Safety Platform for Emergency vACcines (SPEAC)
The Coalition for Epidemic Preparedness Innovations (CEPI) mission is to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people during outbreaks (https://cepi.net/). To achieve its mission CEPI is supporting the development of a wide range of vaccine candidates and platform technologies against prioritized targets.
CEPIs multipronged approach requires harmonization of safety assessment across platforms and targets to allow for meaningful analysis and interpretation of the safety profiles of CEPI vaccines. CEPI has partnered with the Brighton Collaboration in funding the Safety Platform for Emergency vACcines (SPEAC) project in 2019 through the Task Force for Global Health.
SPEAC aims to support the emerging CEPI portfolio by creating capacity and solutions for harmonized safety assessment of CEPI vaccines. Key activities are:
1. Safety monitoring: creation of a large pool of vaccine safety trained DSMB members in target countries to support developers, and the operation of a meta-DSMB that will liaise with study DSMBs across trials and advise on safety issues across different products, target pathogens and platforms
2. Toolbox: Creation of tools (definitions, templates, checklists, prioritized events of interest, landscape analysis on reported events and background rates) and standards (data collection matrices) to monitor safety of CEPI funded vaccines for the developers
3. Evaluation: quality assurance and continuous improvement of SPEAC outputs and its overall impact
4. Coordination & communication: project coordination and interaction with stakeholders (developers, regulators, CEPI, scientific community)
The expertise and materials of the Brighton Collaboration are essential for monitoring the safety of CEPI vaccines.