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ACV meeting statement, Meeting 15, 3 June 2020

Advisory Committee on Vaccines

27 July 2020

Section A: Submissions for registration

The committee's advice was sought on two applications to register new vaccines.

Further details of the ACV discussion and advice associated with this pre-market item may be released within the Australian Public Assessment Report (AusPAR). Please note that there is a delay between when an application is considered by the ACV and the publication of the AusPAR. To browse all AusPARs see AusPAR search.

Section B: Safety

A Risk Management Plan (RMP) is a set of pharmacovigilance and risk minimisation activities designed to identify, characterise and manage the important safety concerns relating to a vaccine. The committee was asked to provide general advice about safety concerns that would be considered important for inclusion in the RMP. The committee advised that a safety specification should have a focus on the adverse events that in clinical practice would be unexpected/novel.

Section C: Immunisation Programs

No matter related to the immunisation programs was discussed.

Further information

For further information on the ACV, please visit Advisory Committee on Vaccines or contact the ACV by email ACV@health.gov.au.