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ACSOV meeting statement, Meeting 2, 24 May 2013

Advisory Committee on the Safety of Vaccines

24 May 2013

Role of the Advisory Committee on the Safety of Vaccines (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 relating to three vaccine safety plans being developed by the OHP. The first safety plan incorporated an active adverse event surveillance system at selected paediatric hospitals to monitor any adverse events associated with the existing use of seasonal influenza vaccines in children aged between 6 months and less than 5 years of age. This safety plan also includes a separate smaller scale survey for collecting from parents, information on vaccine-related adverse events in their children following seasonal influenza vaccination. The second safety plan proposes an active surveillance system that utilises similar methodology to that proposed for the first safety plan to monitor fever and febrile convulsions in young children presenting to paediatric emergency departments. This safety plan relates to implementation of a new vaccine under the National Immunisation Program. The third safety plan recommends that the use of a passive surveillance system is sufficient for a further new vaccination program. The OHP is implementing safety plans before the new vaccine programs are rolled out.

The committee provided advice specifically in relation to the development of each of the three vaccine safety plans for monitoring adverse events following immunisation. The committee provided advice relating to the key features of two of the plans and compared them to alternative adverse event surveillance methods.

Other matters considered

Members were asked to provide advice on three planned public consultation activities associated with the development of a new-to-market risk communication scheme, a draft strategy to improve adverse event reporting for therapeutic goods, and possible mechanisms for ensuring the currency of the Product Information and Consumer Medicine Information documents. The committee's advice on these three items will shortly be provided to the TGA for consideration.

Next meeting

The next meeting of the ACSOV is scheduled for 23 August 2013.

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: