Receipt of licence application from the University of Tasmania for a trial of a genetically modified vaccine against devil facial tumour disease in Tasmanian devils.
The Office of the Gene Technology Regulator (OGTR) has received a licence application (DIR 195) from the University of Tasmania to conduct a trial with a genetically modified (GM) adenoviral vaccine to protect Tasmanian devils against devil facial tumour disease. A summary of the application is posted on our website.
The purpose of the trial is to evaluate the immunogenicity, safety and efficacy of the GM vaccine for the prevention and/or treatment of devil facial tumour disease. The GM vaccine would be administered to Tasmanian devils kept in enclosures within trial sites in Tasmania.
The OGTR is preparing a Risk Assessment and Risk Management Plan for the application. This is expected to be released for public comment and advice from experts, agencies and authorities in March 2023. There will be at least 30 days for submission of comments.
If you have any questions or would like to receive a copy of the full application or the summary, please contact the OGTR and quote the reference number DIR 195.
Office of the Gene Technology Regulator
Licence application – notification
Information for the public and stakeholders that the Regulator has received an application for a licence. It provides early information about the application and the assessment process including a future opportunity for public submissions.
https://www.ogtr.gov.au/gmo-dealings/dealings-involving-intentional-release/dir-195