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ACSOV meeting statement, Meeting 3, 25 October 2013

Advisory Committee on the Safety of Vaccines

25 October 2013

Role of the ACSOV in the TGA's regulatory decision making process

The ACSOV is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.

The TGA currently has nine statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision making and other regulatory processes.

The ACSOV provides advice to the TGA and the Office of Health Protection (OHP) on, amongst other things, matters relating to the safety, risk assessment and risk management of vaccines supplied in Australia.

The advice provided by the ACSOV is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only part of the information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act. While appropriate consideration will be given to such advice, it is important to note that neither the TGA nor a TGA delegate is obliged to follow it.

It should also be noted that information about advice provided by the committee may not become publicly available for sometime after a committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting and for it to be available as soon as reasonably practical after the relevant meeting.

Overview of the safety reviews referred for advice

The committee was asked to provide advice on the strength of the evidence to support an association between different vaccines and new safety signals which had been identified from reports of adverse events following immunisation (AEFIs). The committee also provided advice on recommendations made following a TGA analysis of different methods used to identify new signals from reported AEFIs.

Members were also asked to provide advice on the benefits and limitations of two vaccine safety monitoring plans which were trialled by the Department in 2013.

Committee members were asked to provide advice on the most appropriate mechanisms to communicate information regarding vaccine safety to immunisation providers.

Other matters considered

Members were provided information regarding strategies to improve health professional and consumer awareness of, and participation in, adverse event reporting for all therapeutic products.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the ACSOV, please visit the ACSOV web page or contact the ACSOV Secretary: Dr Katherine Gray by phone on 02 6232 8583 or email: