Table 1 Preconditions for success and remaining gaps

GoR

• MoH

• RBC

• FDA

• National Ethics Committee

• Strong, committed leadership

• Strong coordination mechanisms between the MoH, RBC, and Rwanda FDA

• Partnerships in place with IQVIA, CEPI

• Experience from vaccination campaigns: Ebola, COVID, and Mpox planning

• Existing healthcare infrastructure, including human resources, hospital sites ready to host clinical trials, supply chain capabilities

• Learning from tabletop exercises

• Need for parallel processes

• Contextualizing study designs

• Surge support for conducting trials and analyzing data

• Surge laboratory and trial site support

IQVIA

• Extensive trial experience and local CRO partnerships

• Tools, forms, and protocols that could be rapidly repurposed

• Surge capacity

• Existing pandemic-dedicated personnel

• Existing Vaccine data standards package

• Electronic forms are ready to use

• Adapting study implementation to local context and current circumstances

Sabin

• Phase 2 stage vaccine candidate with available clinical doses, data from multiple clinical trials, and nonclinical efficacy studies

• Trial underway in Uganda/Kenya, including all supportive manufacturing and clinical documentation needed for regulatory and ethics review

• Prior learning on export, import, and labeling of doses

• BARDA supports to use investigational vaccine in Rwanda

• Published Clinical Partnership Framework to enable rapid clinical trial agreement with partner(s) (https://www.sabin.org/resources/clinical-partnership-framework/)

• Non-government-owned vaccine doses available for use in future clinical trials or emergency situations

• Sabin vaccine-specific clinical trial protocols and supporting documentation (e.g., Database, diaries) ready for immediate implementation to gather evidence in case of an outbreak

CEPI

• Deep understanding of 100DM requirements

• R&D operational knowledge and expertise

• Partnership and trust with partners

• Ability to provide funding to support the trial

• Connecting public health intervention needs with scientific evidence generation in support of advancing the product development

• Facilitating the coordination and collaboration in a crisis with respective partners, concentrating on their focus areas

• Need for further scenario planning and trial protocol development tailored for future outbreaks

• Additional strategies for evidence generation and regulatory approval when randomized trials are not feasible

• Manufacturing partnerships with ready candidates