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In order to begin providing vaccine to U.S cattle producers, the Company is required to produce three validated production lots, which will be filled in the United States, in accordance with the Virus-Serum-Toxin Act of 1913, as amended 1985.

It has taken some months for USDA reviewers to complete their assessment of vaccine efficacy data against a pathogen with a complex life cycle in variable real-world environments. Both the USDA and Bioniche have been diligently working through these challenging issues with a view to benefiting public health and the cattle industry. "We are very pleased that the USDA reviewers recognize the scientific merit and importance to the market of this vaccine," added Mr. McRae. "The vaccine is especially novel in that it reduces shedding of an organism that, while potentially lethal to humans, causes no disease in cattle. As a result, it was particularly challenging for regulators - understanding the many implications of this vaccine as a tool in reducing the shedding and colonization of E. coli O157:H7 in cattle."

Food recalls due to E. coli O157:H7 contamination continue to be a concern in beef, produce and prepared food. On-farm interventions to reduce the shedding of E. coli O157:H7 by cattle, such as vaccination, may assist in reducing the potential for food and water contamination and the resulting human illnesses and deaths.

Approximately 100,000 cases of human infection with the E. coli O157:H7 organism are reported each year in North America. 2% to 7% of those people develop hemolytic uremic syndrome (HUS), a disease characterized by kidney failure (in recent outbreaks, this percentage has risen to as high as 16%). Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage.