Adverse events following immunisation
In collaboration with the Commonwealth Department of Health and Ageing, the current definitions of adverse events and the methods of reporting have been revised. Methods for improving collection and analysis of these data have been considered in view of current consumer concern about their validity.
As a result of ongoing collaboration with the special adverse events clinics in Australian States and Territories, data collected from the first 2-3 years of their operation in Adelaide, Melbourne and Sydney were aggregated (Reference 63). As a result of this cooperative research a large case series has now accumulated.
The subset of children experiencing hypotonic hyporesponsive episodes (HHE) was the subject of a separate report, which showed that these children are unlikely to experience a recurrence of the episode (Reference 45).
In collaboration with the National Centre for Disease Control a report on adverse events related to the Measles Control Campaign was published (Reference 54).
A prospective study of adverse events following BCG vaccination was designed by NCIRS in collaboration with South Australia. Data collection was coordinated for the period of enhanced national surveillance which commenced in October 1998. Analysis was performed when 1246 vaccinees had been enrolled and 918 had completed the study. This showed no excess of adverse events over the number expected. Adverse reactions were reported in 5% of vaccinees: Two patients required antituberculosis therapy and 2 required surgical intervention. A report was prepared for NCDC and the Communicable Diseases Network of Australia and New Zealand (CDNANZ), and the work has been published in Clinical Infections Diseases (Reference 96)
In 2002 the Centre began analysing reports of adverse events following immunisation (AEFIs) to the Adverse Drug Reaction Unit of the Therapeutic Goods Administration, and will issue 3-6 monthly reports.