The focus of this document is to give directions and identify issues for countries to consider when establishing or improving the functioning of a National Immunization
Technical Advisory Group (ITAG). The proposed structure may in part be seen as an ideal setting towards which to aim, but it is well accepted that establishing such a committee may only be achieved over a number of years. Further it is acknowledged that this solely represents general guidance and that the optimal process to reach the best evidence-based decisions may vary from country to country. Each ITAG's composition and modus operandi must be adjusted and account for the local situation and social and legal environment.
This document will be updated as we learn more about successful or unsuccessful practices in the establishment and output of these committees. Clearly the aim of such an overall ITAG is not to focus solely on introduction of new vaccines but to regularly advise on the adjustment of existing programmes and strategies.
Immunization is considered to be one of the most cost effective public health interventions leading to measurable and significant reductions in morbidity and mortality from vaccine-preventable diseases. While at both the global level and in many country programmes the focus is on immunization of infants and a limited number of vaccines, the vaccine world is changing - and with it the demands and expectations of global and national policy makers, donors, and other interested parties. Changes pertain to: development of new vaccines and technologies, vaccine safety issues, regulation and approval of vaccines, expanding the immunization schedule, and increased funding flowing through new financing mechanisms. As the scope of immunization efforts expands, the local and global immunization landscapes are changing, with increased efforts needed to coordinate actors in the public and private sectors, and a renewed emphasis on monitoring and ensuring the safety of vaccinations.
Responding at the Global Level: WHO and UNICEF
These evolving changes place a special responsibility on WHO to respond effectively.
WHO has recently reviewed and optimized its policy making structure for vaccines and immunization and adjusted it to the new Global Immunization Vision and Strategy (GIVS)
2006 – 2015 which is a joint UNICEF/WHO plan that has been developed through extensive consultation with partners and endorsed by the World Health Assembly (WHA
58.15) and the UNICEF Executive Board (2005/7). It broadens the scope of immunization efforts to encompass all age groups and vaccines with emphasis on integration of immunization delivery with other health interventions.
The GIVS identifies four strategic areas:
1. Protecting more people in a changing world;
2. Introducing new vaccines and technologies;
3. Integrating immunizations, other linked interventions, and surveillance in the health systems context; and
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4. Immunizing in the context of global interdependence.
WHO's revised policy making structures for vaccines and immunizations, aligned with the principles of the GIVS, includes an extended consultation process to promptly generate evidence-based recommendations, ensuring transparency of the decision making process at global and regional levels, and includes added communication efforts.
Responding at the Country Level: Localizing Evidence-Based Decision Making
The optimization of current immunization programmes, the availability of new vaccines and technologies and the need to introduce them, are realities that countries must strive to take advantage of. In order to enable countries to make evidence-based decisions in any future choices, be it vaccines or technologies, the countries must have the technical capacity to assess the country’s need and the appropriateness of the technology on offer.
Key to the improvement of routine immunization programmes and the sustainable introduction of new vaccines and immunization technologies is for countries to ensure that they have the necessary evidence and clear processes to make informed decisions regarding the establishment of immunization programme priorities, the introduction of new programme strategies, vaccines and technologies. Similarly, such evidence and processes are needed to justify the continuation of, or any necessary adjustments to, existing immunization programmes and policies.
At present some industrialized and developing countries have formally constituted national technical advisory bodies (often referred to as Immunization Technical Advisory
Groups, or ITAGs) to guide immunization policies; others countries are currently working towards establishment of such bodies or contemplating their establishment. Many countries lack credible decision-making processes that can facilitate the review and assessment of immunization interventions and strategies.
Why establish a national Immunization Technical Advisory Group (ITAG)?
A body such as an ITAG with proper membership can assist national governments to address issues of vaccine quality and safety, immunization policy and strategies, introduction of new vaccines and immunization technologies and sustaining routine immunization, promoting national vaccine security, and guiding national authorities on the public health needs for new and emerging vaccine-preventable diseases.
An ITAG can be both the technical resource to assist national authorities in evidencebased decision making and the tool to empower the government in this process.
