The SPEAC Project has released an updated list of Adverse Events of Special Interest (AESI) for Marburg virus disease (MVD) vaccines, v2.1. This update reflects the latest evidence from ongoing vaccine development efforts, advances in filovirus pathogenesis research, and emerging safety data from peer-reviewed and gray literature sources.
As with all SPEAC AESI lists, this update is grounded in three primary criteria for an AESI:
- Known association with immunization or a specific vaccine platform
- Occurrence during wild-type disease due to viral replication and/or immunopathogenesis
- Theoretical association supported by mechanistic insights or animal models
This revision incorporates scientific findings relevant to filovirus vaccine platforms in development—including viral vector (adenovirus, VSV) and other platforms—as well as considerations for special populations such as pregnant women, children, and immunocompromised individuals. It also provides guidance as to how to consider applying the list in clinical trials or other studies, e.g. when to include an AESI as a protocol-specified safety outcome.
The updated AESI list supports vaccine developers, regulators, and public health stakeholders in harmonizing safety monitoring efforts, improving comparability across trials, and accelerating preparedness for potential outbreaks. This update was expedited given the recently confirmed Marburg virus disease outbreak in Ethiopia. As of 30 November 2025, 12 confirmed cases have been reported, and 8 (75%) have been fatal. Three case-patients have recovered, and one is still being treated. Additional suspected cases are under investigation and active contact tracing is ongoing. Tools to conduct rigorous vaccine safety surveillance, like the AESI list, will be essential for possible trials of investigational MVD vaccines during the outbreak response.
The WHO Disease Outbreak News (DON) regarding the outbreak in Ethiopia can be found here: https://www.who.int/emergencies/disease-outbreak-news/item/2025-DON585.
The SPEAC Executive Board welcomes input on this AESI list and will revise it as new data emerge. Feedback may be shared with the SPEAC and Brighton Collaboration team at bc-coordinator@taskforce.org.
👉 Access the updated Marburg AESI list here:
https://speacsafety.net/tools/aesi-lists/marburg/
