A framework for seroepidemiologic investigations in future pandemics: insights from an evaluation of WHO's Unity Studies initiative.

BACKGROUND: The WHO Unity Studies initiative supports countries, especially low- and middle-income countries (LMICs), in conducting seroepidemiologic studies for rapidly informing responses to the COVID-19 pandemic. Ten generic study protocols were developed which standardized epidemiologic and laboratory methods. WHO provided technical support, serological assays and funding for study implementation. An external evaluation was conducted to assess (1) the usefulness of study findings in guiding response strategies, (2) management and support to conduct studies and (3) capacity built from engagement with the initiative. METHODS: The evaluation focused on the three most frequently used protocols, namely first few cases, household transmission and population-based serosurvey, 66% of 339 studies tracked by WHO. All 158 principal investigators (PIs) with contact information were invited to complete an online survey. A total of 19 PIs (randomly selected within WHO regions), 14 WHO Unity focal points at the country, regional and global levels, 12 WHO global-level stakeholders and eight external partners were invited to be interviewed. Interviews were coded in MAXQDA™, synthesized into findings and cross-verified by a second reviewer. RESULTS: Among 69 (44%) survey respondents, 61 (88%) were from LMICs. Ninety-five percent gave positive feedback on technical support, 87% reported that findings contributed to COVID-19 understanding, 65% to guiding public health and social measures, and 58% to guiding vaccination policy. Survey and interview group responses showed that the main technical barriers to using study findings were study quality, variations in study methods (challenge for meta-analysis), completeness of reporting study details and clarity of communicating findings. Untimely study findings were another barrier, caused by delays in ethical clearance, receipt of serological assays and approval to share findings. There was strong agreement that the initiative created equitable research opportunities, connected expertise and facilitated study implementation. Around 90% of respondents agreed the initiative should continue in the future. CONCLUSIONS: The Unity Studies initiative created a highly valued community of practice, contributed to study implementation and research equity, and serves as a valuable framework for future pandemics. To strengthen this platform, WHO should establish emergency-mode procedures to facilitate timeliness and continue to build capacity to rapidly conduct high-quality studies and communicate findings in a format friendly to decision-makers.

A Financial and Global Demand Analysis to Inform Decisions for Funding and Clinical Development of Group B Streptococcus Vaccines for Pregnant Women.

BACKGROUND: Despite group B Streptococcus (GBS) being a leading cause of maternal and infant morbidity and mortality, no vaccine is currently available. To inform vaccine developers, countries, and funders, we analyzed the key factors likely to influence the demand for a GBS vaccine and the long-term financial sustainability for a vaccine developer. METHODS: Using population-based forecasting, we estimated the demand for a GBS vaccine; using a discounted cash flow model we estimated the financial viability for a vaccine developer. RESULTS: Demand for this vaccine can be significant if countries adopt policy recommendations for use, in particular, the largest ones, most of which have a burden that justifies use of the vaccine, and if financing for the vaccine is made available either by countries or by funding mechanisms such as Gavi, the Vaccine Alliance. CONCLUSIONS: This analysis suggests the potential for financial and commercial viability for a vaccine developer pursuing the commercialization of a GBS vaccine. Risks exists in relation to the clinical trial design and costs, the level of competition, countries' ability to pay, the administration schedule, and the availability of policies that encourage use of the vaccine. To reduce those risks and ensure equitable access to a GBS vaccine, the role of donors or financers can prove very important, as can a coordinated operational research agenda that aims at clarifying those areas of uncertainty.

Stakeholder Perceptions About Group B Streptococcus Disease and Potential for Maternal Vaccination in Low- and Middle-Income Countries.

