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The Bioniche vaccine is the world's first vaccine that may be used as anon-farm intervention to reduce the amount of E. coli O157:H7 shed by cattle.Bioniche and its collaborators have been moving the vaccine towards commercialavailability for eight years and it has been extensively tested at theUniversity Nebraska-Lincoln, with efficacy results now being published inpeer-reviewed scientific journals, most recently, the Journal of FoodProtection, in November, 2007. The E. coli O157:H7 cattle vaccine will bemanufactured in the Bioniche production facility in Belleville, Ontario,Canada where a two-year, $25 million expansion is taking place. Vaccine supplywill be limited during this manufacturing expansion period.
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"This is a large step forward for the E. coli O157:H7 vaccine," saidGraeme McRae, President & CEO of Bioniche Life Sciences Inc. "The granting ofa U.S. conditional license will permit U.S. beef and dairy producers access toa scientifically-validated means to reduce the risk of E. coli O157:H7contamination."
Rick Culbert, President of Bioniche Food Safety, added, "There are anestimated 97 million cattle in the United States, many of which carry and shedE. coli O157:H7. We look forward to working with producers to implementvaccination as the first licensed on-farm intervention for E. coli riskreduction."
In order to begin providing vaccine to U.S cattle producers, the Companyis required to produce three validated production lots, which will be filledin the United States, in accordance with the Virus-Serum-Toxin Act of 1913, asamended 1985.
It has taken some months for USDA reviewers to complete their assessmentof vaccine efficacy data against a pathogen with a complex life cycle invariable real-world environments. Both the USDA and Bioniche have beendiligently working through these challenging issues with a view to benefitingpublic health and the cattle industry. "We are very pleased that the USDAreviewers recognize the scientific merit and importance to the market of thisvaccine," added Mr. McRae. "The vaccine is especially novel in that it reducesshedding of an organism that, while potentially lethal to humans, causes nodisease in cattle. As a result, it was particularly challenging for regulators- understanding the many implications of this vaccine as a tool in reducingthe shedding and colonization of E. coli O157:H7 in cattle."
Food recalls due to E. coli O157:H7 contamination continue to be a concernin beef, produce and prepared food. On-farm interventions to reduce theshedding of E. coli O157:H7 by cattle, such as vaccination, may assist inreducing the potential for food and water contamination and the resultinghuman illnesses and deaths.
Approximately 100,000 cases of human infection with the E. coli O157:H7organism are reported each year in North America. 2% to 7% of those peopledevelop hemolytic uremic syndrome (HUS), a disease characterized by kidneyfailure (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
