Licence details
Intervet Australia Pty Ltd
Venezuelan Equine Encephalitis Virus
Removal of structural genes to render replication incompetent, addition of Feline Leukemia Virus antigen
This licence allows Intervet Australia Pty Ltd to import, transport, store and dispose of multivalent cat vaccines containing a genetically modified (GM) component for the prevention of feline leukemia virus infection as part of its commercial supply in Australia. The Australian Pesticides and Veterinary Medicine Authority (APVMA) has responsibility for assessing the quality, safety and efficacy of any vaccine intended for use in animals in Australia. Once approved for use in Australia, products are registered by the APVMA and can then be distributed. You can find out more about the APVMA registration process on their website.
The vaccines protect against feline panleukopenia virus, feline calicivirus, feline herpesvirus, Chlamydia felis and feline leukemia virus infection. These infectious pathogens cause gastrointestinal, respiratory, conjunctival, or immunosuppressive disease in cats, and some can be fatal. The GM Venezuelan Equine Encephalitis Virus (VEEV) produces a protein from feline leukemia virus (FeLV) and cannot produce more viral particles. The GMO does not cause disease in cats but triggers an immune response against the protein and protects against later infection by FeLV. The other components of the vaccine are not GM.
The vaccines have been approved for use by the United States Department of Agriculture since 2024 and are recommended for approval by the European Medicines Agency. Laboratory and field studies have found that the vaccine causes no disease itself and protects cats against later infection.
The licence is for an ongoing commercial supply of a multivalent vaccine to protect cats against feline leukemia virus infection from Intervet Australia Pty ltd. The Regulator has not imposed any specific measures to manage risk because there is negligible risk to the health and safety of people or the environment. Any unused vaccine or waste material will be disposed of in accordance with local requirements for clinical waste.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Documents
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.