SPEAC has created an Ebola Adverse Events of Special Interest (AESI) List, to support the vaccine response to the 2026 Bundibugyo virus disease epidemic in the Democratic Republic of Congo and Uganda. AESI lists provide priority safety outcomes to consider for vaccine safety assessment during clinical trials and pharmacovigilance activities.
AESI lists facilitate standardized vaccine safety monitoring by vaccine developers, researchers, regulators, and public health professionals. The lists serve as a reference for priority safety outcomes that may occur and provide links to case definitions, companion guides, and data collection forms to support their evaluation. Note that in clinical trials, only a subset of AESIs in the 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. Tailored Ebola AESI lists specific to the ChAdOx1, rVSV, and mRNA vaccine platforms are available through SPEAC’s Zenodo site and SPEAC’s Safety Intelligence Platform. These tailored lists highlight AESIs SPEAC recommends be protocol-specified in clinical trials. While an AESI is not necessarily expected to occur following vaccination, identifying and monitoring these possible safety events helps support robust safety assessments and benefit-risk evaluations.
The Ebola AESI List and related SPEAC resources can support a range of activities, including protocol development, safety surveillance planning, data collection, signal detection, and regulatory review.
The addition of Ebola comes at a time when global health partners continue to monitor and respond to Ebola outbreaks, underscoring the importance of maintaining tools and resources that support preparedness for vaccine safety assessment. Standardized AESI lists facilitate consistent monitoring approaches across studies, programs, and geographic regions.
What Are AESI Lists?
SPEAC AESI Lists are pathogen-specific resources that identify adverse events that may require focused attention in vaccine safety monitoring programs. These lists are intended to support:
- Vaccine development and clinical trials
- Pharmacovigilance and post-authorization safety monitoring
- Benefit-risk assessments
- Safety surveillance planning
- Regulatory and public health decision-making
By providing a common reference point, AESI Lists help promote consistency and comparability across vaccine safety activities.
Access the Ebola AESI List
The Ebola AESI List is available here:
https://speacsafety.net/tools/aesi-lists/ebola/
Explore the Full AESI Lists Platform
SPEAC maintains AESI Lists for a growing number of pathogens and disease areas to support vaccine safety preparedness and response efforts.
Browse all available AESI Lists:
