How is vaccine safety monitored 

Each country has its own processes for assessing and monitoring the safety of vaccines. In Australia, the Therapeutic Goods Administration (TGA) assesses vaccines rigorously. All vaccines must meet the TGA’s high standards before they can be registered and approved for use in the public. As a further check, the TGA assesses the quality of every batch of vaccine before it can be supplied in Australia.

Passive surveillance

After a vaccine starts to be given to people, its safety continues to be monitored in several ways. People can report side effects or adverse events directly to the TGA. This is called passive surveillance because it relies on people to make a report. 

Read more about passive surveillance on the TGA website.

Active surveillance

The safety of vaccines is also monitored through active surveillance in Australia. This is done using a system called AusVaxSafety, wherein participating clinics send short messages using SMS to people receiving vaccines (or their parents or carers) to ask if they had any reactions after receiving a vaccine. Independent experts analyse the responses to make sure that any safety issues are detected quickly.

Read more about active surveillance on the AusVaxSafety website.

COVID-19 vaccine safety monitoring

The safety of COVID-19 vaccines is being monitored using both active and passive surveillance systems in Australia. Read more about the national vaccine safety monitoring here.


Related pages:

NCIRS COVID-19 vaccines: Frequently asked questions

COVID-19 vaccination program in Australia

Last updated April 2023