The GVDN™ is a technical partner with the COVID-19-SENT-[Africa-8], Sentinel surveillance of adverse events of special interest (AESIs) after vaccination with COVID-19 vaccines in African Advanced Market Commitment-92 eligible countries, project.* Hospital-based sentinel surveillance designed to detect safety signals of rare adverse events of special interest (AESIs) or to evaluate safety signals arising from other sources, following vaccination with COVID-19 vaccines, is being implemented in eight African AMC-92 countries in the Alive (African Leadership in Vaccinology Expertise) Network: Mali, Ghana, Nigeria, Ethiopia, Kenya, Malawi, Mozambique, Eswatini. Across these countries over 147 million people have received at least one COVID-19 vaccination.
The GVDN™ has assisted with development of a common operational model for data collection at sites, screening and case report forms using the REDCap platform, development of a statistical analysis plan, support training of site teams, review data and support data analysis. Data from the participating countries will be included in the GVDN™ database for pooled analysis on the association of COVID-19 vaccines and risk for myocarditis and pericarditis, Guillain Barre syndrome (GBS), thrombosis with thrombocytopenia syndrome/vaccine-induced immune thrombotic thrombocytopenia (TTS/VITT), and other AESI of interest to the network. These analyses focus on variable risk by age, gender, race, and type and manufacturer of vaccine.
*This project is funded by Gavi, the Vaccine Alliance.