Supporting Immunization Decision-making In Low- And Lower . - JHSPH
Supporting immunization decision-making in lowand lower-middle-income countriesInternational Vaccine Access Center Johns Hopkins Bloomberg School of Public HealthTable of Contents
CONTENTSOVERVIEW . 1BACKGROUND . 1OBJECTIVES . 1APPROACH . 2LIMITATIONS . 2METHODS . 3DEFINING DECISION-MAKING . 3LITERATURE SEARCH . 3STAKEHOLDER AND INITIATIVE MAPPING. 5RESULTS. 5INTERPRETATION AND SUMMARY . 14DECISION-MAKING INITIATIVES . 14COUNTRY AND REGIONAL APPROACHES . 15KEY TAKEAWAYS AND RECOMMENDATIONS . 15CONCLUSION. 17APPENDICES . 18This report was developed by the International Vaccine Access Center (IVAC) at the Johns HopkinsBloomberg School of Public Health (JHSPH), with funding from The Wellcome Trust. Report prepared by(in alphabetical order): E. Wangeci Kagucia, Lois Privor-Dumm, Sanjana Ravi, and Molly Sauer. For moreinformation, please contact Molly Sauer at msauer@jhu.edu.Updated February 2020Table of Contents
OVERVIEWThis project, funded by the Wellcome Trust, was conducted by JHSPH/IVAC in the summer of 2019and provides a brief landscape of the types of initiatives funded to support immunization decisionmaking efforts in low- and lower-middle-income countries, particularly countries ever eligible for Gavisupport.Scope: We defined “decision-making” as the synthesis of clinical, epidemiological, policy, andbehavioral research, data, and expert opinion to ensure effective delivery of vaccines andimmunization services to priority target populations, and focused—for this assessment—onintroduction decision-making rather than implementation decision-making.Approach: We reviewed publicly available peer-reviewed and gray literature, supplemented with keyinformant discussions and institutional knowledge, and mapped results to decision-makingconsiderations, partner/initiative types, global goal alignment, and level of investment.Findings: Decision-making initiatives historically focused on one antigen, but recent shifts to a morecomprehensive approach recognize that few countries consider introduction of one vaccine at a time,absent any competing priorities. Future efforts likely need to shift to viewing new vaccine introductionas a package, within the broader child health domain. Specific inclusion of capacity building has alsobeen limited in existing and past initiatives; cultivating skills such as leadership, change management,and stakeholder engagement are crucial to sustainable decisions in a world with many competingpriorities. Funders should consider how to prioritize community- and country-driven, context-sensitiveinitiatives that approach immunization decision-making with an emphasis on integration,sustainability, and capacity strengthening. Key areas lacking support are life course immunization—considering age groups beyond infants and young children—and middle-income countries, historicallyineligible for financing support and left out of decision-making support initiatives.BACKGROUNDImmunization decision-making is defined as the synthesis of clinical, epidemiological, policy, and behavioralresearch, data, and expert opinion to ensure effective delivery of vaccines and immunization services to prioritytarget populations. The lines between decision-making and implementation are often blurred, and activities tosupport better decisions do not always capture the important nuances that build country capacity for futurescenarios.Nonetheless, an array of donors and partners have been engaged in immunization policy and program initiativesin recent years, conducting projects to support or strengthen country-level decision-making. To betterunderstand this landscape and identify potential areas in need of donor and partner engagement, we conducteda two-pronged assessment of both the global landscape and specific country approaches.OBJECTIVES Summarize publicly available information on donor-supported country-level decision-making initiatives Map existing funders, advisors, and implementing partners engaged in supporting decision-makingrelated efforts in low- and middle-income countries (LMICs) Synthesize evidence to identify gaps in support and/or opportunities for future engagementPage 1 of 19
