The binomial nature of immunization session size distributions and the implications for vaccine wastage

In this paper we demonstrate that immunization session size distributions are governed by binomial statistics and determined by just two readily available programmatic parameters, the birth cohort of the catchment area and the session frequency. Given this new knowledge, the unavoidable component of an immunization facility’s opened vial wastage rate can be determined algebraically for each vial size and discard time. This has significant positive programmatic implications for immunization session planning, vaccine needs forecasting, vaccine wastage monitoring, and vaccine product specification and choice. Further operational research is required to field test the different applications of the model and to inform the development of tools and guidance.     

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

BackgroundDetailed 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.MethodsStart-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.ResultsThe 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.ConclusionThe 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.     

The role of National Immunisation Technical Advisory Groups (NITAGs) in strengthening national vaccine decision-making: A comparative case study of Armenia,Ghana, Indonesia,Nigeria, Senegal and Uganda

IntroductionImproving evidence informed decision-making in immunisation is a global health priority and many low and middle-income countries have established National Immunisation Technical Advisory Groups (NITAGs) as independent technical advisory bodies for this purpose. NITAG development and strengthening has received financial and technical support over the past decade, but relatively little evaluation. This study examined NITAGs in six low and middle-income countries (i.e. Armenia, Ghana, Indonesia, Nigeria, Senegal, Uganda), to examine functionality, quality of recommendation development, and integration with national decision-making bodies and processes.MethodsA mixed-method case-series design, used semi-structured interviews, NITAG meeting observations, and document review. Data were analysed thematically.ResultsFive NITAGs had been legally established with terms of reference and appeared well functioning, with Ghana’s in development. All NITAGs had standard operating procedures and nomination procedures to ensure a range of expertise, generally comprising 10–15 core, 1–5 secretariat, and several ex-officio members. Aside from economics, NITAGs reported a wide range of member expertise. Newer NITAGs had particular concerns about funding. Four used formal conflict of interest procedures, although some commented that implications were not always understood. NITAGs valued local data, and limited evidence suggested NITAG presence might reinforce data production through surveillance and local research studies. All observed meetings demonstrated due process and evidence-based decision-making processes were generally followed, with a critical role played by working-group data syntheses and assessments. NITAGs were seen as well integrated with ministry of health (MoH) decision-making and MoH interviewees were positive about NITAG contributions, indicating NITAGs had an important role. Collaboration with other bodies was more limited, but mitigated by NITAG members’ cross-membership in other bodies.ConclusionsNITAGs have an important and valued role within national immunisation decision-making. However, their position remains insecure, with the need for sustainable technical and financial support.     

Childhood vaccines in Uganda and Zambia: Determinants and barriers to vaccine coverage

BackgroundImproving childhood vaccine coverage is a priority for global health, but challenging in low and middle-income countries. Although previous research has sought to measure determinants of vaccination, most has limitations. We measure determinants using a clearly-defined hypothetical model, multi-faceted data, and modeling strategy that makes full use of the hypothesis and data.MethodsWe use linked, cross-sectional survey data from households, health facilities, patients and health offices in Uganda and Zambia, and Bayesian Structural Equation Modeling to quantify the proportion of variance in childhood vaccination that is explained by key determinants, controlling for known confounding.ResultsWe find evidence that the leading determinant of vaccination is different for different outcomes. For three doses of pentavalent vaccine, intent to vaccinate (on the part of the mother) is the leading driver, but for one dose of the vaccine, community access is a larger factor. For pneumococcal conjugate vaccine, health facility readiness is the leading driver. Considering specifically-modifiable determinants, improvements in cost, facility catchment populations and staffing would be expected to lead to the largest increase in coverage according to the model.ConclusionsThis analysis measures vaccination determinants using improved methods over most existing research. It provides evidence that determinants should be approached in the context of relevant outcomes, and evidence of specific determinants that could have the greatest impact in these two countries, if targeted. Future studies should seek to improve our analytic framework, apply it in different settings, and utilize stronger study designs. Programs that focus on a particular determinant should use these results to select an outcome that is appropriate to measure their effectiveness. Vaccination programs in these countries should use our findings to better target interventions and continue progress against vaccine preventable diseases.     

