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ACSOV meeting statement, Meeting 6, 26 September 2014

Advisory Committee on the Safety of Vaccines

12 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, there was no safety reviews 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, the committee's advice was sought on an RMP for one vaccine with a proposed extension of indication.

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 safety issues in a particular population, the suitability of the proposed pharmacovigilance activities to monitor the safety of the vaccine in the Australian context, and the suitability of the proposed risk minimisation activities.

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 provided advice on the suitability of interim pharmacovigilance activities for Bexsero as the commencement of the originally planned activities had been delayed by factors outside of the Australian sponsor’s control.

Bexsero is indicated for active immunisation against invasive disease caused by Neisseria. meningitides group B strains in individuals from 2 months of age and older. The committee noted that Bexsero was approved by the TGA in August 2013 and launched in Australia in March 2014.

The TGA imposed a condition of registration requiring the sponsor to implement an alternative pharmacovigilance strategy if inclusion on a National Immunisation Program (NIP) had not occurred within a timely manner and therefore delayed the planned pharmacovigilance activities.

The committee advised that the ongoing non-sponsor pharmacovigilance activities comprising the study programs in Canada (conducted by the Quebec Ministry of Health) and the USA (conducted by the Centers for Disease Control and Prevention) would be sufficient surveillance during the period where the proposed United Kingdom (UK) studies were delayed. In considering its advice, the committee noted that the RMP described a pharmacovigilance plan to be conducted upon Bexsero’s inclusion in the UK national immunisation program which included a post-marketing observational safety surveillance study, a post-marketing observational effectiveness study and a post-marketing observational study for monitoring use of Bexsero in pregnancy.

The committee also noted that the proposed pharmacovigilance plan adequately addresses safety and should obtain a high uptake of adverse event reporting and adequate monitoring of Bexsero's use in pregnancy.

Update on matters where the Committee previously provided advice and a TGA decision has been made

Members were provided with an update on the progress that has been made in relation to matters they have previously considered. This included:

  • a Safety Review on Gardasil and complex regional pain syndrome: finalised as publication of safety information for health professionals as 'Complex regional pain syndrome and vaccines' in Medicines Safety Update, June 2014; and
  • a Risk Management Plan for Hexaxim vaccine which was finalised as part of the TGA regulatory decision to register Hexaxim (AUST R 215536).

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: