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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.

Background The World Health Organization (WHO) recommends the use of malaria vaccines for the prevention of Plasmodium falciparum malaria in moderate to high transmission areas, administered in a 4-dose schedule in children from 5 months of age. The vaccine is a ground-breaking new tool to add to the existing package of recommended malaria interventions to reduce malaria morbidity and mortality. Ghana, Kenya, and Malawi were the first countries to introduce the RTS,S/AS01 E (RTS,S) malaria vaccine into their childhood immunization programmes in 2019 as part of a pilot programme called the Malaria Vaccine Implementation Programme (MVIP). Methods The WHO’s post-introduction evaluation (PIE) methodology was adapted to evaluate malaria vaccine implementation in each of the three pilot countries at least a year after the vaccine’s introduction. Semi-structured questionnaires were used to interview immunization staff at national, sub-national, and health facility levels, supplemented with systematic observations of vaccination sessions and vaccine storage sites. At the health facility, a sample of caregivers of eligible children was also interviewed. Sites were purposively selected to include a range of past immunization coverage and varied demographics among the populations served. Results All three countries successfully introduced the malaria vaccine during the MVIP. Reported malaria vaccine median coverage at least 2 years after the start of the pilot ranged from 69–91% for dose 1, 62–82% for dose 2, to 58–81% for dose 3 by 24–30 months from the start of the pilot. Coverage for dose 4 was lower as fewer children were eligible during the PIE reporting timeframe. Best practices identified during the PIEs included: early involvement of subnational stakeholders; advance updating and distribution of recording and reporting tools to include malaria vaccine; pre-assessment of cold chain capacity and scale-up; investment of time and resources in health worker trainings and refreshers; involvement of community health workers; robust defaulter tracing mechanisms; ensuring community “dialogue” with continuity of advocacy, communication, and social mobilization activities after initial introduction; regular onsite supervisory visits before, during and after introduction; and use of social media for messaging. Conclusions Malaria vaccine is an important intervention as part of a comprehensive malaria control strategy. Conducting a PIE is useful to identify best practices and lessons learned. New vaccination contacts take time to establish and achieve high coverage as communities become aware of and understand when, why, and how to access the malaria vaccine. The malaria vaccine was successfully introduced as part of the routine childhood immunization programme with strong intersectoral collaboration and planning, involving both immunization and malaria stakeholders, comprehensive training, and social mobilization efforts pre- and post-introduction.

Background In October 2021, the World Health Organization (WHO) recommended the RTS,S/AS01 E (RTS,S) malaria vaccine for the prevention of Plasmodium falciparum malaria in children living in endemic areas informed by evidence from the subnational pilot introduction and evaluation in Ghana, Kenya, and Malawi as part of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP). With the global vaccine supply boosted by the pre-qualification of a second malaria vaccine, R21/Matrix-M (R21), in October 2023, many endemic countries (20 as of April 2025) have introduced malaria vaccines into their national childhood immunization and malaria control programmes. More endemic countries are expected to introduce or scale up malaria vaccines in 2025 and beyond. This paper summarizes key operational lessons from the pilot countries to facilitate the introduction and scale-up of malaria vaccination in other countries. Methods Pilot areas were identified, in part, based on local malaria epidemiology. RTS,S was initially introduced in randomly selected areas, while other areas served as comparators until the four-dose schedule vaccine was scaled up following the WHO recommendation in 2021. In Ghana and Kenya, the vaccine was administered at ages 6, 7, 9, and 24 months (Ghana switched to administer the fourth dose at age 18 months in 2023), and Malawi chose a schedule of 5, 6, 7, and 22 months. Results Vaccination coverage improved over time, reaching about 80% for the first dose and around 75% for the third dose by 2023 in the initial pilot areas. Implementation challenges included an inadequate understanding of age eligibility among healthcare workers during the early phase of introduction, low fourth dose coverage (with a median coverage of 46% in 2023 across the three countries), and disruptions to service delivery caused by disease outbreaks and other natural disasters. Health stakeholders and caregivers attested to the positive impact of introducing the malaria vaccine, including a reduction in malaria hospitalizations and the strengthening of the National Immunization Programme (NIP) through routine immunization refresher training and supportive supervision. Conclusions The pilot highlighted lessons for malaria vaccine introduction: (1) clearly outlined roles and responsibilities of key stakeholders including NIP and National Malaria Programme (NMP); (2) appropriate approach to vaccine introduction launch, communication, and demand generation to enhance vaccine uptake; (3) flexibility with dose scheduling to optimize coverage; and (4) updated data collection tools for accurate documentation, and data quality.

