6.5 Role of the Australian Technical Advisory Group on Immunisation for requests to list vaccines
ATAGI advises the Minister for Health on the National Immunisation Program (NIP) and other related issues. It is a non-statutory committee comprising experts in immunisation, public health, infectious diseases and consumer issues, as well as medical practitioners and nurses.
ATAGI meets six times a year in February, April, June, August, October and December. Generally, three of these meetings are held face to face, the remainder via videoconference.
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. ATAGI’s terms of reference and strategic intent are available through the Immunisation website on the department’s 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 and the PBS if required.
The ATAGI Secretariat is located in the department. The Secretariats of ATAGI and PBAC liaise regularly to ensure both committees work effectively together to consider submissions for vaccines.
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.
A preliminary meeting is available to applicants prior to deciding to request ATAGI advice, to ensure the proposed vaccine is suitable for public funding.
6.5.2 Pre-submission advice
Industry applicants of vaccines seeking listing on the NIP schedule are required to obtain advice from ATAGI prior to providing a submission to the PBAC. Applicants are required to make a formal request for ATAGI pre-submission advice through the ATAGI Secretariat following the Guidelines for preparing a request for advice from ATAGI to support PBAC considerations of vaccines.
The ATAGI Secretariat, in consultation with the ATAGI Chair, will determine if the request is a simple or complex submission based on the definitions outlined in the Procedures for ATAGI advice to the PBAC.
All requests are required to be lodged according to the published submission calendar for the ATAGI meeting in which the advice is to be endorsed (refer to the ATAGI website).
Applicants are expected to include the ATAGI pre-submission advice as part of the submission to the PBAC.
Further details on the guidelines, submission calendar, procedures and templates for preparing a request for ATAGI advice is on the ATAGI website.
6.5.3 ATAGI consideration of the content of the submission
Once the request has been received by ATAGI Secretariat, it will be passed onto an independent Vaccine Evaluation Group who will assess and draft advice for ATAGI’s consideration.
ATAGI considers this advice at its next face-to-face meeting.
Applicants with questions for ATAGI regarding the ATAGI pre-submission advice or the processes for listing vaccines on the NIP should contact the ATAGI Secretariat (refer to contact details in Appendix A).
6.5.4 Response to questions raised during the evaluation (postsubmission advice)
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 part of the post-submission advice. ATAGI endorses its post-submission advice at one of its face-to-face meetings. The document is then provided to ESC, the PBAC and the applicant.
For some cases, the PBAC may also seek additional information from ATAGI before a vaccine can be listed on the NIP
6.5.5 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 applicant and PBAC (refer to Section 6.1.2).
6.5.6 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.
6.5.7 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, Population Health Division 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.