Ensuring vaccine potency and availability: how evidence shaped Gavi's Immunization Supply Chain Strategy.

BACKGROUND: In 2014, Gavi and partners developed a global Immunization Supply Chain (iSC) Strategy, 2015-2020, which prioritized functioning cold chain equipment (CCE) and additional storage capacity. In 2016, Gavi launched the Cold Chain Equipment Optimization Platform (CCEOP) as a funding mechanism to improve CCE availability. In 2018, Gavi commissioned an evaluation of CCEOP in Guinea, Kenya and Pakistan. The global iSC Strategy has recently been revised, drawing on findings from effective vaccine management assessments and practical experiences. This case study presents the CCEOP evaluation and how its findings reinforced the revision of the iSC strategy. METHODS: The CCEOP evaluation used a prospective mixed-methods research design in all three countries involving key informant interviews at multiple levels of the health system, document reviews, direct observation (as and when possible), and a health facility assessment. RESULTS: Results show that CCEOP was effective at increasing the number of available and reliable CCE, and establishing improved management processes using the project management team (PMT) approach for country management systems and the service bundle provider approach for installation and maintenance. CCEOP also extended the iSC and immunization services in countries. The evaluation results also show gaps in the overall supply chain system, including CCE maintenance. DISCUSSION: Gavi has recently revised its iSC strategy, which has addressed gaps identified through assessments and practical experiences from stakeholders. Results of the CCEOP evaluation reinforce many of these findings. The strategy now provides more emphasis on supporting the fundamental infrastructure and establishing strong processes for maintenance. It also emphasizes strategic planning and forward thinking for iSC decisions, building on the processes established for the PMT through CCEOP. The original iSC strategy was an impetus for the establishment of CCEOP. The new strategy reflects shifting trends and priorities to fill gaps identified through practical experience, advocated for by stakeholders and thought leaders engaged in the iSC, and validated by the evaluation. It demonstrates the importance of aligning stakeholders with clear objectives and a sound strategy.

Rapid diagnostic test supply chain and consumption study in Cabo Delgado, Mozambique: estimating stock shortages and identifying drivers of stock-outs.

BACKGROUND: Malaria rapid diagnostic tests (RDTs) are particularly useful in low-resource settings where follow-through on traditional laboratory diagnosis is challenging or lacking. The availability of these tests depends on supply chain processes within the distribution system. In Mozambique, stock-outs of malaria RDTs are fairly common at health facilities. A longitudinal cross-sectional study was conducted to evaluate drivers of stock shortages in the Cabo Delgado province. METHODS: Data were collected from purposively sampled health facilities, using monthly cross-sectional surveys between October 2011 and May 2012. Estimates of lost consumption (consumption not met due to stock-outs) served as the primary quantitative indicator of stock shortages. This is a better measure of the magnitude of stock-outs than binary indicators that only measure frequency of stock-outs at a given facility. Using a case study based methodology, distribution system characteristics were qualitatively analysed to examine causes of stock-outs at the provincial, district and health centre levels. RESULTS: 15 health facilities were surveyed over 120 time points. Stock-out patterns varied by data source; average monthly proportions of 59%, 17% and 17% of health centres reported a stock-out on stock cards, laboratory and pharmacy forms, respectively. Estimates of lost consumption percentage were significantly high; ranging from 0% to 149%; with a weighted average of 78%. Each ten-unit increase in monthly-observed consumption was associated with a nine-unit increase in lost consumption percentage indicating that higher rates of stock-outs occurred at higher levels of observed consumption. Causes of stock-outs included inaccurate tracking of lost consumption, insufficient sophistication in inventory management and replenishment, and poor process compliance by facility workers, all arguably stemming from inadequate attention to the design and implementation of the distribution system. CONCLUSIONS: Substantially high levels of RDT stock-outs were found in Cabo Delgado. Study findings point to a supply chain with a commendable degree of sophistication. However, insufficient attention paid to system design and implementation resulted in deteriorating performance in areas of increased need. In such settings fast moving commodities like malaria RDTs can call attention to supply chain vulnerabilities, the findings from which can be used to address other slower moving health commodities.

Optimizing immunization services: A Data Envelopment Analysis (DEA) of child immunization facilities in Pakistan.

INTRODUCTION: Child immunization, though cost-beneficial, experiences varying costs influenced by individual facility-level factors. A real-time solution is to optimize resources and enhance vaccination services through proper method to measure immunization facility efficiency using existing data. Additionally, examine the impact of COVID-19 on facility efficiency, with the primary goal of comprehensively assessing child immunization facility efficiency in Pakistan. METHODS: Utilizing survey data collected in four rounds from May 2018 to December 2020, the research focuses on doses administered and stock records for the preceding six months in each phase. In the initial stage, Data Envelopment Analysis (DEA) is utilized to compute facility efficiency, employing two models with varied outputs while maintaining consistent inputs. Model 1 assesses doses administered, encompassing three outputs (pentavalent vaccine 1, 2, and 3). Meanwhile, Model 2, focuses on stock used featuring a single output (total doses used). The inputs considered in both models include stock availability, staff members, cold chain equipment, vaccine carriers, and vaccine sessions. The second stage involves the application of two competing regression specifications (Tobit and Simar-Wilson) to explore the impact of the COVID-19 pandemic and external factors on the efficiency of these facilities. RESULTS: In 12 districts across Punjab and Sindh, we assess 466 facilities in Model 1 and 455 in Model 2. Model 1 shows 59% efficiency, and Model 2 shows 70%, indicating excess stock. Stock of vaccines need to be reduced by from 36% to 43%. In the stage, COVID-19 period reduced efficiency in Model 1 by 10%, however, insignificant in Model 2. CONCLUSIONS: The proposed methodology, utilizing DEA, emerges as a valuable tool for immunization facilities seeking to improve resource utilization and overall efficiency. Model 1, focusing on doses administered indicates facilities low efficiency at average 59% and proves more pertinent for efficiency analysis as it directly correlates with the number of children vaccinated. The prevalent issue of overstocking across all facilities significantly impacts efficiency. This study underscores the critical importance of optimizing resources through the redistribution of excess stock with low efficiency.

COVID-19 Vaccine Collaborative Supply Planning: Is This the Next Frontier for Routine Immunization Supply Chains?

In response to the COVID-19 pandemic, vaccine manufacturers quickly pivoted to develop vaccines, offering limited visibility into production timelines and quantities. Low- and middle-income countries developed vaccine introduction plans within the context of constrained global supply, unknown vaccine availability or timelines, and unknown demand. The Vaccine Collaborative Supply Planning (VCSP) Initiative was established to address the gaps in visibility of supply and demand of COVID-19 vaccines for improved supply planning. The Initiative drew from experiences with supply planning for other health program products. The Initiative's 2 goals for introducing COVID-19 vaccines were to: (1) incorporate the use of supply chain data for forecasting, supply planning, and resupply decisions; and (2) establish a collaborative model for governments and partners to learn and implement. Beginning in September 2021, the Initiative was operational in 15 countries through strategic partnerships with government immunization programs and 7 partnering organizations. Partners noted the Initiative offered several benefits: enabled visibility into stock status; provided ability to triangulate service delivery and stock data; provided insight into products at risk of expiry; facilitated tracking of monthly consumption patterns to inform decisions; offered ability to create forecasting scenarios; provided support to national logistics working groups; improved coordination at the country level; created trust through transparency across global partners; and offered opportunity for real-time adjustments through adaptive learning. Partners also noted challenges, including the influence of political decisions and the availability of quality data. The Initiative successfully applied best practices for supply planning, established a collaborative model with government decision-makers and partners, and used an adaptive learning approach to respond to the challenges of rolling out the COVID-19 vaccine. Lessons learned and recommendations suggest how this approach can be used to strengthen forecasting and supply planning for all vaccines as the COVID-19 vaccine is integrated into routine services.

Thinking outside of the [cold] box: implementing a human-centered design approach to understand barriers and craft solutions to cold chain equipment maintenance in Niger.

