African COVID-19 Vaccine Safety Surveillance (ACVaSS)

The GVDN® is a technical partner with the African COVID-19 Vaccine Safety Surveillance (ACVaSS) 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 in African Advanced Market Commitment-92 (AMC-92) eligible 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 Barré 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 was funded by Gavi, the Vaccine Alliance.