Assessing the Readiness of Local Vaccine Manufacturing in African Countries: Protocol for a Scoping Review.

backgroundAlthough 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.

objectiveThis 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.

methodsThis 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.

resultsEthics 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 synthesis and expert consultation are planned from April to May 2026. We anticipate submitting the completed scoping review paper by June or July 2026.

conclusionsThis review will generate Africa's first continent-focused evidence map of vaccine-manufacturing readiness, compiling indicators by domain, comparing frameworks, identifying gaps, and informing a multidomain Country Readiness Assessment Index for policy and investment decisions.

trial registrationOpen Science Framework 10.17605/OSF.IO/UVSWX; https://osf.io/uvswx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/81231.