BACKGROUND: Vaccines require cold chain equipment (CCE) to ensure quality and potency, yet the risk of CCE failing is well-documented, often due to lack of equipment maintenance. While general barriers to a reliable CCE maintenance system are known, little has been done to understand the barriers from the cold chain technician's perspective. This human-centered design (HCD) study in Niger sought to better understand the gap in the current maintenance approaches from the technicians' perspectives and to collaboratively identify forward-thinking solutions. METHODS: The research team collected data through semi-structured and open-ended in-depth consultations. Rapid qualitative research was followed by co-creation workshops with study participants to identify solutions. RESULTS: The research team conducted 20 in-depth consultations in two regions with participants directly involved in the management of the cold chain. Fourteen people participated in the online co-creation workshop, and 20 people participated in the in-person workshop. Insights were organized in three main areas: (1) the lack of system agility and ability to optimize resources constrain performance of the maintenance system; (2) cold chain is often an afterthought within the overall context of immunization services and should instead be prioritized; and (3) knowledge sharing across the system and key stakeholders is ad hoc with limited understanding of roles and responsibilities. During the co-creation workshop, participants identified four main concepts as potential solutions: (1) create an on-line platform to connect people and to share knowledge across regions; (2) develop practical CCE technical resources; (3) use gamification and friendly competition to motivate staff to value maintenance; and (4) create a real-time maintenance tracking system. DISCUSSION: This study took a unique HCD approach to engage people directly involved in CCE maintenance to more deeply understand challenges with the current system and create space to identify innovative solutions that are tailored to the context. The results demonstrate that stakeholders can identify potential solutions that have not been part of the typical approaches to a maintenance system. This HCD approach has implications for all global health challenges and demonstrates a methodology that can encourage key stakeholders to think about problems and solutions differently.

Uncovering the Drivers of Childhood Immunization Inequality with Caregivers, Community Members and Health System Stakeholders: Results from a Human-Centered Design Study in DRC, Mozambique and Nigeria.

BACKGROUND: The importance of immunization for child survival underscores the need to eliminate immunization inequalities. Few existing studies of inequalities use approaches that view the challenges and potential solutions from the perspective of caregivers. This study aimed to identify barriers and context-appropriate solutions by engaging deeply with caregivers, community members, health workers, and other health system actors through participatory action research, intersectionality, and human-centered design lenses. METHODS: This study was conducted in the Demographic Republic of Congo, Mozambique and Nigeria. Rapid qualitative research was followed by co-creation workshops with study participants to identify solutions. We analyzed the data using the UNICEF Journey to Health and Immunization Framework. RESULTS: Caregivers of zero-dose and under-immunized children faced multiple intersecting and interacting barriers related to gender, poverty, geographic access, and service experience. Immunization programs were not aligned with needs of the most vulnerable due to the sub-optimal implementation of pro-equity strategies, such as outreach vaccination. Caregivers and communities identified feasible solutions through co-creation workshops and this approach should be used whenever possible to inform local planning. CONCLUSIONS: Policymakers and managers can integrate HCD and intersectionality mindsets into existing planning and assessment processes, and focus on overcoming root causes of sub-optimal implementation.

Early Lessons From Ethiopia in Establishing a Data Triangulation Process to Analyze Immunization Program and Supply Data for Decision Making.

Strengthening data use and quality is critical to achieving high, equitable immunization coverage. One approach that is being increasingly recognized as effective in improving data use and quality is data triangulation, which can provide more information for decision making in public health programs.In Ethiopia, immunization program data has had ongoing quality challenges, including timeliness, completeness, and accuracy. Some data are reported through different systems to different departments, and coordination between departments is limited.JSI, through the Universal Immunization through Improving Family Health Services (UI-FHS) project, introduced a data review process and an Excel tool for triangulating immunization program data and vaccine supply data to improve data quality and programmatic decision making. The user-friendly Immunization Data Triangulation Tool (IDTT) provides decision-support information-such as scoring of districts based on performance-and suggests follow-up actions. It also highlights gaps between vaccines supplied and consumed and helps managers determine the next steps to address programmatic, supply, or data quality issues.The data review process and IDTT were rolled out in 2 regions in Ethiopia. UI-FHS documented learning to understand the feasibility of the IDTT's application as a decision-making tool by conducting key informant interviews and observing how the IDTT was used at monthly data review meetings.Health managers who used the tool reported ease of use and clear benefits, including more accessible and synthesized data, which prompted decision making and actions to improve services and supply, such as expanding the number of immunization sites. Challenges with the availability of vaccine supply data hindered managers' ability to leverage triangulated data fully, but the data triangulation process prompted cross-departmental collaboration to address this gap.These early findings show promise in the ability of immunization programs to successfully use triangulated data to address challenges and provide lessons for introducing new tools or processes into health systems.