Cost-effectiveness of maternal pertussis immunization: Implications of a dynamic transmission model for low- and middle-income countries

ObjectiveThis study evaluates the cost-effectiveness of maternal acellular pertussis (aP) immunization in low- and middle-income countries using a dynamic transmission model.MethodsWe developed a dynamic transmission model to simulate the impact of infant vaccination with whole-cell pertussis (wP) vaccine with and without maternal aP immunization. The model was calibrated to Brazilian surveillance data and then used to project health outcomes and costs under alternative strategies in Brazil, and, after adjusting model parameter values to reflect their conditions, in Nigeria and Bangladesh. The primary measure of cost-effectiveness is incremental cost (2014 USD) per disability-adjusted life-year (DALY).ResultsThe dynamic model shows that maternal aP immunization would be cost-effective in Brazil, a middle-income country, under the base-case assumptions, but would be very expensive at infant vaccination coverage in and above the threshold range necessary to eliminate the disease (90–95%). At 2007 infant coverage (DTP1 90%, DTP3 61% at 1 year of age), maternal immunization would cost < $4,000 per DALY averted. At high infant coverage, such as Brazil in 1996 (DTP1 94%, DTP3 74% at 1 year), cost/DALY increases to $1.27 million. When the model’s time horizon was extended from 2030 to 2100, cost/DALY increased under both infant coverage levels, but more steeply with high coverage. The results were moderately sensitive to discount rate, maternal vaccine price, and maternal aP coverage and were robust using the 100 best-fitting parameter sets. Scenarios representing low-income countries showed that maternal aP immunization could be cost-saving in countries with low infant coverage, such as Nigeria, but very expensive in countries, such as Bangladesh, with high infant coverage.ConclusionA dynamic model, which captures the herd immunity benefits of pertussis vaccination, shows that, in low- and middle-income countries, maternal aP immunization is cost-effective when infant vaccination coverage is moderate, even cost-saving when it is low, but not cost-effective when coverage levels pass 90–95%.     

Human papillomavirus (HPV) vaccine implementation in low and middle-income countries (LMICs): Health system experiences and prospects

Prophylactic vaccines for human papillomavirus (HPV) are being introduced in many countries for the prevention of cervical cancer, the second most important cause of cancer-related death in women globally. This is likely to have a significant impact on the future burden of cervical cancer, particularly where screening is non-existent or limited in scale. Previous research on the challenges of vaccinating girls with the HPV vaccine has focused on evidence from developed countries. We conducted a systematic search of the literature in order to describe the barriers and challenges to implementation of HPV vaccine in low- and middle-income countries. We identified literature published post-2006 to September 2012 from five major databases. We validated the findings of the literature review with evidence from qualitative key informant interviews. Three key barriers to HPV vaccine implementation were identified: sociocultural, health systems and political. A linked theme, the sustainability of HPV vaccines programmes in low- and middle-income countries, cuts across these three barriers. Delivering HPV vaccine successfully will require multiple barriers to be addressed. Earlier research in developed countries emphasised sociocultural issues as the most significant barriers for vaccine roll-out. Our evidence suggests that the range of challenges for poorer countries is significantly greater, not least the challenge of reaching girls for three doses in settings where school attendance is low and/or irregular. Financial and political barriers to HPV vaccine roll-out continue to be significant for many poorer countries. Several demonstration and pilot projects have achieved high rates of acceptability and coverage and lessons learned should be documented and shared.     

An assessment of parental knowledge,attitudes, and beliefs regarding influenza vaccination

