The Office of the Gene Technology Regulator (OGTR) has received a licence application from PaxVax Australia Pty Ltd (PaxVax) for the intentional release of a genetically modified (GM) bacterial vaccine into the environment (DIR 126), which qualifies as a limited and controlled release under section 50A of the Gene Technology Act 2000 (the Act).
PaxVax is seeking approval to conduct a clinical trial of a GM live bacterial vaccine against cholera. Once underway the trial is expected to be completed within one year, with trial sites selected from local government areas (LGAs) in Queensland, South Australia, Victoria and Western Australia. The trial will involve the inoculation of approximately 1000 children and adults. The applicant has proposed a number of control measures to restrict the spread and persistence of the GM vaccine and its introduced genetic material.
PaxVax has indicated that a Clinical Trial Notification will be submitted to the Therapeutic Goods Administration, and that they will be applying to Department of Agriculture for a permit to import the vaccines.
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