A Tale of 2 Countries: Implementation of the Cold Chain Equipment Optimization Platform in Guinea and Kenya.

In 2016, the Gavi Cold Chain Equipment Optimization Platform (CCEOP) was approved and launched in recognition of the fact that functional cold chain equipment (CCE) is essential to strengthening vaccine supply chains and ultimately achieving Gavi's immunization equity and coverage goals. Through CCEOP, Gavi committed to investing US$250 million between 2016 and 2021 to commission CCE in more than 63,000 facilities to upgrade and expand their CCE footprint while stimulating the market to provide affordable, technologically advanced, and accessible equipment. We present case studies from Guinea and Kenya, both of which received CCEOP support, that highlight 2 ways for countries to prioritize investments and implement activities through a large funding and support mechanism. The studies explore the different ways that each country implemented CCEOP and consider how aspects of leadership and technical capacity influence country priorities and results. They also uncover key lessons on sustainability of a large immunization supply chain effort. The experiences of Guinea and Kenya can help other countries embarking on similarly large health system interventions, especially related to supply chain strengthening and immunization programs. In particular, these experiences offer important lessons in leadership, processes and systems, country ownership, technical capacity, and sustainability.

Designing supply chains to meet the growing need of vaccines: evidence from four countries.

BACKGROUND: Immunization supply chains (iSCs) move vaccines from manufacturer to point of use with the added complexities of requiring cold chain and an increasing need for agility and efficiency to ensure vaccine quality and availability. Underperforming iSCs have been widely acknowledged as a key constraint to achieving high immunization coverage rates in low- and middle-income countries. This paper details the system design approach used to analyze the iSC network in Sierra Leone, Madagascar, Niger and Guinea and documents six lessons. METHODOLOGY: Between 2018 and 2020, these countries implemented the system design approach, involving four key steps: (1) advocate and introduce to engage stakeholders and prioritize identification of modeling scenarios; (2) collect data and plan analysis through document review and key informant interviews; (3) analyze system design scenarios using computer software modeling tools (LLamasoft's Supply Chain Guru and AnyLogic's AnyLogistix) for optimization and simulation modeling as well as further analysis with Excel, Google maps, and OpenStreetMap; and (4) build consensus on optimized model and implementation roadmap using the Traffic Light Analysis tool and building on stakeholder input. FINDINGS: Key lessons include the following: (1) define system design objectives based on country priorities; (2) establish consensus with stakeholders on scenarios to model; (3) modeling provides the evidence but not the answer; (4) costs should not be weighted above other decision criteria; (5) data collection-work smarter, not harder; (6) not all questions can be answered with a computer model. DISCUSSION: A system design approach can identify changes to the design of the supply chain that can introduce efficiencies and improve reliability. This approach can be more effective when these lessons and principles are applied at the country level. The lessons from these four countries contribute to global thinking and best practices related to system design. The modeling and system design approach provides illustrative results to guide decision-makers. It does not give a "final answer", but compares and contrasts.

Redesigning immunization supply chains: Results from three country analyses.

