What is AusVaxSafety?
AusVaxSafety is a national, collaborative active vaccine safety surveillance initiative led by NCIRS and funded by the Australian Government Department of Health.
Why is vaccine safety monitored?
Vaccines prevent millions of deaths worldwide each year and have dramatically reduced deaths and disability from infectious diseases in Australia. While we continue to receive these benefits through immunisation programs, it is vital that we monitor vaccines to ensure continuing safety and to maintain public confidence in immunisation.
What is an adverse event following immunisation?
An adverse event following immunisation is any unfavourable and unintended symptom in a person who has been given a vaccine. In many cases, adverse events reported in the days or weeks after vaccination have nothing to do with the vaccine itself, but are a 'coincidence'. AusVaxSafety monitors all adverse events, even those not caused by the vaccine. By monitoring all adverse events occurring after vaccination, and investigating those that are unusual, any unexpected events will be identified early to allow effective public health action.
How does AusVaxSafety monitor vaccine safety?
AusVaxSafety monitors the safety of vaccines in three ways:
1. Sentinel Active Participant-based Surveillance
SmartVax and Vaxtracker are software programs run by general practitioners and immunisation clinics that send an SMS or email to patients or parents following a vaccination. De-identified information from SmartVax and Vaxtracker are combined and monitored by AusVaxSafety to detect possible safety signals for vaccines.
SmartVax and Vaxtracker are used by more than 200 sentinel surveillance sites including general practices, immunisation clinics, hospital- and community-based clinics, and Aboriginal Medical Services spread across all Australian states and territories.
AusVaxSafety sentinel surveillance sites
AusVaxSafety monitors the safety of pertussis, zoster and influenza vaccines via participants recruited in sentinel surveillance sites nationwide.
AusVaxSafety sentinel surveillance sites by jurisdiction (N= 265) as at 14 September 2018
2. Adverse Events Following Immunisation – Clinical Assessment Network (AEFI-CAN)
AEFI-CAN is a formal collaboration between state- and territory-based immunisation specialist clinics. It includes representatives from the Department of Health (Office of Health Protection and the Therapeutic Goods Administration) and most jurisdictional health departments. It is coordinated by Victoria’s state-based surveillance body SAEFVIC (at the Murdoch Children’s Research Institute) in collaboration with NCIRS.
As a national network, AEFI-CAN works collaboratively with all stakeholders to develop a consistent and robust national approach to serious and/or severe AEFI. This involves creating standardised clinical protocols and facilitating uniform AEFI clinical follow up through a national AEFI-CAN clinical database.
AEFI-CAN holds regular teleconferences with members, which provides a platform for a diverse group of vaccine safety clinical experts and policy makers to discuss a range of clinically relevant issues, and has helped strengthen collaborative working relationships among members.
3. National Prescribing Service (NPS) MedicineInsight Data
NPS MedicineInsight collects de-identified patient information from over 600 general practices. The Telethon Kids Institute (TKI), NCIRS and NPS are combining strengths to investigate the safety of the zoster (shingles) vaccine in hundreds of thousands of older Australians.
How is data monitored and reported?
Data is analysed by NCIRS in collaboration with colleagues at TKI, who use statistical methods to automatically detect safety signals. Regular reports (weekly to monthly) are provided to the Australian Government Department of Health Immunisation Branch and the Therapeutic Goods Administration (TGA), and shared with participating state and territory health departments. Other specific studies are undertaken as required.
Vaccine safety surveillance in 2018
During 2018, AusVaxSafety surveillance will be conducted for the following vaccines and age groups:
- Influenza vaccine in all ages during influenza season (April–September)
- Pertussis (whooping cough)-containing booster vaccines in children aged 12 months to <7 years
- Zoster (shingles) vaccine in adults aged 70–79 years
Surveillance will be expanded to other vaccines and age groups in the near future.
For more information
For further information on AusVaxSafety:
Last updated January 2018
and State & Territory Governments