Conditional License Granted For E. Coli Vaccine

Feb 11, 2008 11:28 AM

Bioniche Life Sciences, Inc., a Canadian biopharmaceutical company, has received a conditional license from USDA for the world’s first vaccine that may be used as an on-farm intervention to reduce the amount of E. coli O157:H7 shed by cattle. Bioniche and its collaborators have been moving the vaccine towards commercial availability for eight years, with extensive testing done at the University of Nebraska-Lincoln.

According to USDA, the vaccine “meets the ‘expectation of efficacy’ standard,” and is eligible for a conditional license, providing the company develops a plan that would collect sufficient data to move the product to full licensure. The conditional license will provide the company full access to the U.S. market, with two restrictions: 1) at least one step in the manufacturing process must be performed in the U.S. ; and 2) Bioniche will not be permitted to use a trademark name for the vaccine.

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