27 October 2022

Invitation to comment on the assessment of a chicken respiratory virus vaccine

The Office of the Gene Technology Regulator (OGTR) is assessing an application from Bioproperties Pty Ltd for a live attenuated, genetically modified chicken respiratory virus vaccine (known as Vaxsafe® ILT). The vaccine will be used to vaccinate commercial poultry to protect them against infectious laryngotracheitis virus.

The vaccine must also be registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) before it is approved for commercial use in Australia.

The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and welcomes written submissions on any risks to human health and the environment posed by the conducting of experiments, transport, storage and disposal of this vaccine, and is seeking comment on the assessment prior to making a decision on whether or not to issue the licence. The consultation RARMP and related information can be obtained via our website (search for DIR 193), or from the contacts below. Submissions should reference DIR 193 and be received by 21 December 2022

Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601

Telephone: 1800 181 030   Website: www.ogtr.gov.au

E-mail: ogtr@health.gov.au