The Background Rates of Adverse Events for Vaccine Evaluation (BRAVE) project is led by the Global Vaccine Data Network (GVDN) to establish a network of sites, as a platform for the generation of evidence of safety, for the vaccines being developed against CEPI priority pathogens relevant to the African continent.

The BRAVE project is a multi-country observational study designed to establish baseline rates of adverse events of special interest (AESIs) in Africa. This initiative is critical for supporting ongoing vaccine safety monitoring and public health decision-making, particularly in the context of introducing new vaccines. The project includes both retrospective and prospective components, implemented across hospitals in Nigeria, Ghana, Kenya, the DRC Congo and Rwanda.

Researchers from the University of the Witwatersrand in South Africa, Navrongo Health Research Centre in Ghana, International Foundation Against Infectious Diseases in Nigeria, Eagle Research Centre in Rwanda, University of Kinshasa in the DRC Congo and Health Research Operations Kenya (operating as the KEMRI-Wellcome Trust Research Programme) in Kenya will validate relevant safety endpoint definitions from the SPEAC project within their local contexts and adapt these as needed to generate background rates.

The prospective component of the BRAVE study is the monitoring of hospital admissions, identifying AESI cases using predefined diagnostic criteria, and to estimate the incidence rates of AESIs. The retrospective component of the study will utilise electronic health records (EHR) data, where available and deemed reliable, to estimate background rates of selected AESIs using International Classification of Diseases (ICD)-coded diagnoses.

Surveillance of the same AESIs in a comparable population after a vaccine is introduced, and comparison of these ‘observed rates’ with the established ‘background rates’, can help identify potential vaccine safety signals that warrant further investigation.