BACKGROUND: To inform the World Health Organization's full value of vaccine assessment for group B Streptococcus (GBS) vaccines, a rapid literature appraisal was conducted to inform the operationalization of maternal GBS vaccination. We found limited published information on stakeholder perceptions of the public health importance of GBS disease and vaccination, and we therefore undertook a multicountry survey. METHODS: An online survey was conducted in late 2019 to collect information on stakeholders' awareness of GBS disease and the priority accorded to vaccination. The survey was distributed by email to 395 representatives of national pediatric, gynecology, and obstetrics associations, national immunization technical advisory groups (NITAGs), national regulatory agencies, academia, and United Nations organizations. RESULTS: Among 101 survey respondents from 66 countries, 36% were pediatricians, 25% obstetricians/gynecologists, 21% immunization specialists, and 18% other public health specialists. More than half (58%) of respondents reported being familiar with GBS disease as a public health problem; familiarity decreased by country income level. Knowledge of GBS disease was greatest in the Americas (68%) and Europe (66%) and lowest in Asia (13%-38%). Perception of GBS disease as a public health problem was highest among pediatricians (71%) and lowest among public health policy makers and NITAG members (30%) across country groupings. Approximately half of respondents (49%) considered the introduction of a GBS vaccine as a priority. CONCLUSIONS: The information obtained will inform the appropriate packaging and presentation of information to address stakeholder perceptions and promote evidence-based decision making on GBS vaccination.

National immunization programmes.

Immunization represents one of the most cost-effective means to improve the health and well-being of populations and contribute to sustainable development. Since the inception of the Expanded Programme on Immunization (EPI) in 1974, considerable gains have been made in improving access to vaccination in all countries. However, the full potential of vaccination is yet to be tapped.Health system weaknesses have prevented universal access to vaccination and are a limitation for sustainable use of the increasing array of new vaccines. Fortunately, solutions exist and opportunities are available to strengthen immunization systems and to implement strategies to achieve the vision of universal access to vaccines. National immunization programmes are responsible for the management of immunization at the country level and cover a range of functions from establishing evidence-based policies to financing and procurement of vaccines, vaccine management and logistics, delivery of vaccination services and collection, as well as analysis and use of immunization data. Well-functioning immunization programmes that deliver high-quality services using tailored strategies to meet the needs of different population groups can reap the health benefits of high and equitable coverage with vaccines.

New immunization strategies: adapting to global challenges.

Immunization has made an enormous contribution to global health. Global vaccination coverage has dramatically improved and mortality rates among children due to vaccine-preventable diseases have been significantly reduced since the creation of the Expanded Programme of Immunization in 1974, the formation of Gavi, the Vaccine Alliance, in 2000, and the development of the Global Vaccine Action Plan in 2012. However, challenges remain and persisting inequities in vaccine uptake contribute to the continued occurrence and outbreaks of vaccine-preventable diseases. Inequalities in immunization coverage by geography, urban-rural, and socio-economic status jeopardize the achievement of global immunization goals and call for renewed immunization strategies. These should take into account emerging opportunities for building better immunization systems and services, as well as the development of new vaccine products and delivery technologies. Such strategies need to achieve equity in vaccination coverage across and within countries. This will require the participation of communities, a better understanding of vaccine acceptance and hesitancy, the expansion of vaccination across the life course, approaches to improve immunization in middle-income countries, enhanced use of data and possible financial and non-financial incentives. Vaccines also have an important role to play in comprehensive disease control, including the fight against antimicrobial resistance. Lessons learned from disease eradication and elimination efforts of polio, measles and maternal and neonatal tetanus are instrumental in further enhancing global immunization strategies in line with the revised goals and targets of the new Immunization Agenda 2030, which is currently being developed.

Administering Multiple Injectable Vaccines During a Single Visit-Summary of Findings From the Accelerated Introduction of Inactivated Polio Vaccine Globally.

