E. Coli Vaccine One Step Closer to Approval

An <"http://www.yourlawyer.com/topics/overview/e_coli_O157_H7">E. coli vaccine for cattle is a bit closer to reality, following a United States Department of Agriculture (USDA) determination that  Canada’s Bioniche Life Sciences Inc’s E. coli vaccine is eligible for a conditional license. The USDA said Bioniche’s E. coli vaccine  “meets the ‘expectation of efficacy’ standard” making it eligible for a conditional license once it develops a plan to “collect sufficient data to move the product to full licensure.”

The Bioniche vaccine is the world’s first vaccine approved for use on on-farm intervention to reduce the amount of E. coli O157:H7 shed by cattle.  Bioniche and collaborators have worked for eight years to make the vaccine commercially available, which included extensive testing at the University Nebraska-Lincoln.

“This is a large step forward for the E. coli O157:H7 vaccine,” said Graeme McRae, President & CEO of Bioniche. “The granting of a U.S. conditional license will permit U.S. beef and dairy producers access to a scientifically-validated means to reduce the risk of E. coli O157:H7 contamination.”  Rick Culbert, President of Bioniche Food Safety, added, “There are an estimated 97 million cattle in the United States, many of which carry and shed E. coli O157:H7.  We look forward to working with producers to implement vaccination as the first licensed on-farm intervention for E. coli risk reduction.”

Once the conditional license is granted, Bioniche will receive access to the U.S. market with two restrictions:  at least one manufacturing step must be performed in the U.S. and Bioniche cannot use a trademark name for the vaccine.  Bioniche must produce three validated production lots, filled in the U.S., in accordance with the 1985-amended Virus-Serum-Toxin Act of 1913.  The vaccine will be manufactured in Bioniche’s Belleville, Ontario facility where a two-year, $25 million expansion is occurring.  Vaccine supply will be limited during expansion.

It has taken months for USDA reviewers to complete their assessment of the E. coli vaccine.  “We are very pleased that the USDA reviewers recognize the scientific merit and importance to the market of this vaccine,” said 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.”

With approximately 100,000 cases of human infection with E. coli O157:H7 reported yearly in North America, food recalls due to E. coli contamination continue to be a concern.  On-farm interventions to reduce the shedding of E. coli O157:H7 by cattle, such as vaccination, may assist in reducing food and water contamination and the resulting human illnesses and deaths.  People can also become infected by visiting animal exhibits and with direct exposure to animals, sawdust shavings, and soiled clothing or shoes.

The vaccine prevents E. coli O157:H7 from attaching to the intestines of vaccinated cattle, reducing their reproduction within the animal and in bacteria released through cattle.  Over 30,000 cattle have been involved in clinical testing of the vaccine over the past five years.

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