There’s a good chance you’ve never heard of Borrelia burgdorferi, but odds are you’re familiar with the illness it can lead to. Borrelia burgdorferi is the bacterium for Lyme disease, the most common vector-borne disease in the U.S.
It’s spread to humans by black-legged ticks — the only known vector — which are usually infected with Borrelia burgdorferi by white-footed mice. But a Memphis-based biotech company has developed a vaccine for these mice. And now, it’s received a greenlight from the U.S. Department of Agriculture (USDA).
Getting the go-ahead
US Biologic has received conditional licensure from the USDA for its Lyme disease vaccine for mice, with the product meeting all conditional licensure requirements, including the unique addressing of an emergency condition and the demonstration of safety.
The approval allows US Biologic to take the vaccine to market. It comes after the company took years to research, develop, and test the vaccine — with field trials that showed impact being conducted and co-published by groups like the Cary Institute of Ecosystem Studies, the Centers for Disease Control (CDC) and Prevention, the University of Pennsylvania, the University of Tennessee Health Science Center (UTHSC), Yale University, and the Connecticut Agricultural Experiment Station (CAES).
"Lyme disease and other tick-borne diseases present a tremendous public health care challenge," said Scott Williams, Ph.D., chief scientist and department head at CAES, in a press release. "We need to continue to support efforts to innovate and provide these types of new tools."
The news also comes less than a week after MBJ explored the work being done by US Biologic in a cover story. The company is set to start by distributing the vaccine for mice in the 16 states with the highest incidences of Lyme disease infection: Connecticut, Delaware, Illinois, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia (including Washington, D.C.), West Virginia, and Wisconsin.
After this, US Biologic plans to expand to meet market demand. But don’t expect to see lines of mice waiting outside of clinics to get shots. Rather than injecting the bacterin into a mouse’s body, it’s given to them orally, through pellets coated with the vaccine.
The company has a partnership with Purina, which provides it with brown, non-nutritive pellets that are the size of an acorn.
These are shipped to US Biologic’s 5,000-square-foot facility, located at Agricenter International, where it has a state-of-the-art coating machine. This machine coats doses of the vaccine for two minutes. The pellets then go to a large, adjacent dryer and are dried for eight minutes. In a continuous process, US Biologic can produce 10,000 coated pellets a minute and about two million in a day.
These pellets, ready to go, are then set to be placed in the field by pest management professionals and located within US Biologic’s LymeShield Stations, green and blue devices that have timed-release systems.
The vaccine is expected to be brought to three markets. One, the residential market, focuses on homeowners. The others are the commercial market — think golf courses, colleges, sports facilities, and summer camps — and the public market, which focuses on places like federal parks, state parks, and military installations.
What's next
US Biologic isn’t about to call it quits after it launches the Lyme vaccine. The company’s ambitions span well beyond this, and it’s developing a chewable flu vaccine in the form of a gummy that can be flavored, shaped into things like hearts and dinosaurs, and stored at room temperature.
Currently in the pre-clinical phase of testing, the goal is to begin human trials with the gummy by the end of 2024. And both it and the Lyme disease vaccine are part of a bigger picture US Biologic is painting: a plug-and-play platform that its leaders believe could rapidly develop vaccines needed to prevent diseases from spreading in communities.
The company is also planning to build a major campus at the Agricenter that would consolidate its headquarters, research and development, vaccine production, and coating all in one location.
Currently, the cost for such a facility is set at $100 million — though this number could rise — and the first stage is set to encompass up to 80,000 square feet. The goal is to break ground in 2024 to keep up with anticipated product demand.
