An adverse event is an undesirable experience associated with the use of a medical product such as a vaccine. The Council for International Organizations of Medical Sciences (CIOMS) defines an adverse event of special interest (AESI) as a scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate. Such an event might require further investigation in order to characterize and understand it.
The SPEAC Project identifies AESIs based on three criteria:
- Known association with immunization or a specific vaccine platform.
- Occurrence during wild-type disease as a result of viral replication and/or immunopathogenesis.
- Theoretical association based on animal models.
AESI lists are meant to be a reference; if certain AESIs 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.
AESI Landscape Reviews
SPEAC experts conduct landscape reviews to inform which adverse events of special interest (AESI) should be prioritized. These landscape reviews are part of the development process for the list of AESI for each CEPI-priority pathogen. SPEAC experts are currently updating AESI lists developed in an earlier phase of the project. All landscape reviews and updates completed to date are listed below.
- Priority List of Adverse Events of Special Interest: Marburg
- Priority List of Adverse Events of Special Interest: Mpox
- Priority List of Adverse Events of Special Interest: Nipah
- Priority List of Adverse Events of Special Interest: Lassa Fever and MERS
- Landscape analysis and Priority list of Adverse Events of Special Interest (AESI): Lassa Fever
- Priority List of Adverse Events of Special Interest: Rift Valley Fever
- Updated Landscape Analysis for Priority List of Adverse Events of Special Interest (AESI): Rift Valley Fever
- Priority List of Adverse Events of Special Interest: Chikungunya
- Updated Landscape Analysis for Priority List of Adverse Events of Special Interest (AESI): Chikungunya
- Priority List of Adverse Events of Special Interest: COVID-19
- First update – Priority List of Adverse Events of Special Interest: COVID-19
- Second update – Priority List of Adverse Events of Special Interest: COVID-19
- Third update – Priority List of Adverse Events of Special Interest: COVID-19
- Landscape Analysis of Background Rates Methods and Dashboard to Capture Background Rates of Interest for COVID-19 AESI Methods
