Automated Vaccine Safety

Overview:

Vaccines, like any other drugs, are associated with adverse events. Post-licensure surveillance of these adverse events is important not only to detect safety signals but to also maintain trust of the public. Like other countries, Australia too relies on passive surveillance, which is simple and inexpensive. However in 2010, passive surveillance took six weeks to detect the signal of febrile convulsions associated with the seasonal trivalent influenza vaccines used in young children. Such delays in detection are a major setback and result in unnecessary exposure of the public to unsafe vaccines.

To tackle this, a small number of active surveillance methods (including the children’s hospitals based PAEDS and solicited SMS based AusVaxSafety) have been established. However, they are expensive, lack power to promptly detect rare AEFI, are age-specific and may take weeks to recruit sufficient sample size. To overcome these shortcomings, we aim to utilise electronic healthcare data because it is routinely collected, is non-specific, provides near-real time data and has made significant advances in its technology and methods of extraction. We aim to use it to detect vaccine safety signals as early as possible and maintain trust of the public and the health authorities.

Outcome:

As part of the SAFESIG-GP project, the Epidemiology and Informatics team at the Murdoch Children’s Research Institute (MCRI) used PATRON, to support vaccine safety monitoring. The project analysed de-identified general practice data to track health presentations following the rollout of the Shingrix® vaccine in 2023 and the RSV vaccine in 2025. This work provided timely insights into the safety of newly introduced vaccines and helped inform public health responses, offering reassurance to clinicians and the wider community.

The project is now complete. In line with PATRON archiving and retention rules, all data have been securely archived and stored with encryption both at rest and in transit. Access is strictly limited to authorised personnel with safeguards in place to prevent unauthorised copying. A qualified data custodian oversees all handling and retention of the sensitive data. No further analyses will be undertaken beyond the approved project scope.