FAQs

• 1. What is BRAVE?

  The BRAVE project (Background Rates of Adverse events for Vaccine Evaluation in Africa) is a multi-partner project to establish reliable background rates of adverse health events that occur across the populations of five countries in Africa over a period of time. 

  Understanding rates of adverse health events occurring before a particular vaccine is introduced to a region (background rates) allows public health experts to assess vaccine safety by comparing those rates to rates of the same events occurring across the population after a particular vaccine is introduced. 

• 2. Why is BRAVE important for vaccine safety in Africa?

  People trust vaccines when they know that their safety has been thoroughly evaluated. However, rigorous assessment of vaccine safety across African countries using African data has not previously taken place.  BRAVE is working to close that gap and ensure that Africans can rely on vaccine safety information that is derived in Africa, from African data.  

• 3. Who is involved in the BRAVE Project?

  BRAVE is a collaborative project led by the GVDN (Global Vaccine Data Network) and its partner sites in Africa.  

  Participating countries and lead organisations: 

  • Ghana (Navrongo Health Research Centre) 

  • Kenya (KEMRI Wellcome Trust Research Programme, Kilifi) 

  • Nigeria (International Foundation Against Infectious Disease in Nigeria (IFAIN)) 

  • Rwanda (Eagle Research Center, Kigali) 

  • Democratic Republic of Congo (University of Kinshasa) 

  In addition, BRAVE’s African Coordinating Centre (ACC) coordinates training and acts as the project data hub. The ACC is based in South Africa (Wits ALIVE at the University of the Witwatersrand) and GVDN’s Global Coordinating Centre (GCC), is based in New Zealand.  The GCC leads the coordination of the project and liaises with key stakeholders including the funder, CEPI.  

• 4. What are ‘Background Rates’ of ‘Adverse Events of Special Interest’?

  Background rates are how often a health condition or medical event naturally occurs in a population over time. 

  In the context of vaccine safety research, an Adverse Event refers to any unwanted health outcome. Adverse events that happen after vaccination can include very mild events (like a sore arm or mild fever) to serious conditions (such as allergic reactions or heart issues). Importantly, just because an adverse event happens after vaccination does not mean the vaccine caused it. 

  An Adverse Event of Special Interest (AESI) is a specific health outcome monitored closely because it could be linked to a vaccine or has been associated with vaccines in the past.  

  Background rates for AESIs provide a baseline: they show how often these events happen before a vaccine is introduced. Comparing these rates to what happens after vaccination helps experts spot changes that may need further investigation to determine if there’s a causal link or another explanation. 

• 5. Why do we need background rates for vaccine evaluation?

  Background rates are essential for interpreting vaccine safety. Clinical trials may not capture rare or long-term adverse events, so ongoing monitoring after vaccines are introduced (known as post-licensure surveillance) is crucial. Without background rates, it’s difficult to know if health events seen after vaccination are simply coincidental or possibly related to the vaccine. BRAVE provides these real-world benchmarks, helping experts quickly and accurately assess vaccine safety. 

• 6. How might BRAVE data be used in vaccine safety assessments to support public health decision-making?

  BRAVE findings can help regulators, researchers, and public health agencies evaluate the safety of new vaccines as they are introduced. By comparing background rates of adverse events of special interest to rates observed after vaccination, experts can quickly identify any changes that may signal a potential safety concern. If a difference is detected, further investigation can determine whether the vaccine is linked to the event or if another factor is responsible. 

  Evidence-based public health decision making supports public trust in immunisation programs. 

• 7. What types of adverse events are monitored?

  BRAVE focuses on conditions or events that are commonly assessed in vaccine safety studies. These include neurological (brain), cardiovascular (heart and circulation), renal (kidneys), respiratory (breathing), musculoskeletal (muscles and bones) and haematologic (blood) and obstetric (pregnancy, birth and newborns) conditions/events. 

• 8. Where does BRAVE get its data?

  BRAVE data comes from national health systems, hospital databases and community population surveys within the participating countries. Hospital records provide information on diagnoses and health events documented by medical professionals, while community surveys help capture health events that may not be recorded in hospitals, offering a broader view of population health. All data used by BRAVE are anonymised at source, ensuring that no identifiable personal information is shared or published. BRAVE study team researchers work with local health workers and authorities to ensure accuracy and completeness.

• 9. What ethical guidelines does BRAVE follow?

  The BRAVE project follows both local and international ethical guidelines for research. Before starting data collection, each participating site must provide evidence of ethics approval from their local/national ethics committee or institutional review board. Sites must also ensure they comply with all applicable data protection and/or privacy laws. This process is systematically managed and documented. 

• 10. Will data be publicly available?

  Aggregated, anonymised findings will be shared on the BRAVE website and in scientific publications. 

• 11. Who funds the BRAVE Project?

  BRAVE is funded in whole by CEPI, the Coalition for Epidemic Preparedness Innovations.