Review of the management of adverse events associated with Panvax and Fluvax
Recommendation 1 - The Governance of the Vaccine Safety SystemThat 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:
- 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.
- 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.
- 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 ImmunisationThat 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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