Vaccine Data Linkage Study

Section A: What is the study about?

The Vaccine Data Linkage Study is a project which is studying a new method of checking for rare reactions to vaccinations in children. 

This method known as ‘Data Linkage’, has not been routinely used in Australia. However, data linkage has been used overseas in countries such as the United States.

All vaccines currently available in Australia must pass strict safety testing before being approved for use by the Commonwealth Government. Vaccines undergo extensive testing in laboratories and then in clinical trials of thousands of children (usually between 5 and 10,000 children) generally done over many years. However, even though the testing involves thousands of children, these trials only identify the more common vaccine reactions. Most common reactions to vaccines are minor and resolve quickly. They include pain and redness at the injection site, crying and irritability, and low-grade fever.

Rare vaccine reactions (reactions which occur less often than once per 1,000 vaccine doses) are not easily identified in clinical trials.  This is because not enough children are usually included in vaccine trials to identify these rare reactions.

Data linkage is able to study large numbers of children – that is, more children than are usually included in clinical trials.  For this reason data linkage can detect rare reactions after vaccination more quickly, efficiently and with less cost than clinical trials.

For any queries, please contact the study’s Project Manager, Katherine on 8161 7244, Monday-Wednesday during business hours. 

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