USDA Agrees to Grant Conditional License to Bioniche for its E. coli O157:H7 Cattle VaccineWednesday, February 6, 2008
(American Meat Institute)
Bioniche Life Sciences Inc., a
research-based, technology-driven Canadian
biopharmaceutical company, has received notice
from the United States Department of
Agriculture (USDA) that the latest data for its
E. coli O157:H7 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 the company full access to the U.S. market with two restrictions: At least one step in the manufacturing process must be performed in the United States and Bioniche will not be permitted to use a trademark name for the vaccine.
The Bioniche vaccine is 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 and it has been extensively tested at the University Nebraska-Lincoln, with efficacy results now being published in peer-reviewed scientific journals, most recently, the Journal of Food Protection, in November, 2007.share on facebook share on twitter