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“The conditional licensing of this vaccine is an important step toward our goal of improving food safety in this country,” he says.
E. coli O157:H7 can cause severe illness and death in humans who consume food tainted with the pathogen. A common path for the pathogen to enter the food supply is when muscle tissue becomes contaminated with E. coli 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. The department will continue to explore solutions with all stakeholders to better control E. coli O157:H7 and other foodborne pathogens to reduce the incidence of foodborne illness.
“It really is a major milestone for our industry,” says Michelle Rossman, director of beef-safety research for the National Cattlemen’s Beef Association.
The vaccine works by preventing E. coli O157:H7 present in cows’ intestines from absorbing iron. It takes the proteins that E. coli use to absorb iron from the host animal and injects them back into the cattle to generate an immune response against those proteins. The bacteria die since they can’t absorb iron without those proteins, according to Epitopix.
Bioniche Life Sciences Inc. of Canada was granted similar approval last October, and is also seeking USDA approval to sell the vaccine in the United States. A Colorado company, GeneThera Inc., is also working on a vaccine, but it’s further away from approval.
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.