Vaccine Safety Resources for Mpox
Here you will find The Safety Platform for Emergency vACcines (SPEAC) Project’s 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.
CEM Implementation Templates
Templates to support implementation of Cohort Event Monitoring (CEM) for active safety surveillance following mpox vaccination. This package includes resources for study design, operational planning, data management, and statistical analysis.
CEM Protocol Template
Template protocol for designing and implementing cohort event monitoring studies following mpox vaccination.
Operational Planning*
Template to support study setup, roles, workflows, and implementation timelines.
Data Management Plan*
Template for data collection, management, quality assurance, and governance.
Statistical Analysis Plan*
Template outlining analysis populations, endpoints, and methods for safety evaluation.
*Developed collaboratively by PATH, the National Pharmacovigilance Centre (CNPV) of the Democratic Republic of the Congo (DRC), Africa CDC, WHO AFRO, and SPEAC.
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.
List of potential AESI that could follow vaccines to prevent Mpox developed based on criteria 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.
Informed consent form designed for adults who will receive an mpox vaccine.
Resource focusing on key elements for data collection for pregnant women and newborns.
