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ACSOV meeting statement, Meeting 5, 25 July 2014

Advisory Committee on the Safety of Vaccines

9 February 2015

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) (Department of Health) 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, the committee's advice was sought on the following safety review.

Enhanced passive surveillance of acute adverse events following immunisation with human papillomavirus (HPV) vaccine: 2013 results

The committee noted that school-based HPV vaccination, using Gardasil, commenced for females in 2007 and was extended to include males from the beginning of the school year in 2013. The Department of Health sought advice on safety surveillance for the program rollout and the HPV Implementation Ad Hoc Working Group recommended the implementation of enhanced passive surveillance for four acute adverse events to enable early identification, investigation and action (if needed) should an unexpected safety signal occur following the extension of the program.

The four adverse events of special interest (AESI) recommended for surveillance were anaphylaxis, generalised allergic reaction, loss of consciousness (syncope or seizure), and referral to an Emergency Department/hospital for any reason temporally related to the administration of the vaccine.

The TGA's report on this matter was considered by ACSOV. The committee noted that the report concluded that no new safety concern was identified in females or males and the types and rates of adverse events following immunisation (AEFI), observed for both males and females, were consistent with the approved Product Information (PI) for the vaccine and the details included in the earlier TGA statement published on 24 June 2010 - Gardasil (human papillomavirus vaccine).

In determining the appropriateness of the methods used in the report for the outcomes measured, the committee discussed the inclusion and exclusion criteria, the search strategy, the case reaction terms/definitions and the data presented. Overall, ACSOV agreed that the methods used were largely appropriate for the outcomes measured but sought further clarification on some aspects of the methodology used. The committee also suggested additional data analyses that the TGA should consider, subject to the necessary data being available.

The committee also advised that two additional AESI, ovarian insufficiency and chronic fatigue are of potential significance in terms of community perception and impact on the program; and therefore, also warrant being monitored.

The ongoing and regular communication between the TGA, the Jurisdictional Immunisation Coordinators and the Office of Health Protection was highlighted as an important factor which contributed to the success of the surveillance program.

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, the committee's advice was sought on an RMP for a vaccine with a novel method of manufacture.

In broad terms, the committee was asked to provide advice regarding the adequacy of the RMP to monitor, and mitigate the risks for the vaccine. The committee provided specific advice on the strength of the evidence to support the inclusion or removal of additional safety concerns in the RMP (including those related to the method of manufacture), the suitability of the proposed pharmacovigilance activities to monitor the safety of the vaccine in the Australian context (including in a particular population group), and the suitability of the proposed risk minimisation activities to ensure risks such as the potential for off-label use associated with the vaccine are adequately mitigated.

The committee's advice has now been provided to TGA delegates 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.

Other matters considered

The committee also noted a paper which outlined the TGA processes for considering causality assessment in relation to adverse events following immunisation (AEFI), in relation to the 2013 edition of the WHO publication, Causality Assessment of an Adverse Event Following Immunization (AEFI): User Manual for the Revised WHO Classification.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the ACSOV, please visit the ACSOV webpage or contact the ACSOV Secretary, Mr Craig Davies on 02 6232 8641 (telephone) or via email: