Systematic review of cost projections of new vaccine introduction.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Cost-effectiveness of measles and rubella elimination in low-income and middle-income countries.

BACKGROUND: Since 2000, the incidence of measles and rubella has declined as measles-rubella (MR) vaccine coverage increased due to intensified routine immunisation (RI) and supplementary immunisation activities (SIAs). The World Health Assembly commissioned a feasibility assessment of eliminating measles and rubella. The objective of this paper is to present the findings of cost-effectiveness analysis (CEA) of ramping up MR vaccination with a goal of eliminating transmission in every country. METHODS: We used projections of impact of routine and SIAs during 2018-2047 for four scenarios of ramping up MR vaccination. These were combined with economic parameters to estimate costs and disability-adjusted life years averted under each scenario. Data from the literature were used for estimating the cost of increasing routine coverage, timing of SIAs and introduction of rubella vaccine in countries. RESULTS: The CEA showed that all three scenarios with ramping up coverage above the current trend were more cost-effective in most countries than the 2018 trend for both measles and rubella. When the measles and rubella scenarios were compared with each other, the most cost-effective scenario was likely to be the most accelerated one. Even though this scenario is costlier, it averts more cases and deaths and substantially reduces the cost of treatment. CONCLUSIONS: The Intensified Investment scenario is likely the most cost-effective of the vaccination scenarios evaluated for reaching both measles and rubella disease elimination. Some data gaps on costs of increasing coverage were identified and future efforts should focus on filling these gaps.

Cost of introducing and delivering malaria vaccine (RTS,S/AS01E) in areas of seasonal malaria transmission, Mali and Burkina Faso.

BACKGROUND: The WHO recommends use of the RTS,S/AS01E (RTS,S) malaria vaccine for young children living in areas of moderate to high Plasmodium falciparum malaria transmission and suggests countries consider seasonal vaccination in areas with highly seasonal malaria. Seasonal vaccination is uncommon and may require adaptations with potential cost consequences. This study prospectively estimates cost of seasonal malaria vaccine delivery in Mali and Burkina Faso. METHODS: Three scenarios for seasonal vaccine delivery are costed (1) mass campaign only, (2) routine Expanded Programme on Immunisation (EPI) and (3) mixed delivery (mass campaign and routine EPI)), from the government's perspective. Resource use data are informed by previous new vaccine introductions, supplemented with primary data from a sample of health facilities and administrative units. FINDINGS: At an assumed vaccine price of US $5 per dose, the economic cost per dose administered ranges between $7.73 and $8.68 (mass campaign), $7.04 and $7.38 (routine EPI) and $7.26 and $7.93 (mixed delivery). Excluding commodities, the cost ranges between $1.17 and $2.12 (mass campaign), $0.48 and $0.82 (routine EPI) and $0.70 and $1.37 (mixed delivery). The financial non-commodity cost per dose administered ranges between $0.99 and $1.99 (mass campaign), $0.39 and $0.76 (routine EPI) and $0.58 and $1.28 (mixed delivery). Excluding commodity costs, service delivery is the main cost driver under the mass campaign scenario, accounting for 36% to 55% of the financial cost. Service delivery accounts for 2%-8% and 12%-23% of the total financial cost under routine EPI and mixed delivery scenarios, respectively. CONCLUSION: Vaccine delivery using the mass campaign approach is most costly followed by mixed delivery and routine EPI delivery approaches, in both countries. Our cost estimates provide useful insights for decisions regarding delivery approaches, as countries plan the malaria vaccine rollout.

Cost of introducing and delivering RTS,S/AS01 malaria vaccine within the malaria vaccine implementation program.

