DIR 144

Clinical trial of live attenuated genetically modified influenza vaccines

Licence details

Licence number:
DIR 144
Licence status:
Limited and controlled

Novotech (Australia) Pty Ltd

Parent organism:

Influenza virus

Modified trait:

Human therapeutic - attenuation

Licence issue date:

This licence allows Novotech (Australia) Pty Ltd to conduct a clinical trial of live attenuated genetically modified influenza vaccines. For the GM SAVE flu vaccine strains, a large number of point mutations which don’t change the proteins which the virus makes during infection but reduce the efficiency with which they are made. This is also expected to reduce their ability to grow and cause disease, making them useful as vaccines. Clinical trials in Australia are also overseen by the Therapeutic Goods Administration (TGA) and so Novotech will also need approval from TGA before the trial can start.

The GM flu vaccines would be nasally administered to up to 500 healthy adult male volunteers by qualified health professionals, with a final assessment after 30-35 days. Control measures include limiting the GMOs that can be used in the clinical trials, administration of the GM vaccines only by trained medical staff, appropriate waste disposal, and requiring volunteers participating in the trial to take measures to limit the potential spread of the GMOs. Clinical trials in Australia must also follow the National Statement on Ethical Conduct in Human Research and the Guidelines for Good Clinical Practice of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Novotech will also need permission from the Department of Agriculture, Water and the Environment to import the GM vaccine.

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:


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.