APPROACHLandscape assessmentTo assess global and regional support for and engagement in decision-making among low- and lower-middleincome countries, we considered: Key stakeholders involved in immunization decision-making at global, regional, and country levels (i.e.donors/funders, implementers, advisory groups) Donor-funded decision-making initiatives and obvious gaps Gaps or opportunities in decision-making fundingWe conducted a literature review to methodically search the body of published, peer-reviewed literature ondonor/funder investments in initiatives that support or enable immunization decision-making in LMICs. Initiativescould be country-focused, regional, or global. Information abstracted through this review enabled us to identifykey funding or implementing stakeholders, priority areas (geographic, topical, etc.) among and acrossstakeholders (stratified by donors/funders and implementers), peak funding/implementation periods and theiralignment with global initiatives or benchmarks. These and other outputs from the review were incorporated intoa matrix.We supplemented the review with a targeted search of grey literature and institutional knowledge of past andcurrent initiatives that involve decision-making support.Country decision-making approachesWe developed brief, high-level summaries of immunization decision-making approaches, stakeholder roles, and,where possible, integration with other health and non-health intervention decisions in two LMIC, India andBangladesh, as well as the AFRO Regional Immunization Technical Advisory Group. Understanding thecontext-specific approaches LMICs and regional bodies employ to balance competing budgetary andprogrammatic priorities—including immunization, other preventive health measures, and non-health programs—and weigh sometimes complex evidence for new vaccines may help to inform strategies for further funder andGavi engagement with current and transitioning countries.To this end, we reviewed available literature to identify existing published articles outlining decision-makingapproaches in LMICs, supplemented with targeted searches of grey literature, institutional knowledge, and keyinformant discussions where possible.LIMITATIONSWhile we aimed to be as comprehensive as possible in this review, we recognize a number of limitations.Across all aspects of this initiative, we are limited to that information that is published, either in peer reviewed orgrey literature, and identified in some way as supporting immunization decision-making and/or policy.Our search terms aimed to cast a wide net and gather as many potentially relevant papers as possible from thepeer-reviewed and grey literature. However, in some cases content was not captured through this search. Inorder to maintain the systematic approach as much as possible, we continued with our initial approach but donote that there is likely a body of relevant literature not captured. In a future review, conducted under more idealconditions, we would propose expanding the number of search term tests to ensure all relevant literature iscaptured and incorporated.We included two grey literature databases in our review as well—again, with the aim of keeping our approach assystematic as possible—but affirm that these databases are far from comprehensive resources. The content ofinterest for this landscape assessment is often unpublished, and may only appear on a listing of projects on anorganizational website or not at all. We relied heavily on institutional knowledge and conversations with keyinformants to identify additional initiatives and funders to include in this review. However, there is little to nodetail available on many of these efforts. In part, this is attributable to sensitivities around external support fordecision-making efforts; in some settings, there are significant concerns about undue influence in countrydecisions, particularly from international entities. Additionally, many of these efforts are likely included under alarger umbrella project not specifically defined as supporting decision-making, limiting our ability to identify themPage 2 of 19
through the literature review and manual searches. For a future review, additional key informant interviewswould help capture the many nuances that are not documented in scholarly or grey literature, both becausedecision-making may not have been a primary objective and because decision-making-related engagement maynot have been highlighted due to potential sensitivities.Finally, while we recognize that implementation decision-making considerations—how to actually roll out a newvaccine in the national immunization program; plan and conduct health worker trainings; develop information,education, and communication materials; and other key implementation steps—are equally critical componentsunder the immunization decision-making umbrella, we determined that including both introduction decisionmaking and implementation decision-making would create too broad of a scope for this review and limit ourability to