Breadcrumbs

DIR 137

Commercial supply of attenuated GM influenza vaccines

Licence details

Licence number:
DIR 137
Licence status:
Current
Category:
Medical
Release:
Commercial
Organisation:

AstraZeneca Pty Ltd

Parent organism:

Influenza virus

Modified trait:

Vaccine - attenuation

Licence issue date:
Description:

This licence allows AstraZeneca Pty Ltd to commence the commercial supply of attenuated GM influenza vaccines. Similar vaccines were first marketed in the US as FluMist® during the 2003/2004 flu season and in the EU as Fluenz® during the 2012/2013 flu season. They are currently authorised in the USA and Canada as FluMist Quadrivalent, and in the EU as Fluenz Tetra.

The GM vaccines are based on attenuated human flu strains which have reduced ability to grow and cause disease. These attenuated strains are modified by incorporation of antigens from current circulating flu strains to provide protection against these flu strains. The Regulator has not imposed any specific measures to manage risk, as the risk assessment concluded that commercial supply of the GM virus poses negligible risks to the health and safety of people and the environment. 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.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:

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.

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.