Technical resource is particularly important in view of complexity of issues and body of evidence. A well balanced and institutionalized group can help resist pressure from any interest group including, but not only, that of industry. This protective function is important, because without it, pressure from special interest groups could result in changes to the programme that are not well justified in the local context. The formation and the functioning of an expert group at the national level would enhance the national government’s capacity to make the best decision about choices in vaccines and immunization. Having competent bodies such as an ITAG at the national level will also contribute to building regional capacity and that, in turn, will contribute to global capacity.
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Other advantages include the credibility of the government and national programmes and process by which they are arrived at. This of course is linked with the rigor, transparency, and informed/evidence-based process by which decisions are made.
This can positively impact on internal (within the country and within the government) as well as on external perceptions, thereby lending additional weight to proposed adjustments to the programme and enhancing the ability to secure government or donor funding. A part of the process is the transfer of responsibility to a national body versus leaving it in the hands of one or a few decision makers. This in turn may and will likely help deflect undue pressure from specific lobbying groups with narrow scopes or interests, including anti-immunization groups. In addition, this will facilitate and render more neutral a process whereby a series of disease or vaccine specific task forces or ad hoc committees are in existence and provide recommendations that are not fully integrated. A national advisory committee on immunization or even with a broader mandate, such as an infectious disease control committee, will help consolidate programmes and have a more comprehensive and integrated approach and consider the health of the entire population versus that of infants only. An immunization focus is recommended, however, to ensure that the right expertise is there and the right attention given to vaccines that could not otherwise be given by a more generic or all-purpose advisory committee serving the government.
What are the minimal requirements for an ITAG?
The establishment of a national ITAG requires sufficient financial and managerial investment if it is to succeed, and will potentially add some delays in the decision making process whereby without such a process a decision could be made instantaneously - but perhaps may not be as robust. Although the role of such committees is essentially consultative and the administrative decisions about programme adjustments remains in the hand of government officials, this process requires the acceptance of the government to yield some level of control over the decision making process.
Alternatively, some small countries with limited resources may prefer to collaboratively explore a sub-regional/intercountry mechanism to provide independent and expert advice rather than an individual country approach.
An ITAG should not be considered synonymous to the Interagency Coordinating
Committees (ICC) that are already established in GAVI eligible countries: ICC's may be asked for policy decisions on certain immunization issues, but their work is primarily operational and not technical.
Linkages between national ITAGs and Global and Regional Advisory Bodies
Although proper linkages have to be established between a national ITAG, regional ones and global advisory committees, they all serve different purposes. At the global level the
Strategic Advisory Group of Experts (SAGE) on Immunization is set to: provide global policy recommendations and strategies; support regional/national challenges; perform cross-cutting assessment of implications for global and regional policy. It provides oversight for the development of WHO vaccine position papers that are aimed to provide general guidance on vaccine programmes and use.
Other global technical advisory committees are set to provide global technical analysis and guidance; global standards and help develop a global research agenda. This
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includes the Expert Committee on Biological standardization, the Global Advisory
Committee on Vaccine Safety, and the Advisory Committee of the Initiative for Vaccine
Research. More information on SAGE and these committees as well as on other WHO global advisory committees can be found at http://www.who.int/immunization/en/.
The Regional TAGs exist in all regions and function to provide technical and policy guidance to Immunization and Vaccine Development (IVD) units. These are important bodies that contribute to the development of customized Regional Strategic Frameworks to promote immunization in practice, as well as research and development in immunization. The mandate of Regional TAGs are to help develop regional policies and strategies; identify and set regional priorities; and monitor regional progress.
National ITAGs have the specific mandate to recommend national policies and strategies in the local epidemiologic and social context; to prioritize problems and define optimal solutions; advise on implementation of national programmes, and monitor their impact.
With the above in mind, the general objective of establishing a functioning technical advisory body at the country level is to guide policy makers and programme managers to enable them to make evidence-based immunization related policy decisions, including on the choices of new vaccines and technologies and on needed adjustments to existing programmes and schedules. The broad general terms of reference (TORs) for such a group are outlined below.
Depending on individual country capacity and need, each country may need to organize such a group to best suit the country’s requirements. Therefore, the TORs proposed are broad-based and not necessarily exhaustive.
