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Objective To evaluate the evidence describing how the controlled temperature chain approach for vaccination could lead to improved equitable immunization coverage in low- and middle-income countries. Methods We created a theory of change construct from the Controlled temperature chain: strategic roadmap for priority vaccines 2017-2020, containing four domains: (i) uptake and demand for the approach; (ii) compliance and safe use of the approach; (iii) programmatic efficiency gains from the approach; and (iv) improved equitable immunization coverage. To verify and improve the theory of change, we applied a realist review method to analyse published descriptions of controlled temperature chain or closely related experiences. Findings We evaluated 34 articles, describing 22 unique controlled temperature chain or closely related experiences across four World Health Organization regions. We identified a strong demand for this approach among service delivery providers; however, generating an equal level of demand among policy-makers requires greater evidence on economic benefits and on vaccination coverage gains, and use case definitions. Consistent evidence supported safety of the approach when integrated into special vaccination programmes. Feasible training and supervision supported providers in complying with protocols. Time-savings were the main evidence for efficiency gains, while cost-saving data were minimal. Improved equitable coverage was reported where vaccine storage beyond the cold chain enabled access to hard-to-reach populations. No evidence indicated an inferior vaccine effectiveness nor increased adverse event rates for vaccines delivered under the approach. Conclusion Synthesized evidence broadly supported the initial theory of change. Addressing evidence gaps on economic benefits and coverage gains may increase future uptake. [phrase omitted] [phrase omitted] Objectif Evaluer les preuves exposant la manlere dont la chaine de temperature controlee pourrait constituer l'approche Ideale pour garantir une couverture vaccinale plus equitable dans les pays a revenu faible et intermediaire. Methodes Nous avons elabore un concept base sur la theorie du changement figurant dans Chaine de temperature controlee: feuille de route strategique pour les vaccins prioritaires 2017-2020, et portant sur quatre domaines: (i) demande et adhesion a l'approche; (ii) respect et securite d'utilisation de l'approche; (iii) avantages de l'approche au niveau de l'efficacite des programmes; et enfin, (iv) couverture vaccinale plus equitable. Afin de verifier et d'affiner la theorie du changement, nous avons employe une methode de synthese realiste destinee a analyser les descriptions publiees concernant la chaine de temperature controlee ou toute autre experience etroitement liee au sujet. Resultats Nous avons examine 34 articles decrivant 22 chaines de temperature controlee ou d'autres experiences similaires dans quatre regions de l'Organisation mondiale de la Sante. Nous avons identifie une forte demande pour cette approche chez les fournisseurs de services; cependant, pour declencher une demande identique chez les legislateurs, il faut plus d'arguments axes sur les retombees economiques et l'amelioration de la couverture vaccinale, ainsi que des definitions de cas d'utilisation. De nombreux elements probants ont confirme que l'approche etait sure lorsqu'elle est integree dans des programmes de vaccination speciaux. Assurer un niveau de formation et de supervision acceptable a permis aux fournisseurs de se conformer aux protocoles. Le gain de temps est le principal atout en termes d'efficacite, tandis que les donnees sur la reduction des couts sont limitees. Stocker les vaccins au-dela de la chaine du froid a rendu la couverture vaccinale plus equitable car les populations difficiles a atteindre ont ainsi pu y avoir acces. Rien n'a permis d'indiquer une diminution de l'efficacite des vaccins ou un taux d'effets indesirables plus eleve pour les vaccins fournis dans le cadre de cette approche. Conclusion La synthese des preuves a largement corrobore la theorie du changement. Apporter des arguments supplementaires pour demontrer ses bienfaits en matiere d'economie et de couverture vaccinale pourrait favoriser l'adhesion. [phrase omitted] Objetivo Evaluar las pruebas que describen como el enfoque de la cadena de temperatura controlada para la vacunacion podria suponer una mejora de la cobertura de inmunizacion equitativa en los paises de ingresos bajos y medios. Metodos Se creo un constructo de teoria del cambio a partir de la Cadena de temperatura controlada: hoja de ruta estrategica para las vacunas prioritarias 2017-2020, que contiene cuatro dominios: (i) adopcion y demanda del enfoque; (ii) cumplimiento y uso seguro del enfoque; (iii) beneficios del enfoque en terminos