Consultation Document for Case Definitions: Adverse Events of Special Interest and Adverse Events Following Immunization during COVID-19 Vaccine Introduction

Abstract

This consultation document lists and provides definitions of adverse events of special interest and adverse events following immunization for COVID-19 vaccines that can be used as a common language for reporting these events. The importance of standardizing definitions of adverse events and their guidelines is that this will allow for data comparability and will lead to a better understanding of the adverse event. COVID-19 vaccine safety surveillance will be of the utmost importance and will require collaboration by all stakeholders once a vaccine is introduced. Sharing data and information will be critical and thus criteria and definitions for events and clinical developments need to be standardized as part of the vaccine safety surveillance. Regarding post-vaccination adverse event surveillance, conventional vaccine safety surveillance and pharmacovigilance systems will need to adapt quickly to new surveillance techniques and ensure that post-vaccination safety and exposure information is collected and processed quickly. Clinical studies of vaccines that have received emergency authorization for use will require close follow-up by multiple stakeholders to ensure that use of these vaccines will continue to be as safe and effective in the field as in clinical trials.