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•Countries served by a functional NITAG increased from 40 in 2010 to 120 in 2019.•NITAGs can ensure expenditure on immunization has the greatest population benefit.•To achieve impact, NITAGs’ importance needs to be recognized at the national level.•Global and regional partners must continue to support the development of NITAG.•Countries need to commit NITAG long-term sustainable resources. 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.

•New tools are available to support NITAGs to develop evidence-based vaccine recommendations.•Facilitated trainings using the Evidence to recommendations (EtR) toolkit have reached 30+ countries.•An online eLearning module to introduce the EtR approach is available for NITAG members and others.•A new tool to assess NITAG maturity (NMAT) in 7 functional areas has been used in 40+ countries. Increasing opportunities for prevention of infectious diseases by new, effective vaccines and the expansion of global immunization programs across the life course highlight the importance and value of evidence-informed decision-making (EIDM) by National Immunization Technical Advisory Groups (NITAGs). The U.S. Centers for Disease Control and Prevention (CDC) and Task Force for Global Health (TFGH) have developed and made available new tools to support NITAGs in EIDM. These include a toolkit for conducting facilitated training of NITAGs, Secretariats, or work groups on the use of the Evidence to Recommendations (EtR) approach to advise Ministries of Health (MoH) on specific vaccine policies, and an eLearning module on the EtR approach for NITAG members, Secretariat and others. The CDC and TFGH have also supported final development and implementation of the NITAG Maturity Assessment Tool (NMAT) for assessing maturity of NITAG capabilities in seven functional domains. The EtR toolkit and eLearning have been widely promoted in collaboration with the World Health Organization (WHO) Headquarters and Regional Offices through workshops engaging over 30 countries to date, and the NMAT assessment tool used in most countries in 3 WHO regions (Americas, Eastern Mediterranean, African). Important lessons have been learned regarding planning and conducting trainings for multiple countries and additional ways to support countries in applying the EtR approach to complete vaccine recommendations. Priorities for future work include the need to evaluate the impact of EtR training and NMAT assessments, working with partners to expand and adapt these tools for wider use, synergizing with other approaches for NITAG strengthening, and developing the best approaches to empower NITAGs to use the EtR approach.

•The COVID-19 pandemic has challenged traditional vaccine guidance infrastructure.•NACI made many strategic adaptations to facilitate timely vaccine advice in Canada.•The pandemic highlighted critical roles for NITAGs in vaccine program design.•Learning from COVID-19 pandemic adaptations, we see a roadmap for future pandemics. The COVID-19 pandemic has challenged traditional vaccine guidance infrastructure and frameworks, and added urgency and complexity to the operation of National Immunization Technical Advisory Groups (NITAGs). Canada’s National Advisory Committee on Immunization (NACI) provides immunization guidance to the Public Health Agency of Canada (PHAC) who publicly shares expert and evidence-informed guidance with Canadian provinces and territories. Throughout the pandemic, NACI and PHAC implemented many adaptations to meet urgent needs for pandemic vaccine guidance. In this paper, we describe: structural adaptations in response to the accelerated pace and amount of work required to issue recommendations that were timed around product authorizations and dynamic epidemiology; technical adaptations in response to rapidly evolving evidence of variable quality which required close monitoring, and which promoted reliance on basic vaccine principles due to incomplete direct evidence; the need to provide nimble advice (e.g., off-label recommendations, preferential recommendations); communications adaptations (e.g. identify sustainable spokespeople for the committee, receive stakeholder feedback, and ensure urgent nuanced advice was communicated to a diverse audience); and research adaptations focussing on solutions to constrained supply (e.g. prioritisation, extended intervals, and heterologous schedules). The early pandemic vaccine experience has created a roadmap of lessons and adaptations that should be leveraged in future pandemic vaccine programs, and has highlighted the essential role of NITAGs to complement regulatory structures during pandemics to ensure timely, impactful, and evidence-informed public health vaccine guidance.

