According to a Press Release from Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, the company last week received authorization from the Canadian Food Inspection Agency (CFIA) to distribute its E. coli O157:H7 cattle vaccine to Canadian veterinarians under a Permit to Release Veterinary Biologics as specified in the Canadian Health of Animal Regulations. This authorization equates to what is referred to as a “conditional license” in the U.S. This is the first vaccine technology for control of E. coli O157:H7 to be authorized for field use by a regulator globally. The vaccine is indicated for the reduction of shedding of E. coli O157:H7 bacteria in cattle.
Recent outbreaks of E. coli O157:H7 affecting spinach and other produce in North America have highlighted the fact that this is an increasingly serious human health threat that goes beyond meat (the first major foodborne outbreak of E. coli O157:H7 occurred in 1982 and was associated with ground beef). Human exposure to E. coli O157:H7 is being increasingly associated with contaminated fruit, vegetables, unpasteurized milk and fruit juice, potable and recreational water, and from direct contact with animals at fairs and petting zoos
Clinical trials have been conducted with the Company’s vaccine over the past four years involving more than 30,000 cattle. Studies have consistently shown a significant decrease in the number of cattle shedding these deadly bacteria in their manure. In a controlled experiment conducted at VIDO, vaccinated cattle were challenged with a very large dose of bacteria, and there was a reduction in the magnitude of shedding by 99.47%. In clinical trials conducted by the University of Nebraska-Lincoln in commercial feedlot settings (where vaccinates and non-vaccinates were mixed), there was a 75% lower prevalence of E. coli O157:H7 in cattle vaccinated with two doses of the Bioniche vaccine. Another three-dose vaccination study was performed by the university, which showed that vaccinated cattle were 98.3% less likely to colonize the bacteria in their intestine.