Background: In 2013, the World Health Organization's (WHO's) Strategic Advisory Group of Experts (SAGE) recommended that all 126 countries using only oral polio vaccine (OPV) introduce at least 1 dose of inactivated polio vaccine (IPV) into their routine immunization schedules by the end of 2015. In many countries, the addition of IPV would necessitate delivery of multiple injectable vaccines (hereafter, "multiple injections") during a single visit, with infants receiving IPV alongside pentavalent vaccine (which covers diphtheria, tetanus, and whole-cell pertussis; hepatitis B; and Haemophilus influenzae type b) and pneumococcal vaccine. Unanticipated concerns emerged from countries over acceptability of multiple injections, sites of administration, and safety. We contextualized the issues surrounding multiple injections by documenting concerns associated with administration of ≥3 injections, existing evidence in the published literature, and findings of a systematic review on administration practices and techniques. Methods: Concerns associated with multiple-injection visits were documented from meetings and personal communications with immunization program managers. Published literature on the acceptability of multiple injections by providers and caregivers was summarized, and a systematic review of the literature on administration practices was completed on the following topics: spacing between injection sites (ie, vaccine spacing), site of injection, route of injection, and procedural preparedness. WHO and United Nations Children's Fund data from 2013-2015 were used to assess multiple-injection visits included in national immunization schedules. Results: Healthcare provider and caregiver attitudes and practices indicated concerns about infant pain, potential adverse effects, and uncertainty about vaccine effectiveness with multiple-injection visits. Published literature reinforced the record of safety and acceptance of the recommended schedule of IPV by the SAGE, but the evidence was largely from developed countries. Parental acceptance of multiple injections was associated with a positive provider recommendation to the caregiver. Findings of the systematic review identified that the intramuscular route is preferred over the subcutaneous route for vaccine administration and that the vastus lateralis muscle is preferred over the deltoid muscle for intramuscular injections. Recommendations on vaccine spacing and procedural preparedness were based on practical necessities, but comparative evidence was not identified. During 2013-2015, 85 countries added IPV to their immunization schedules, 46 (55%) of which adopted a schedule resulting in 3 injectable vaccines being administered in a single visit. Conclusion: The multiple-injection experience identified gaps in guidance for future vaccine introductions. Global partner organizations quickly mobilized to assess, document, and communicate the existing global experience on multiple-injection visits. This evidence-based approach provided reassurance to opinion leaders, health workers, and professional societies, thus encouraging uptake of IPV as a second or third injection in an accelerated manner globally.

Status of New Vaccine Introduction - Worldwide, September 2016.

Since the global Expanded Program on Immunization (EPI) was launched in 1974, vaccination against six diseases (tuberculosis, polio, diphtheria, tetanus, pertussis, and measles) has prevented millions of deaths and disabilities (1). Significant advances have been made in the development and introduction of vaccines, and licensed vaccines are now available to prevent 25 diseases (2,3). Historically, new vaccines only became available in low-income and middle-income countries decades after being introduced in high-income countries. However, with the support of global partners, including the World Health Organization (WHO) and the United Nations Children's Fund, which assist with vaccine prequalification and procurement, as well as Gavi, the Vaccine Alliance (Gavi) (4), which provides funding and shapes vaccine markets through forecasting and assurances of demand in low-income countries in exchange for lower vaccine prices, vaccines are now introduced more rapidly. Based on data compiled in the WHO Immunization Vaccines and Biologicals Database* (5), this report describes the current status of introduction of Haemophilus influenzae type b (Hib), hepatitis B, pneumococcal conjugate, rotavirus, human papillomavirus, and rubella vaccines, and the second dose of measles vaccine. As of September 2016, a total of 191 (99%) of 194 WHO member countries had introduced Hib vaccine, 190 (98%) had introduced hepatitis B vaccine, 132 (68%) had introduced pneumococcal conjugate vaccine (PCV), and 86 (44%) had introduced rotavirus vaccine into infant vaccination schedules. Human papillomavirus vaccine (HPV) had been introduced in 67 (35%) countries, primarily targeted for routine use in adolescent girls. A second dose of measles-containing vaccine (MCV2) had been introduced in 161 (83%) countries, and rubella vaccine had been introduced in 149 (77%). These efforts support the commitment outlined in the Global Vaccine Action Plan (GVAP), 2011-2020 (2), endorsed by the World Health Assembly in 2012, to extend the full benefits of immunization to all persons.

Exploring potential applications of measles and rubella microarray patches (MR-MAPs): use case identification.

