Question Number: 141
PDR Number: SQ22-000228
Date Submitted: 24/02/2022
Department or Body: Departmnet of Health

For the registration of any medicine or vaccine, sponsors are required to submit a range of clinical trial data, which are based on individual patient-level data, to the Therapeutic Goods Administration (TGA) as part of the application process.

The TGA does not generally request that all raw individual participant data be submitted with applications to register a vaccine. Some regulators such as the United States Food and Drug Administration (US FDA), do this. The TGA has met regularly with the US FDA throughout the vaccine’s evaluation process and several of the meetings have included discussion of the data the US FDA has reviewed. However, 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.

Since these vaccines were granted provisional approval, more than 11 billion people have received doses of COVID-19 vaccines worldwide. Data on real-world use of the COVID-19 vaccines approved in Australia provides reassurance about their safety and that the trials were carried out correctly. This is supported by reviews of safety data by international medicines regulators in countries with extensive COVID-19 vaccine experience who have found no new safety concerns associated with the use of COVID-19 vaccines. In addition, the TGA’s monitoring program has not detected any new safety signals in relation to COVID-19 vaccines to date.