► New vaccines put great pressure on already weak vaccine supply chain systems. ► Failure to improve supply chains increases cost and lowers performance of EPI. ► Investments are critical and can take advantage of new technology. ► Action plans for a global vision address five key supply chain areas. With the introduction of new vaccines, developing countries are facing serious challenges in their vaccine supply and logistics systems. Storage capacity bottlenecks occur at national, regional, and district levels and system inefficiencies threaten vaccine access, availability, and quality. As countries adopt newer and more expensive vaccines and attempt to reach people at different ages and in new settings, their logistics systems must be strengthened and optimized. As a first step, national governments, donors, and international agencies have crafted a global vision for 2020 vaccine supply and logistics systems with detailed plans of action to achieve five priority objectives. Vaccine products and packaging are designed to meet the needs of developing countries. Immunization supply systems support efficient and effective vaccine delivery. The environmental impact of energy, materials, and processes used in immunization systems is minimized. Immunization information systems enable better and more timely decision-making. Competent and motivated personnel are empowered to handle immunization supply chain issues. Over the next decade, vaccine supply and logistics systems in nearly all developing countries will require significant investments of time and resources from global and national partners, donors, and governments. These investments are critical if we are to reach more people with current and newer vaccines.

Background In May 2019, Ghana piloted the introduction of RTS,S malaria vaccine into routine immunization in 42 districts of seven of the 16 regions. The RTS,S malaria vaccine implementation programme (MVIP) post-introduction evaluation (PIE) conducted in Ghana, assessed the immunization system as well as healthcare worker and caregiver experiences during the phase-one rollout but was less expressive on quantitative grading of the respective thematic areas of the vaccine introduction plan. Given the utility of summary statistics in programme evaluation and communication, this follow-up study aimed to provide an overall rating of the country's performance regarding the MVIP . Methods A retrospective study was conducted from 10th January to 5th February 2024. It involved review of records to assess key thematic areas of the national MVIP plan, using a study tool adapted from the WHO New Vaccine Introduction (NVI) checklist. A composite score ranging from zero to 100 per cent was generated to assess the country's overall performance regarding introduction of the malaria vaccine, rated on a Likert scale as comprehensive, good, fair, and poor. Results The overall performance in the MVIP was rated 78.9% (30/38) corresponding to a grading of “good” on the Likert scale. Performance indicators under thematic areas including policy, national coordination mechanisms, waste management, health worker training, and pharmacovigilance were completely achieved. However,  some weaknesses were exhibited in areas such as financial consideration, cold chain, logistics, and vaccine management, and monitoring and evaluation. Conclusion Ghana’s MVIP demonstrated remarkable strengths worth leveraging  to improve the national immunization programme. The weaknesses observed in some of the thematic areas present opportunities to engage key immunization partners and stakeholders towards aligning efforts to ensure a more robust expansion phase. The lessons from the MVIP may be relevant to areas introducing malaria vaccine irrespective of the product type—RTS,S or R21.

•“Integration” approaches in the context of HPV vaccination vary by setting.•Four African country experiences demonstrate common enablers and challenges.•HPV is integrated in these settings with other new and existing vaccines and/or with adolescent health services.•Based on these examples we propose a three-level framework for considering integration.•We call for greater, more precise consideration of integrated services. Primary prevention of human papillomavirus (HPV) infection is particularly important in Africa, where there is a high and accelerating burden of cervical cancer. Stakeholders have increasingly called for integration of other services with HPV vaccination in low- and middle-income countries, yet successful and sustainable integration requires intensive resource inputs, and few countries in Africa have tested integrated approaches. We describe co-author experience and previously published assessments to present the experiences of four African countries, Senegal, Togo, Tanzania, and Lesotho, with integrating HPV vaccine services with other programmes and services. The resulting case series explores how countries are operationalizing the concept of integration and describes contextual factors for success and sustainability. A simple three-level framework for describing HPV vaccine integrated service delivery has emerged to guide future endeavors.

