National vaccine safety surveillance

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, like other regulatory agencies around the world, monitors AEFIs through a national passive (spontaneous) surveillance system where reports are initiated by the reporter. Anyone, including consumers, parents or carers, health professionals, immunisation providers, pharmaceutical companies, state/territory health departments and other Australian vaccine safety organisations can report adverse events to the TGA.

AEFI reports can be sent directly to the TGA or to your state or territory health department. For more information, please refer to https://www.ncirs.org.au/health-professionals/specialist-immunisation-services or 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 and Aged Care. It expands on and enhances Australia’s established passive AEFI surveillance system to monitor the safety of vaccines through four components:

• active surveillance
• clinical assessment network
• adverse events of special interest follow up
• population-based safety investigation using linked data.