Purpose

The AIVC provides advice to the TGA about the composition of the seasonal influenza vaccine.

Role and function

The AIVC advises the Principal Medical Adviser¹ (PMA) of the TGA about:

• the suitability, for the Australian market, of the recommendation that has been made by the WHO regarding the selection of influenza viruses for inclusion in the influenza vaccines for the upcoming Southern Hemisphere season; and
• appropriate candidate vaccine viruses, reassortants and reagents for the nominated viruses; and
• any other matters relating to influenza vaccines as requested.

The AIVC follows the principle that the relevant WHO-recommended virus(s) for the Southern Hemisphere is suitable unless:

• there is relevant epidemiological and scientific evidence that the circulating strains in Australia differ antigenically from the WHO-recommended viruses for the Southern Hemisphere, in which case the AIVC provides advice about other suitable strains for inclusion in the vaccine; and/or
• practical issues demand that another strain be considered as high yielding viruses and/or reagents may not be available in time.

Composition

The following are ex-officio 'voting' members:

• the Directors of the WHO National Influenza Centres in Australia.

The following are ex-officio 'non-voting' members:

• the Director and Deputy Director of the WHO Collaborating Centre for Reference and Research on Influenza;
• the Directors of the WHO National Influenza Centres in New Zealand and South Africa;
• four officers of the Department of Health nominated by the PMA, one of whom will also be nominated as the Chairperson.

The PMA will appoint up to 6 independent 'voting' members with expertise in influenza.

Each member of the AIVC must have expertise in a least one of the following fields:

1. influenza disease epidemiology
2. influenza vaccine manufacturing process
3. influenza virus genetics
4. influenza virus characterisation
5. regulatory requirements for influenza vaccines
6. clinical trials and vaccine effectiveness studies.

Quorum

A quorum exits when half of the voting-members are present.

Deliverables

• The AIVC advises the PMA on the influenza virus(s) to be included in the seasonal vaccines for Australia.
• Taking into account the advice of the AIVC, the PMA's recommendation on strain selection is officially announced shortly after the meeting via publication of the TGA website.
• A link to suitable candidate vaccine viruses, reassortants and reagent availability is also published via the TGA website.
• The AIVC advises the PMA on any other matter relating to influenza vaccines, as requested.

Timeframes

The AIVC meets annually in early October, following the WHO Southern Hemisphere recommendation in September and otherwise as requested by the PMA.

Reporting

The AIVC reports to the PMA via the Chairperson.

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Reference

1. In these Terms of Reference, a reference to the Principal Medical Adviser includes a person acting or from time to time performing the duties of that position.