National watch on adverse immunisation events

 

By Dr Alan Leeb, GP, Ballajura

Before the rise of pyrexia and seizures associated with one brand of flu vaccination in April 2010, Australia had a passive event surveillance system. This has changed.

<leadpara>The first rule of medicine is to do no harm. The events of April 2010 led to the development in WA (by the author and Ian Peters with WA Health Department support) of SmartVax, a software application using SMS and smartphone technology for the active surveillance of adverse events (AEFI) following all immunisations. De-identified data is uploaded to a secure central server for analysis and monitoring.

SmartVax is fully automated, integrates with existing patient management systems, is endorsed by the RACGP and free for practices.

A national network now has over 165 sites (over 60 in WA), including general practice, immunisation clinics, Aboriginal medical centres and major hospital immunisation clinics.

The database houses over 500,000 immunisation encounters and over 700,000 individual profiles across more than 50 vaccine brands, including scheduled, private and all travel vaccines. Patient engagement is over 70%.

All medically attended AEFI are notified to the GP’s medical software inbox ensuring a record is incorporated in the electronic clinical record as well as an option of automated notification to WA Health department’s WAVVS as statutory notification.

AusVaxSafety(AVS) is a collaborative initiative led by the National Centre for Immunisation Research and Surveillance (NCIRS) and funded by the Australian Department of Health (DOH).

SmartVax sends AVS de-identified data which analyses it then reports to DOH, Therapeutic Goods Administration (TGA), GPs and, most importantly, the general public. It currently actively monitors the safety of influenza vaccine in all ages, pertussis vaccines in toddlers and young children, and zoster vaccine in adults.

NCIRS provides regular reports to the DOH, TGA, vaccine safety experts and clinicians throughout Australia. Any safety concerns are reviewed by its expert leadership group and if necessary more detailed data analysis and clinical follow-ups of patients.

AVS is the only national AEFI system of its type in the world. The findings are contributing significantly to international data.

For 2017, we can confidently report that there have been no significant safety concerns for adult and paediatric influenza vaccines and no brand variation within the first week of the program. Pertussis has been safely re-introduced to the National Immunisation Program (NIP) at 18 months, and after 12,000 encounters. We have no safety concerns around Zostavax.

The plan over the next three years is for AVS to receive and monitor all vaccines on the NIP and continue to monitor all other vaccines locally.

The ultimate goal is a nationally coordinated, near real-time AEFI system.

<declarationbox>Author competing interests. The author co-developed SmartVax. Questions? Contact the author alan@illawarramedical.com.au