Background

CEPI has contracted with the Brighton Collaboration, through the Task Force for Global Health, to harmonize the
safety assessment of CEPI-funded vaccines via its Safety Platform for Emergency vACcines (SPEAC) Project.
A key aspect of this harmonization has been creation of lists of priority potential adverse events of special interest
(AESI) that are relevant to vaccines targeting CEPI target diseases.

The initial AESI list for COVID-19 was approved March 5, 2020 based on the first published experiences from China.
Subsequently PubMed searches were done on a daily basis and new articles screened for newly emerging COVID-
19 clinical patterns and complications. A full description of the methodology and results including citations for
the first two COVID-19 AESI lists is available on the Brighton website.

The COVID-19 list was presented to the WHO global Advisory Committee on Vaccine safety (GACVS) at a virtual
meeting held May 27-28, 2020. The GACVS agreed to adopt the AESI list.1 At the time it was clearly understood
that new AESI could be added to the COVID-19 list as needed based on new knowledge learnt during the global
pandemic. Accordingly, SPEAC continues to monitor the literature with quarterly updates to the AESI list planned
(September 9 and December 9, 2020; March 10 and June 9, 2021. This deliverable presents the results of the 1st
quarterly update and includes modifications to streamline the search strategy.