BACKGROUND: The World Health Organization (WHO) recommended widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children residing in regions of moderate to high malaria transmission. This recommendation is informed by RTS,S evidence, including findings from the pilot rollout of the vaccine in Ghana, Kenya, and Malawi. This study estimates the incremental costs of introducing and delivering the malaria vaccine within routine immunization programs in the context of malaria vaccine pilot introduction, to help inform decision-making. METHODS: An activity-based, retrospective costing was conducted from the governments' perspective. Vaccine introduction and delivery costs supported by the donors during the pilot introduction were attributed as costs to the governments under routine implementation. Detailed resource use data were extracted from the pilot program expenditure and activity reports for 2019-2021. Primary data from representative health facilities were collected to inform recurrent operational and service delivery costs.Costs were categorized as introduction or recurrent costs. Both financial and economic costs were estimated and reported in 2020 USD. The cost of donated vaccine doses was evaluated at $2, $5 and $10 per dose and included in the economic cost estimates. Financial costs include the procurement add on costs for the donated vaccines and immunization supplies, along with other direct expenses. FINDINGS: At a vaccine price of $5 per dose, the incremental cost per dose administered across countries ranges from $2.30 to $3.01 (financial), and $8.28 to $10.29 (economic). The non-vaccine cost of delivery ranges between $1.04 and $2.46 (financial) and $1.52 and $4.62 (economic), by country. Considering only recurrent costs, the non-vaccine cost of delivery per dose ranges between $0.29 and $0.89 (financial) and $0.59 and $2.29 (economic), by country. Introduction costs constitute between 33% and 71% of total financial costs. Commodity and procurement add-on costs are the main cost drivers of total cost across countries. Incremental resource needs for implementation are dependent on country's baseline immunization program capacity constraints. INTERPRETATION: The financial costs of introducing RTS,S are comparable with costs of introducing other new vaccines. Country resource requirements for malaria vaccine introduction are most influenced by vaccine price and potential donor funding for vaccine purchases and introduction support.

Costs of delivering human papillomavirus vaccination using a one- or two-dose strategy in Tanzania.

OBJECTIVE: As part of the Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls (DoRIS; NCT02834637), the current study is one of the first to evaluate the financial and economic costs of the national rollout of an HPV vaccination program in school-aged girls in sub-Saharan Africa and the potential costs associated with a single dose HPV vaccine program, given recent evidence suggesting that a single dose may be as efficacious as a two-dose regimen. METHODS: The World Health Organization's (WHO) Cervical Cancer Prevention and Control Costing (C4P) micro-costing tool was used to estimate the total financial and economic costs of the national vaccination program from the perspective of the Tanzanian government. Cost data were collected in 2019 via surveys, workshops, and interviews with local stakeholders for vaccines and injection supplies, microplanning, training, sensitization, service delivery, supervision, and cold chain. The cost per two-dose and one-dose fully immunized girl (FIG) was calculated. RESULTS: The total financial and economic costs were US$10,117,455 and US$45,683,204, respectively, at a financial cost of $5.17 per two-dose FIG, and an economic cost of $23.34 per FIG. Vaccine and vaccine-related costs comprised the largest proportion of costs, followed by service delivery. In a one-dose scenario, the cost per FIG reduced to $2.51 (financial) and $12.18 (economic), with the largest reductions in vaccine and injection supply costs, and service delivery. CONCLUSIONS: The overall cost of Tanzania's HPV vaccination program was lower per vaccinee than costs estimated from previous demonstration projects in the region, especially in a single-dose scenario. Given the WHO Strategic Advisory Group of Experts on Immunization's recent recommendation to update dosing schedules to either one or two doses of the HPV vaccine, these data provide important baseline data for Tanzania and may serve as a guide for improving coverage going forward. The findings may also aid in the prioritization of funding for countries that have not yet added HPV vaccines to their routine immunizations.

Comprehensive approach to costing cervical cancer prevention and control: a case study in the United Republic of Tanzania using the Cervical Cancer Prevention and Control Costing (C4P) tool.

