E. coli vaccine moves closer to approval

News
Dec 16, 2008
by WLJ
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The efficacy and safety requirements for a new E. coli vaccine have been met, the Canadian Food Inspection Agency (CFIA) recently said, which now clears the way for the vaccine for a full license.

The vaccine, produced by Canadian biopharmaceutical company Bioniche Life Sciences, reduces the amount of E. coli shedding in vaccinated animals, lessening the likelihood of E. coli contamination in food or water sources.

Estimates of North American incidences of E. coli infection among humans climb as high as 100,000 cases a year, of which some 2 percent to 7 percent of patients develop a disease which includes kidney failure. Some 5 percent of the afflicted die, most often including children and senior citizens.

Massive beef recalls in both the U.S. and Canada in 2008 prompted many consumer watchdog groups to question the sanitation procedures of beef plants and to worry that USDA’s and CFIA’s inspection processes are inadequate.

“This news from CFIA is extremely encouraging,” said Graeme McRae, Bioniche CEO. “We have demonstrated definitive efficacy of the vaccine and, on completing one last task, we’ll have a full license in hand.” Bioniche is currently working to meet the requirements for a U.S. conditional license for the vaccine. US- DA informed Bioniche in February of this year that the latest data for its E. coli cattle vaccine “meets the ‘expectation of efficacy’ standard” and is eligible for a conditional license, providing that the company develops a plan “that would collect sufficient data to move the product to full licensure.” The conditional license, when granted, will provide Bioniche full access to the U.S. market with two restrictions: At least one step in the manufacturing process must be performed in the U.S., and Bioniche will not be permitted to use a trademark name for the vaccine. The vaccine has been developed with data compiled from research conducted at the University of Saskatchewan in conjunction with the Vaccine and Infectious Disease Organization. The study has shown that vaccination significantly reduces the number of bacteria shed, and the number of animals shedding the bacteria from the gastrointestinal tract. Bioniche claims that more than 30,000 cattle have been involved in clinical testing of the vaccine over the past five years. — Tait Berlier, WLJ Editor

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