Australian OGTR Authorizes Clinical Trial of GM Influenza Vaccine

The Office of the Gene Technology Regulator of Australia has issued license DIR 171 to Clinical Network Services (CNS) Pty Ltd, authorizing clinical trial of a live genetically modified (GM) vaccine against influenza virus infection. The Risk Assessment and Risk Management Plan (RARMP) and the license were finalized taking into account the input received during a consultation with the public, State and Territory governments, Australian Government agencies, the Minister for the Environment, the Gene Technology Technical Advisory Committee and local councils.

The finalized RARMP concludes that this clinical trial poses negligible risks to the health and safety of people and the environment, thus it does not require specific risk treatment measures. However, the RARMP states that the license conditions have been imposed to limit the size, location, and duration of the clinical trial and to restrict the spread and persistence of the GMOs and their genetic material in the environment.

The finalized RARMP, a summary of the RARMP, license, and Questions and Answers about this decision are available online from the DIR 171 page of the OGTR website.