The Australian Immunisation Handbook 10th Edition

1.2 Development of the 10th edition of the Handbook

Page last updated: 30 August 2016

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The 10th edition of the Handbook has been developed by the Australian Technical Advisory Group on Immunisation (ATAGI), which provides advice to the Federal Minister for Health on the Immunise Australia Program and other vaccine-related issues. In addition to technical experts from many fields, the ATAGI’s membership includes a consumer representative and general practitioners. Staff of the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS) provided the technical support to the ATAGI to develop the Handbook.

It is important to note that recommendations contained within the Handbook do not formally address the cost-effectiveness of different vaccines or different vaccine schedules. Since January 2006, the cost-effectiveness of vaccines is assessed by the Pharmaceutical Benefits Advisory Committee (PBAC), which advises government on the funding of vaccines under the National Immunisation Program and/or Pharmaceutical Benefits Scheme (PBS). Most, but not all, of the recommendations made within the Handbook will be funded under the NIP, PBS or via other means, such as through special schemes and state- or territory-based programs.

1.2.1 Process of developing Handbook recommendations

The Handbook is designed as a general guide to inform clinicians on the safest and most effective vaccination strategies, using the highest quality evidence available. In the absence of high-quality evidence, such as well-conducted randomised controlled trials and meta-analyses, the ATAGI based its recommendations on less rigorous studies, such as uncontrolled clinical trials, case-series and/or other observational studies. Where clinical guidelines were available on specific topics, these were also consulted to help frame recommendations, if relevant, in the Australian setting. Further details on literature search strategies utilised for the production of this edition can be found in Appendix 2. The ATAGI also consulted immunisation handbooks produced by comparable countries. When published sources were inadequate, recommendations were based on expert opinion. However, limitations and challenges to developing recommendations continue to exist when there are unaddressed scientific questions, complex medical practice issues and continuous new information, as well as differences in expert opinion. Despite these limitations, the ATAGI has sought to provide clear and relevant recommendations wherever possible.

The 1st edition of The Australian Immunisation Handbook was published in 1975. Due to its longevity, scope and complexity, the Handbook does differ from other NHMRC guidelines. As such, recommendations contained in the Handbook do not contain formal levels or grades of evidence or evidence tables. The grades of evidence assigned to recommendations for the three newly vaccine-preventable diseases (human papillomavirus (HPV), rotavirus and herpes zoster) that were included in the 9th edition Handbook (and its electronic amendments) have now been removed and replaced with an evidence statement for consistency with other chapters in the 10th edition of the Handbook. The ATAGI has developed new recommendations for the Handbook after considering clinical questions, reviewing available evidence, as described above, and through extensive consultation with other experts (described below). Evidence statements for recommendations, with cross reference to other relevant sections of the Handbook, have been included wherever possible.

1.2.2 Consultation and input into the draft 10th edition Handbook

Prior to completion of the draft 10th edition Handbook, the ATAGI sought expert review of individual chapters by leading Australian experts. These reviewers, who are acknowledged in the front of this Handbook, provided input to further refine each chapter. The ATAGI also, where relevant, consulted members of each of its current disease-based Working Parties. Other peak advisory groups, in particular the National Immunisation Committee, were also consulted and provided valuable input into the development of this revised edition. The draft 10th edition of the Handbook was available for public consultation over a 4-week period during July–August 2012. The ATAGI reviewed all public comments received and, where necessary, incorporated these as changes to the Handbook. The NHMRC was also consulted throughout the development of the 10th edition of the Handbook, prior to the Handbook being proposed for submission to the NHMRC for consideration of approval (under section 14A of the NHMRC Act 1992).

1.2.3 Implementation of recommendations in the 10th edition Handbook

The 10th edition of the Handbook is disseminated directly to all registered medical practitioners in Australia. Additional hard copies are distributed to other immunisation service providers via their state or territory health authority. An electronic version of the Handbook is freely accessible on the Immunise Australia Program website. Implementation of the recommendations as stated in the Handbook is undertaken by immunisation service providers in conjunction with their state or territory health authority and the Immunise Australia Program of the Australian Government Department of Health.