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ACSOV meeting statement, Meeting 4, 28 March 2014

Advisory Committee on the Safety of Vaccines

28 March 2014

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) on, amongst other things, matters relating to the safety, risk assessment and risk management of vaccines supplied in Australia.

The advice provided by the ACSOV 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, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act. 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 information about advice provided by the committee may not become publicly available for sometime after a 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.

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.

Review of the 2013/14 Northern Hemisphere Influenza Data

As part of the influenza vaccine safety monitoring program, all sponsors supplying influenza vaccine in Australia in 2014 were requested to provide the TGA with data from routine surveillance of adverse events following immunisation (AEFI) associated with the use of their vaccine in the Northern Hemisphere during 2013-2014, along with the results of any safety studies undertaken with the vaccine.

The committee discussed the TGA's Office of Product Review's (OPR) assessment of the 2013-2014 Northern Hemisphere data from five sponsors on the following six influenza vaccines: Influvac (Abbott), Fluvax (bioCSL), Fluarix (GSK), Agrippal (Novartis), Vaxigrip and Intanza (Sanofi Pasteur). For these vaccines, there were 2,364 spontaneous adverse event reports across a range of age groups from 6 months to 65 years.

The committee noted that the Southern Hemisphere 2014 influenza vaccine contains two strain changes compared with the 2013 influenza vaccine and that the vaccine has a similar composition to the 2013-14 Northern Hemisphere influenza vaccine.

The committee agreed with the OPR reviewer that there was no new safety issues identified in the Northern Hemisphere 2013-14 AEFI data and that the AEFI identified were all covered in the relevant Product Information documents.

ACSOV noted the usage estimates provided by some sponsors for their vaccines, and that the overall reporting rate for AEFI varied from 12 to 23 cases per million doses distributed. Additional distribution data broken down by country demonstrated that across different Northern Hemisphere countries reporting rates for adverse events varied between 10 and 19 cases per million doses distributed.

By comparison, ACSOV noted the calculations by the OPR reviewer which showed that in Australia the overall reporting rate of approximately 81 cases per million doses distributed is considerably higher than in other countries. This difference is likely to be due to a more sensitive surveillance or lower threshold for reporting influenza vaccine AEFI rather than a higher adverse vaccine reaction rate. The committee noted that an annual report on surveillance of AEFIs is published in Communicable Diseases Intelligence which captures the passive surveillance data reported to the TGA.

The annual reports on AEFIs and further information are available through the Communicable Disease Intelligence webpage.

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 RMPs for two vaccines.

In broad terms, the committee was asked to provide advice regarding the adequacy of the RMP to monitor, and mitigate the risks for each vaccine. The committee provided specific advice on the strength of the evidence to support the inclusion of additional safety concerns in the RMPs, the suitability of the proposed pharmacovigilance activities to monitor the safety of vaccines in the Australian context and the suitability of the proposed risk minimisation activities to ensure risks associated with the vaccine are adequately mitigated.

The committee's advice will shortly be 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).

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: Dr Katherine Gray by phone on 02 6232 8583 or email: