Role of the Advisory Committee on Vaccines (ACV) in the TGA’s regulatory decision making process
The ACV is a statutory advisory committee established by the Therapeutic Goods Act 1989.
The TGA currently has seven 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 ACV provides advice to the TGA on, amongst other things, the safety, quality and efficacy of vaccines, including in relation to pharmacovigilance.
The advice provided by the ACV 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 a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989. While appropriate consideration will be given to such advice, it is important to note that neither a TGA delegate nor the TGA is obliged to seek this advice in making a decision or to follow it.
The ACV also provides advice to the Office of Health Protection on post-market monitoring and safe use of vaccines in national immunisation programs.
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.
Submissions for registration
The sponsoring company of a vaccine is required to submit an application to the TGA, including data that support the quality, safety and efficacy of the product for its intended use. The committee was not asked to provide advice on a submission for registration.
Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other vaccine or medicine-related problem. The committee was not asked to provide advice on a pharmacovigilance matter.
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 vaccine. The committee was not asked to provide advice on an RMP.
Immunisation Program
The committee was asked to provide advice on a review of the Vaccine Safety Plan (VSP) that is in place as part of the National Shingles Vaccination Program (‘the Program’), which commenced on 1 November 2016.
The committee advised that additional risk mitigation strategies and pharmacovigilance activities should be considered for inclusion in the VSP, potentially, including support for providers in screening patients before vaccination.
The committee did not advise that additional or different communications direct to the public were required. The committee did not advise that regulatory actions were required (e.g. ‘black box warning’ in the Product Information).
Update on matters where the committee previously provided advice
This matter was not addressed for this inaugural committee meeting.
Further information
Meeting statements are made publicly available after each meeting.
For further information on the ACV, please visit the Advisory Committee on Vaccines or email: ACV@health.com.au