Priority List of Adverse Events of Special Interest (AESI) for Marburg Virus Disease Vaccines

This list of potential Adverse Events of Special Interest (AESI) that could follow vaccines to prevent Marburg Virus Disease (MVD) was developed based on criteria established by the Safety Platform for Emergency Vaccines (SPEAC), which include: A known association with immunization or a specific vaccine platform. The occurrence during wild-type disease due to viral replication and/or immunopathogenesis. 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. Note: Several AESI highlighted in gray are included due to their presence in MVD itself but are only relevant for possible live-attenuated vaccines (e.g. live attenuated MARV, measles vector, etc). These are not recommended to include for all platforms, e.g. Adenovirus-vectored vaccines. This list is based on available data for MVD vaccines, for consideration in deployment of investigational MVD vaccines in response to the 2024 outbreak in Rwanda. Adaptions may be needed depending on the application.