BACKGROUND: The World Health Organization (WHO) has developed a costing tool, the Cervical Cancer Prevention and Control Costing (C4P) tool, to estimate the comprehensive cost of cervical cancer primary, secondary and tertiary prevention in low- and middle-income countries. The tool was piloted in the United Republic of Tanzania, a country with a high incidence of cervical cancer with 62.5 cases per 100,000 women in 2020. This paper presents the costing tool methods as well as the results from the pilot in Tanzania. METHODS: The C4P tool estimates the incremental costs of cervical cancer prevention and control programmes. It estimates the financial (monetary costs to the government) and economic costs (opportunity costs). For the pilot, the study team collected data on costs and programme assumptions for human papillomavirus (HPV) vaccination of 14-year-old girls and scaling up of cervical cancer screening (visual inspection with acetic acid and HPV-DNA testing) and treatment for women for 2020-2024. Assumptions were made on how vaccination coverage would increase over the 5 years as well as developing additional screening and treatment capacity through health personnel training and infrastructure strengthening. RESULTS: The total financial and economic costs of the comprehensive programme during 2020-2024 are projected to be US$68 million and US$124 million, respectively. The financial and economic costs of a fully immunized girl with HPV vaccine are estimated to be US$6.68 and US$17.31, respectively, while the costs per woman screened for cervical cancer are, on average, US$4.02 and US$5.83, respectively; US$6.44 and US$9.37 for pre-cancer treatment, respectively; and US$101 and US$107 for diagnosis of invasive cancer, respectively. The cost of treating and managing invasive cancer range from US$7.05 and US$7.83 for outpatient palliative care to US$800.21 and US$893.80 for radiotherapy, respectively. CONCLUSIONS: The C4P costing tool can assist national cervical cancer programmes to estimate monetary resources needed as well as opportunity costs of reducing national cervical cancer incidence through primary, secondary and tertiary prevention.

WHO-led consensus statement on vaccine delivery costing: process, methods, and findings.

BACKGROUND: Differences in definitions and methodological approaches have hindered comparison and synthesis of economic evaluation results across multiple health domains, including immunization. At the request of the World Health Organization's (WHO) Immunization and Vaccines-related Implementation Research Advisory Committee (IVIR-AC), WHO convened an ad hoc Vaccine Delivery Costing Working Group, comprising experts from eight organizations working in immunization costing, to address a lack of standardization and gaps in definitions and methodological guidance. The aim of the Working Group was to develop a consensus statement harmonizing terminology and principles and to formulate recommendations for vaccine delivery costing for decision making. This paper discusses the process, findings of the review, and recommendations in the Consensus Statement. METHODS: The Working Group conducted several interviews, teleconferences, and one in-person meeting to identify groups working in vaccine delivery costing as well as existing guidance documents and costing tools, focusing on those for low- and middle-income country settings. They then reviewed the costing aims, perspectives, terms, methods, and principles in these documents. Consensus statement principles were drafted to align with the Global Health Cost Consortium costing guide as an agreed normative reference, and consensus definitions were drafted to reflect the predominant view across the documents reviewed. RESULTS: The Working Group identified four major workstreams on vaccine delivery costing as well as nine guidance documents and eleven costing tools for immunization costing. They found that some terms and principles were commonly defined while others were specific to individual workstreams. Based on these findings and extensive consultation, recommendations to harmonize differences in terminology and principles were made. CONCLUSIONS: Use of standardized principles and definitions outlined in the Consensus Statement within the immunization delivery costing community of practice can facilitate interpretation of economic evidence by global, regional, and national decision makers. Improving methodological alignment and clarity in program costing of health services such as immunization is important to support evidence-based policies and optimal resource allocation. On the other hand, this review and Consensus Statement development process revealed the limitations of our ability to harmonize given that study designs will vary depending upon the policy question that is being addressed and the country context.

Costing electronic private sector malaria surveillance in the Greater Mekong Subregion.

