Region-wide assessment of National Immunization Technical Advisory Groups (NITAGs) using the NITAG Maturity Assessment Tool (NMAT) - Experience from the Eastern Mediterranean Region of the World Health Organization, 2023.

National Immunization Technical Advisory Groups (NITAGs) are independent bodies that help improve national immunization programmes in decision making on immunization policy. The new NITAG Maturity Assessment Tool (NMAT) provided an opportunity to conduct a region-wide assessment to improve NITAG capacity and foster institutional growth. We share experience of the Eastern Mediterranean Region (EMR) of the World Health Organization (WHO) in using NMAT and the use of findings to develop improvement plans. NITAG chairs and secretariats from 22 EMR countries attended a virtual NMAT training in 2023. They self-assessed their NITAGs using the tool and developed improvement plans. An algorithm used the data to determine maturity levels for seven indicators. We consolidated results for the region by income groups. Of 22 countries (or NITAGs), 20 (91%) submitted NITAG assessment findings and 19 an improvement plan. The proportion of criteria met per indicator varied from 36% for independence and non-bias to 74% for establishment and composition. Maturity level varied by indicator. Of 20 NITAGs, less than half had an intermediate or higher-level maturity for the indicators of independence and non-bias 1 (5%), operations 3 (15%), making recommendations 4 (20%), stakeholder recognition 6 (30%), and resources and secretariat support 7 (35%). Meanwhile 11 (55%) NITAGs had an intermediate or higher maturity level for the indicators of establishment and composition and for integration into policy making process. Participants described NMAT as a concise, useful, user-friendly tool. NMAT is a practical tool that can be used by NITAGs to provide insights and strategic direction for individual countries and regionally. Prevention and management of conflict of interest is the domain that requires the most improvement in EMR. Planned activities should be implemented, monitored and a follow up assessment conducted in 2025.

Use of existing systematic reviews for the development of evidence-based vaccination recommendations: Guidance from the SYSVAC expert panel.

National immunization technical advisory groups (NITAGs) develop immunization-related recommendations and assist policy-makers in making evidence informed decisions. Systematic reviews (SRs) that summarize the available evidence on a specific topic are a valuable source of evidence in the development of such recommendations. However, conducting SRs requires significant human, time, and financial resources, which many NITAGs lack. Given that SRs already exist for many immunization-related topics, and to prevent duplication and overlap of reviews, a more practical approach may be for NITAGs to use existing SRs. Nevertheless, it can be challenging to identify relevant SRs, to select one SR from among multiple SRs, or to critically assess and effectively use them. To support NITAGs, the London School of Hygiene and Tropical Medicine, Robert Koch Institute and collaborators developed the SYSVAC project, which consists of an online registry of systematic reviews on immunization-related topics and an e-learning course, that supports the use of them (both freely accessible at https://www.nitag-resource.org/sysvac-systematic-reviews). Drawing from the e-learning course and recommendations from an expert panel, this paper outlines methods for using existing systematic reviews when making immunization-related recommendations. With specific examples and reference to the SYSVAC registry and other resources, it offers guidance on locating existing systematic reviews; assessing their relevance to a research question, up-to-dateness, and methodological quality and/or risk of bias; and considering the transferability and applicability of their findings to other populations or settings.

COVID-19 vaccine policy development in a sample of 44 countries - Key findings from a December 2021 survey of National Immunization Technical Advisory Groups (NITAGs).

National Immunization Technical Advisory Committees (NITAGs) are tasked with the responsibility of guiding ministries of health and national immunization programmes in their policy development processes. Many NITAGs rely on evidence reviewed by the World Health Organization's (WHO) Strategic Group of Experts(SAGE) on immunization and aim to adapt WHO's recommendations to their respective contexts. This relationship took on exceptional importance since the onset of the COVID-19 pandemic, during which NITAGs have expressed a notable struggle to craft appropriate policies on population prioritization and vaccine utilization in the face of supply constraints and complex programmatic and delivery logistics. This online survey was conducted to assess the usefulness of the SAGE guidance documents for COVID-19 vaccine policies and to examine the persisting needs and challenges facing NITAGs. Results confirmed that SAGE recommendations concerning COVID-19 vaccines are easy to access, understand, and adapt. They have been found to be comprehensive and timely under the data and time constrained circumstances confronting SAGE. The Global NITAG Network (GNN) appears to be the most popular vehicle for addressing questions among high income countries, in contrast to lower income countries who favour WHO Country or Regional Offices. NITAGs place much value on interaction with other NITAGs, which requires facilitation and could benefit from increased opportunities, especially within regions. It is further noted that some NITAGs have had to tackle issues during the pandemic not typically considered by SAGE, such as supply chain logistics and vaccine demand. Learning from the COVID-19 experience offers opportunities to strengthen NITAGs and the pandemic recovery effort through the development of more concrete procedures and consideration of more varied types of data, including implementation effectiveness and uptake data. There is also an opportunity for an increasing involvement of Country Office WHO personnel to support NITAGs, while ensuring information and evidence needs of countries are adequately reflected in SAGE deliberations.