Introduction: Innovative vaccine products will be critical in helping to address the existing implementation barriers that have prevented the achievement of the measles and rubella (MR) vaccine coverage targets. Overcoming those barriers will be necessary to achieve the "Immunization Agenda 2030" goals. Microarray patches (MAPs), an innovative needle-free delivery device currently in clinical development, can be a potential game changer in this respect and contribute to the equitable delivery of vaccines in low- and middle-income countries and pandemic preparedness and response. Developing in-depth knowledge of the most desired and impactful uses of MRMAPs can prove critical to identifying the critical attributes of the target product profile, informing policy and adoption decisions, and helping to evaluate the potential public health and economic value of this technology. The first step in this process is the definition of the potential use cases for MR-MAPs, i.e., where and how this product is most likely to be used within the immunization programme. Methods: By applying a design-based user-centric approach, we implemented a three-step process, including a desk review, a survey, and interviews, to define the most relevant use cases for MR MAPS. Results: Six use cases have been identified as relevant across all different countries and immunization programme designs and validated by experts. Discussion: The identified use cases have already informed the demand estimate for MR-MAPs and provided the foundation for developing an initial full vaccine value assessment. We believe that, in the future, they will be highly valuable in ensuring that the roll-out of this promising innovation is designed in a way that maximizes the impact, particularly in populations and countries that are most in need.

Estimating the future global dose demand for measles-rubella microarray patches.

Background: Progress toward measles and rubella (MR) elimination has stagnated as countries are unable to reach the required 95% vaccine coverage. Microarray patches (MAPs) are anticipated to offer significant programmatic advantages to needle and syringe (N/S) presentation and increase MR vaccination coverage. A demand forecast analysis of the programmatic doses required (PDR) could accelerate MR-MAP development by informing the size and return of the investment required to manufacture MAPs. Methods: Unconstrained global MR-MAP demand for 2030-2040 was estimated for three scenarios, for groups of countries with similar characteristics (archetypes), and four types of uses of MR-MAPs (use cases). The base scenario 1 assumed that MR-MAPs would replace a share of MR doses delivered by N/S, and that MAPs can reach a proportion of previously unimmunised populations. Scenario 2 assumed that MR-MAPs would be piloted in selected countries in each region of the World Health Organization (WHO); and scenario 3 explored introduction of MR-MAPs earlier in countries with the lowest measles vaccine coverage and highest MR disease burden. We conducted sensitivity analyses to measure the impact of data uncertainty. Results: For the base scenario (1), the estimated global PDR for MR-MAPs was forecasted at 30 million doses in 2030 and increased to 220 million doses by 2040. Compared to scenario 1, scenario 2 resulted in an overall decrease in PDR of 18%, and scenario 3 resulted in a 21% increase in PDR between 2030 and 2040. Sensitivity analyses revealed that assumptions around the anticipated reach or coverage of MR-MAPs, particularly in the hard-to-reach and MOV populations, and the market penetration of MR-MAPs significantly impacted the estimated PDR. Conclusions: Significant demand is expected for MR-MAPs between 2030 and 2040, however, efforts are required to address remaining data quality, uncertainties and gaps that underpin the assumptions in this analysis.

Human leishmaniasis vaccines: Use cases, target population and potential global demand.

The development of vaccines against one or all forms of human leishmaniasis remains hampered by a paucity of investment, at least in part resulting from the lack of well-evidenced and agreed estimates of vaccine demand. Starting from the definition of 4 main use cases (prevention of visceral leishmaniasis, prevention of cutaneous leishmaniasis, prevention of post-kala-azar dermal leishmaniasis and treatment of post-kala-azar dermal leishmaniasis), we have estimated the size of each target population, focusing on those endemic countries where incidence levels are sufficiently high to justify decisions to adopt a vaccine. We assumed a dual vaccine delivery strategy, including a wide age-range catch-up campaign before the start of routine immunisation. Vaccine characteristics and delivery parameters reflective of a target product profile and the likely duration of the clinical development effort were considered in forecasting the demand for each of the four indications. Over a period of 10 years, this demand is forecasted to range from 300-830 million doses for a vaccine preventing visceral leishmaniasis and 557-1400 million doses for a vaccine preventing cutaneous leishmaniasis under the different scenarios we simulated. In a scenario with an effective prophylactic visceral leishmaniasis vaccine, demand for use to prevent or treat post-kala-azar dermal leishmaniasis would be more limited (over the 10 years ~160,000 doses for prevention and ~7,000 doses for treatment). Demand would rise to exceed 330,000 doses, however, in the absence of an effective vaccine for visceral leishmaniasis. Because of the sizeable demand and potential for public health impact, a single-indication prophylactic vaccine for visceral or cutaneous leishmaniasis, and even more so a cross-protective prophylactic vaccine could attract the interest of commercial developers. Continuous refinement of these first-of-their kind estimates and confirmation of country willingness and ability to pay will be paramount to inform the decisions of policy makers and developers in relation to a leishmaniasis vaccine. Positive decisions can provide a much-needed contribution towards the achievement of global leishmaniasis control.

