<i>E Coli</i> Cattle Vaccine Gets Green Light
CANADA - Bioniche Life Sciences Inc. has received notice from the Canadian Food Inspection Agency (CFIA) that the data package for its E. coli O157 cattle vaccine provides definitive evidence that the vaccine meets the efficacy and safety requirements for full licensing of the vaccine.
25 September 2008
2 minute read
Additional data confirming reduction in E. coli O157 shedding by vaccinated animals was provided by the Company, which led to this recognition from the CFIA. The most recent submission to the regulator involved data from a controlled challenge study conducted at the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan. This study demonstrated a significant reduction in the number of bacteria shed by vaccinated animals and the number of animals shedding.
* "On completing one last task, we'll have a full license in hand." |
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Graeme McRae, Chairman, President & CEO of Bioniche Life Sciences Inc.
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The National Manager of the Veterinary Biologics Section, Animal Health and Production Division of CFIA, Dr. Glen Gifford, stated, "Based on the satisfactory results of the Bioniche-VIDO study, and supplemental information from Bioniche's other studies, we have concluded that Bioniche has met the efficacy and safety requirements for licensing of this product."
As part of standard licensing requirements, the Company is required to complete quality control tests on three pre-commercial batches to verify consistency of manufacturing processes. The Company expects to meet these requirements within the next few months.
"This news from CFIA is extremely encouraging," said Graeme McRae, Chairman, President & CEO of Bioniche Life Sciences Inc. "We have demonstrated definitive efficacy of the vaccine and, on completing one last task, we'll have a full license in hand."
The vaccine has been developed by a strategic alliance formed in 2000 between the University of British Columbia (UBC), the Alberta Research Council (ARC), the University of Saskatchewan's Vaccine & Infectious Disease Organization (VIDO), and Bioniche, which holds the rights for worldwide commercialization of the vaccine.
The vaccine works by preventing the E. coli O157 bacteria from attaching to the intestines of vaccinated cattle, thereby reducing their reproduction within the animal, and reducing the amount of bacteria that can be released through cattle manure in the environment.
More than 30,000 cattle have been involved in clinical testing of the vaccine over the past five years.
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