Bioniche E. coli vaccine cleared for import into UK

A UK government department has approved the import of Bioniche's (ASX:BNC) cattle vaccine against E. coli O157 bacteria.

The veterinary medicines division of the department for the environment, food and rural affairs has granted a Special Treatment Certificate (STC) for the vaccine.

STCs are issued when there is no approved remedy for an animal disease in the UK, but there are products available in other countries.

The certificate will allow the use of the vaccine prior to Bioniche receiving formal regulatory approvals for the product in Europe.

The vaccine will need to meet the EU's Good Manufacturing Practice (GMP) production standards before it can be approved for sale.

This certification process is expected to take 12-18 months, and Bioniche is currently concentrating on validating that its animal vaccine manufacturing facility in Canada meets North American standards.

E. coli O157 occurs naturally in – but has no affect on – domestic cattle. But exposure to the faeces of cows carrying the bacteria is a common cause of E. coli O157 transmission, as is ingestion of contaminated meat.

Human infection with the bacteria can cause symptoms including abdominal pain, bloody diarrhoea and in severe cases kidney damage and even death.

In the UK, the vaccine is expected to be initially used in situations where the public faces a direct risk of exposure to the bacteria – for example, for vaccinating cows on visitor farms.

Bioniche is a biotech developing products for both human and animal health. The company is headquartered in Canada, but has Australian operations focused on the animal health end of the business.

Bioniche (ASX:BNC) shares were level at $0.60 as of midday Thursday after a bump to $0.645 during Wednesday’s trading.