As Ethiopia faces growing demands to introduce new vaccines amid constrained resources and declining donor support, evidence-based prioritization is essential. This paper describes the experience of Ethiopian National Immunization Technical Advisory Group's (ENITAG) in using a structured, multi-criteria decision analysis (MCDA) approach—the New Vaccine Introduction Prioritization and Sequencing Tool (NVI-PST)—to guide new vaccine introduction and sequencing for the 2026–2030 period. ENITAG, in collaboration with the Federal Ministry of Health (FMoH) and partners, adapted the NVI-PST to Ethiopia's context. Six candidate vaccines were shortlisted—hexavalent, rubella (MR), multivalent meningococcal conjugate (MMCV), typhoid (TCV), cholera (OCV), and respiratory syncytial virus (RSV) vaccines. Thirteen criteria across importance and feasibility domains were selected and weighted. Data were gathered by thematic working groups and used to score and rank each vaccine through a participatory process involving ENITAG members and stakeholders. The hexavalent and rubella vaccines were prioritized the highest for early introduction due to their combined public health importance and programmatic feasibility. RSV and MMCV were ranked as medium priorities, while TCV and OCV were deemed lower priorities for routine immunization. The recommendations considered existing programmatic constraints, such as upcoming introductions (e.g., malaria, yellow fever, hepatitis B birth dose) and supplementary campaigns. ENITAG also emphasized strengthening its secretariat, improving data systems, and integrating community perspectives in future prioritization efforts. This exercise marks a pivotal shift in Ethiopia's immunization decision-making—from reactive, one-off vaccine assessments to a strategic, systematic approach aligned with national priorities and health system capacity. Despite challenges related to data quality and resource limitations, the process offers a replicable model for other low-income countries seeking to optimize immunization investments in a transparent, evidence-informed manner. •Ethiopia faces growing demand for new vaccines while donor support declines, making evidence-based prioritization crucial.•The ENITAG applied MCDA tool (NVI-PST), adapted to the national context, to rank six candidate vaccines for 2026–2030.•Hexavalent and rubella vaccines emerged as top priorities while RSV and MMCV as medium priorities for routine introduction.•Recommendations factored in vaccines in the pipeline, health system constraints, and the need for stronger data systems.•It marks a shift to strategic, transparent, and replicable decision-making in Ethiopia's EPI, offering a model for other LIC.

•NITAGs can rely on accessible and adaptable COVID-19 vaccine recommendations from WHO’s SAGE.•NITAGs find interaction with fellow advisory groups within and beyond their regions beneficial.•WHO country and regional offices can improve communications with NITAGs.•The COVID-19 pandemic experience highlighted challenges in evidence-based policy development.•NITAGs have opportunities to better address future pandemics and current recovery efforts. 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.

National Immunization Technical Advisory Groups (NITAGs) are crucial for enhancing vaccine use in immunization programs, particularly through off-label recommendations. This study sought to assess the adoption and trends of off-label vaccine recommendations made by NITAGs across low-, middle-, and high-income countries since the COVID-19 pandemic. An online survey was distributed to NITAG representatives in World Health Organization (WHO) member states, asking questions related to off-label use of vaccines including policies, procedures, legislation, and regulations for NITAGs in participants' countries. Respondents across all six WHO regions were invited to participate. Respondents from 76 countries participated in the survey (55 %) were NITAG representatives, and 45 % were immunization program managers or from the NITAG secretariat). Most respondents 52 (68 %) reported their NITAG makes off-label recommendations, 18 (24 %) indicated their NITAG does not make off-label recommendations, and 6 (8 %) were unsure of their NITAG's role. There was a noticeable shift relating to off-label vaccine recommendations observed pre, during, and post-pandemic period. Prior to 2022, 25 (48 %) respondents indicated their country recommended off-label vaccines, 11 (21 %) specified off-label recommendations were limited to emergencies as temporary or conditional expansions, and 6 (12 %) were unsure. After 2022, 30 (58 %) respondents indicated their country recommended off-label vaccines, 4 (8 %) specified off-label recommendations were limited to emergencies as temporary or conditional expansions, 18 (35 %) selected no, and 0 (0%) were unsure. While most countries make off-label recommendations, few (15 %) have policies and procedures to support implementation. Although WHO broadly provides guidance on the mandate and core functions of NITAGs, globally, they have differing mandates and operational capacities related to off-label vaccine use. These findings suggest the need for increased awareness of off-label vaccine recommendations and strengthened dialogue around implementation of off-label recommendations.

