Mon, 02/08/2021 | News

Active and enhanced vaccine safety surveillance for COVID-19 vaccines in Australia

The AusVaxSafety system, coordinated by NCIRS and funded by the Australian Government Department of Health, will be conducting comprehensive safety monitoring of COVID-19 vaccines. This is to ensure the safety of COVID-19 vaccines and provide clinician and consumer confidence in the vaccination program.

As part of the national COVID-19 Vaccine Pharmacovigilance Plan, led by the Therapeutic Goods Administration (TGA) and the Australian Government, AusVaxSafety will work closely with the TGA, the COVID-19 Vaccine Taskforce and all state and territory health departments to ensure that monitoring of COVID-19 vaccine safety is of the highest possible standard in Australia. Our active surveillance system complements other safety surveillance systems that rely on spontaneous reporting at the TGA and state and territory levels. 

As part of this program, AusVaxSafety will use its established active surveillance system to monitor adverse events following immunisation (AEFI) in people who receive a COVID-19 vaccine. This will help facilitate early detection of any potential vaccine safety issues through responses to a brief survey in the days following vaccination sent via an automated SMS or email. Surveys will be sent by collaborating AusVaxSafety surveillance tools Smartvax and Vaxtracker, and in some cases will come directly from the new patient management systems of states and territories. AusVaxSafety has in-built safety signal detection and daily monitoring that allow us to get a complete picture of how the vaccines perform under real-world conditions. 

AusVaxSafety is already used in over 300 clinic sites across Australia to monitor routine vaccination. It is currently expanding to include more sites that will deliver COVID-19 vaccinations. 

Active surveillance of people vaccinated helps confirm the safety profile of vaccines used in Australia. This is essential to build and maintain public confidence in COVID-19 and other vaccines. 

Australia’s AusVaxSafety system, established since 2014, has been mirrored by others for use in the pandemic, including the new V-SAFE program in the United States of America. 

Learn more about AusVaxSafety active vaccine safety surveillance here

Access AusVaxSafety vaccination surveillance data here 

Read about Australia's COVID-19 vaccine safety monitoring system here