Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO

Overview

This document provides advice to manufacturers on both the process and the criteria that will be used by the World Health Organization (WHO) to evaluate COVID-19 vaccines that are submitted either for prequalification (PQ) or for Emergency Use Listing (EUL). The current status of development of a candidate Covid-19 vaccine, the extent of the available quality, safety and efficacy data and regulatory approvals by relevant NRAs will guide WHO’s decision on which pathway (PQ or EUL) to follow for each vaccine.

The submission and review processes are described. Only vaccines that have undergone phase IIb or phase III studies and have received authorization from a reference NRA should be submitted for consideration. Criteria that will be used to assess clinical trial design, endpoints, and statistical criteria are described. Specific data that should be submitted to answer programmatically relevant questions are outlined. Manufacturing, quality control and labelling requirements are summarized, as are non-clinical data to address the potential for vaccine-associated enhanced disease. Post-authorization commitments are specified.

This document should be read in conjunction with the following:

Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies 
WHO Technical Report Series 978, Annex 6, 2013 

WHO EUL document 

Guidelines on clinical evaluation of vaccines: regulatory expectations 
WHO Technical Report Series 1004, Annex 9, 2017

COVAX SAGE Compendium of Covid-19 vaccine research questions

Guidelines for assuring the quality, safety, and efficacy of plasmid DNA vaccines” adopted by the Seventy-first Meeting of the World Health Organization Expert Committee on Biological Standardization, 24–28August 2020