Overcoming roadblocks in the development of vaccines for leishmaniasis.

INTRODUCTION: The leishmaniases represent a group of parasitic diseases caused by infection with one of several species of Leishmania parasites. Disease presentation varies because of differences in parasite and host genetics and may be influenced by additional factors such as host nutritional status or co-infection. Studies in experimental models of Leishmania infection, vaccination of companion animals and human epidemiological data suggest that many forms of leishmaniasis could be prevented by vaccination, but no vaccines are currently available for human use. AREAS COVERED: We describe some of the existing roadblocks to the development and implementation of an effective leishmaniasis vaccine, based on a review of recent literature found on PubMed, BioRxiv and MedRxiv. In addition to discussing scientific unknowns that hinder vaccine candidate identification and selection, we explore gaps in knowledge regarding the commercial and public health value propositions underpinning vaccine development and provide a route map for future research and advocacy. EXPERT OPINION: Despite significant progress, leishmaniasis vaccine development remains hindered by significant gaps in understanding that span the vaccine development pipeline. Increased coordination and adoption of a more holistic view to vaccine development will be required to ensure more rapid progress in the years ahead.

Maternal immunization country readiness: a checklist approach.

Prior to the addition of a maternal vaccine onto the National Immunization Programme, it is important for a country to evaluate their capacity and readiness. This checklist has been developed that is deliberately not restricted to any particular vaccine so it can be applied by national-level stakeholders during the decision-making stage for the introduction of any additional or new maternal vaccine. It is suggested that a team consisting of representatives from the Ministry of Health, including the National Immunization Programme (NIP) and Maternal, Newborn and Child Health (MNCH) programs complete and review the checklist together. This checklist enables countries to assess their capacity, strengths and weaknesses and identify a list of priorities to allow for smooth implementation of maternal vaccines.

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

BACKGROUND: Vaccines 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. METHODS: An 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. RESULTS: Data 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. CONCLUSION: The 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.

Global Vaccine Action Plan lessons learned III: Monitoring and evaluation/accountability framework.

INTRODUCTION: The Monitoring & Evaluation/Accountability (M&E/A) framework of the Global Vaccine Action Plan (GVAP) was used to report progress annually to the World Health Assembly (WHA). METHODS: Stakeholder feedback was obtained through five reviews consisting of surveys and semi-structured interviews conducted from 2017 to 2019. Participants consisted of individuals involved in the development and implementation of GVAP or its M&E/A process, national immunization managers, academics, representatives of non-governmental organizations, and civil society organizations. RESULTS: The feedback was mixed and contradictory for some components, though most participants reported that the M&E/A process was a highlight of GVAP and a step in the right direction. Several of the goals and targets were considered aspirational and unrealistic for many countries. There were mixed responses on whether it promoted accountability, especially at the country level. DISCUSSION: The mixed and contradictory views on the M&E/A processes and its impact suggested a failure of communication about its scope and intent. Though the process, especially the annual reporting to the WHA, kept immunization high on the global agenda, it failed to fully meet the expectations in promoting accountability. Engaging with countries to capture the local context in setting global goals and targets and promoting local M&E/A processes will be important to achieve accountability in the next decade.

