Thu, 09/23/2021 | News

AusVaxSafety to monitor Moderna COVID-19 vaccine safety

With the first Moderna COVID-19 vaccines administered to Australians this week, Australia’s active vaccine safety surveillance system AusVaxSafety has started monitoring the adverse event profile and safety of the Moderna COVID-19 vaccine in near-real time. 

Initially, the Moderna COVID-19 vaccine is being exclusively administered in pharmacies, making this the first time vaccine safety surveillance will be conducted on such a large scale in pharmacies in Australia. 

AusVaxSafety is using two vaccine safety surveillance tools – SmartVax and Vaxtracker – to send out a short online survey via SMS or email to individuals who receive their Moderna COVID-19 vaccine at a participating AusVaxSafety pharmacy site. Pharmacies across Australia have been selected to ensure a representative sample across the country for effective safety surveillance. 

AusVaxSafety surveys are designed by vaccine experts and allow participants to report any adverse events they may have experienced at different intervals – day 3, day 8 and day 42 – after their vaccination. 

Once a survey is completed, de-identified data are provided to AusVaxSafety in near-real time, to be analysed and monitored for any potential vaccine safety signals. This gives us reassurance that the vaccine is performing as safely and effectively as we expect it to.

The addition of the Moderna COVID-19 vaccine to the AusVaxSafety program builds on the ongoing surveillance of the Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) COVID-19 vaccines currently in use, ensuring the safety of all COVID-19 vaccines in use in Australia is monitored.

Since February 2021, more than 2 million Australians have participated in the AusVaxSafety COVID-19 vaccine surveillance program, by completing more than 3.4 million safety surveys sharing their experience following their Comirnaty (Pfizer) or AstraZeneca COVID-19 vaccination.

Associate Professor Nick Wood, Associate Director of Clinical Research and Services at the National Centre for Immunisation Research and Surveillance, said, “This is the largest scale active safety surveillance ever conducted on vaccines used in Australia and as a result of the high level of participation, we now have an unprecedented amount of safety data, specific to Australia, on short-term adverse events following COVID-19 vaccination.”

“The addition of Moderna COVID-19 vaccine to the AusVaxSafety surveillance program will help us provide the public with near real time safety information as the Moderna COVID-19 vaccine program rolls out,” continued Associate Professor Wood. 

COVID-19 vaccine safety data are released on the AusVaxSafety website weekly, with the first set of Moderna COVID-19 vaccine safety data due to be published on 6 October 2021.

AusVaxSafety active vaccine safety surveillance system complements the enhanced safety surveillance activities of the Therapeutic Goods Administration (TGA). Find out more about how the TGA monitors the safety of COVID-19 vaccines and how you can report side effects on the TGA website

AusVaxSafety is led by the National Centre for Immunisation Research and Surveillance, and is funded by the Australian Government Department of Health.