Questions and answers (Q&A) on regulatory matters related to the introduction and pharmacovigilance of vaccines against COVID-19. 19 January 2021
Other Language Versions
Abstract
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.
Subject
Collections
This notice should be preserved along with the article's original URL.Attribution-NonCommercial-ShareAlike 3.0 IGO
Related items
Showing items related by title, author, creator and subject.
-
La aprobación de CoronaVac en Brasil y Chile: algunas lecciones sobre los retos regulatorios de vacunas
(2022-07-13)[RESUMEN]. Este análisis compara y sistematiza algunos hitos de la aprobación en Brasil y Chile de la vacuna CoronaVac del laboratorio chino Sinovac, desde diciembre 2020 hasta octubre 2021, respecto de cómo se fundamentó ... -
Summary on Advances in the Development of Vaccines against COVID-19, 3 April 2020
(Washington, D.C., PAHO, 2020-06-03)This document presents a brief summary of vaccines in development for COVID-19. At the end of 2019, the new SARS-CoV-2 coronavirus emerged. Although there is not yet a vaccine against this virus, the field of research for ... -
Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies
(Washington, D.C., PAHO, 2021-07-16)The objective of this document is to identify the main gaps in readiness for the introduction of COVID-19 vaccines and to propose the regulatory procedures needed to manage and reduce these gaps, which were detected through ...
