Breadcrumbs

DIR 098

Commercial release of a genetically modified live viral vaccine to protect against Japanese encephalitis (IMOJEV™)

Licence details

Licence number:
DIR 098
Licence status:
Current
Category:
Medical
Release:
Commercial
Organisation:

Sanofi-Aventis Australia Pty Ltd

Parent organism:

Yellow fever virus (YF 17D)

Modified trait:

Vaccine - attenuation, Vaccine - antigen expression

Licence issue date:
Description:

This licence allows Sanofi-Aventis Australia Pty Ltd to commence the commercial  release of a genetically modified live viral vaccine to protect against Japanese encephalitis (IMOJEV)™. The GM vaccine is based on the existing vaccine for Yellow fever in which two genes have been replaced by similar genes from JEV. Previous clinical studies have shown that this GM vaccine protects adults and children against JEV.

The Regulator has not imposed any specific measures to manage risk, as the risk assessment concluded that commercial supply of the GM vaccine poses negligible risks to the health and safety of people and the environment. However, general conditions have been imposed to ensure that there is ongoing oversight of the release. Commercial supply of vaccines in Australia will follow the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 (2011), the WHO’s Good Distribution Practices for pharmaceutical products (WHO 2010), and the Standard for the Uniform Scheduling of Medicines and Poisons (as current) which all provide appropriate controls and informed the risk assessment. 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

Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Licence application - summary

A summary of the application including brief description of the GMO(s) and proposed work with GMO(s). Also explains the assessment and public consultation process.

Risk assessment and risk management plan - summary

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.

Risk assessment and risk management plan - full version

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.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.