Review of the management of adverse events associated with Panvax and Fluvax

2.0 Introduction

Page last updated: April 2015

Immunisation has been repeatedly demonstrated to be one of the most effective medical interventions for preventing disease. As with all medicines, vaccines can cause adverse events in some people but serious reactions to immunisation are rare. All vaccines used in Australia are made to very high quality standards. They have been demonstrated to be safe and effective prior to being approved for use and post-marketing monitoring of all vaccines is undertaken to ensure their continued safety.

Safety monitoring is considered an essential part of every immunisation program in which vaccines are administered on a large scale to healthy individuals. Adverse events following immunisation may be related to the vaccine or may have occurred by chance. The aim of monitoring is to identify any signal that there may be a safety concern in order to investigate it and take appropriate action. Maintaining public confidence in vaccines and the immunisation program through effective safety monitoring is also important.

In 2010, an increase in febrile convulsions among young children following seasonal influenza vaccination was observed in Western Australia. The identification of and response to this finding is the subject of this document.

2.1 Background to the Review

On 23 April 2010, the Chief Medical Officer (CMO) of Australia suspended the use of seasonal influenza vaccines for all children aged 5 years and under, pending further investigation of an apparent increase in febrile convulsions following administration of the vaccines in this age group. The previous evening, the Western Australian (WA) Government had announced the suspension of its program of seasonal influenza vaccination for children under the age of 5 years.

The use of all seasonal influenza vaccines in young children remained suspended until a detailed evaluation by the Therapeutic Goods Administration (TGA) and the Australian Technical Advisory Group on Immunisation (ATAGI) confirmed an increased occurrence of febrile convulsions related to the use of the CSL trivalent (seasonal) influenza vaccine, Fluvax®. On 27 July 2010, the CMO advised that seasonal influenza vaccination of young children under the age of 5 years could be resumed using the two alternative brands of the vaccine available for use in this age group in Australia in 2010, Vaxigrip® (Sanofi Paster) and Influvac® (Abbott/Solvay).

On 16 May 2010, a Ministerial Review of the public health response to the adverse events to seasonal influenza vaccine was announced by the WA Minister for Health, the Hon Dr Kim Hames MP, and on 24 May 2010 Professor Bryant Stokes, the former Western Australian Chief Medical Officer, was appointed as the reviewer. The report of the Stokes review (‘the Stokes Report’) was tabled in the WA Parliament on 11 August 2010. It contained a number of criticisms of both the WA and the national response, which were subsequently aired in the media.

In October 2010, the Australian Government Parliamentary Secretary for Health and Ageing, the Hon Ms Catherine King MP, asked the Department of Health and Ageing (DoHA) to initiate an independent review of the national response to the reported adverse events following immunisation which resulted in suspension of the seasonal influenza vaccine program for children throughout Australia. She requested the former Chief Medical Officer, Professor John Horvath AO, undertake the Review. Professor Horvath commenced his work on the Review in mid-November 2010.

The aim of the Review has been to consider the national response to the 2010 influenza vaccine adverse event reporting, look at international reporting arrangements and identify improvements that could be made to the current Australian system. The Review did not aim to provide a point by point response to issues raised in Stokes Report, but to consider more broadly the lessons that can be learned from the national response to the 2010 events.

The Review took place concurrently with two other projects with a potential for overlap and linkage. The first is the Transparency Review of the TGA, which was announced by the Hon Mrs Catherine King MP on 16 November 2010. This comprehensive review of the way in which the TGA communicates its regulatory processes and decisions is being undertaken by a panel chaired by Professor Dennis Pearce AO and is focused on improving the TGA's transparency in relation to all therapeutic goods. Some aspects of safety monitoring of vaccines under consideration through the adverse events Review will be best addressed by referring them to the Transparency Review.

Work is currently underway to develop a National Immunisation Strategy (NIS) to improve immunisation coverage and reduce vaccine preventable diseases. The work is being undertaken as a joint Australian and state/territory government process, overseen by the National Immunisation Committee (NIC). Through the Office of Health Protection (OHP) within the DoHA, Professor Michael Frommer has been engaged as a consultant to develop the Strategy. Within its broad scope, the NIS will address issues of vaccine safety and it will be important to ensure that the findings and recommendations from the adverse events Review are taken into account in the development of the NIS.

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2.2 Terms of Reference

  1. Examine data relating to recent influenza vaccine adverse event reporting put forward by the:
    1. Government of Western Australia (including that contained in the ‘Stokes review’);
    2. Therapeutic Goods Administration;
    3. Australian Technical Advisory Group on Immunisation; and
    4. meeting of the chairs of expert groups and committees involved in the recent analysis surrounding the adverse events reports.
  2. Review overseas benchmarks for reporting of, and responses to, adverse events associated with vaccination.
  3. Identify improvements that could be made to current Australian adverse events reporting arrangements, with particular reference to improvements in transparency and communication.

A report is to be provided by Professor Horvath to the Parliamentary Secretary for Health and Ageing by 28 February 2011.

2.3 Matters outside the Terms of Reference

The following matters have not been addressed in the Review as they are outside the Terms of Reference:
  • issues specific to WA, including the interactions within the WA health department and between the department and the public health units;
  • the debate in the media as to the need for vaccination of the population, and children in particular, with pandemic H1N1 containing vaccines; and
  • the perceived conflicts of interest of experts in providing vaccination advice and of the TGA in post market surveillance.

2.4 Method of the Review

Professor Horvath:
  • reviewed the data, documents and communications detailed in Appendix I;
  • wrote to all the Chief Health Officers in Australia to advise them of the Review and ask them to provide input if they wished;
  • wrote to the European Medicines Agency and the national medicines regulatory agencies of Canada, Ireland, New Zealand (NZ), Japan, Singapore, Switzerland, United Kingdom (UK) and the United States of America (US), asking for information about their adverse events monitoring systems; and
  • interviewed the key informants listed in Appendix II. The interviews were semi-structured and covered a range of aspects, including: how the current system works; its strengths and weaknesses; the roles played by key organisations; the processes involved in identifying and managing a safety signal; the analysis required to identify signals; reporting arrangements; communications between jurisdictions and the TGA; communications with health professionals and consumers; lessons learned from the 2010 influenza season experience; and views on safety monitoring system improvements.
The Review was also informed by the outcomes of a Meeting of Experts convened by the Chief Medical Officer, Professor Jim Bishop AO, on 1 December 2010.

Administrative support to the Review was provided by Dr Bronwen Harvey, Medical Adviser with expertise in immunisation policy and programs, and Mr Joel Willis, Departmental Officer with experience in seasonal and pandemic influenza vaccine programs.

2.5 Structure of the Report

The Report describes the Australian regulatory system for drugs and vaccines (Section 3.0) and how the post-marketing surveillance component compares with international systems (Section 3.4). The Report then outlines the National Immunisation Program and its governance structures (Section 4.0). Information about influenza and influenza vaccination is presented Section 5.0. The Review findings on the response to the 2010 seasonal influenza vaccine adverse events and on potential improvements to the vaccine safety monitoring system are presented in Section 6.0 and the Review recommendations in Section 7.0.

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