The proposed TORs are to:
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Conduct policy analysis and determine the optimal national immunization policies,
• Guide the national government and the national immunization programme (NIP) on the formulation of strategies for the control of vaccine preventable diseases through immunization,
•
Advise the national authorities in the monitoring of the NIP so that impact can be measured and quantified,
• Advise the government in the collection of important data and information,
•
Identify the need for further data for policy making,
• Guide, where appropriate, organizations, institutions or government agencies in the formulation of policies, plans and strategies for research and development in new vaccines and vaccine delivery technologies of the future.
Such a group will also:
• Foster inter-departmental linkages for those diseases that may already have a vaccine or a potential vaccine in the pipeline,
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• Promote partnership between government, civil society, industry and donors to promote immunization in a sustainable, scientifically and credible manner.
In addition to the above one of the benefits of a national ITAG is to help keep the national authorities and the NIP updated on the latest scientific development in the area of vaccines and vaccine preventable diseases.
Size
While there are no fixed rules about the size of a national ITAG and this can be influenced by local considerations, it seems that most successful committees function with 10 to 15 expert members who serve in their personal capacity and represent a broad range of disciplines encompassing many aspects of immunization and vaccines.
Composition
It is recommended that the committee be multidisciplinary and represent a broad range of skills and expertise through the selection of technically sound and experienced individuals as members. While it is up to the national governments to identify which individuals should be in the group, it is recommended to include at least the following:
A senior pediatrician
An (infectious disease) epidemiologist
A public health expert
A health economist
A vaccinology expert
An expert on clinical trials or someone who has been or is currently involved in a vaccine clinical trial
Clinicians and representatives from Research Institutes or Academia
A logistics/cold chain expert may also be useful to have on the committee.
Other considerations in terms of membership include: gender distribution, geographic diversity, representation of special population groups, if needed and the need or not to ensure representation of the public/civil society.
It is essential that all members should be independent and function in their own capacity and not represent a particular interest group or stakeholder. It is essential to ensure that members are free of conflict of interests and enjoy satisfactory credibility.
A process of membership rotation with limited terms of serving is essential. Terms of three to four years with provisions for renewal of term are common practices. The Chair should be identified as a senior and widely respected person who is an effective chair.
It is important to differentiate members involved in the decision making process from observers or invited experts who can contribute to the discussion and can help to provide background material or needed evidence but who should not be involved in the final decision making.
Consideration should also be given to participation of representatives of the government such as the national immunization programme manager and/or representatives of the
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National Regulatory Authority or drug/vaccine licensing body and from the National
Control Laboratory performing the controls of vaccines and representatives from Finance and Planning Ministries. Some committees have categories of ex-officio members or liaison members. The latter usually include representation from various organizations such as representatives of professional societies (which can play a coordinating, supporting and dissemination role), other national advisory committees, and representatives from key technical partners (e.g. WHO, UNICEF, etc.).
Nomination process
Members should be appointed formally by senior level government officials. Public calls for nominations and the establishment of an independent selection process may be envisioned for the purposes of transparency and credibility.
Prior to being appointed it is important that members be asked to complete a declaration of interests. Members may also be required to sign a confidentiality agreement if in the process of the meeting/work of the group they are provided in trust with confidential information.
Membership in committees might be terminated for any of the following reasons:
(1) a failure to attend a specified number of consecutive meetings;
(2) a change in affiliation resulting in a conflict of interests; and
(3) a lack of professionalism involving, for example, a breach of confidentiality.
Subject to the above, members would normally be appointed for a term of a fixed number of years, which can be renewed (sometimes, the number of renewals allowed is specified). Care should be taken to ensure there is continuity in the committee so that not all members' terms would expire at the same time.
The committee should be formally established which usually also provides for necessary funding. This can be done through ministerial decree or any other appropriate mechanism. It is important that the committee reports to a high level official of the
Ministry of Health to ensure that proper attention is given to the recommendations of the committee. A formal relationship should be established between the committee and the
Ministry of Health, delineating roles and responsibilities. This would include clarifying reporting requirements, financial arrangements and secretarial support. This may include appointing an Executive Secretary who may or not be a staff member from the
MoH.
