Australia’s active vaccine safety system

AusVaxSafety, together with the Australian Government Department of Health, state and territory health departments and the Therapeutic Goods Administration (TGA), is conducting long-term follow-up surveillance of individuals who experienced an adverse event of special interest (AESI) following COVID-19 vaccination. 

The program will help us gain a greater understanding of the characteristics, progress and outcomes of individuals affected by AESIs following COVID-19 vaccination. Data captured from the program will provide clinicians treating patients affected by these AESIs with important clinical management information and will inform future government and expert advisory body guidance around COVID-19 vaccination in Australia.

How it works

1. Potential participants identified

Individuals that meet the program selection criteria are identified and invited to participate in AusVaxSafety follow-up program.

2. Participant enrolls in follow-up program

Following consultation, individual agrees to participate and is enrolled in the relevant AESI study arm.

3. Follow-up of participant begins

Participants are contacted and/or sent surveys at different time points over a period which ask questions around general health, relevant follow up investigations and psychological health.

4. De-identified data are collected and analysed

Data collected from participants are de-identified and analysed by clinical specialists and epidemiologists.

5. Findings published

Results published highlighting key findings and recommendations for the future.

What is an adverse event of special interest?

An AESI is a defined condition or event that occurs in some individuals following immunisation, that has the potential to be causally associated with a vaccine product. Examples of AESIs include anaphylaxis, myocarditis and more recently TTS. AESIs need to be carefully monitored and confirmed by further research studies, which is what the AusVaxSafety AESI follow-up program will help contribute to in an Australian setting.

AESIs currently being investigated 

The AusVaxSafety follow-up program is currently investigating the following AESIs:

  • Study arm 1 - Thrombosis with thrombocytopenia syndrome (TTS)
  • Study arm 2 - Myocarditis and/or pericarditis


Click on the tiles below to find out more about each AESI being investigated.