Australian Influenza Vaccine Committee (AIVC) terms of reference

Purpose

The AIVC provides advice to the Therapeutic Goods Administration on the composition of the seasonal influenza vaccine to be supplied each year in Australia, following the World Health Organisation (WHO) strain consultation meeting.

Role and function

The AIVC advises the Deputy Secretary of Health Products Regulation Group^[1] about:

• the suitability, for the Australian market, of the recommendation 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 seasonal or pandemic 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 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 Deputy Secretary, one of whom will also be nominated as the Chairperson.

The Deputy Secretary will appoint up to six 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 Deputy Secretary of Health Products Regulation Group on the influenza virus(s) to be included in the seasonal vaccines for Australia.
• Taking into account the advice of the AIVC, the Deputy Secretary's approval of the recommended strain for Australian influenza vaccines for the season is officially announced shortly after the meeting via publication on 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 Deputy Secretary on any other matter relating to seasonal or pandemic 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 Deputy Secretary.

Reporting

The AIVC reports to the Deputy Secretary of Health Products Regulation Group via the nominated Chairperson.

The AIVC is not involved in any decision making process under the Therapeutic Goods Act 1989.