IntroductionSeasonal influenza imposes a significant clinical and economic burden. Despite the availability of an annual vaccine to prevent influenza infection and reduce disease severity, influenza vaccination rates remain suboptimal. Research suggests personal experience, perceived effectiveness, and concerns regarding vaccine safety and side effects are the most influential factors in predicting a parent’s decision to vaccinate. However, current literature is primarily focused on the vaccine decision-making of healthcare workers and those at high risk for influenza complications.MethodsTo assess parental attitudes and beliefs regarding the influenza vaccine, a brief mixed-methods survey was developed and optimized for an electronic platform. The Health Belief Model informed survey design and data analysis. Questions were classified into five core concepts: knowledge, barriers, benefits, experience, and severity. Participants were solicited from a population of parents whose children had participated in a school-based influenza surveillance study (n = 244, 73% response rate). We tested associations between responses and children’s influenza vaccination status the prior season. Categorical questions were tested using Pearson's chi-squared tests and numerical or ordered questions using Mann-Whitney tests. P-values were corrected using the Bonferroni method.ResultsDoubting effectiveness, concerns about side effects, inconvenience, and believing the vaccine is unnecessary were barriers negatively associated with parents’ decision to vaccinate their children during the 2017–18 flu season (p < 0.001). Knowledge that the vaccine is effective in lowering risk, duration, and severity of influenza; receiving the influenza vaccine as an adult; and recognizing the importance of vaccination to prevent influenza transmission in high-risk populations were positively associated with parents’ decision to vaccinate (p < 0.001).ConclusionUnderstanding barriers and motivators behind parents’ decision to vaccinate provides valuable insight that has the potential to shape vaccine messaging, recommendations, and policy. The motivation to vaccinate to prevent influenza transmission in high-risk populations is a novel finding that warrants further investigation.     

The budget impact of controlling wastage with smaller vials: A data driven model of session sizes in Bangladesh,India (Uttar Pradesh), Mozambique,and Uganda

Introduction

Open vial vaccine wastage in multi-dose vials is a major contributor to vaccine wastage. Although switching from 10-dose vials to 5-dose vials could reduce wastage, a higher total cost could be triggered because smaller vials cost more to purchase and store.

Methods

This study drew field data of daily session sizes in local vaccination facilities from Bangladesh, India (Uttar Pradesh), Mozambique, and Uganda, and used Akaike Information Criteria to determine the best fit statistical distribution across various clinic types. These distributions were input to estimate the vaccine wastage using Lee's (2010) model. Inactivated polio vaccine (IPV) immunization was simulated to compare the costs over ten years with 10-dose vials versus 5-dose vials.

Results

By switching from 10- to 5-dose vials, the observed open vial wastage rate due to vial size preference and session size for IPV was reduced from 0.25 to 0.11 in Bangladesh, 0.17 to 0.08 in India (Uttar Pradesh), 0.13 to 0.06 in Mozambique, and 0.09 to 0.04 in Uganda, respectively. The cost savings realized from lower IPV wastage did not offset the higher costs of procurement and storage costs associated with smaller dose presentation.

Conclusion

While our model showed that switching from 10-dose vials to 5-dose vials of IPV reduced open vial wastage, it was not cost-saving.     

Seasonal influenza vaccination in middle-income countries: Assessment of immunization practices in Belarus,Morocco, and Thailand

BackgroundVaccines for the control of seasonal influenza are recommended by the World Health Organization (WHO) for use in specific risk groups, but their use requires operational considerations that may challenge immunization programs. Several middle-income countries have recently implemented seasonal influenza vaccination. Early program evaluation following vaccine introduction can help ascertain positive lessons learned and areas for improvement.MethodsAn influenza vaccine post-introduction evaluation (IPIE) tool was developed jointly by WHO and the U.S. Centers for Disease Control and Prevention to provide a systematic approach to assess influenza vaccine implementation processes. The tool was used in 2017 in three middle-income countries: Belarus, Morocco and Thailand.ResultsData from the three countries highlighted a number of critical factors: Health workers (HWs) are a key target group, given their roles as key influencers of acceptance by other groups, and for ensuring vaccine delivery and improved coverage. Despite WHO recommendations, pregnant women were not always prioritized and may present unique challenges for acceptance. Target group denominators need to be better defined, and vaccine coverage should be validated with vaccine distribution data, including from the private sector. There is a need for strengthening adverse events reporting and for addressing potential vaccine hesitancy through the establishment of risk communication plans. The assessments led to improvements in the countries’ influenza vaccination programs, including a revision of policies, changes in vaccine management and coverage estimation, enhanced strategies for educating HWs and intensified collaboration between departments involved in implementing seasonal influenza vaccination.ConclusionThe IPIE tool was found useful for delineating operational strengths and weaknesses of seasonal influenza vaccination programs. HWs emerged as a critical target group to be addressed in follow-up action. Findings from this study can help direct influenza vaccination programs in other countries, as well as contribute to pandemic preparedness efforts. The updated IPIE tool is available on the WHO website http://www.who.int/immunization/research/development/influenza/en/index1.html.     