Global Vaccine Action Plan Lessons Learned II: Stakeholder Perspectives.

INTRODUCTION: The Global Vaccine Action Plan (GVAP), unanimously endorsed by the World Health Assembly in 2012, defined an ambitious strategy to improve immunization. At the end of the decade, significant progress has been made but four of the five GVAP goals are likely to be missed. This report describes a set of surveys and interviews relating to GVAP, conducted to inform the immunization strategy for the next decade. METHODS: Three surveys and two sets of semi-structured interviews were conducted from 2017 to 2019. Respondents consisted of immunization stakeholders at global, regional, and country levels, and included individuals who had been involved in the development and implementation of GVAP or its monitoring, evaluation and accountability (M&E/A) process; national immunization managers; academics; and personnel from non-governmental organizations and civil society organizations. RESULTS: The surveys and interviews gave consistent results. They highlighted the value of GVAP in increasing visibility for immunization and the benefits of the GVAP M&E/A framework. The main limitations of GVAP were identified as the limited ownership by countries and other stakeholders leading to incomplete implementation of the strategy and poor accountability for achieving GVAP targets. DISCUSSION: These results informed the review of GVAP and the development of its successor strategy, the Immunization Agenda 2030. In addition, these surveys and interviews identified two challenges in assessing the value of GVAP: the need to rely exclusively on stakeholder perspectives and difficulties in attributing benefits. These challenges are inherent in evaluating an over-arching strategy such as GVAP and should be factored into interpretation of the results.

Factors and considerations for establishing and improving seasonal influenza vaccination of health workers: Report from a WHO meeting, January 16-17, Berlin, Germany.

Health workers represent an important target group for seasonal influenza vaccination because of their increased risk of infection as well as the risk of transmitting infection to vulnerable patients in the health care setting. Moreover, seasonal vaccination of health workers contributes to pandemic preparedness. However, many countries, especially in Africa and Asia, do not have policies for health worker influenza vaccination. In countries where such policies exist, vaccination coverage is often low. The World Health Organization (WHO) is developing a manual to guide the introduction of seasonal influenza vaccination of health workers. An Independent External Advisory Group (IEAG) that is advising WHO on the content of the manual met to discuss issues that are relevant and often unique to health worker vaccination. This meeting report summarizes the main issues that were discussed and the outcomes of the discussion. The issues include policy considerations, including the evidence in support of health worker vaccination; categorization and prioritization of health workers; the choice of vaccination strategy; its integration into broader health worker vaccination and occupational health policies; planning and management of vaccination, particularly the approaches for communication and demand generation; and the challenges with monitoring and evaluation of health worker vaccination, especially in low and middle-income countries.

Maternal Immunization and Antenatal Care Situation Analysis (MIACSA) study protocol: a multiregional, cross-sectional analysis of maternal immunization delivery strategies to reduce maternal and neonatal morbidity and mortality.

INTRODUCTION: Maternal immunization (MI) with tetanus toxoid containing vaccine, is a safe and cost-effective way of preventing neonatal tetanus. Given the prospect of introducing new maternal vaccines in the near future, it is essential to identify and understand current policies, practices and unmet needs for introducing and/or scaling up MI in low-income and middle-income countries (LMICs). METHODS AND ANALYSIS: The Maternal Immunization and Antenatal Care Situation Analysis (MIACSA) is a mixed methods, cross-sectional study that will collect data in four phases: (1) a review of global databases for selected health indicators in 136 LMICs; (2) a structured online survey directed at Maternal, Newborn and Child Health and Expanded Programme on Immunization focal points in all 136 LMICs; (3) semistructured telephone interviews of 30 selected LMICs and (4) 10 week-long country visits, including key informant interviews, health facility visits and focus group discussions. The principal analyses will assess correlations between the various aspects of MI delivery strategies and proxy measures of health systems performance related to vaccine-preventable disease control. The primary outcome will be a typology of existing MI delivery models, and secondary outcomes will include country profiles of child and maternal health indicators, and a MI gaps and needs analysis. ETHICS AND DISSEMINATION: The protocol was approved by the WHO Ethics Review Committee (ERC.0002908). The results will be made available in a project report and submitted for publication in peer-reviewed journals that will be shared broadly among global health decision-makers, researchers, product developers and country-level stakeholders.

