Adverse events following immunisation
Post-licensure surveillance of adverse events following immunisation (AEFI) is an important component of any national immunisation program and essential to maintaining confidence of the general public and immunisation providers in the National Immunisation Program.
Reported AEFI may be either causally related to, or coincidental with, an immunisation.
Surveillance of AEFI can include reports of well-recognised adverse events associated with particular vaccines, as well as events not previously associated with a vaccine.
It can provide signals or generate hypotheses about previously unknown AEFI. However, other more rigorous scientific techniques are required before causality can be determined.
In Australia, national passive surveillance (initiated by the reporter) is carried out through voluntary reporting to the Adverse Drug Reactions Unit (ADRU) of the Therapeutic Goods Administration (TGA).
Reports can be made by immunisation providers, parents, pharmaceutical companies or other parties, and in some jurisdictions this is done via the local health authorities.
Individual-reported AEFI are assessed and classified by the Adverse Drug Reactions Advisory Committee (ADRAC) of the TGA. They are then passed in de-identified form to NCIRS for various analyses, including the preparation of regular national AEFI surveillance reports, national immunisation program evaluations, reports to the Australian Technical Advisory Group on Immunisation (ATAGI) and ad-hoc analyses.
Annual surveillance reports have been prepared by NCIRS in collaboration with the TGA and published in Communicable Diseases Intelligence since 2003. The most recent report:
For the first 6 months each year, a supplement is published. The latest is:
