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

1.0 Executive summary

Page last updated: April 2015

1.1 Background

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 well children under the age of 5 years.

A Ministerial Review of the public health response to the adverse events to seasonal influenza vaccine was undertaken for the WA Minister for Health, the Hon Dr Kim Hames MP, by Professor Bryant Stokes. 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 former Chief Medical Officer, Professor John Horvath AO, to undertake 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.

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.

1.2 Method

The Review interviewed key informants, examined data, documents and communications relating to the national response to the reported adverse events and sought and considered information provided by Chief Health Officers of Australia and overseas national regulatory bodies. 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.

1.3 Findings

The Review has found there was no safety signal from the use of seasonal influenza vaccine in WA in 2008 and 2009 or from the use of Panvax in the pandemic H1N1 influenza vaccination program that would have indicated a need to change the use of Fluvax in the subsequent seasonal influenza vaccination program in 2010.

The Review has found that the Australian system has a number of strengths. It is similar to passive adverse event surveillance systems in comparable countries and was able to detect the safety signal associated with the use of the 2010 seasonal influenza vaccine, take appropriate action and undertake a rigorous investigation.

The Review has found that the reporting of adverse events following immunisation could be more timely. Factors that impact on the timeliness of reporting include: health professional and consumer knowledge of how to report; delays in information exchange between the jurisdictions and the TGA; reports being sent in batches; differing forms and protocols used in each jurisdiction; and a lack of agreed case definitions.

The Review considers that, once the first batch of case reports had been received by the TGA, its actions in starting a thorough investigation were appropriate and timely. The decision of the CMO to suspend the use of all seasonal influenza vaccines in young children was also appropriate, timely and proportionate. The subsequent investigation was extensive and thorough. Updates were provided by the CMO to keep jurisdictions, health professionals, consumers and the media informed of the findings of the investigation as they became available.

The Review has found that the Governance arrangements for vaccine safety issues are complex. While the TGA has legislated responsibility to monitor the safety of vaccines, many organisations, committees and individuals have a role, and there is a lack of clarity of the relationships between these groups and their roles and responsibilities in vaccine safety monitoring and responding to the identification of a possible signal. The Review notes that there are no Standard Operating Procedures for responding to a vaccine safety issue that does not require regulatory action but which has possible implications for the use of a vaccine in a vaccination program.

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The Review has found that knowledge and awareness of the vaccine surveillance system and its processes and procedures among jurisdictions, health professionals and consumers could be improved.

Some health professionals and consumers felt they were not sufficiently informed of the unfolding events surrounding the suspension of the use of seasonal influenza vaccines and the subsequent investigation, particularly in the early stages before the suspension was announced. The Review notes there are significant challenges in determining how to communicate with health professionals and the community during the early stages of an investigation, when there is a level of doubt about the significance of the events.

There is a perception amongst some stakeholders that there is a lack of transparency in the TGA vaccine surveillance processes and that information about investigations into adverse events associated with vaccines is slow to be made public.

1.4 Recommendations

Recommendation 1 - The Governance of the Vaccine Safety System

That the Department establishes a Working Party to consider the current governance arrangements for monitoring and responding to vaccine safety issues in Australia and make recommendations for an improved system of governance for vaccine safety monitoring. Options for achieving improved governance recommended for consideration by the Working Party include:
  1. maintaining the current organisations and structures but developing more robust and clear governance and reporting through clearly defining the roles and key areas of responsibility of each of the existing committees and organisations and their relationships to each other.
  2. establishing and resourcing a Vaccine Safety Committee (VSC), a new body with responsibility for monitoring vaccine safety in Australia. The new body could be a subcommittee of the Therapeutic Goods Administration (TGA) Advisory Committee on the Safety of Medicines (ACSOM). It should have a broad membership of experts with knowledge of vaccines, vaccine safety, pharmacoepidemiology and vaccine program implementation.
  3. restructuring immunisation governance in Australia to provide a consolidated and simpler governance pathway by creating a new independent body to carry out vaccine safety monitoring functions.

Recommendation 2 – Defining Surveillance Objectives and Establishing Protocols and Procedures for Managing Adverse Events Following Immunisation

That the Department establishes a Working Party of Experts, including state and territory health authority representatives, to develop, in consultation with the TGA and key national immunisation bodies, the principles and objectives of the Australian adverse events following immunisation (AEFI) surveillance system, agreed case definitions for AEFIs, agreed triggers for when further investigation should be undertaken and protocols and procedures for such investigations. This Working Party will need to evaluate the benefits of additional surveillance mechanisms to ensure the safety of vaccines.

Recommendation 3 - Improving the National System for Timely Reporting of Adverse Events Following Immunisation

That the Department requests the TGA to establish a joint TGA/National Immunisation Committee working group to develop mechanisms for improved and timely information flows between TGA and the jurisdictions and agreed templates for nationally consistent reporting of adverse events following immunisation.

Recommendation 4 – Raising Community and Health Professional Awareness of Vaccine Safety Monitoring to Ensure More Complete Reporting of Adverse Events Following Immunisation

That the Department considers the development of a communications strategy to inform jurisdictions, health professionals and consumers of the vaccine safety monitoring processes in Australia.

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Recommendation 5 - Nationally Agreed Protocols for Program Action and Communication

That the Department develops and agrees with jurisdictions a protocol for taking program action, including informing health professionals, consumers and the media, in the event a possible safety signal is detected affecting a National Immunisation Program vaccine.

Recommendation 6 - Transparency and the Functions of the TGA to Ensure Better Access to Vaccine Safety Information for Consumers and Health Professionals

Improvements to the transparency of the TGA’s vaccine safety monitoring processes should be considered by the independent Transparency Review of the TGA being chaired by Professor Dennis Pearce.

    Recommendation 7 - Vaccine Usage and Safety Monitoring Data

    The collection of vaccine usage and safety monitoring data should be a key priority for future e-health planning and development.

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