Improving the efficiency and standards of a National Immunization Program Review: lessons learnt from United Republic of Tanzania.

A National Immunization Program Review (NIP Review) is a comprehensive external assessment of the performance of a country's immunization programme. The number of recommended special-topic NIP assessments, such as those for vaccine introduction or vaccine management, has increased. These assessments often have substantial overlap with NIP reviews, raising concern about duplication. Innovative technical and management approaches, including integrating several assessments into one, were applied in the United Republic of Tanzania's 2015 NIP Review. These approaches and processes were documented and a post-Review survey and group discussion. The Tanzania Review found that integrating assessments so they can be conducted at one time was feasible and efficient. There are concrete approaches for successfully managing a Review that can be shared and practiced including having a well-planned desk review and nominating topic-leads. The use of tablets for data entry has the potential to improve Review data quality and timely analysis; however, careful team training is needed. A key area to improve was to better coordinate and link findings from the national-level and field teams.

Ending preventable child deaths from pneumonia and diarrhoea by 2025. Development of the integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea.

Despite the existence of low-cost and effective interventions for childhood pneumonia and diarrhoea, these conditions remain two of the leading killers of young children. Based on feedback from health professionals in countries with high child mortality, in 2009, WHO and Unicef began conceptualising an integrated approach for pneumonia and diarrhoea control. As part of this initiative, WHO and Unicef, with support from other partners, conducted a series of five workshops to facilitate the inclusion of coordinated actions for pneumonia and diarrhoea into the national health plans of 36 countries with high child mortality. This paper presents the findings from workshop and post-workshop follow-up activities and discusses the contribution of these findings to the development of the integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea, which outlines the necessary actions for elimination of preventable child deaths from pneumonia and diarrhoea by 2025. Though this goal is ambitious, it is attainable through concerted efforts. By applying the lessons learned thus far and continuing to build upon them, and by leveraging existing political will and momentum for child survival, national governments and their supporting partners can ensure that preventable child deaths from pneumonia and diarrhoea are eventually eliminated.

Risk factors for malaria infection and anemia for pregnant women in the Sahel area of Bandiagara, Mali.

Malaria infection and anemia during pregnancy are the primary causes of maternal and fetal morbidity and mortality. The aims of this study were to identify risk factors for malaria infection and to assess the relationship between malaria infection and anemia in pregnant women. Two cross-sectional surveys were conducted in September 1993 and then again in May 1994 (the end of the rainy and dry seasons respectively). A total of 235 pregnant women were randomly selected from both the rural and urban areas of Bandiagara, Mali. According to results from multivariate analysis, the risk of malaria infection was significantly higher during the rainy season (OR= 4.85, 95% CI 2.42-9.75) the first trimester of gestation (OR= 2.21, 95% CI 1.00-4.87, in younger women (OR= 2.48, 95% CI 1.19-5.16), and in women living in the rural area (2.49, 95% CI 0.99-6.27). The risk of anemia was also higher during the rainy season (OR= 1.93, 95% CI 1.10-3.39, in the rural area (OR= 3.55, 95% CI 1.46-8.62). The risk of anemia was lower during the first trimester of gestational age (OR= 0.45, 95% CI 0.22-0.92). The relationship between malaria infection and anemia also varied with season. During the rainy season, the risk for anemia was similar among malaria-infected and non-infected pregnant women. In contrast, the risk was higher among infected pregnant women during the dry season (OR= 3.43, 95% CI 1.09-10.07). In conclusion, the data suggest, that earlier gestation age, living in the rural area, and young age rather than parity are important risk factors for malaria infection in pregnant women. Further, malaria infection is strongly associated with anemia in pregnant women particularly during the dry season and is most likely the cause of anemia. Thus, control measures against malaria infection should target younger rural women in their first trimester of pregnancy.