BACKGROUND: Private sector malaria programmes contribute to government-led malaria elimination strategies in Cambodia, Lao PDR, and Myanmar by increasing access to quality malaria services and surveillance data. However, reporting from private sector providers remains suboptimal in many settings. To support surveillance strengthening for elimination, a key programme strategy is to introduce electronic surveillance tools and systems to integrate private sector data with national systems, and enhance the use of data for decision-making. During 2013-2017, an electronic surveillance system based on open source software, District Health Information System 2 (DHIS2), was implemented as part of a private sector malaria case management and surveillance programme. The electronic surveillance system covered 16,000 private providers in Myanmar (electronic reporting conducted by 200 field officers with tablets), 710 in Cambodia (585 providers reporting through mobile app), and 432 in Laos (250 providers reporting through mobile app). METHODS: The purpose of the study was to document the costs of introducing electronic surveillance systems and mobile reporting solutions in Cambodia, Lao PDR, and Myanmar, comparing the cost in different operational settings, the cost of introduction and maintenance over time, and assessing the affordability and financial sustainability of electronic surveillance. The data collection methods included extracting data from PSI's financial and operational records, collecting data on prices and quantities of resources used, and interviewing key informants in each setting. The costing study used an ingredients-based approach and estimated both financial and economic costs. RESULTS: Annual economic costs of electronic surveillance systems were $152,805 in Laos, $263,224 in Cambodia, and $1,310,912 in Myanmar. The annual economic cost per private provider surveilled was $82 in Myanmar, $371 in Cambodia, and $354 in Laos. Cost drivers varied depending on operational settings and number of private sector outlets covered in each country; whether purchased or personal mobile devices were used; and whether electronic (mobile) reporting was introduced at provider level or among field officers who support multiple providers for case reporting. CONCLUSION: The study found that electronic surveillance comprises about 0.5-1.5% of national malaria strategic plan cost and 7-21% of surveillance budgets and deemed to be affordable and financially sustainable.

Correction: Costs of continuing RTS,S/ASO1E malaria vaccination in the three malaria vaccine pilot implementation countries.

[This corrects the article DOI: 10.1371/journal.pone.0244995.].

Costs of continuing RTS,S/ASO1E malaria vaccination in the three malaria vaccine pilot implementation countries.

BACKGROUND: The RTS,S/ASO1E malaria vaccine is being piloted in three countries-Ghana, Kenya, and Malawi-as part of a coordinated evaluation led by the World Health Organization, with support from global partners. This study estimates the costs of continuing malaria vaccination upon completion of the pilot evaluation to inform decision-making and planning around potential further use of the vaccine in pilot areas. METHODS: We used an activity-based costing approach to estimate the incremental costs of continuing to deliver four doses of RTS,S/ASO1E through the existing Expanded Program on Immunization platform, from each government's perspective. The RTS,S/ASO1E pilot introduction plans were reviewed and adapted to identify activities for costing. Key informant interviews with representatives from Ministries of Health (MOH) were conducted to inform the activities, resource requirements, and assumptions that, in turn, inform the analysis. Both financial and economic costs per dose, cost of delivery per dose, and cost per fully vaccinated child (FVC) are estimated and reported in 2017 USD units. RESULTS: At a vaccine price of $5 per dose and assuming the vaccine is donor-funded, our estimated incremental financial costs range from $1.70 (Kenya) to $2.44 (Malawi) per dose, $0.23 (Malawi) to $0.71 (Kenya) per dose delivered (excluding procurement add-on costs), and $11.50 (Ghana) to $13.69 (Malawi) per FVC. Estimates of economic costs per dose are between three and five times higher than financial costs. Variations in activities used for costing, procurement add-on costs, unit costs of per diems, and allowances contributed to differences in cost estimates across countries. CONCLUSION: Cost estimates in this analysis are meant to inform country decision-makers as they face the question of whether to continue malaria vaccination, should the intervention receive a positive recommendation for broader use. Additionally, important cost drivers for vaccine delivery are highlighted, some of which might be influenced by global and country-specific financing and existing procurement mechanisms. This analysis also adds to the evidence available on vaccine delivery costs for products delivered outside the standard immunization schedule.

Costing oral cholera vaccine delivery using a generic oral cholera vaccine delivery planning and costing tool (CholTool).