Using existing systematic reviews for developing vaccination recommendations: Results of an international expert workshop.

National immunization technical advisory groups (NITAGs) develop immunization-related recommendations. Systematic reviews are recommended to be used in this process, but conducting them requires significant resources, which many NITAGs lack. Using existing systematic reviews could help address this problem. The Robert Koch Institute and collaborators set up the SYSVAC2 project to facilitate the retrieval of existing systematic reviews and offer guidance on using them. This will include an online registry of systematic reviews relevant to immunization policy and an online course on how to use existing reviews. This report describes an international expert workshop held in December 2019 to develop consensus on methods for using existing reviews and other relevant factors for the registry and course. Members from NITAGs representing different regions of the world presented their experiences of using systematic reviews and reflected on challenges inhibiting use. Three methodologists considered different aspects of using systematic reviews. Interactive sessions followed, where implications for SYSVAC2 were discussed. Participants supported having critical appraisal ratings, plain language summaries, keyword search, and data visualization functions in the registry. They suggested tailoring course content to different audiences and including overviews of reviews as a topic and examples of how NITAGs have used or could use existing reviews. Participants agreed that whether a review is out-of-date should be decided by those using the review rather than registry staff. The registry could help by highlighting the date of literature search or included primary studies. Participants recommended a visualization function to highlight overlap across reviews and guidance on handling challenges to using reviews, ideally, involving a practical element. No consensus was reached on which critical appraisal tool to use for reviews in the registry, but a majority of participants wanted registry staff to perform appraisals. Formative research is planned before the registry and online course are launched in 2020.

Evidence-informed vaccination decision-making in countries: Progress, challenges and opportunities.

Countries face an increasingly complex vaccination landscape. As well as ever-changing infectious disease epidemiology, the number and diversity of vaccine-preventable diseases, vaccine products, and vaccine technologies continue to increase. To ensure that vaccination decision-making is transparent, country-owned and informed by sound scientific evidence, many countries have established national immunization technical advisory groups (NITAGs) to provide independent expert advice. The past decade has seen substantial growth in NITAG numbers and functionality, and there is now a need to consolidate this progress, by further capacity building, to ensure that NITAGs are responsive to the changing face of immunization over the next decade.

Immunization governance: Mandatory immunization in 28 Global NITAG Network countries.

International trends currently favour greater use of mandatory immunization. There has been little academic consideration or comparison of the existence and scope of mandatory immunization internationally. In this paper, we examine mandatory immunization in 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, including countries from every WHO region and World Bank income level classification. We found that although mandatory immunization programs, or mandatory elements within broader immunization programs, are relatively common, jurisdictions vary significantly with respect to the immunizations required, population groups affected, grounds for exemptions, and penalties for non-compliance. We also observed some loose associations with geography and income level. Based on these data, we categorized policies into a spectrum ranging from Narrow to Broad scope.

Building immunization decision-making capacity within the World Health Organization European Region.

A National Immunization Technical Advisory Group (NITAG) is a multi-disciplinary body of national experts that provides evidence-based recommendations to policy-makers, assisting them in making sound immunization policy and programme decisions. The World Health Organization (WHO) Regional Office for Europe is working to strengthen the capacity of newly-established NITAGs and has targeted efforts on low- and middle-income countries. The Regional Office, in collaboration with WHO Headquarters and USA Centers for Disease Control and Prevention (CDC), developed a new training strategy and held training workshops to improve NITAGs' functioning and ability to make evidence-based recommendations. Feedback from countries that participated in trainings indicated that the updated training materials and interactive approach with follow-up technical support enabled them to align their NITAG charters and processes with WHO recommendations. To ensure continued progress, global and regional partners such as WHO and CDC should continue providing technical support to recently established NITAGs.

Strengthening vaccination frameworks: Findings of a study on the legal foundations of National Immunization Technical Advisory Groups (NITAGs).

