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ACSOV meeting statement, Meeting 13, 9 December 2016
Advisory Committee on the Safety of Vaccines
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 eleven 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 on, amongst other things, matters relating to the safety, risk assessment and risk management of vaccines supplied in Australia.
How this statement should be read
The advice provided by the ACSOV is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only one part of the total body of information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989 ('the Act'). Therefore, 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 details of the committee's advice may not become publicly available for some time after the 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.
Additionally, following publication of this statement, it is most likely that further work will be undertaken by the TGA to investigate, monitor and/or evaluate the vaccines considered by the ACSOV; and this will continue for some time into the future. It is therefore possible that further information about the vaccines will become publicly available at a later time and this will be pursuant to a regulatory decision under the Act being made and following further consultation with the vaccine’s sponsor and/or manufacturer.
Overview of the safety reviews and therapeutic goods referred for advice
The TGA continually monitors therapeutic goods supplied in Australia to ensure their ongoing safety, efficacy and quality. As part of this process, the TGA routinely undertakes safety reviews of therapeutic goods.
At this meeting, there was no safety review referred to the committee for its advice.
Risk Management Plans
A Risk Management Plan (RMP) is a set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine or a vaccine. At this meeting, the committee's advice was sought on two RMPs for vaccines with indications relating to vaccination against infectious diseases.
The committee was asked to provide advice on matters including:
- the adequacy of the summary of safety concerns, such as whether 'Patients with renal and hepatic impairment' should be mentioned
- the adequacy of the proposed pharmacovigilance plan, including whether the implementation of additional activities being dependent on the vaccine's inclusion in the national immunisation program was acceptable
- the adequacy of the proposed risk minimisation plan, including the adequacy of proposed additional risk minimisation activities
- the suitability of the proposed age range to be mentioned in the indications, and the risk of off-label use in patients of other ages.
The committee's advice has been provided to the TGA for consideration as part of the TGA's regulatory decision making processes.
Following complete assessment of the application, information on the RMP evaluation will be included in the Australian Public Assessment Reports (AusPAR), which is published on the TGA website once it is finalised.
Immunisation Program advice
No specific program advice was sought at this meeting.
Meeting statements are made publicly available after each meeting.