New bid to restore footrot vaccine access

The strain-specific Custom Footrot R-Pilus vaccine was pulled off the market in late 2020 after the return of Cooper's Animal Health Ovilis Footvax vaccine to market voided its emergency use permit.

Attempts by product manufacturer Tréidlia Biovet to get the emergency use permit extended did not work, with the Administrative Appeals Tribunal in 2022 upholding the Australian Pesticides and Veterinary Medicines Authority's decision to refuse the application.

At the time, Tréidlia Biovet argued that the difficulty and uncertainty involved in any application for registration was a barrier to making an application, while also stating it was not commercially viable for the company to apply to register Custom R-Pilus.

The Australian Wool Innovation-funded vaccine was developed by University of Sydney researchers in 2017, and now WoolProducers will turn back to the university in the hopes that an alternative manufacturer might be willing to go through the registration process.

WoolProducers general manager Adam Dawes said while there was potentially significant work to go into product registration, there hadn't been much progress to date and it was time to take a new direction.

"It would depend on whether a new prospective manufacturer might need to generate some data that's manufacturer-specific and whether there would be any data gaps," he said.

"The most desirable pathway would be for the current licensee to fully commit to progressing registration quickly because they're already experienced with the product, but it is a lower priority for the company than it is for growers."

Mr Dawes said the WoolProducers board hoped that the University of Sydney might step in to make sure that its research is being used to deliver a product to woolgrowers.

"All that we want is for someone to use it... we've got a highly effective proven vaccine that just needs to be registered," he said.

"Growers are frustrated that they haven't been able to access this product since late 2020... to date there's been no definable progress needed to return the product to market."

Evidence given to the Administrative Appeals Tribunal shows that Tréidlia Biovet estimated the initial cost of registration of Custom R-Pilus to be close to $4 million, including $1.85 million and $2.13 million in other costs of registration.

But evidence was given by APVMA that the existing facility was suitable for manufacturing Custom Footrot R-Pilus as a registered product, with the tribunal ruling that the removal of all of the site facility and equipment upgrade costs alone was sufficient to conclude that Custom R-Pilus would produce sufficient return to meet the costs of registration, based on a forecast sales revenue of $386,555 in year one with an annual growth rate of 5 per cent for the next ten years.