accurately and adequately detail the landscape and country experiences. Where possible andappropriate, we have included implementation advisors and implementation activities that are frequentlyconsidered as part of the pre-introduction decision phase (i.e., considerations of cold chain capacity, etc.), butdo recognize that there are many partners and funders, and potentially different approaches at the country level,to address implementation decision-making. We do not address these in this assessment.METHODSDEFINING DECISION-MAKINGDecision-making for immunization is a complex, dynamic concept which can encompass a wide range ofactivities along the vaccine introduction continuum. For the purposes of this assessment, we considered thefollowing working definition of immunization decision-making:Synthesis of clinical, epidemiological, policy, and behavioral research, data, and expert opinion to ensureeffective delivery of vaccines and immunization services to priority target populations.This process typically includes considerations of disease burden, health need, and potential impact; costeffectiveness and financing; different vaccine formulations, products, and/or dosages; how to ensure equitableaccess to vaccines; social, political, and ethical factors affecting vaccine promotion and uptake; the logistics ofintroducing new vaccines and/or scaling up vaccine delivery efforts; monitoring and evaluation of immunizationdelivery and uptake efforts; and the long-term sustainability of immunization programs and systems for vaccinedelivery.While we recognize that immunization decision-making can include any or all of these considerations in a givensetting, the line between immunization decision-making and immunization program implementation is oftenblurred. In this assessment, we focused primarily on pre-introduction decision-making, although there arecomponents of implementation that are included given their overlap between both the pre- and post-introductiondecision phases.LITERATURE SEARCHWe conducted a systematic review of the scholarly literature and a complementary, non-systematic review ofthe grey literature to identify peer-reviewed studies, technical guidance, and policy documents addressingdecision-making processes around immunization and related programs.DatabasesOur search was conducted across the following scholarly literature databases: PubMED Embase Health Systems Evidence Database Scopus Web of Science LILACSPage 3 of 19
We also searched grey literature databases OAlster and OpenGrey, and conducted targeted searches ofdocument libraries for key funders, implementing partners, and technical groups, including, but not limited to:WHO, CDC Stacks, DFID, Gavi, UNICEF, PATH, Sabin Vaccine Institute, JSI, CHAI, the Task Force for GlobalHealth, USAID, and PAHO.Search terms("national" OR "country") AND ((immunization[MeSH Terms]) AND ("decision making" OR policy))Inclusion criteria English-language articles and documents published between January 1, 2000 and April 30, 2019Address decision-making processes, policymaking, and/or funding efforts around national immunizationsystems and programsFlowchart1,872 records identified throughdatabase searching162 additional records identified through reviewof document libraries of key stakeholderwebsites2,034 records identified241 duplicates removed1,793 titles & abstracts independently screenedby 2 reviewers under primary screening1,573 records excluded(i.e. topically irrelevant)220 titles & abstracts independently screenedunder secondary screening81 records excluded(i.e. high-income countries)139 records for full-text review & codingAnalysisWe developed a coding framework (Appendix) based on a priori knowledge of immunization programs, policies,and decision-making processes, as well as on the working definition of decision-making with respect toimmunization. Documents selected for in-depth review were coded iteratively using NVivo 12 coding software,with new codes added to the framework as they emerge from the literature. Key data abstracted from theliterature include: Key stakeholders (i.e. donors/funders, implementers, advisory groups) involved in immunizationdecision-making at global, regional, and country levelso How do they interact?o Gaps in interactionDecision-making-focused initiatives supported by Gavi and other donors/funders, which may include,but are not limited to:o Geographical, topical, and/or other gaps in funded initiatives;o Redundant or duplicative funding for specific antigens, target populations, and/or geographies;Page 4 of 19