Conduct of meetings
The following points and mode of operating have to be decided upon and made clear in the mode of operation of the group:
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Open versus closed meeting
• Participation of industry
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Manufacturers should usually not be allowed in meetings but occasionally invited in highly structured participation settings to inform the committee about their products.
• Decision by vote or consensus
Establishment of working groups and their mode of operation (working groups may be helpful to prepare topics for decision making by the full ITAG).
Alternatively other mechanisms to bring information and facilitate the decision- making process could be used.
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Basis for decision making (see annexed links):
Some criteria that are frequently used include the following (but this list is not exhaustive):
Vaccine effectiveness and safety
Disease burden including age specific burden (morbidity, mortality, and societal impact)
Public health/epidemiology
Actions in other countries
Financial (cost-effectiveness, affordability)
Where sufficient data is not available, the committee should solicit additional data/work to secure the relevant data.
• Recording and adequate communication on any potential conflict of interest declared by members
• Process for deciding on agenda items and input requested form the committee
In preparation for the meeting specific questions put to the committee should be clearly articulated.
It is essential that sufficient administrative (e.g. secretarial) support be provided to prepare for meetings.
Meeting frequency
It is recommended that Ministry of Health budget this activity in their annual plans, and ensure that the national ITAG meet regularly and at least twice a year. Several groups operate successfully with three or four meetings a year.
Communication/reports
Summary minutes of each meeting must be available and endorsed by the group.
It must be decided if the minutes are public or private and if public how they will be published i.e. through government bulletins, journals, web site, etc…. Some committees are periodically publishing books/compendiums with all of their vaccines recommendations and recommendations and information about the committees and their work is posted on the web site (e.g. http://www.advisorybodies.doh.gov.uk/jcvi/ ; http://www.phac-aspc.gc.ca/naci-ccni/ ; http://www.cdc.gov/vaccines/recs/acip/ ).
Consideration should also be given to a communication strategy/plan.
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WHO, through its country offices, can support the establishment of such a body at the national level. Once established, WHO can also provide support to the functioning of the
ITAG in several ways. They could include:
• Providing technical guidance to the national ITAG in the formulation of immunization policies and strategies for vaccine preventable disease control.
• Providing regular updates and latest developments on the vaccine pipeline, guidance about recommended immunization schedules, vaccine delivery technology, vaccine preventable disease surveillance, safety and quality data/information etc. WHO will send, on a regular basis, information on the latest developments in vaccines and immunization to the chairman of the national ITAG who, in turn, will circulate it to the other members.
• WHO might also be able to provide assistance or guidance in identify potential sources of financial support to help with establishment of ITAG.
• WHO also can support the assessment, at some appropriate point of time in future, the impact and utility of such a body to the national government.
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Annexe s
1. Sample Agenda http://www.who.int/immunization/sage/en/index.html
http://www.cdc.gov/vaccines/recs/acip/meetings.htm
2. Sample TORs and modus operandi http://www.who.int/immunization/sage/en/index.html
http://www.advisorybodies.doh.gov.uk/jcvi/index.htm
http://www.cdc.gov/vaccines/recs/acip/charter.htm
http://www.phac-aspc.gc.ca/naci-ccni/tor_e.html
3. Sample Decision making models
Tools for considering individual vaccines:
Advanced Immunization Management (AIM) e-learning modules: http://aim.path.org/
A Canadian perspective on the role of epidemiology in public health decision making http://www.phac-aspc.gc.ca/csc-ccs/pdf/epidemiology_e.pdf
General information on priority setting in public health http://www.dcp2.org
Kimman T, Boot H, Berbers G et al. Developing a vaccination evaluation model to support evidence-based decision making on national immunization programs. Vaccine
2006;24;4769 http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&uid=16616803&cmd=showdetailvi ew&indexed=google
4. Sample Reports http://www.who.int/immunization/sage_conclusions/en/index.html
http://www.advisorybodies.doh.gov.uk/jcvi/minutes.htm
http://www.advisorybodies.doh.gov.uk/jcvi/annualreports.htm
http://www.advisorybodies.doh.gov.uk/jcvi/statements.htm
http://www.cdc.gov/vaccines/recs/acip/ http://www.phac-aspc.gc.ca/naci-ccni/
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