The medication – manufactured by Bioniche Life Sciences, Inc. – was granted a Special Treatment Certificate (STC) by the UK’s Veterinary Medical Directorate, a branch of the Department for the Environment, Food and Rural Affairs. An STC is issued when no treatment for a given animal disease has been approved by the European Union, but one is available in a country outside the EU.
Although cattle cannot get sick from E. coli O157:H7, their intestines serve as a reservoir for the bacteria, which is shed in their feces and can be passed on to humans, in whom it can cause serious and sometimes fatal infection.
“I am very pleased to see an STC issued for this application,” said Dr. Chris Low, Director of One Health at the University of Edinbugh’s School of Veterinary Studies in a Tuesday press release. “On-farm vaccination is a logical preventative measure to reduce the risk of human exposure to E. coli O157 and this initiative by Bioniche Life Sciences adds to the armoury of those involved in livestock agriculture to ensure that, in the many contexts where country meets city, human illness is not a result.”
The first application of the drug is likely to be on farms where the public risks exposure to cow feces, according to Low.
The STC allows UK veterinary surgeons to use the foreign drug until an equivalent one, or that same drug, is approved for use in the EU.
Before it can be approved across the European Union, the Bioniche drug – Econiche – must meet EU’s Good Manufacturing Practices, a process that’s expected to take anywhere from a year to a year and a half.
Econiche was approved for use in Canada in October of 2008. However, it has not yet received a green light from the U.S. Department of Agriculture – the agency responsible for licensing and regulating Shiga toxin-producing E. coli vaccines in the United States.
In the U.S., another drug designed to prevent E. coli shedding in cattle — Pfizer’s E coli Bacterial Extract Vaccine with SRP® Technology — has been approved by USDA, but has yet to find the funding it needs to be put to widespread use.
That vaccine got a boost this week, however, when Kansas State University released a study showing that an “E. coli Vaccine,” presumed to be the Pfizer drug, reduces shedding of E. coli O157:H7 from cows by more than 50 percent, and that less of the drug is needed to achieve this effect than originally thought, meaning that the cost to farmers would be lower than expected.© Food Safety News