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al\u003Cbr>Protocol\u003Cbr>Assessing the Readiness of Local Vaccine Manufacturing in African Countries: Protocol for a Scoping Review |\n| --- |\n|  |\n| Uchenna Anderson Amaechi1*, BDS, MSc; Chukwudi Arnest Nnaji2*, PhD; Kelechi Julian Uzor3*, MBBS, MBA, MPH; Justice Nonvignon4,5*, PhD; Nicolas Ray1*, PhD |\n| 1Institute of Global Health, Faculty of Medicine, University of Geneva, Geneva, Switzerland 2Malaria Consortium, London, United Kingdom\u003Cbr>3Harvard University, Cambridge, MA, United States 4Management Sciences for Health, Arlington, VA, United States 5University of Ghana, Accra, Greater Accra, Ghana\u003Cbr>*all authors contributed equally\u003Cbr>Corresponding Author:\u003Cbr>Uchenna Anderson Amaechi, BDS, MSc Institute of Global Health\u003Cbr>Faculty of Medicine, University of Geneva Campus Biotech\u003Cbr>Chemin de Mine 9 Geneva, 1202 Switzerland\u003Cbr>Phone: 41 0786265288\u003Cbr>Email: uchenna.amaechi@etu.unige.ch\u003Cbr>Abstract |\n\nBackground: Although Africa experiences the highest burden of infectious diseases, the continent currently produces less than 1% of its vaccine needs. In 2021, the African Union set a target to locally produce at least 60% of the continent’s vaccine needs by 2040. However, at the time of developing this scoping review protocol, there is no consolidated, evidence-based framework for assessing national or regional “readiness” to establish or scale vaccine production.  \nObjective: This protocol aims to describe a methodological approach that will be used to review existing literature to identify, map, and synthesize the existing evidence on all relevant frameworks, indicator sets, and policy documents (global or national) developed pre-and post–COVID-19 pandemic (January 1, 2010, to December 31, 2025) that addresses readiness for local human vaccine manufacturing with focus on African countries.  \nMethods: This scoping review will be conducted and reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, following the 9-step framework outlined in the Arksey and O’Malley methodology and further informed by guidance from the Joanna Briggs Institute. We will search MEDLINE (PubMed), Scopus, Web of Science, Africa-focused databases (eg, Africa-Wide Information, African Index Medicus, and African Journals Online), and gray literature. Eligibility criteria will follow Population, Concept, and Context guidelines (Population: 55 African Union member states; Concept: readiness frameworks, indices, indicators, and policies for human vaccine manufacturing; Context: African national or regional initiatives or global frameworks applied to Africa) . Materials in English, French, Portuguese, or Arabic will be included. Publication types will be limited to frameworks, policies, guidance, and reports. Two reviewers will perform calibrated dual screening (Cohen κ) and standardized data charting. We will create an evidence map and inductive thematic synthesis using a vaccine-specific Political, Economic, Social, Technological, Legal, Environmental, plus Market taxonomy. Consistent with the guidance by the Joanna Briggs Institute, critical appraisal will not be performed. An optional expert consultation will help identify missed sources and validate domains.  \nResults: Ethics approval for the expert consultation component was obtained from the University of Geneva Research Ethics Committee (application submitted May 21, 2025; approval September 9, 2025) . The initial search strategy has been finalized, and pilot searches were completed (May-August 2025) . The screening calibration is planned; dual-review title and abstract screening begins in December 2025, with full-text screening and data charting scheduled for January-March 2026. Thematic  \n[https://www.researchprotocols.org/2025/1/e81231](https://www.researchprotocols.org/2025/1/e81231)  \nXSL• FO  \nRenderX  \nJMIR Res Protoc 2025 | vol. 14 | e81231 | p. 1 (page number not f","cbCaifbUXujPJMOf","https://ap.wps.com/l/cbCaifbUXujPJMOf","pdf",158842,13,"English","# Background\n## Objective\n## Methods\n## Results\n## Conclusions\n## Trial Registration","[{\"question\":\"What is the main purpose of this scoping review protocol?\",\"answer\":\"It outlines a methodological approach to review existing literature and map and synthesize evidence on readiness frameworks, indicator sets, and policy documents related to local human vaccine manufacturing in African countries.\"},{\"question\":\"Which types of sources will be included?\",\"answer\":\"Frameworks, policies, guidance, and reports addressing readiness for local human vaccine manufacturing, including materials in English, French, Portuguese, or Arabic.\"},{\"question\":\"How will screening and data charting be performed?\",\"answer\":\"Two reviewers will conduct calibrated dual screening and standardized data charting, and the review will create an evidence map with inductive thematic synthesis without critical appraisal.\"}]","Assessing the Readiness of Local Vaccine Manufacturing in African Countries - Protocol for a Scoping Review | PDF",1790743895,33]