Determinants and Consequences of Adolescent Fatherhood: A Longitudinal Study in Ethiopia,India, Peru,and Vietnam

PurposeAdolescent parenthood is a major challenge in low- and middle-income countries (LMICs). However, the vast majority of the evidence has focused on adolescent motherhood. Little is known about adolescent fatherhood in LMICs. The aim of this study was to examine the determinants of early fatherhood and its consequences on a range of outcomes among adolescent males.MethodsThis study used three waves of longitudinal data from the multicountry Young Lives cohort study, specifically following a sample of 1,779 adolescent boys at ages 15, 19, and 22 years in Ethiopia, India, Peru, and Vietnam. Individual fixed effects models were conducted to investigate the sociodemographic determinants of adolescent fatherhood and the consequences of adolescent fatherhood on males' education, health, psychosocial well-being, and time use outcomes.ResultsThe results indicated that lower educational attainment, absence of the adolescent's mother and father from the home, larger household size, and poverty increased the likelihood of becoming an adolescent father by age 22 years. The results revealed that becoming an adolescent father was associated with a higher likelihood of school dropout, being overweight, smoking, greater internalizing problems, and less time spent on leisure activities and more time spent on caregiving responsibilities.ConclusionsHighlighting the experiences of young men as adolescent parents in LMICs, findings underscore the importance of prevention strategies to delay early parenthood for adolescent boys and multicomponent interventions to support young fathers and their unique health, socioeconomic, psychosocial, and behavioral needs.     

The partnership for influenza vaccine introduction (PIVI): Supporting influenza vaccine program development in low and middle-income countries through public-private partnerships

Influenza vaccination remains the most effective tool for reducing seasonal influenza disease burden. Few Low and Middle-Income Countries (LMICs) have robust, sustainable annual influenza national vaccination programs. The Partnership for Influenza Vaccine Introduction (PIVI) was developed as a public-private partnership to support LMICs to develop and sustain national vaccination programs through time-limited vaccine donations and technical support. We review the first 5 years of experience with PIVI, including the concept, country progress toward sustainability, and lesson learned. Between 2013 and 2018, PIVI worked with Ministries of Health in 17 countries. Eight countries have received donated vaccines and technical support; of these, two have transitioned to sustained national support of influenza vaccination and six are increasing national support of the vaccine programs towards full transition to local vaccine program support by 2023. Nine additional countries have received technical support for building the evidence base for national policy development and/or program evaluation. PIVI has resulted in increased use of vaccines in partner countries, and early countries have demonstrated progress towards sustainability, suggesting that a model of vaccine and technical support can work in LMICs. PIVI expects to add new country partners as current countries transition to self-reliance.     

Strengthening national vaccine decision-making: Assessing the impact of SIVAC Initiative support on national immunisation technical advisory group (NITAG) functionality in 77 low and middle-income countries

Background

National Immunisation Technical Advisory Groups (NITAGs) are multi-disciplinary expert groups that provide policy-makers with independent, evidence-based advice on vaccination. Between 2008 and 2017, the SIVAC Initiative supported establishment and strengthening of NITAGs in low and lower-middle income countries though its impact was never assessed quantitatively.

Enablers and inhibitors: A review of the situation regarding mHealth adoption in low- and middle-income countries

Objective

The objective of this review is to identify enabling and inhibiting factors for mHealth adoption in low resource settings, by giving emphasis on the stakeholders representing the caregiving side. Another objective of this study is to support implementation agencies (governmental and non-governmental) in designing scalable mHealth interventions.

