Hooves affected by virulent footrot.

WOOLPRODUCERS Australia believes a clear pathway to availability of a custom footrot vaccine has been identified after work with intellectual property owner the University of Sydney and other agencies.

For several years leading up until the end of 2020, Australian sheep producers had access to a custom footrot R-Pilus vaccine as a management tool.

This access was possible under an emergency use permit. With the return of Footvax® to the Australian market in late 2020, the validity of the emergency use permit for the custom vaccine ceased, and it unfortunately has remained unavailable to growers.

However, WoolProducers general manager Adam Dawes said in July last year the University of Sydney implemented non-exclusive intellectual property licensing arrangements for the vaccine.

“This meant that we can then approach the open market to see who is keen on progressing registration of this, because it has not progressed in the past five years and it must.”

Meat and Livestock Australia found that the economic cost of benign and virulent footrot to the Australian sheep and wool industry is $83.4 million per annum. Mr Dawes said WPA regularly engage our members and have consistently found for the last few years that footrot always features within the top three health and welfare issues for wool growers.

The bacteria that causes footrot (Dichelobacter nodosus) is classified into one of 10 serogroups (or strains), with multiple serogroups often occurring within an infected flock. The custom vaccine targets just one (or two) serogroups of footrot, based on the results of swabbing infected sheep on a property wanting to undertake a control or eradication program. Limiting the number of serogroups targeted by the vaccine to those present within the flock results in a more targeted immune response, WoolProducers said.

WoolProducers said it has been working tirelessly since late 2020 to restore grower access to the custom vaccine. This work has included working closely with the University of Sydney, manufacturers, the Australian Pesticides and Veterinary Medicines Authority, rural development corporations and other stakeholders to emphasise the need to restore access to the custom vaccine and explore access pathways.

“Since late 2020, WoolProducers has worked tirelessly with constant support and guidance from our members to explore all options to get the vaccine back to growers.

“Having explored all permit pathways, it is now clear that the only way to consistently restore grower access is via full product registration,” Mr Dawes said.

WPA said a collaboration with the University of Sydney and experts in APVMA registration requirements and Animal Health Australia has identified the research and documentation requirements to facilitate a registration of the custom vaccine. As part of this process, the University has been consulting with APVMA to identify a suitable registration process to restore grower access as quickly and efficiently as possible, while adhering to regulatory obligations.

A report is in the final stages of drafting, after finalisation an approach market will take place to identify partners to progress the registration of vaccine and identify the necessary funding arrangements and timeframes.

Mr Dawes said the report will give clarity around the requirements for registration and will allow WPA to find the right partners to get the vaccine back to growers.

“We still have at least another three years ahead of us before we obtain full registration of the custom vaccine.

“We still need to find the funds to support the research and registration process, however it’s reassuring to finally see some light at the end of the tunnel,” he said.