USDA Approves Novel Vaccine Against Wildlife Spread of the Bacterium Responsible for Lyme Disease

MEMPHIS, Tenn., May 9, 2023 /PRNewswire/ -- US Biologic, Inc., a leading global entity in the development, commercialization, and distribution of orally delivered vaccines, announces USDA Conditional Licensure of its novel oral vaccine against the wildlife spread of Borrelia burgdorferi, the bacterium responsible for Lyme disease, the number one vector-borne disease in the U.S.

The only known vector is the blacklegged tick, which is infected primarily by feeding on small wildlife mammals, particularly white-footed mice. The vaccine, called "Borrelia Burgdorferi Bacterin," is spray-coated onto pellets that the mice consume.

Field trials demonstrating real-world impact have been conducted and co-published by the Cary Institute of Ecosystem Studies, the CDC, the Connecticut Agricultural Experiment Station (CAES), the University of Pennsylvania, the University of Tennessee Health Science Center, Yale University, and others.

The product meets all Conditional Licensure requirements, including uniquely addressing an emergency condition and demonstrated safety. "We thank the USDA for their efforts to help launch innovative products," says Dr. Steve Zatechka, US Biologic Chief Regulatory Officer & Chief Manufacturing Officer.

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, Inc.

"Lyme disease and other tick-borne diseases present a tremendous public healthcare challenge," says 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, Connecticut. "We need to continue to support efforts to innovate and provide these types of new tools."

"Our team members, our leadership, and our partners are dedicated to disease prevention," says US Biologic Chief Executive Officer Mason Kauffman. "This product is only our first step."

About Lyme Disease

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.

About US Biologic

US Biologic envisions a world without endemic and pandemic disease. Our role in achieving this vision is by "Delivering Disease Prevention" through the development and distribution of oral vaccines and therapeutics. The company's proprietary OrisBio oral-delivery platform is changing global disease prevention, allowing safe, effective, and cost-efficient delivery of vaccines and therapeutics.

SOURCE US Biologic, Inc.