Capacity-building with respect to policy processes, interpreting data, enhancing data quality,and advocacy;o Engagement with external partners in the immunization space;o Building robust evidence bases for immunization decision-making;o Modelling, forecasting, and planning;o Budgeting and financial analysis;o Preparing for public health emergencies;o Assessing trade-offs between immunization and other health priorities; ando Building, sustaining, and sharing of institutional knowledge and expertiseSupport for National Immunization Technical Advisory Groups (NITAGs) and other national stakeholdersand entities involved in decision-makingInitiatives or efforts requiring additional supporto Based on these results—supplemented with institutional knowledge and grey literature targeted searching—wedeveloped a matrix of partner engagement and potential areas of opportunity for further effort.STAKEHOLDER AND INITIATIVE MAPPINGWe mapped stakeholders and partners—those identified through the literature review and based on bothsubsequent targeted searches, institutional knowledge, and key informant insight—to core categories ofengagement in order to identify areas with possible gaps in support: Donors – those providing funding to countries, partners, and initiatives Advisors (scientific, economics/financing, policy, implementation) – those providing technical expertise,guidance, or review Funded partners – partners funded to conduct project work Policy makers – entities responsible for developing/issuing recommendations or policies Advocates – entities conducting issues advocacyBased on the analysis of the literature, we further identified (1) specific decision-making criteria used by NITAGsand other decision-making or -supporting entities, and (2) areas of current or potentially needed support insupport of decision-making and improving immunization policies. We mapped the areas of potential support tokey questions regarding the saturation of existing support—based on the literature, not necessarily on countryinput—and potential impact of these investments. Across all analyses, we summarize the results of the literaturereview and incorporate additional insight from institutional knowledge and key informant input.RESULTSHere we provide the results of the literature review, conversations with key informants, and review of institutionalknowledge on support for decision-making and country approaches. Where appropriate, we have mapped theseresults to provide an evidence-informed approach to identifying gaps and opportunities for future engagement.These results are synthesized and summarized in the Tables 1-3 and Figure 1.These results are blinded to avoid highlighting specific partners and initiatives and instead look holistically at thebody of funding and funded efforts to support country immunization decision-making. We do, however, provideexamples of initiatives, partners, and funders for each category.Page 5 of 19
Table 1: Mapping known funders, partners/stakeholders, and initiatives supporting country immunization decision-making by stakeholder type androle in decision-making supportInterpretation: Each partner, donor, or initiative identified through this assessment as funding or funded to support country immunization decision-making is classified by entity type/category (i.e.donor, multi-partner initiative, advisory group, etc.) and role in supporting decision-making (i.e. provide scientific advice, complete project work, develop policy recommendations, advocate, etc.).Examples of each category are included below. – No stakeholders and/or initiatives found to be working in this role – At least one stakeholder and/or initiative working in this rolePARTNER/INITIATIVE (BY TYPE)Known stakeholders by type/categoryPartners, initiatives, or other stakeholders funding or funded to supportimmunization decision-making in LIC/LMICROLE IN IMMUNIZATION countriesor partnersScientific Funded partnerPolicy makerAdvocateFunded tocomplete projectworkDevelop policies orrecommendationsConductissuesadvocacy PolicyImplementationProvide technical expertise, guidance, or reviewADVISORY GROUPS/COMMITTEESExample: WHO’s Strategic Advisory Group of Experts (SAGE) onImmunization provides expert guidance and developspolicies/recommendations to support country decision-makingNational Immunization Technical Advisory Groups (NITAGs)Regional Immunization Technical Advisory Groups (RITAGs)Advisory Committee AAdvisory Committee BAdvisory Committee CAdvisory Committee DAdvisory Committee EAdvisory Committee FDONORS/FUNDERSExample: The Bill & Melinda Gates Foundation funds partners andinitiatives to support country-decision making, provides technical expertadvice on key areas, and supports advocacy efforts. Governmentinternational development agencies like UK DFID and USAID are alsoincluded in this category.Donor/Funder ADonor/Funder BDonor/Funder CDonor/Funder DDonor/Funder EDonor/Funder FDonor/Funder GGLOBAL CORE PARTNERSExample: UNICEF funds initiatives, provides expert advice/guidance, andsupports advocacy effortsCore Partner ACore Partner BCore Partner CPage 6 of 19