In 2017, the Strategic Advisory Group of Experts on Immunization's Assessment Report of the Global Vaccine Action Plan noted the need to "better document the ways in which legislation and regulations have been used to promote or undermine immunization at the national level". Despite National Immunization Technical Advisory Groups (NITAGs) now existing in over 134 countries worldwide, there has been very little academic consideration of their legal underpinnings. In this paper, we compare the legal foundations and authority of 28 NITAGs from the six WHO Regions. All are members of the Global NITAG Network. We categorize the NITAGs based on their legal foundation and on the authority granted to them by their government, organizing them into a taxonomy of models. We then propose legal considerations for governments contemplating establishing or reforming a NITAG.

Governing off-label vaccine use: An environmental scan of the Global National Immunization Technical Advisory Group Network.

BACKGROUND: National Regulatory Authorities approve the indications for vaccine use in the product information. Occasionally, National Immunization Technical Advisory Groups (NITAGs) make off-label recommendations for use in different age groups, populations, and dosing schedules from the product information. We sought to determine the rationale, policies and procedures for NITAG off-label recommendations. METHODS: We conducted an environmental scan of Global NITAG Network members, immunization program managers and regulators in 38 high-, middle- and low-income countries. Participants completed an online survey regarding policies, procedures, and legislation governing development of off-label recommendations. A sub-sample of respondents met for a focus group and interviews which were analyzed qualitatively. RESULTS: Thirty-four people responded from 26/38 (68%) countries surveyed; 76% of respondents were NITAG members or immunization program managers. Recommendations for off-label vaccine use were made in 14/26 (54%) countries; the NITAG made those recommendations in 8/14 (57%) countries. Reasons for off-label vaccine recommendations included response to disease outbreaks or vaccine shortages. Only one country had standard operating procedures for developing off-label recommendations while 6/14 (43%) countries had policies for implementing off-label recommendations. Nine respondents from 8 countries agreed to participate in a focus group (n = 6) or individual interviews (n = 3). Barriers to off-label recommendations included legal concerns, lack of standard definition for off-label use, and manufacturer reluctance to update product information. Facilitators included confidence in the decision-making process, and transparency of open communication among stakeholders. CONCLUSIONS: Best practice guidelines are needed that define off-label use and outline a transparent, evidence-based approach to develop off-label recommendations.

Moving forward on strengthening and sustaining National Immunization Technical Advisory Groups (NITAGs) globally: Recommendations from the 2nd global NITAG network meeting.

National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. This is complex work and many NITAGs face challenges in fulfilling their roles. Inter-country NITAG collaboration opportunities have the potential to enhance NITAG function and grow the quality of recommendations. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. The first Global NITAG Network (GNN) meeting, held in 2016, led to a push to launch the GNN and grow the network. At the second GNN meeting, held June 28-29, 2017 in Berlin, the GNN was formally inaugurated. Participants discussed GNN governance, reflected on the April 2017 Strategic Advisory Group of Experts (SAGE) on Immunization conclusions concerning strengthening of NITAGs and also shared NITAG experiences in evaluation and inter-country collaborations and independence. They also discussed the role of Regional Technical Advisory Groups on Immunization (RTAGs) and regional networks. A number of issues were raised including NITAGs and communications, dissemination of recommendations and vaccine implementation as well as implications of off-label recommendations. Participants were alerted to immunization evidence assessment sites and value of sharing of resources. They also discussed potential GNN funding opportunities, developed an action plan for 2017-18 and selected a Steering Committee to help move the GNN forward. All participants agreed on the importance of the GNN and the value in attracting more countries to join the GNN.

The NITAG Resource Centre (NRC): One-stop shop towards a collaborative platform.

It has long been acknowledged that there is little interaction between National Immunization Technical Advisory Groups (NITAGs) in the North and even less between those in the North and those in the South. Three international meetings of NITAGs recommended establishing an international network of NITAGs centred on a core functional structure and platform to facilitate future exchanges. The SIVAC Initiative (as part of a WHO Collaborating Center) followed-up with this recommendation, and launched an interactive platform involving all NITAGs worldwide in an active network and open collaboration: the NITAG Resource Center (NRC), accessible at http://www.nitag-resource.org. The NRC offers NITAG members and secretariats a centralized access to NITAG recommendations from around the world, systematic reviews, scientific publications, technical reports, updates from partners, and upcoming immunization events. A dedicated network manager will proactively update all contents through a strong network of regional and national focal points. The NRC is a first step towards a more fruitful and global collaboration between NITAGs.