Vaccine safety monitoring in Australia

All vaccines registered for use in Australia must pass stringent vaccine clinical trials, which include vaccine safety evaluation, before they are approved for use by the Therapeutic Goods Administration (TGA). The safety of vaccines is continually monitored once they are registered and introduced into the population for use. The post-licensure safety surveillance relies on the detection and notification of adverse events following immunisation.

What is an adverse event following immunisation? 

An adverse event following immunisation (AEFI) is any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the use of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.

AEFIs can be categorised into: 

  • reaction related to vaccine product 
  • reaction related to vaccine quality defect
  • reaction related to immunisation error
  • reaction related to immunisation anxiety
  • coincidental event.

AEFI reporting is an essential strategy for ensuring the safety of vaccines.  

Passive surveillance

The TGA monitors AEFIs through a national passive surveillance (i.e. initiated by the ‘reporter’). The reporting is voluntary and anyone, including immunisation providers, pharmaceutical companies, parents or other parties, can report adverse events to the TGA.

In all states and territories, except Tasmania, it is preferable that reporting of AEFI for National Immunisation Program (NIP) vaccines is done via the local health authority, which then sends the report to the TGA. In Tasmania, an AEFI needs to be directly reported to the TGA. For more information, check with your state/territory health department or with the TGA.

Active and enhanced surveillance 

AusVaxSafety is a national collaborative vaccine safety surveillance system led by NCIRS and funded by the Australian Government Department of Health. It expands on and enhances Australia’s established passive AEFI surveillance system to monitor the safety of vaccines through four components:

Related pages:

COVID-19 vaccine safety surveillance

Safety data

 

Last updated October 2021