Current research projects in vaccine safety
Project 1: Assessing vaccine safety by linking medical databases
This research project aims to pioneer new methods of evaluating vaccine safety in children by linking the Australian Childhood Immunisation Register to hospital morbidity databases, which records hospital admissions from different state jurisdictions. By "linking" these different datasets we can identify those children who have been admitted to hospital due to adverse vaccine reactions.
By pin-pointing very rare adverse reactions (i.e. reactions occurring less commonly than once every 1,000 vaccinations), we can then take steps to inform immunisation policy by determine the risks and benefits of vaccination. Our study is also assessing the community attitudes towards data linkage and the feasibility of obtaining parental consent for linkage via the "opt-in" vs "opt-out" consent method.
Begun in 2008 with an $858,000 grant from the Australian Research Council, this project is being carried out in collaboration with the Data Linkage Unit of the Department of Health in Western Australia; Medicare; the National Centre for Immunisation Research and Surveillance; the Centre for Health Record Linkage; the University of Wollongong; and the state and federal governments. Our project involves over 16 researchers led by Dr Michael Gold, leader of the Vaccine Safety Stream at the Children's Research Centre and Head of the Department of Allergy and Immunology at the Women's and Children's Hospital.
Project 2: Using sentinel surveillance as a method to monitor Adverse Events Following Immunisations (AEFIs)
The purpose of this research project is to evaluate the effectiveness of sentinel surveillance as a method of monitoring adverse vaccine reactions in children.
Sentinel surveillance involves the analysis of health records from designated hospitals and health-care facilities, known as "sentinel sites". These "sentinel sites" have the potential to provide an early indication of the spread of disease, or in this case the prevalence of AEFIs. The information gained from sentinel sites can be used to predict major health trends in the larger population, and identify rare but serious vaccine reactions in children.
We hope to use the sentinel surveillance method to collect accurate information about vaccine safety that can be used in future prevention strategies. This method has already been useful in characterising those children admitted to hospital with swine flu in 2009 (H1N1 influenza A pandemic virus).
Begun in 2006, this project is being funded by a $30,000 annual grant from the Department of Health and Ageing, and is a "multicentre" study being carried out at several locations, including the Royal Children's Hospital in Melbourne; the Princess Margaret Hospital for Children in Perth; the Children's Hospital at Westmead in Sydney; and the Women's and Children's Hospital in Adelaide. The South Australian arm of this study is being led by Dr Michael Gold, leader of the Vaccine Safety Stream at the Children's Research Centre and Head of the Department of Allergy and Immunology at the Women's and Children's Hospital.
Project 3: Reporting of Adverse Events Following Immunisations (AEFIs) in children
This project is investigating the reporting practices of health carers in response to AEFIs among children. The aim of our research is to find out why AEFIss are under-reported by health-care providers and parents.
The ongoing success and acceptance of licensed vaccines is critically dependant on the perception of vaccine safety. The primary mechanism of safety surveillance, after a vaccine is licensed, is the "passive reporting" of AEFIs to national regulators (such as the Therapeutic Goods Administration). However, less than 10% of adverse vaccine reactions are currently reported. Using a range of electronic and print-based surveys, it is hoped that this research project will identify the barriers in existing reporting methods and contribute to the development of a more effective reporting system.
Begun in 2009, this project is funded by an annual PhD scholarship worth $30,000 per year, and is being led by Dr Michael Gold, leader of the Vaccine Safety Stream at the Children's Research Centre and Head of the Department of Allergy and Immunology at the Women's and Children's Hospital.