de eficacia del programa; y (iv) mejora de la cobertura de inmunizacion equitativa. Para verificar y mejorar la teoria del cambio, se aplico un metodo de revision realista para analizar las descripciones publicadas de la cadena de temperatura controlada o de experiencias muy relacionadas. Resultados Se evaluaron 34 articulos, que describian 22 experiencias especificas de cadena de temperatura controlada o muy relacionadas en cuatro regiones de la Organizacion Mundial de la Salud. Se identifico una fuerte demanda de este enfoque entre los prestadores de servicios; sin embargo, para generar un nivel igual de demanda entre los responsables de formular politicas se requieren mayores pruebas sobre los beneficios economicos y de la cobertura de vacunacion, asi como definiciones de casos de uso. Las pruebas consistentes apoyan la seguridad del enfoque cuando se integra en programas especiales de vacunacion. La formacion y la supervision factibles ayudaron a los prestadores a cumplir los protocolos. El ahorro de tiempo fue la principal prueba de los beneficios de eficiencia, mientras que los datos de ahorro de costes fueron minimos. Se informo de una mayor cobertura equitativa cuando el almacenamiento de vacunas mas alla de la cadena de frio permitio el acceso a poblaciones de dificil acceso. No hay pruebas que indiquen una menor eficacia de las vacunas ni un aumento de las tasas de efectos adversos de las vacunas suministradas mediante este enfoque. Conclusion La sintesis de las pruebas apoyaron ampliamente la teoria inicial del cambio. Resolver las deficiencias de las pruebas sobre los beneficios economicos y de cobertura podria aumentar su adopcion en el futuro., Introduction In many low- and middle-income countries, standard cold chain (2-8 [degrees]C) capacity for vaccine delivery is often restricted or unreliable, (1) leading to vaccine stock-outs, increasing equipment costs and [...]

Background: Microarray patches (MAPs) are innovative, needle-free vaccine delivery systems, suitable for administration by minimally trained health care workers or trained community health workers. Their introduction may transform immunization programmes, particularly for vaccines where high coverage is required for population immunity, such as measles, and where vaccine delivery is challenging, such as in low- and middle-income countries. Recognizing the need to understand how best to tailor these products to reflect country priorities, workshops on measles and rubella MAPs (MR-MAPs) were conducted in multiple regions to collect insights on needs and preferences from relevant stakeholders at country level. Methods: The CAPACITI Innovation Framework was used to structure stakeholder discussions in nine countries in the period from August 2022 to July 2023. The discussions, building on the findings from a situation analysis on the barriers related to measles and rubella vaccine delivery, followed the four-step process outlined in the framework. Results: Key barriers hindering delivery of measles and rubella vaccines across the countries were in the categories of human resource management, service delivery, and demand generation. MR-MAP attributes that stakeholders believed would reduce or eliminate these barriers included ease of preparation and administration, improved thermostability, fewer (ancillary) components, and single-dose presentation. Some attributes such as the site of administration, wear time, and storage volume could exacerbate certain barriers. Based on an understanding of key barriers, product attributes, and underserved populations, stakeholders identified several potential use cases for MR-MAPs: (i) delivery at a fixed health post, (ii) delivery through outreach sessions conducted by health workers, and (iii) administration by community health workers. To enable robust national decision making about the introduction of MR-MAPs and successful implementation, global and national evidence on feasibility and acceptability of MR-MAPs should be generated. To prepare for the potential introduction of MR-MAPs, immunization programmes should evaluate their immunization policies based on their preferred use cases and modify them if needed, for example, to enable community health workers to administer vaccines, along with making programmatic adjustments to waste management and training. Conclusions: MR-MAPs have the potential to reduce key barriers to MR delivery. Yet, their future impact depends on the ability of global stakeholders to steer the development of MR-MAPs to be responsive to country needs and preferences. The generation of evidence to enable robust decision making, timely modification of vaccine policies, and addressing programmatic considerations will be key to successful uptake. [ABSTRACT FROM AUTHOR]

Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare that they have no conflict of interest.