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

7.0 Recommendations of the Review

Page last updated: April 2015

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.
    or
  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.
    or
  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.

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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.

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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