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ACSOV meeting statement, Meeting 11, 8 April 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 ten 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.
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 (RMP)
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, there was no RMP referred to the committee for its advice.
Immunisation Program advice
Draft National Shingles Vaccination Program Vaccine Safety Plan
The committee was asked to provide advice on specific aspects of a Vaccine Safety Plan (VSP) which has been developed as part of the forthcoming National Shingles Vaccination Program ("the Program"), which will commence on 1 November 2016, subject to vaccine availability. The committee noted the importance of a VSP to provide confidence on the benefit-risk balance of the vaccine.
In May 2015, the Australian Government announced the addition of a shingles vaccine on the National Immunisation Program (NIP) and agreed to the establishment of an adult vaccination register.
The draft VSP has been developed to support the commencement of the vaccination program and is being consulted on with key stakeholders.
The large cohort size, prevalence of comorbidities, chronic medical conditions and use of multiple medications in the cohort has been taken into consideration when developing the proposed surveillance activities in the VSP.
These activities involve Commonwealth and jurisdictional consideration of any adverse events following immunisation (AEFI) associated with the shingles vaccine in the 70 year old cohort and in the five year catch-up program for people aged 71-79 years; and a funded enhanced surveillance project to monitor any AEFI which will be sourced via an open tender process.
ACSOV was asked about the suitability of the proposed enhanced surveillance activities to support the rollout of the Program. As part of its advice, the committee advised that the following points should be taken into consideration when finalising the VSP.
- Analysis will need to consider the background age-specific mortality rates in the 70 year old cohort and in the 71-79 year old catch-up population. Background information on the historic rates of mortality and morbidity (stroke, acute myocardial infarction) will be important for the analysis to differentiate any effect of the vaccine on the cohort.
- The committee noted that the regulatory approval of the shingles vaccine predated the requirement for a Risk Management Plan (RMP). As an RMP is not available, the VSP would be strengthened by inclusion of similar information to an RMP regarding identified and potential risks of the vaccine. Additionally, relevant international data to inform risk management would also be usefully included in the VSP.
- Patients, carers and healthcare providers (including geriatricians and rheumatologists) should ideally receive specific education in conjunction with the vaccine (and ACSOV provided several suggestions in this regard).
- ACSOV agreed that appropriate technologies should be used for the target age group of 70 to 79 years e.g. phone interviews.
- Different active surveillance strategies may be appropriate for different AEFI. The committee also noted that for events that are expected to be rare (e.g. varicella-like rash or disseminated disease) spontaneous reporting from an educated population may be more effective than active surveillance.
The committee noted that, at this time, the VSP is proposed to run for two years during the initial implementation of the program. The committee commented that beyond this time formal data linkages with the Australian Immunisation Register (AIR) or appropriate longitudinal studies could be considered, if feasible.
Meeting statements are made publicly available after each meeting.