PARTNER/INITIATIVE (BY TYPE)Known stakeholders by type/categoryPartners, initiatives, or other stakeholders funding or funded to supportimmunization decision-making in LIC/LMICGOVERNMENT ENTITIESExample: The U.S. CDC funds initiatives like surveillance, provides expertadvice/guidance, and develops recommendations.ROLE IN IMMUNIZATION ngFundcountriesor partnersScientific Funded partnerPolicy makerAdvocateFunded tocomplete projectworkDevelop policies orrecommendationsConductissuesadvocacy ImplementationProvide technical expertise, guidance, or reviewGovernment MinistriesGovernment Health AgencyCountry Support UnitINTERNATIONAL NGOsExample: PATH is funded to complete project work, provides technicaladvice/expertise, and conducts advocacy activities. Individual NGOs, likePATH, are part of some multi-partner initiatives/networks and may alsohave single-partner initiatives.International NGO AInternational NGO BInternational NGO CInternational NGO DInternational NGO EInternational NGO FInternational NGO GInternational NGO HInternational NGO IMULTI-PARTNER INITIATIVES/NETWORKSExample: The Rotavirus Accelerated Vaccine Introduction Network(RAVIN) is a consortium consisting of IVAC, JSI, and CDC, and providesscientific, policy, and implementation advice to 8 Gavi-eligible countries, isfunded to complete project work, and conducts advocacy. Other initiativesprovide single-country support. ADIPs like PneumoADIP, RotaADIP, andthe Hib Initiative are also included here. Individual partners may also beclassified above as International NGOs, core partners, or others.Multi-partner Initiative AMulti-partner Initiative BMulti-partner Initiative CMulti-partner Initiative DMulti-partner Initiative EMulti-partner Initiative FMulti-partner Initiative GMulti-partner Initiative HMulti-partner Initiative IMulti-partner Initiative JMulti-partner Initiative KPage 7 of 19
PARTNER/INITIATIVE (BY TYPE)Known stakeholders by type/categoryPartners, initiatives, or other stakeholders funding or funded to supportimmunization decision-making in LIC/LMICMulti-partner Initiative LMulti-partner Initiative MMulti-partner Initiative NMulti-partner Initiative OOTHERExample: India’s Immunization Technical Support Unit (ITSU) is funded toconduct project activities and provides technical expert advice/guidance.ROLE IN IMMUNIZATION ngFundcountriesor partnersScientific Funded partnerPolicy makerAdvocateFunded tocomplete projectworkDevelop policies orrecommendationsConductissuesadvocacy ImplementationProvide technical expertise, guidance, or reviewProfessional Medical SocietiesVaccine ManufacturersCountry Support UnitsPARTNER INITIATIVESExample: The Sabin Vaccine Institute’s Sustainable ImmunizationFinancing (SIF) initiative provides expert advice on economics/financingand policy for immunization decision-making, is funded to completeproject activities, and engages in advocacy efforts. Sabin is also classifiedas an international NGO and may be part of multi-partner initiatives.Partner Initiative APartner Initiative BPartner Initiative CPage 8 of 19
Figure 1: Decision-making factorsSocial, political, and demographic factors Country size & population densityPublic perceptions of the diseasePublic trust in health authorities; anticipated burden,discomfort, and inconvenience for target populationsPolitical and/or civil unrestEthical, legal, and political considerationsGovernment spending on healthOngoing, anticipated, or emergent public health crisesPublic health & clinical considerations Existing burden of infectious disease in questionDisease severityBurden of disease in question in neighboring countriesDisease incidenceExisting burden of comorbidities affecting immunity (e.g.malnutrition, anemia, HIV/AIDS)Existing treatment options for the disease in questionPotential for disease transmissionDTP3 coverageExisting disparities in vaccine coverage and mortalityAge of effectivenessRisks, benefits, and trade-offs Number of deaths to be avertedNumber of hospitalizations to be avertedTrade-offs between new vaccine introductions, existingvaccination programs, and other health threats andprioritiesVaccine characteristics Formulation; presentation (i.e. intramuscular injection vs.oral); valency; dosageAttrition between