Cholera is both an endemic and epidemic disease in many low and middle-income countries (LMICs). Strategies for cholera control include improving water, sanitation, and hygiene; providing early and effective treatment; and deploying oral cholera vaccine (OCV). This last strategy is relatively new, and countries considering its introduction are interested in knowing the potential cost not only of the vaccine, but also the cost of introduction. This paper describes the costing of OCV introduction in LMICs using a publicly available Excel-based tool known as the CholTool. It includes estimates of delivery cost categories which cover not only the service delivery costs (e.g. vaccine procurement, handling, storage, and transport; vaccination administration, monitoring supervision, and field support), but also the programmatic costs associated with introducing a new vaccine (i.e. microplanning, communication and training materials development, sensitization/social mobilization, and personnel training) to ensure that a comprehensive estimate is provided with health payer perspective. CholTool takes the user through a structured sequence of interlinked modules containing input parameter cells (assumptions), decision cells (variable selections), and formulas (calculations) to produce customized cost estimates based on standardized methods. The tool provides both financial and economic cost estimates, to ensure that both costs are available for consideration. Four examples of applications of CholTool are presented in three countries- one in Ethiopia, two in Malawi and one in Nepal. The estimates of economic delivery cost per dose (including service delivery and programmatic costs) were (in USD 2016): $2.89 in Ethiopia, $3.04 in Malawi1, $3.35 in Malawi2 and $3.06 in Nepal. A cost projection conducted before the campaign using the tool and a retrospective costing using the tool in Nepal resulted in no significant difference between economic delivery costs per dose.

A cost-effectiveness analysis of traditional and geographic information system-supported microplanning approaches for routine immunization program management in northern Nigeria.

Effective RI microplanning requires accurate population estimates and maps showing health facilities and locations of villages and target populations. Traditional microplanning relies on census figures to project target populations and on community estimates of distances, while GIS microplanning uses satellite imagery to estimate target populations and spatial analyses to estimate distances. This paper estimates the cost-effectiveness of geographical information systems (GIS)-based microplanning for routine immunization (RI) programming in two states in northern Nigeria. For our cost-effectiveness analysis, we captured the cost of all inputs for both approaches to capture the incremental cost of GIS over traditional microplanning and present the incremental cost-effectiveness ratios for each vaccine-preventable illness, death, and disability-adjusted life year (DALY) averted. We considered two scenarios for estimating vaccine requirements for each microplanning approach, one based on administrative vaccination coverage rates and one based on National Nutrition and Health Survey rates. With the administrative rates, GIS microplanning projected approximately 194,000 and 157,000 more required vaccinations than traditional microplanning in Bauchi and Sokoto States; with the survey rates, the additional number of vaccinations required was nearly 113,000 in Bauchi and about 47,000 in Sokoto. For each state under each scenario, we present numbers of and costs per measles and pertussis cases, deaths, and DALYs averted by the additional vaccinations, as well as annual costs. As expected, GIS-based microplanning incurs higher costs than traditional microplanning, due mainly to the additional vaccinations required for populations previously unreached. Our estimates of cost per DALY averted suggest, however, that GIS microplanning is more cost-effective than traditional microplanning in both states under both coverage scenarios and that the higher costs incurred by GIS microplanning are worth adopting.

Program cost analysis of influenza vaccination of health care workers in Albania.

BACKGROUND: Since 2012, WHO has recommended influenza vaccination for health care workers (HCWs), which has different costs than routine infant immunization; however, few cost estimates exist from low- and middle-income countries. Albania, a middle-income country, has self-procured influenza vaccine for some HCWs since 2014, supplemented by vaccine donations since 2016 through the Partnership for Influenza Vaccine Introduction (PIVI). We conducted a cost analysis of HCW influenza vaccination in Albania to inform scale-up and sustainability decisions. METHODS: We used the WHO's Seasonal Influenza Immunization Costing Tool (SIICT) micro-costing approach to estimate incremental costs from the government perspective of facility-based vaccination of HCWs in Albania with trivalent inactivated influenza vaccine for the 2018-19 season based on 2016-17 season data from administrative records, key informant consultations, and a convenience sample of site visits. Scenario analyses varied coverage, vaccine presentation, and vaccine prices. RESULTS: In the baseline scenario, 13,377 HCWs (70% of eligible HCWs) would be vaccinated at an incremental financial cost of US$61,296 and economic cost of US$161,639. Vaccine and vaccination supplies represented the largest share of financial (89%) and economic costs (44%). Per vaccinated HCW financial cost was US$4.58 and economic cost was US$12.08 including vaccine and vaccination supplies (US$0.49 and US$6.76 respectively without vaccine and vaccination supplies). Scenarios with higher coverage, pre-filled syringes, and higher vaccine prices increased total economic and financial costs, although the economic cost per HCW vaccinated decreased with higher coverage as some costs were spread over more HCWs. Across all scenarios, economic costs were <0.07% of Albania's estimated government health expenditure, and <5.07% of Albania's estimated immunization program economic costs. CONCLUSIONS: Cost estimates can help inform decisions about scaling up influenza vaccination for HCWs and other risk groups.