•The majority of new vaccine cost projections have been conducted in high- and middle-income countries.•Most cost projections were part of a cost-effectiveness or cost-benefit analysis to assist decision-making on introducting a new vaccine.•Over half of the studies utilized secondary cost data, indicating the importance of improving accuracy of vaccine cost projection estimates.•Around half of studies underestimated delivery costs of introducing new vaccines since these left out introduction and operational costs. A recent review of guidance documents on vaccine delivery costing revealed current guidance on cost projections for new vaccine introduction has gaps on methods of sampling, data collection and analysis. In preparation for updating the respective guidance, this systematic review was undertaken to qualitatively assess methodologies used in new vaccine cost projection studies. This will inform researchers and stakeholders about the methods of new vaccine introduction cost projections for strategic directions in countries where cost data are not available. We systematically searched four search engines (PubMed, Cochrane Open Access, Mendeley and Google Scholar) for articles on cost projections for new vaccines published between 1999 and 15 June 2022. We developed inclusion and exclusion criteria for the selection of articles and analyzed the results using a PRISMA 2020 flow diagram. Out of 1,108 articles identified, 171 met the criteria for inclusion in the study. Half of the articles were from high-income countries (50%), and most cost projections were part of cost-effectiveness analysis (84%). The most common source of cost data was secondary national information (43%), followed by author’s assumptions (17%), secondary international information (14%), and primary data collection (7%). 19% of studies didn’t include costs to deliver vaccines in their cost estimation. Among studies that included secondary vaccine delivery costs, approximately half only calculated vaccine administration costs (50%), while 35% included incremental system costs and 15% utilized ingredients data. Two thirds of the studies were conducted to inform policymakers of the cost-effectiveness or cost-benefit of introducing the vaccine. Half of the economic evaluations on new vaccine introductions only included partial vaccine delivery costs. Thus, total costs of vaccine introduction were often being underestimated in economic evaluations. This suggests that guidelines on economic evaluations and journals should recommend that authors include more extensive vaccine delivery costs in their studies.

There has been increasing recognition of vaccine access challenges in middle-income countries and the need for increased action, particularly in countries that are not eligible for or have transitioned out of Gavi, the Vaccine Alliance support. These countries’ immunization systems are more vulnerable than ever as the COVID-19 pandemic exacerbates existing programme challenges, increasing the risk of delayed vaccine introductions, backsliding immunization coverage rates, and increased coverage inequity. The potential health and equity impact of improving immunization outcomes in middle-income countries is substantial. Modelling suggests that the introduction of pneumococcal conjugate vaccine and vaccines for rotavirus and human papillomavirus in this set of Gavi-transitioned and non-Gavieligible middle-income countries in 2020 could have saved an estimated 70,000 lives if 90 % coverage had been reached. Further, increasing coverage for already-introduced vaccines to 90 % could have saved an additional estimated 16,000 lives. Over the past decade, stakeholders have made considerable efforts to identify immunization challenges in middle-income countries as documented in the 2015 SAGE-endorsed Shared Partner Middle-Income Country Strategy. In the coming decade, new global platforms like Gavi 5.0 and the Immunization Agenda 2030 provide opportunities to align on MIC strategies and provide coordinated global support to middle-income countries. The international COVID-19 pandemic response has the potential to lay the foundation for long term support beyond the scope of COVID-19 to non-Gavi eligible middle-income countries. Meanwhile regional mechanisms to address immunization barriers in middle-income countries have grown in number and strength, offering sustainable platforms for cross-country collaboration and the provision of tailored technical support. To ensure that these opportunities are successfully acted upon and that middle-income countries achieve the Immunization Agenda 2030 goals, comprehensive, multi-stakeholder consultations were conducted to identify areas of action with the greatest potential to accelerate immunization progress. Stakeholders should work together to put these findings, highlighted in this paper, into action, adapting their approaches to specific country contexts and learning from and building on existing efforts.

