Safety of Vaccines

Page last updated: 27 April 2017

Ensuring the safety of vaccines is a critical component of registering vaccines for use in Australia and an integral part of the implementation of the National Immunisation Program. Safety is of paramount importance as vaccines are given to millions of people, including young children at the most vulnerable time in their lives.the vaccines for the 16 infectious diseases that are currently included on the National Immunisation Program are subjected to some of the most rigorous vaccine testing and registration processes in the world.

Vaccine safety testing

Safety research and testing underpin every aspect of vaccine development and manufacture in Australia. Before vaccines are made available for use, they are rigorously tested in thousands of people in progressively larger clinical trials which are strictly monitored for safety. The results of these trials form the foundation for an ongoing process of testing and monitoring that lasts for the lifetime of each vaccine.

All vaccines registered in Australia by the Therapeutic Goods Administration (TGA) are evaluated to ensure they are effective, comply with strict manufacturing and production standards, and have a strong safety record. This includes stringent testing for each vaccine component, including preservatives, additives and vaccine adjuvants. It can take up to 10 years for a vaccine to be approved for use.

Ongoing monitoring

Once a vaccine is in use, its efficacy and safety are continually monitored by the TGA and vaccine sponsors through further clinical trials and detailed surveillance of disease and vaccine adverse events. Australia has a national surveillance system, which includes reports of adverse events following immunisation (AEFI) from health authorities, immunisation providers, doctors, consumers and vaccine sponsors. All AEFI reports are are reviewed by the TGA, and any potential vaccine safety concerns are referred to the Advisory Committee on Vaccines (ACV) an independent committee of medical experts established in 2013 to advise the Minister for Health and the TGA on the safety and risk management of vaccines.

The TGA provides a searchable database, the Database of Adverse Event Notification (DAEN), that lists all adverse event reports made in Australia for medicines including vaccines. A summary of AEFI reports that are made to the TGA is also published in the journal of Communicable Disease Intelligence and made available on the Department of Health website.

Further information

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