Mpox CEM template protocol. APPENDIX 1: Mpox Adverse Events of Special Interest (AESIs)

Appendix to SPEAC's Mpox Cohort Event Monitoring (CEM) Template Protocol, focusing on adverse events of special interest (AESI), based on SPEAC Mpox AESI list, v1.1, 17 September 2024.

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This list of potential Adverse Events of Special Interest (AESI) that could follow vaccines to prevent Mpox 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 the available data for mpox vaccines, which are to be used in response to the 2024 Public Health Emergency of International Concern (PHEIC) for mpox in Africa.