6.5 Role of the Australian Technical Advisory Group on Immunisation for requests to list vaccines
ATAGI advises the Minister for Health on the NIP and other related issues. It is a nonstatutory committee comprising experts in immunisation, public health, infectious diseases and consumer issues, as well as medical practitioners and nurses.
ATAGI meets face to face three times a year in February, June and October.
ATAGI provides advice to the PBAC on matters relating to the ongoing strength of evidence pertaining to existing, new and emerging vaccines – specifically about their effectiveness and use in Australian populations. The terms of reference of ATAGI are available through the Immunise Australia website.
One of the major roles of ATAGI is to provide the PBAC and ESC with technical advice in relation to the consideration of listing a vaccine on the NIP.
The ATAGI Secretariat is located in the Department of Health. The secretariats of ATAGI and PBAC liaise regularly to ensure both committees work effectively together to consider submissions to list vaccines on the NIP.
6.5.1 Preparation of technical advice for submissions to consider vaccines
ATAGI has a number of horizon-scanning methods, and may be aware of the existence of a new vaccine before being approached for advice to be prepared on a submission. The horizon scanning includes:
- presentations by vaccine manufacturers at the annual ATAGI Industry Day
- reviews of literature and decisions by regulatory authorities in other countries
- TGA advice to ATAGI regarding new applications for registration.
Sponsors preparing a submission for a vaccine can request a presubmission meeting with the department (refer to Section 4.5).
PBAC requires presubmission advice from ATAGI for each vaccine submission. ATAGI presubmission advice is prepared by the relevant ATAGI Working Party and endorsed by ATAGI at one of its face-to-face meetings. It is provided to the sponsor soon after endorsement.
Sponsors are required to make a formal request for ATAGI presubmission advice through the ATAGI Secretariat. All requests are required to be lodged at least six months before the ATAGI meeting in which the advice is to be endorsed (refer to Appendix A for contact details).
Sponsors are expected to include the ATAGI presubmission advice as part of the submission to the PBAC to list a vaccine on the NIP.
ATAGI consideration of the content of the submission
Sponsors with questions for ATAGI regarding the ATAGI presubmission advice or the processes for listing vaccines on the NIP should contact the ATAGI Secretariat (refer to contact details in Appendix A). Top of page
Response to questions raised during the evaluation (postsubmission advice)
A copy of the submission to list a vaccine on the NIP is provided to the Chair of ATAGI and the Chair of the relevant ATAGI Working Party.
During the evaluation of the submission, the evaluation entity prepares a list of questions relating to the listing of the vaccine for ATAGI’s consideration.
ATAGI’s response to these questions forms ATAGI postsubmission advice. In developing ATAGI postsubmission advice, the relevant ATAGI Working Party will consider the evaluators’ questions alongside the vaccine sponsor’s PBAC submission. During this phase, ATAGI may seek additional information from the sponsor to help respond to the evaluators’ questions.
ATAGI endorses its postsubmission advice at one of its face-to-face meetings. The document is then provided to ESC, the PBAC and the sponsor.
For some cases, the PBAC may also seek additional information from ATAGI before a vaccine can be listed on the NIP.
ATAGI’s role at ESC meetings
When ESC considers a vaccine submission, representatives from ATAGI and the ATAGI Secretariat attend the discussion. ATAGI members are available to answer any additional questions raised during the ESC discussion. A copy of the ESC Advice on a vaccine is provided to the ATAGI Chair. ESC Advice is also provided to the sponsor and PBAC (refer to Section 6.1.2).
ATAGI’s role at PBAC meetings
The Chair of ATAGI and the ATAGI Secretariat attend the discussion of vaccine items at the PBAC meeting and the Chair is available to answer any questions raised during the PBAC discussion.
6.5.2 After the PBAC recommendation
Where the PBAC makes a positive recommendation to list a new vaccine (or vary an existing vaccine listing) on the NIP, the Office of Health Protection will start the necessary steps to amend the National Health (Immunisation Program-Designated Vaccines) Determination (refer to Section 8.7). For management of cases where the PBAC recommends to defer or ‘not recommend’ a vaccine submission, refer to Section 7.1.