DIR 174

Commercial supply of a genetically modified cholera vaccine, Vaxchora®

Licence details

Licence number:
DIR 174
Licence status:

Biocelect Pty Ltd

Parent organism:

Cholera bacterium (Vibrio cholerae)

Modified trait:

Vaccine – attenuation, Selectable marker – other

Licence issue date:

This licence allows Biocelect Pty Ltd to commercially supply a genetically modified cholera vaccine, Vaxchora®. The vaccine has been produced by deleting a part of the cholera toxin gene and inserting a marker into the haemolysin gene. As a result of these genetic modifications, the vaccine cannot produce the cholera toxin or the protein which breaks open red blood cells and will not cause disease. Before it can be used commercially, Vaxchora® must be registered by the TGA. It is proposed that the vaccine would be made available under prescription for oral administration at home or in medical facilities.

The Regulator has not imposed any specific measures to manage risk, as the risk assessment concluded that this release of the GM vaccine poses negligible risks to the health and safety of people or 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.

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.