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Vaccine Safety

All vaccines currently available in Australia must pass stringent safety testing before being approved for use by the Therapeutic Goods Administration (TGA). This testing is required by law and is usually done over many years during the vaccine’s development. Before vaccines are made available for use they are rigorously tested in various phases, and progress to include thousands of people in larger clinical trials. These trials have a ‘control’ group (that doesn't receive the vaccine) and a trial group that receives the vaccine. These trials are strictly monitored for safety. The approval process can take up to 10 years. As a result of such detailed testing, a number of vaccines that failed in these early tests have never been released.
Safety surveillance and monitoring is continued once the vaccine is licensed for use. The Adverse Drug Reactions Advisory Committee (ADRAC) and other organisations follow up reports of adverse events. ADRAC was formed in 1970, to advise the TGA on the safety of medicines. ADRAC is composed of independent medical experts who have expertise in areas of importance to the evaluation of medicine safety.
The commonest side effect from vaccination includes redness, slight swelling and mild discomfort or pain over the injection site, and mild fever, these side effects usually which resolves within a day or two.
An adverse event following immunisation (AEFI) is an unwanted or unexpected event occurring after the administration of a vaccine(s). Such an event may be caused by the vaccine(s) or may occur by chance after vaccination (i.e. it would have occurred regardless of vaccination). Adverse events can be reported to your GP, your immunisation provider or your local public health unit. These reports will be forwarded to ADRAC and investigated to ensure that the adverse event was linked to immunisation.

Vaccine safety not only relates to the vaccine but also policy and procedures of vaccine use. Several organisations in Australia all contribute information, data, research and studies in regards to immunisation, disease surveillance and vaccine use.

The Australian Technical Advisory Group on Immunisation (ATAGI)

 ATAGI provides advice to the Minister for Health and Ageing on the Immunise Australia Program and other related issues. In addition to technical experts, ATAGI’s membership includes a consumer and general practitioners.

The National Immunisation Committee (NIC)

NIC is the peak group responsible for overseeing the development, implementation and delivery of the Immunise Australia Program and reports to the Australian Health Protection Principal Committee (AHPPC) through the Communicable Disease Network Australia (CDNA). NIC provides leadership and takes responsibility for policy development, implementation and ongoing review of the Immunise Australia Program; Collaborates with other peak immunisation related committees (including the ATAGI and CDNA), on issues relating to immunisation policy development and program implementation.

The National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS)

NCIRS was established at the Children's Hospital at Westmead by the Commonwealth Department of Health in August 1997. NCIRS carry out research and give independent expert advice about all aspects of diseases which can be prevented by vaccination, particularly in children. It provides a national perspective on social and other issues related to immunisation.


Page last updated: 23 Sep 2009