Licence details
Intervet Australia Pty Ltd
Canine parvovirus type 2
Introduction of a wild type CPV-2c capsid into the attenuated CPV 154 strain, resulting in an attenuated live vaccine that does not cause severe disease in dogs.
This licence allows Intervet Australia Pty Ltd to import, transport, store and dispose of a vaccine containing genetically modified (GM) canine parvovirus (CPV) as part of its commercial supply as a vaccine against canine parvovirus disease 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 GM CPV contained in the vaccine is derived from a vaccine strain that is already used in Australia. The vaccine strain was modified to include a protein from a currently circulating CPV-2 strain. The included protein has been further modified to reduce its ability to cause disease. The resulting vaccine is a weakened strain unable to cause disease in dogs but triggers an immune response to protect against later infection. The canine distemper virus is an attenuated wild type strain and contains no genetic modifications.
The vaccine has been approved for use in 36 countries by the European Medicines Agency and the Philippines Food and Drug Agency to vaccinate dogs from the age of 4 weeks. Laboratory studies have found that the vaccine causes no disease itself and protects animals against later infection with either disease.
The licence is for an ongoing commercial supply of a CPV vaccine 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.