National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. However, many NITAGs face challenges in fulfilling their roles. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. To address this request, the Health Policy and Institutional Development (HPID) Center (a WHO Collaborating Center at the Agence de Médecine Préventive - AMP), in collaboration with WHO, organized a meeting in Veyrier-du-Lac, France, on 11 and 12 May 2016, to establish a Global NITAG Network (GNN). The meeting focused on two areas: the requirements for (a) the establishment of a global NITAG collaborative network; and (b) the global assessment/evaluation of the performance of NITAGs. 35 participants from 26 countries reviewed the proposed GNN framework documents and NITAG performance evaluation. Participants recommended that a GNN should be established, agreed on its governance, function, scope and a proposed work plan as well as setting a framework for NITAG evaluation.

•NITAGs provide independent, evidence-informed immunization advice to governments.•Global NITAG Network (GNN) now formally launched.•GNN: country lead organization formed to strengthen NITAGs, no participation fees.•GNN: nurture development of inter-country NITAG relationships.•GNN: facilitate voluntary sharing information, technical expertise.•GNN: venue to discuss NITAG immunization decision-making, implementation concerns. 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.

National immunization technical advisory groups (NITAGs) develop evidence-based vaccination recommendations. Systematic reviews (SRs) are important tools in that process, but conducting them is very resource-intensive. Given the considerable number of immunization-related SRs published and to minimize duplication of effort, a more practical approach for NITAGs is to use existing SRs. Among multiple initiatives and resources to strengthen NITAGs, the freely accessible SYSVAC registry supports NITAGs in identifying suitable SRs when developing vaccination recommendations. Additional SYSVAC courses provide step-by-step training on how to use SRs. This cross-sectional survey was conducted online and involved 108 participants globally. The aim was to explore NITAGs user experience with evidence retrieval, to assess impact and use of the SYSVAC resources and training needs. Data were collected using a structured questionnaire. Most of the respondents were > 45 years old (75.9%) and represented 50 NITAGs from all six World Health Organization (WHO) regions. In total, 13/50 NITAGs (26.0%) had ease accessing full text publications. The preferred data sources to search for evidence were peer reviewed literature via PubMed and the WHO website (Strategic Advisory Group of Experts – SAGE – on Immunization). When developing vaccination recommendations, respondents stated using SRs mostly conducted by SAGE, other institutions or NITAGs (83.2%), recommendations of other countries (79.4%) and primary studies (73.8%). Respondents from 35 NITAGs stated to use the SYSVAC registry to search for evidence, leading to ≥69 recommendations being developed by NITAGs globally with its support. Aside existing SYSVAC courses on SR use, there was great interest in training on SR use in the development of vaccination recommendations. Our survey gathered information on evidence use and training needs. Survey results serve as a starting point to improve support of NITAGs in developing recommendations. •Only a quarter of NITAGs have easy access to full text of publications found online.•Most NITAGs use systematic reviews and recommendations of other countries.•Only a limited number of NITAGs conduct or commission systematic reviews themselves.•NITAGs use SYSVAC; numerous recommendations were developed with SYSVAC registry.•High interest in training on systematic review use.

In the Eastern Mediterranean Region (EMR) of the World Health Organization (WHO), little is known on National Immunization Technical Advisory Groups’ (NITAGs) outputs, including recommendations and their outcomes. We abstracted information from the WHO/UNICEF joint reporting forms and extracted implemented immunization policy decisions from the WHO immunization portal. We describe trends in establishments and functionality of NITAGs and immunization policies implemented in EMR from 2010 to 2021. In 2013, all 22 EMR countries had a NITAG, although only 20 remained active in 2021. The number of countries meeting six NITAG process indicators increased from 7 in 2010, to 14 in 2019, then reduced to 12 in 2021. In 2021, the proportion of countries with a functional NITAG decreased with income level, from 83% in high-income countries, to 55% in middle-income countries and 20% in low-income countries. From 2010 to 2021, there were 103 new vaccine introductions, 31 vaccine switches, and 28 schedule changes implemented across all 22 countries, irrespective of income groups. While NITAGs are established and making recommendations in countries, their functionality decreases with income level. Governments should continue to invest in NITAGs, including on strengthening processes and ensuring that recommendations made are based on evidence to decision frameworks.