Diarrhea is a leading cause of mortality worldwide and rotavirus accounts for many of these deaths. As of August 2018, 96 countries have introduced rotavirus vaccines into their immunization programs. Two rotavirus vaccines, Rotarix® and RotaTeq®, have been WHO-prequalified since 2009, with Rotarix® being the preferred product of most Gavi-supported countries. ROTAVAC® and ROTASIIL® have both been prequalified recently. We reevaluated the costs and cost-effectiveness of rotavirus vaccination in Bangladesh, Ghana, and Malawi and compared Rotarix®, ROTAVAC®, and ROTASIIL® in each country. For consistency with previously published analyses in these countries, we used the same Excel-based cohort model and much of the same data as the original analyses. We varied the expected price (with and without Gavi subsidy), wastage, and incremental health system costs associated with each vaccine. We assumed the same efficacy and waning assumptions following administration of two or three doses for the respective product. The discounted cost per DALY averted compared to no vaccination ranged from 0.3 to 1.3 times GNI per capita for each vaccine. With the Gavi subsidy, the average cost-effectiveness ratios were below 0.3 times GNI per capita in all three countries. Though critical empirical cost data are not yet available, Rotarix® is the least costly and most cost-effective product in the countries examined in this modelling study. However, small decreases in the incremental health system cost for other products could result in cost and cost-effectiveness outcomes that match or surpass those of Rotarix®. Countries may wish to consider new rotavirus vaccines entering the market. Countries should carefully examine multiple product attributes including price and the incremental health system costs associated with each vaccine. These costs will vary by country and may be a defining factor in determining the least costly and most cost-effective product for the population.

•An effective and affordable injectable rotavirus vaccine may be attractive to LMICs.•Co-administering oral and injectable vaccines is acceptable to many stakeholders.•Oral vaccine with a birth dose is favored over a higher cost, standalone injectable.•Providing rotavirus vaccine in a DTP combination is the most preferred option. Currently available live, oral rotavirus vaccines (LORVs) have significantly reduced severe rotavirus hospitalizations and deaths worldwide. However, LORVs are not as effective in low- and middle-income countries (LMIC) where rotavirus disease burden is highest. Next-generation rotavirus vaccine (NGRV) candidates in development may have a greater public health impact where they are needed most. The feasibility and acceptability of possible new rotavirus vaccines were explored as part of a larger public health value proposition for injectable NGRVs in LMICs. To assess national stakeholder preferences for currently available LORVs and hypothetical NGRVs and understand rationales and drivers for stated preferences. Interviews were conducted with 71 national stakeholders who influence vaccine policy and national programming. Stakeholders from Ghana, Kenya, Malawi, Peru, Senegal, and Sri Lanka were interviewed using a mixed-method guide. Vaccine preferences were elicited on seven vaccine comparisons involving LORVs and hypothetical NGRVs based on information presented comparing the vaccines’ attributes. Reasons for vaccine preference were elicited in open-ended questions, and the qualitative data were analyzed on key preference drivers. Nearly half of the national stakeholders interviewed preferred a highly effective standalone, injectable NGRV over current LORVs. When presented as having similar efficacy to the LORV, however, very few stakeholders preferred the injectable NGRV, even at substantially lower cost. Similarly, a highly effective standalone injectable NGRV was generally not favored over an equally effective oral NGRV following a neonatal-infant schedule, despite higher cost of the neonatal option. An NGRV-DTP-containing combination vaccine was strongly preferred over all other options, whether delivered alone with efficacy similar to current LORVs or co-administered alongside an LORV (LORV + NGRV-DTP) to increase efficacy. Results from these national stakeholder interviews provide valuable insights to inform ongoing and future NGRV research and development.