dosesVaccine efficacyVaccine safety (i.e. risk of adverse events)Pathogen strainReduction of risks associated with currentstrategies/vaccinesQuality of existing evidence Methodological limitations of available studies; reportingbiasInconsistencies across studies; imprecision of findingsIndirectness of findings (e.g. use of surrogate endpoints,use of immunogenicity vs. clinical endpoints, indirectcomparisons between two treatments)Page 9 of 19Economic/financial considerations Vaccine pricingImported vs. locally produced vaccineCosts of vaccine introduction & cost-effectiveness ratiosCost per DALY; cost per life savedUninterrupted availability and fungibility of funds forvaccine development, delivery, and uptakeExisting health system capacities Communication and educationDisease surveillanceCold chain capacityPresence of a robust health workforceAbility to carry out equitable health service deliveryWater & sanitation capacitiesAbility to link vaccination to other public healthinterventions (e.g. vector control, disease screening) andpoverty-reduction effortsInjection safety and waste disposalData Availability of country-level morbidity-, mortality-, andcost-related dataAvailability and reliability of clinical and safety dataData relating to vaccine forecasting, supply, anddistributionManufacturing dataLogistics Vaccine delivery strategyAbility to incorporate new vaccine(s) into existing vaccineschedule(s)Scope of vaccination strategy (i.e. national vs. high-riskpopulations only)Limited infrastructure and resources for deliveringvaccinesOther criteria Presence of official recommendations & position papersfrom technical bodies (e.g. WHO, UNICEF, NITAGs, etc.)Projected impactsProjected health equity impactsTemporal proximity of projected benefitsNumber needed to vaccinateRisk of undermining existing public health programsAvailability of vaccines via the private sector
Table 2: Mapping priorities and areas of need identified through literature against known funding, partner prioritization, and potential impactInterpretation examples:Infants: This area has extensive recent and ongoing funding (dark gray, indicating a saturated space with lower opportunity for new investment); has been identified as a high priority bypartners and funders, regardless of whether funding is associated (orange, indicating a priority area and potential opportunity for engagement); and has substantial potential for health andeconomic impact as a result of further investment.Adults (life course): This area has little funding (orange, indicating opportunity for catalytic investment); that has been identified as a priority by some partners, despite limited funding beingallocated (light grey, indicating moderate opportunity); and has moderate potential health and economic impact (light grey)KEYPotential opportunity for funder/partner engagementModerate opportunity (e.g. some existing funding, moderate impact)Low opportunity (saturated space, not noted as a priority area)Key PopulationsLow-income populationsMobile populations; nomadic, scattered, and border-settled populationsMigrant populationsHealthcare personnelNon- and/or under-immunized children; children requiring “catch-up” vaccinationHidden populations (e.g. individuals living in remote areas, community newcomers)Adults (life course)Pregnant womenInfants“Active refuser” populations“Hidden” urban poor populationTechnical SupportImproving operational execution of supplemental immunization activitiesImproving national disease screening capacitiesConsider alternate indicators and inequality measures to understand immunizationcoverage challengesSupport establishment of systematic, methodological, structured approaches to guidedecision makers through considering all evidenceImplementing community-based approaches to social mobilization, handling vaccinenoncompliance, and addressing vaccine safety issuesDevelop approaches to address lagging immunization (esp. for low-income/underservedpopulations) in MIC and HICPage 10 of 19FundingFunder/partner priorityPotential impactIs area known to havecurrent or recent past donorfunding?Has topic been identified as a donor orkey partner (e.g. WHO) priority,regardless of funding availability?What is the potential impact (i.e.lives saved, return oninvestment, etc.)?
KEYPotential opportunity for funder/partner engagementModerate opportunity (e.g. some existing funding, moderate impact)Low opportunity (saturated space, not noted as a priority area)Process (Structures) SupportStrengthen the technical capacities of NITAGsTrain secretariats and members on
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