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. STARSS is a study evaluating the use of SMS and telephone follow-up after vaccination. De-identified information from SmartVax, Vaxtracker and STARSS are combined and monitored by AusVaxSafety to detect possible safety signals for vaccines.
SmartVax, Vaxtracker and STARSS are used by more than 156 sentinel surveillance sites including general practices, immunisation clinics, hospital- and community-based clinics, and Aboriginal Medical Services spread across all Australian states and territories.
156 AusVaxSafety sentinel surveillance sites
AusVaxSafety currently monitors the safety of pertussis, zoster and influenza vaccines via participants recruited in 156 sentinel surveillance sites nationwide, and will expand to over 200 sites during 2017.
2. Adverse Events Following Immunisation – Clinical Assessment Network
Specialist immunisation clinics operate across Australia where people who have had an adverse event or vaccine safety concern can be seen by specialist doctors and nurses. These clinic services participate in AusVaxSafety and review reports on a monthly basis.
3. National Prescribing Service (NPS) MedicineInsight Data
NPS MedicineInsight collects de-identified patient information from over 600 general practices. The AusVaxSafety team and NPS MedicineInsight 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 the Telethon Kids Institute, 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 2017
During 2017, AusVaxSafety surveillance will be conducted for the following vaccines and age groups:
- Influenza vaccine in all ages during influenza season (April–October)
- 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
Last updated May 2017