INTRODUCTION: Immunization supply chains (iSC) are essential for ensuring access to vaccines that prevent diseases. Guinea, Madagascar, and Niger initiated iSC system design efforts to conduct analysis of alternative supply chain scenarios to identify areas for improvement. METHODOLOGY: Key stakeholders from Ministries of Health and immunization programs identified bottlenecks in the current iSC and prioritized five general design scenarios to model in each country. Scenarios included aspects of integration, changing supply chain levels and delivery frequency, ignoring administrative boundaries, and direct delivery. Primary and secondary data were collected and cleaned. Analysis was completed using Supply Chain Guru (Madagascar and Niger) and AnyLogistix (Guinea) modeling software to build a virtual representation of the iSC physical components and operating policies. RESULTS: Modeling results were compared using both quantitative and qualitative criteria (total operating costs, cost per dose, cold chain capacity, risk of mishandling, logistics burden on healthcare workers, feasibility to implement, and equity). Using a Stop Light Analysis for user-friendly understanding of positive, negative or minimal impact on scenarios, cost savings were realized in most scenarios in Madagascar (except using autonomous aerial vehicles); proposed scenarios in Guinea increased costs or had minimal impact; in Niger, eliminating regional tiers reduced costs. Facility level cold chain was sufficient in all countries. Effect on qualitative indicators largely depended on the scenario and country context. DISCUSSION: Similarities in scenarios selected were seen across the three countries. Results suggest that efficiencies can be found through changes to the iSC design, but the benefits of each scenario must be considered in the country context. Results of the analysis do not provide "the right answer" but rather options and guidance which then must be grounded in the country context and used as evidence for decision making to ensure reliable availability of vaccines.

The effects of switching from 10 to 5-dose vials of MR vaccine on vaccination coverage and wastage: A mixed-method study in Zambia.

INTRODUCTION: Vaccines procured for low-income countries are often packaged in multi-dose vials to reduce program costs. To avoid wastage, health workers may refrain from opening a vial if few children attend an immunization session, possibly leading to lower coverage. Lowering the number of doses in a vial may increase coverage and reduce wastage. METHODS: We used a mixed methods approach to measure the effects of switching from conventional 10-dose measles containing vaccine (MCV) vials to 5-dose MCV vials on coverage and open vial wastage in 14 districts purposely selected from two provinces in Zambia. The districts were paired based on the number of health facilities and the average size of the health facility catchment population. One district from each pair was randomly allocated to receive 5-dose vials while the other continued with the conventional vials. We applied propensity score matched difference-in-difference analysis to estimate intervention effects on coverage using pre-intervention household survey and post-intervention household survey after 11 months of the intervention. The intervention effects on wastage rates were estimated from multivariate analysis of the administrative data. Key informant interviews were conducted to better understand health workers' behavior and preferences at baseline, midline and endline, and analyzed using thematic analysis techniques. RESULTS: MCV coverage rates increased across both arms for both doses. A five percentage-point intervention effect was detected for MCV1 and 3.5 percentage-point effect for MCV2. The MCV wastage rate was 47% lower in facilities using 5-dose vials (16.2%) versus 10-dose vials (30.5%). Healthcare workers reported being more willing to open a 5-dose vial than a 10-dose vial for one child, as they were less concerned about wastage. DISCUSSION: Switching 10-dose MCV vials to 5-dose vials improved coverage, decreased wastage, and improved willingness to open a vial. These findings can contribute to strategies for reducing missed opportunities for vaccination.

The value of tailoring vial sizes to populations and locations.

BACKGROUND: Frequently, a country will procure a single vaccine vial size, but the question remains whether tailoring the use of different size vaccine vial presentations based on populations or location characteristics within a single country could provide additional benefits, such as reducing open vial wastage (OVW) or reducing missed vaccination opportunities. METHODS: Using the Highly Extensible Resource for Modeling Supply Chains (HERMES) software, we built a simulation model of the Zambia routine vaccine supply chain. At baseline, we distributed 10-dose Measles-Rubella (MR) vials to all locations, and then distributed 5-dose and 1-dose MR vials to (1) all locations, (2) rural districts, (3) rural health facilities, (4) outreach sites, and (5) locations with average MR session sizes <5 and <10 children. We ran sensitivity on each scenario using MR vial opening thresholds of 0% and 50%, i.e. a healthcare worker opens an MR vaccine for any number of children (0%) or if at least half will be used (50%). RESULTS: Replacing 10-dose MR with 5-dose MR vials everywhere led to the largest reduction in MR OVW, saving 573,892 doses (103,161 doses with the 50% vial opening threshold) and improving MR availability by 1% (9%). This scenario, however, increased cold chain utilization and led to a 1% decrease in availability of other vaccines. Tailoring 5-dose MR vials to rural health facilities or based on average session size reduced cold transport constraints, increased total vaccine availability (+1%) and reduced total cost per dose administered (-$0.01) compared to baseline. CONCLUSIONS: In Zambia, tailoring 5-dose MR vials to rural health facilities or by average session size results in the highest total vaccine availability compared to all other scenarios (regardless of OVT policy) by reducing open vial wastage without increasing cold chain utilization.

