Roadmap for evaluation of AstraZeneca AZD1222 Vaccine against Covid-19

Overview

In the context of the current public health emergency, regulatory alignment and collaboration are some of the key components that will help to facilitate equitable access to safe and effective vaccines that meet international quality and manufacturing standards. In addition to its procedures for PQ and EUL of vaccines, WHO has also developed principles for regulatory collaboration during the scientific review of any vaccine submitted to WHO for assessment. These principles are based on the framework used for prequalification of the Merck ebola vaccine and subsequent registration in 5 African countries in 2019¹. The principles for collaboration post-introduction have also been strengthening in view of the heightened need for alignment in this area. The scale of cooperation in the context of COVID is anticipated to be much greater in the context of the large number of vaccines under development and the large number of countries who could benefit from such vaccines. This draft roadmap is intended to serve as a model for subsequent product specific vaccine evaluations, provided there is agreement from the manufacturers and the regulators concerned.