Priority List of Adverse Events of Special Interest for Ebola

The SPEAC Executive Board welcomes input on this AESI list and will update it periodically. Please share input with the SPEAC and Brighton Collaboration team at bc-coordinator@taskforce.org.

This list of potential Adverse Events of Special Interest (AESI) that could follow vaccines to prevent Ebola was developed based on criteria established by the Safety Platform for Emergency Vaccines (SPEAC), which include:  

1. A known association with immunization or a specific vaccine platform. 
2. The occurrence during wild-type disease due to viral replication and/or immunopathogenesis. 
3. A theoretical association derived from animal models.  

Special populations, including pregnant women, children, adolescents, and immunosuppressed individuals, may experience an increased frequency and severity of any of the AESIs listed as relevant to all populations. There are also specific AESI that are of particular relevance to special populations, and these are listed according to the population. It is important to note that children, pregnant women and immunocompromised individuals may also have increased severity of expected local and systemic reactogenicity, as well as unexpected autoimmune conditions.  

This list is based on available data for Ebola vaccines, for consideration in deployment of investigational vaccines in response to the 2026 epidemic of Bundibugyo virus disease (BVD) in the Democratic Republic of Congo and Uganda. Adaptions may be needed depending on the application. 

Note: This AESI list is meant to be a reference; if certain AESIs on the list will be captured in routine safety surveillance in a study, those AESIs may not need to be protocol-specified. Only a subset of the AESI list will typically need to be included as protocol-specified AESIs: those that would require a systematic approach to data collection to characterize; or that may not be captured in routine safety surveillance.