DIR 161

A genetically modified respiratory syncytial virus (RSV) vaccine for use in clinical trials

Licence details

Licence number:
DIR 161
Licence status:
Limited and controlled

Novotech (Australia) Pty Ltd

Parent organism:

Respiratory syncytial virus

Modified trait:

Human therapeutic - attenuation

Licence issue date:

This licence allows Novotech (Australia) Pty Ltd to run a clinical trial of a genetically modified respiratory syncytial virus (RSV) vaccine. The vaccine contains a natural RSV strain which was modified to reduce viral transcription, protein expression and viral replication during infection, compared with unmodified RSV. 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 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. 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.

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.