Bioniche Life Sciences Inc., the research-based, technology-driven Canadian biopharmaceutical company, has been asked by the Canadian Food Inspection Agency (CFIA) to provide additional safety data on its E. coli O157:H7 cattle vaccine. The CFIA is the regulatory authority with responsibility for licensing this vaccine.
Based on data submitted in 2003, Bioniche has just received a response from the Veterinary Biologics Section of the CFIA. After consultations with Health Canada, concerns were expressed about potential health risks associated with accidental injection of the vaccine into the administrator, the Bioniche release says.
In order to provide the requested data to the CFIA, Bioniche will be conducting an additional animal safety study. "We are absolutely committed to ensuring the safety of our vaccine before it reaches the market," said Martin Warmelink, president of the Food Safety Division of Bioniche Life Sciences Inc., which is responsible for the vaccine's commercialization. "We are working diligently with the regulators to ensure their satisfaction with every aspect of this product, which has consistently shown efficacy in North American field and challenge studies involving approximately 20,000 head of cattle over three consecutive years," he added.
Meanwhile, research continues by Bioniche and its partners into further animal vaccines to reduce food and water contamination from such bacteria as Salmonella enteritidis, Campylobacter jejuni, and Cryptosporidium parvum. These three animal-to-human-transmitted pathogens cause illnesses that can be serious and, in some cases, fatal.