Scope and magnitude of private sector financing and provision of immunization in Benin, Malawi and Georgia.

BACKGROUND: Little is known about the role of private sector providers in providing and financing immunization. To fill this gap, the authors conducted a study in Benin, Malawi, and Georgia to estimate (1) the proportion of vaccinations taking place through the private sector; (2) private expenditures for vaccination; and (3) the extent of regulation. METHODS: In each country, the authors surveyed a stratified random sample of 50 private providers (private for-profit and not-for-profit) using a standardized, pre-tested questionnaire administered by trained enumerators. In addition, the authors conducted 300 or more client exit interviews in each country. RESULTS: The three countries had different models of private service provision of vaccination. In Malawi, 44% of private facilities, predominantly faith-based organizations, administered an estimated 27% of all vaccinations. In Benin, 18% of private for-profit and not-for-profit facilities provided vaccinations, accounting for 8% of total vaccinations. In Georgia, all sample facilities were privately managed, and conducted 100% of private vaccinations. In all three countries, the Ministries of Health (MoHs) supplied vaccines and other support to private facilities. The study found that 6-76% of clients paid nominal fees for vaccination cards and services, and a small percentage (2-26%) chose to pay higher fees for vaccines not within their countries' national schedules. The percentage of private expenditure on vaccination was less than 1% of national health expenditures. The case studies revealed that service quality at private facilities was mixed, a finding that is similar to those of other studies on private sector vaccination. The three countries varied in how well the MoHs managed and supervised private sector services. DISCUSSION/CONCLUSION: The private sector plays a growing role in lower-income countries and is expanding access to services. Governments' ability to regulate and monitor immunization services and promote quality and affordable services in the private sector should be a priority.

The impact and cost-effectiveness of controlling cholera through the use of oral cholera vaccines in urban Bangladesh: A disease modeling and economic analysis.

BACKGROUND: Cholera remains an important public health problem in major cities in Bangladesh, especially in slum areas. In response to growing interest among local policymakers to control this disease, this study estimated the impact and cost-effectiveness of preventive cholera vaccination over a ten-year period in a high-risk slum population in Dhaka to inform decisions about the use of oral cholera vaccines as a key tool in reducing cholera risk in such populations. METHODOLOGY/PRINCIPAL FINDINGS: Assuming use of a two-dose killed whole-cell oral cholera vaccine to be produced locally, the number of cholera cases and deaths averted was estimated for three target group options (1-4 year olds, 1-14 year olds, and all persons 1+), using cholera incidence data from Dhaka, estimates of vaccination coverage rates from the literature, and a dynamic model of cholera transmission based on data from Matlab, which incorporates herd effects. Local estimates of vaccination costs minus savings in treatment costs, were used to obtain incremental cost-effectiveness ratios for one- and ten-dose vial sizes. Vaccinating 1-14 year olds every three years, combined with annual routine vaccination of children, would be the most cost-effective strategy, reducing incidence in this population by 45% (assuming 10% annual migration), and costing was $823 (2015 USD) for single dose vials and $591 (2015 USD) for ten-dose vials per disability-adjusted life year (DALY) averted. Vaccinating all ages one year and above would reduce incidence by >90%, but would be 50% less cost-effective ($894-1,234/DALY averted). Limiting vaccination to 1-4 year olds would be the least cost-effective strategy (preventing only 7% of cases and costing $1,276-$1,731/DALY averted), due to the limited herd effects of vaccinating this small population and the lower vaccine efficacy in this age group. CONCLUSIONS/SIGNIFICANCE: Providing cholera vaccine to slum populations in Dhaka through periodic vaccination campaigns would significantly reduce cholera incidence and inequities, and be especially cost-effective if all 1-14 year olds are targeted.

Maternal influenza immunization in Malawi: Piloting a maternal influenza immunization program costing tool by examining a prospective program.

