USDA Says No To E. coli Cattle Vaccine

BELLEVILLE - Bioniche Life Sciences Inc. (TSX:BNC) disclosed Friday that the U.S. Department of Agriculture has refused to approve its E. coli O157:H7 cattle vaccine.
calendar icon 9 October 2007
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The company said the USDA found that data from a field use study last year at the University of Nebraska "would not support licensure at this time."

Bioniche said it will submit additional statistical analyses and supporting material to the USDA within weeks, but "if the regulator retains its current position, the company will be required to pursue additional vaccine studies in 2008.

The vaccine is undergoing a separate review by the Canadian Food Inspection Agency, which has provided conditional approval for Canadian cattle owners to buy it through their veterinarians.

Escherichia coli bacteria are normal inhabitants in the intestinal tracts of all animals, but the O157:H7 variant, first identified in South America in the late 1970s and now found in many North American beef and dairy herds, produces a powerful toxin that can cause severe illness in humans.

Bioniche cites a U.S. Centers for Disease Control estimate that E. coli O157:H7 infects 73,000 Americans annually, and as many as 16 per cent of them develop kidney failure.

The vaccine was developed in a strategic alliance formed in 2000 between Bioniche and the University of British Columbia, the Alberta Research Council and the University of Saskatchewan.

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