135. Given the TGA failed to review the gene technology around the Pfizer vaccine did the TGA seek advice and analysis from the Office of Gene Technology Regulator before approving the Pfizer vaccine which involves gene technology? If not why not? 136. Was the TGA required to get authorisation from the Office of the Gene Technology Regulator before approving the Pfizer vaccine? 137. Did the Office of the Gene Technology Regulator provide analysis to the TGA for either of the Astra Zeneca or Pfizer vaccines? If so, could copies please be provided.

Question Number: 126
PDR Number: SQ22-000134
Date Submitted: 24/02/2022
Department or Body: Department of Health

The Office of Gene Technology Regulator (OGTR) regulates genetically modified organisms (GMOs). A GMO is defined as a plant, animal or other organism whose genetic material has been modified using gene technology or an organism that has inherited modified traits from a GMO.

The Therapeutic Goods Administration (TGA) did not seek advice or analysis from the OGTR before approving the Pfizer vaccine, nor was authorisation required from OGTR. This is because messenger RNA (mRNA) vaccines, such as the Pfizer and Moderna COVID-19 vaccines, are not considered to be GMOs.

mRNA vaccines contain fragments of mRNA that give our cells instructions about how to make the coronavirus’ antigenic protein, the spike protein. When our body has made the protein encoded by the mRNA vaccine, it then recognises that the spike protein is foreign and mounts an immune response against it. The mRNA is broken down quickly by the body. It never enters the cell nucleus and cannot affect or combine with our DNA in any way to change our genetic code.

The viral vector COVID-19 vaccines, including the AstraZeneca (Vaxzevria) and Janssen COVID-19 vaccines, contain genetically modified material so do fall under the OGTR’s remit.

Viral vector vaccines use a genetically modified, non-pathogenic, weakened virus that contains the genetic code for the coronavirus’ unique spike protein (Vaxzevria uses an animal virus, Janssen uses a human virus). When this enters our body, the genetic material contained in the viral vector instructs our cells to make the copies of the coronavirus spike protein. Our body then recognises the spike protein as being foreign and mounts an immune response against it. As with mRNA vaccines, the genetic material from viral vector vaccines does not change, or interact, with our DNA in any way.

Subsection 30C(2) of the Therapeutic Goods Act 1989, states that the TGA must provide written notice to the OGTR stating that an application to register a therapeutic good containing a GMO has been made and requesting that the OGTR provide advice about the application. Accordingly, the OGTR did provide an analysis to the TGA about the AstraZeneca and Janssen COVID-19 vaccines.

OGTR assessed and issued a licence to AstraZeneca and Janssen for the importation, transport, storage and disposal of their COVID-19 vaccines.

• The AstraZeneca COVID-19 vaccine licence is available at: www.ogtr.gov.au/gmo-dealings/dealings-involving-intentional-release/dir-180
• The Janssen COVID-19 vaccine licence is available at: www.ogtr.gov.au/gmo-dealings/dealings-involving-intentional-release/dir-182

In addition, the TGA have several dozen scientific and regulatory staff with extensive experience in gene technology.