Factors limiting data quality in the expanded programme on immunization in low and middle-income countries: A scoping review

Few public health interventions can match the immense achievements of immunization in terms of mortality and morbidity reduction. However, progress in reaching global coverage goals and achieving universal immunization coverage have stalled; with key stakeholders concerned about the accuracy of reported coverage figures. Incomplete and incorrect data has made it challenging to obtain an accurate overview of immunization coverage, particularly in low- and middle-income countries (LMIC).To date, only one literature review concerning immunization data quality exists. However, it only included articles from Gavi-eligible countries, did not go deep into the characteristics of the data quality problems, and used a narrow ‘data quality’ definition. This scoping review builds upon that work; exploring the “state of data quality” in LMIC, factors affecting data quality in these settings and potential means to improve it.Only a small volume of literature addressing immunization data quality in LMIC was found and definitions of ‘data quality’ varied widely. Data quality was, on the whole, considered poor in the articles included. Coverage numerators were seen to be inflated for official reports and denominators were inaccurate and infrequently adjusted. Numerous factors related to these deficiencies were reported, including health information system fragmentation, overreliance on targets and poor data management processes. Factors associated with health workers were noted most frequently. Authors suggested that data quality could be improved by ensuring proper data collection tools, increasing workers’ capacities and motivation through training and supervision, whilst also ensuring adequate and timely feedback on the data collected.The findings of this scoping review can serve as the basis to identify and address barriers to good quality immunization data in LMICs. Overcoming said barriers is essential if immunization’s historic successes are to continue.     

Increasing Burden of Acute Hepatitis A among Ethiopian Children,Adolescents, and Young adults: A Change in Epidemiological Pattern and Need for Hepatitis A Vaccine

BackgroundHepatitis A is a vaccine-preventable, feco-oral infection due to poor sanitary conditions. It is predominantly acquired during early childhood and results in lasting acquired protective immunity. However, it results in severe disease which can end up in acute fulminant hepatitis and hepatic failure when acquired during adolescence and adulthood. The prevalence of acute hepatitis A is increasing among children, adolescents, and young adults from higher-income households. They acquire this infection at a later age when they are exposed for the first time to contaminated food and drinks after being brought up in a relatively clean environment. This calls for the introduction of the Hepatitis A vaccine in Ethiopia; possibly as part of the Expanded Program on Immunization (EPI).MethodsSocio-demographic and clinical data were collected from patients who were diagnosed to have hepatitis A infection at Adera Medical Center in 2020.ResultsThis study showed that clinical acute hepatitis A is becoming common among children, adolescents, and young adults from relatively high-income families. Among patients with acute hepatitis, 89% were from middle and high-income families.ConclusionsThere is a need for the incorporation of hepatitis A vaccine in the Ethiopian EPI program.     

Vaccine purchasing groups in the United States: An overview of their policies and practices

BackgroundVaccine purchasing groups (VPGs) may help reduce the upfront cost of vaccines. The objective of this study was to describe key business practices of VPGs in the United States.MethodsSemi-structured, qualitative telephone interviews were conducted with representatives from 11 VPGs, based on a sampling frame of 53 VPGs. Interviews were transcribed and summarized by topic.ResultsCharacteristics of the 11 VPGs interviewed reflect the broader VPG population: 64% national vs 36% regional; 8% charge a membership fee; membership ranging from 40 to over 300,000 sites.VPGs establish agreements with vaccine manufacturers, typically with either GlaxoSmithKline or Merck and Sanofi Pasteur; 1 VPG reported a single-product (Trumenba) agreement with Pfizer. VPG agreements specify “product loyalty” benchmarks (proportion of that manufacturer’s product line) that the VPG and its members must meet to receive discounted vaccine pricing. The amount of discount is considered proprietary. Practices may actively participate with only one VPG; the member discount is automatically applied by the manufacturer at the time of ordering. Vaccine manufacturers monitor sales data to ensure compliance with product loyalty terms; practices that do not meet benchmarks may be removed from the VPG.VPGs are paid administration fees by the manufacturers. VPGs use these fees to cover their operating expenses and often rebate a portion of these fees back to their members. All 11 VPGs offer additional services to members, ranging from immunization-focused education and technical assistance to discounts on a broad range of medical and business supplies.ConclusionsVPGs can facilitate access to reduced purchase prices for most vaccines routinely recommended in the United States. Data on the magnitude of the price reductions were not publicly available. VPG members must balance loyalty-based price reductions against considerations of having a wider choice of vaccine products.