System redesign of the immunization supply chain: Experiences from Benin and Mozambique.

INTRODUCTION: Evidence suggests that immunization supply chains are becoming outdated and unable to deliver needed vaccines due to growing populations and new vaccine introductions. Redesigning a supply chain could result in meeting current demands. METHODS: The Ministries of Health in Benin in Mozambique recognized known barriers to the immunization supply chain and undertook a system redesign to address those barriers. Changes were made to introduce an informed push system while consolidating storage points, introducing transport loops, and increasing human resource capacity for distribution. Evaluations were completed in each country. RESULTS: Evaluation in each country indicated improved performance of the supply chain. The Effective Vaccine Management (EVM) assessment in Benin documented notable improvements in the distribution criteria of the tool, increasing from 40% to 100% at the district level. In Mozambique, results showed reduced stockouts at health facility level from 79% at baseline to less than 1% at endline. Coverage rates of DTP3 also increased from 68.9% to 92.8%. DISCUSSION: Benin and Mozambique are undertaking system redesign in order to respond to constraints identified in the vaccine supply chain. Results and learnings show improvements in supply chain performance and make a strong case for system redesign. These countries demonstrate the feasibility of system redesign for other countries considering how to address outdated supply chains.

Re-designing the Mozambique vaccine supply chain to improve access to vaccines.

INTRODUCTION: Populations and routine childhood vaccine regimens have changed substantially since supply chains were designed in the 1980s, and introducing new vaccines during the "Decade of Vaccine" may exacerbate existing bottlenecks, further inhibiting the flow of all vaccines. METHODS: Working with the Mozambique Ministry of Health, our team implemented a new process that integrated HERMES computational simulation modeling and on-the-ground implementers to evaluate and improve the Mozambique vaccine supply chain using a system-re-design that integrated new supply chain structures, information technology, equipment, personnel, and policies. RESULTS: The alternative system design raised vaccine availability (from 66% to 93% in Gaza; from 76% to 84% in Cabo Delgado) and reduced the logistics cost per dose administered (from $0.53 to $0.32 in Gaza; from $0.38 to $0.24 in Cabo Delgado) as compared to the multi-tiered system under the current EPI. The alternative system also produced higher availability at lower costs after new vaccine introductions. Since reviewing scenarios modeling deliveries every two months in the north of Gaza, the provincial directorate has decided to pilot this approach diverging from decades of policies dictating monthly deliveries. DISCUSSION: Re-design improved not only supply chain efficacy but also efficiency, important since resources to deliver vaccines are limited. The Mozambique experience and process can serve as a model for other countries during the Decade of Vaccines. For the Decade of Vaccines, getting vaccines at affordable prices to the market is not enough. Vaccines must reach the population to be successful.

Knowledge, beliefs, and practices regarding exclusive breastfeeding of infants younger than 6 months in Mozambique: a qualitative study.

Only 37% of infants younger than 6 months in Mozambique are exclusively breastfed. A qualitative assessment was undertaken to identify the knowledge, beliefs, and practices around exclusive breastfeeding--specifically, those of mothers, fathers, grandmothers, and nurses--and to identify the support networks. Results show many barriers. In addition to receiving breast milk, infants receive water, traditional medicines, and porridges before 6 months of age. Many mothers had heard of the recommendation to exclusively breastfeed for 6 months. However, other family decision makers had heard less about exclusive breastfeeding, and many expressed doubts about its feasibility. Some of them expressed willingness to support exclusive breastfeeding if they were informed by health workers. Nurses know the benefits of exclusive breastfeeding and pass this information on verbally but have insufficient counseling skills. Interventions to improve exclusive breastfeeding should target family and community members and include training of health workers in counseling to resolve breastfeeding problems.