Question Number: 231
PDR Number: SQ22-000601
Date Submitted: 21/11/2022
Department or Body: Department of Health
125 There is an extensive program of local Therapeutic Goods Administration (TGA) testing. The TGA independently tests every batch of COVID-19 vaccines released in Australia. Batches are not distributed until the TGA has completed batch release testing. The results of testing are published on the TGA website: www.tga.gov.au/batch-release-assessment-covid-19- vaccines.
127 The TGA does not conduct clinical trials, nor does it request that all raw individual participant data be submitted with applications to register a medicine, however it is aware that some regulators such as the United States Food and Drug Administration (US FDA) do this. The Senator could request this information from the US FDA or Pfizer if he wishes. The TGA has met very regularly with the US FDA throughout the COVID-19 pandemic and several of the meetings have included discussion of the data FDA has reviewed. However, it should be noted that the TGA does receive and review some raw individual participant data, such as information about serious adverse events. These are the same requirements as other comparable international regulators. Detailed information about the evaluation of COVID-19 vaccines, including clinical trial data at different stages post vaccination, can be found in the Australian Public Assessment Reports (AusPARs), which are publicly available on the TGAs website at: www.tga.gov.au/covid-19-vaccines.
