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Bioniche Food Safety Vaccine Receives Global Top Honours in Industry Excellence Awards
Date:9/27/2007

vaccine to the marketplace."

The vaccine remains under review by The Canadian Food Inspection Agency (CFIA) and The United States Department of Agriculture (USDA). It is important to recognize that there is no precedent for a vaccine against a zoonotic agent (disease that transmits from animals to humans) where the animal is not made ill. In the course of its review process, the CFIA approved distribution of the vaccine under its Permit to Release Veterinary Biologics regulations. This is equivalent to a conditional license in the U.S. These regulations allow cattle owners, through their veterinarians, to request vaccine be supplied to them by Bioniche.

Since that time, Bioniche has commenced production of the E. coli O157:H7 cattle vaccine at its Belleville, Ontario facility. This supply is now being provided to veterinarians requesting vaccine under the Canadian Permit to Release regulations. Bioniche will continue to scale up as full domestic and international approvals are received. Until such approvals are received, all vaccine will be shipped to Canadian veterinarians as permit requests are received and approved by the CFIA.

In order to progress from shipping under permits to a full license, the CFIA indicated that Bioniche was required to provide additional data confirming reduction in E. coli O157:H7 shedding by vaccinated animals. This information was provided to the CFIA in the spring and is currently under review.

About E. coli O157:H7

Escherichia coli (E. coli) bacteria are normal organisms found in the intestinal tract of all animals and humans. Most E. coli are non-pathogenic (non-disease-causing) to their host, however certain strains can cause intestinal disease and, occasionally, other significant systemic disease. The E. coli O157:H7 bacterium, which was first identified in South America in the late 1970s and drifted northward, produces a powerful toxin (shiga/vero toxin) that can cause severe illness in humans and oft
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SOURCE Bioniche Life Sciences Inc.
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