterium responsible for Lyme disease.
The only known vector is the black-legged, or deer tick (Ixodes scapularis), which is infected primarily by feeding on small wildlife mammals, particularly white-footed mice (Peromyscus leucopus). The vaccine, called “Borrelia Burgdorferi Bacterin,” is spray-coated onto pellets that the mice consume, according to the news release.
Field trials demonstrating real-world impact have been conducted and co-published by the Cary Institute of Ecosystem Studies, the Centers for Disease Control and Prevention (CDC), the Connecticut Agricultural Experiment Station (CAES), the University of Pennsylvania, the University of Tennessee Health Science Center, Yale University and others.
The product, which will be marketed as the LymeShield System, meets all USDA Conditional Licensure requirements, including addressing an emergency condition and demonstrated safety.
US Biologic will provide the product in residential settings, public lands, including parks, and commercial areas, such as golf courses and other recreational facilities. The company will work closely with federal and state health agencies and pest management professionals that service the areas most at risk for infection, as well as partners like the Global Lyme Alliance and the Lyme Disease Association.
“Lyme disease and other tick-borne diseases present a tremendous public healthcare challenge,” said Dr. Scott Williams, chief scientist and department head at CAES, which performed field trials showing the positive impact of the vaccine in residential settings in Redding, Conn. “We need to continue to support efforts to innovate and provide these types of new tools.”
Ticks infected with Borrelia burgdorferi feed on humans, pets, and other animals and can cause Lyme disease, which can result in severe damage to joints, neurologic systems, and the heart. The CDC estimates that 476,000 U.S. citizens are diagnosed with and treated for Lyme disease annually.