BACKGROUND: This costing study in Malawi is a first evaluation of a Maternal Influenza Immunization Program Costing Tool (Costing Tool) for maternal immunization. The tool was designed to help low- and middle-income countries plan for maternal influenza immunization programs that differ from infant vaccination programs because of differences in the target population and potential differences in delivery strategy or venue. METHODS: This analysis examines the incremental costs of a prospective seasonal maternal influenza immunization program that is added to a successful routine childhood immunization and antenatal care program. The Costing Tool estimates financial and economic costs for different vaccine delivery scenarios for each of the major components of the expanded immunization program. RESULTS: In our base scenario, which specifies a donated single dose pre-filled vaccine formulation, the total financial cost of a program that would reach 2.3 million women is approximately $1.2 million over five years. The economic cost of the program, including the donated vaccine, is $10.4 million over the same period. The financial and economic costs per immunized pregnancy are $0.52 and $4.58, respectively. Other scenarios examine lower vaccine uptake, reaching 1.2 million women, and a vaccine purchased at $2.80 per dose with an alternative presentation. CONCLUSION: This study estimates the financial and economic costs associated with a prospective maternal influenza immunization program in a low-income country. In some scenarios, the incremental delivery cost of a maternal influenza immunization program may be as low as some estimates of childhood vaccination programs, assuming the routine childhood immunization and antenatal care systems are capable of serving as the platform for an additional vaccination program. However, purchasing influenza vaccines at the prices assumed in this analysis, instead of having them donated, is likely to be challenging for lower-income countries. This result should be considered as a starting point to understanding the costs of maternal immunization programs in low- and middle-income countries.

Scale Matters: A Cost-Outcome Analysis of an m-Health Intervention in Malawi.

BACKGROUND: The primary objectives of this study are to determine cost per user and cost per contact with users of a mobile health (m-health) intervention. The secondary objectives are to map costs to changes in maternal, newborn, and child health (MNCH) and to estimate costs of alternate implementation and usage scenarios. MATERIALS AND METHODS: A base cost model, constructed from recurrent costs and selected capital costs, was used to estimate average cost per user and per contact of an m-health intervention. This model was mapped to statistically significant changes in MNCH intermediate outcomes to determine the cost of improvements in MNCH indicators. Sensitivity analyses were conducted to estimate costs in alternate scenarios. RESULTS: The m-health intervention cost $29.33 per user and $4.33 per successful contact. The average cost for each user experiencing a change in an MNCH indicator ranged from $67 to $355. The sensitivity analyses showed that cost per user could be reduced by 48% if the service were to operate at full capacity. CONCLUSIONS: We believe that the intervention, operating at scale, has potential to be a cost-effective method for improving maternal and child health indicators.

A cost comparison of introducing and delivering pneumococcal, rotavirus and human papillomavirus vaccines in Rwanda.

BACKGROUND: Detailed cost evaluations of delivery of new vaccines such as pneumococcal conjugate, human papillomavirus (HPV), and rotavirus vaccines in low and middle-income countries are scarce. This paper differs from others by comparing the costs of introducing multiple vaccines in a single country and then assessing the financial and economic impact at the time and implications for the future. The objective of the analysis was to understand the introduction and delivery cost per dose or per child of the three new vaccines in Rwanda to inform domestic and external financial resource mobilization. METHODS: Start-up, recurrent, and capital costs from a government perspective were collected in 2012. Since pneumococcal conjugate and HPV vaccines had already been introduced, cost data for those vaccines were collected retrospectively while prospective (projected) costing was done for rotavirus vaccine. RESULTS: The financial unit cost per fully immunized child (or girl for HPV vaccine) of delivering 3 doses of each vaccine (without costs related to vaccine procurement) was $0.37 for rotavirus (RotaTeq(®)) vaccine, $0.54 for pneumococcal (Prevnar(®)) vaccine in pre-filled syringes, and $10.23 for HPV (Gardasil (®)) vaccine. The financial delivery costs of Prevnar(®) and RotaTeq(®) were similar since both were delivered using existing health system infrastructure to deliver infant vaccines at health centers. The total financial cost of delivering Gardasil(®) was higher than those of the two infant vaccines due to greater resource requirements associated with creating a new vaccine delivery system in for a new target population of 12-year-old girls who have not previously been served by the existing routine infant immunization program. CONCLUSION: The analysis indicates that service delivery strategies have an important influence on costs of introducing new vaccines and costs per girl reached with HPV vaccine are higher than the other two vaccines because of its delivery strategy. Documented information on financial commitments for new vaccines, particularly from government sources, is a useful input into country policy dialogue on sustainable financing and co-financing of new vaccines, as well as for policy decisions by donors such as Gavi, the Vaccine Alliance.

