USDA issues conditional license for cattle vaccine for E. coli

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3/18/2009-Agriculture Secretary Tom Vilsack announced that the U.S. Dept. of Agriculture has issued a conditional license to Epitopix, LLC, of Willmar, Minn., for a vaccine to reduce the prevalence of E. coli O157 in feedlot cattle. A common path for E. coli O157 to enter the food supply is when muscle tissue becomes contaminated with the pathogen from the intestinal tract of cattle during the slaughtering process. Vaccines to reduce the prevalence and shedding of E. coli pathogens in cattle are one component of a wide-range of options to enhance food safety controls.

USDA's Animal and Plant Health Inspection Service (APHIS) granted the conditional license following the acceptance of data supporting product safety and a reasonable expectation of efficacy. The safety data included the results of studies that evaluated the product under normal conditions, including field safety trials of the size and scope required for full licensure. The company will conduct additional potency and efficacy studies during the one-year period of the condition license.

APHIS issues conditional licenses in the event of an emergency situation, limited market, or other special circumstance. The special circumstance in this case is the absence of other licensed veterinary biological products for use in reducing the prevalence and shedding of E. coli O157 in cattle.

“Providing the American people with safe and nutritious food is a top priority for President Obama and the U.S. Department of Agriculture," Vilsack said. “The conditional licensing of this vaccine is an important step toward our goal of improving food safety in this country.”

USDA release


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