Questions and answers (Q&A) on regulatory matters related to the introduction and pharmacovigilance of vaccines against COVID-19. 19 January 2021

This document provides answers to the most frequently asked questions related to regulatory mechanisms for the approval and post-monitoring approval of COVID-19 vaccines as well as relevant information on the COVAX Facility requirements related to vaccine eligibility. It also summarizes additional guidance on emergency use authorization processes, WHO emergency use listing procedure applied to COVID-19 vaccines, and the role of regulatory authorities during post-approval monitoring of COVID-19 vaccines.