Costs of introducing and delivering HPV vaccines in low and lower middle income countries: inputs for GAVI policy on introduction grant support to countries.

BACKGROUND: In November 2011, the GAVI Alliance made the decision to add HPV vaccine as one of the new vaccines for which countries eligible for its funding (less than $1520 per capita income) could apply to receive support for national HPV vaccination, provided they could demonstrate the ability to deliver HPV vaccines. This paper describes the data and analysis shared with GAVI policymakers for this decision regarding GAVI HPV vaccine support. The paper reviews why strategies and costs for HPV vaccine delivery are different from other vaccines and what is known about the cost components from available data that originated primarily from HPV vaccine delivery costing studies in low and middle income-countries. METHODS: Financial costs of HPV vaccine delivery were compared across three sources of data: 1) vaccine delivery costing of pilot projects in five low and lower-middle income countries; 2) cost estimates of national HPV vaccination in two low income countries; and 3) actual expenditure data from national HPV vaccine introduction in a low income country. Both costs of resources required to introduce the vaccine (or initial one-time investment, such as cold chain equipment purchases) and recurrent (ongoing costs that repeat every year) costs, such as transport and health personnel time, were analyzed. The cost per dose, cost per fully immunized girl (FIG) and cost per eligible girl were compared across studies. RESULTS: Costs varied among pilot projects and estimates of national programs due to differences in scale and service delivery strategy. The average introduction costs per fully immunized girl ranged from $1.49 to $18.94 while recurrent costs per girl ranged from $1.00 to $15.69, with both types of costs varying by delivery strategy and country. Evaluating delivery costs along programme characteristics as well as country characteristics (population density, income/cost level, existing service delivery infrastructure) are likely the most informative and useful for anticipating costs for HPV vaccine delivery. CONCLUSIONS: This paper demonstrates the importance of country level cost data to inform global donor policies for vaccine introduction support. Such data are also valuable for informing national decisions on HPV vaccine introduction.

The burden of cholera in Uganda.

INTRODUCTION: In 2010, the World Health Organization released a new cholera vaccine position paper, which recommended the use of cholera vaccines in high-risk endemic areas. However, there is a paucity of data on the burden of cholera in endemic countries. This article reviewed available cholera surveillance data from Uganda and assessed the sufficiency of these data to inform country-specific strategies for cholera vaccination. METHODS: The Uganda Ministry of Health conducts cholera surveillance to guide cholera outbreak control activities. This includes reporting the number of cases based on a standardized clinical definition plus systematic laboratory testing of stool samples from suspected cases at the outset and conclusion of outbreaks. This retrospective study analyzes available data by district and by age to estimate incidence rates. Since surveillance activities focus on more severe hospitalized cases and deaths, a sensitivity analysis was conducted to estimate the number of non-severe cases and unrecognized deaths that may not have been captured. RESULTS: Cholera affected all ages, but the geographic distribution of the disease was very heterogeneous in Uganda. We estimated that an average of about 11,000 cholera cases occurred in Uganda each year, which led to approximately 61-182 deaths. The majority of these cases (81%) occurred in a relatively small number of districts comprising just 24% of Uganda's total population. These districts included rural areas bordering the Democratic Republic of Congo, South Sudan, and Kenya as well as the slums of Kampala city. When outbreaks occurred, the average duration was about 15 weeks with a range of 4-44 weeks. DISCUSSION: There is a clear subdivision between high-risk and low-risk districts in Uganda. Vaccination efforts should be focused on the high-risk population. However, enhanced or sentinel surveillance activities should be undertaken to better quantify the endemic disease burden and high-risk populations prior to introducing the vaccine.