SPEAC's Vaccine Safety Resources for Mpox
The Safety Platform for Emergency vACcines (SPEAC) Project has posted a protocol template for cohort event monitoring for active safety surveillance after vaccination with mpox vaccines. The protocol template includes a list of adverse events of special interest, CEM questionnaires, an adult informed consent form, and key elements for data collection for pregnant women and newborns. All resources are linked below.
This protocol template is to be used as template for observational study protocols for Cohort event monitoring (CEM) for active safety surveillance after vaccination with mpox vaccines.
This list of potential AESI that could follow vaccines to prevent Mpox was developed based on criteria 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, and 3) A theoretical association derived from animal models.
This set of cohort event monitoring (CEM) questionnaires is part of the SPEAC Project’s CEM Protocol Template for active vaccine safety surveillance after vaccination with mpox vaccines.
This adult informed consent form is designed for adults who will receive an mpox vaccine.
This resource focuses on key elements for data collection for pregnant women and newborns.
