Points to consider for manufacturers of COVID19 vaccines

Comments are possible until 8 October 2020

1. EXECUTIVE SUMMARY

This document provides advice to manufacturers on both the process and also 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 document is not to be read as a standalone document. Other relevant documents, as cited, must also be consulted. 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 vaccineassociated enhanced disease. Post-authorization commitments are specified. WHO encourages early, pre-submission discussions with interested manufacturers.

2. INTRODUCTION

The United Nations Children's Fund (UNICEF) and other United Nations (UN) agencies take into consideration advice provided by the World Health Organization (WHO), through its Department of Regulation and Prequalification (RPQ), on the acceptability, in principle, of vaccines considered for purchase by such agencies; this is known as vaccine prequalification (PQ). In addition WHO has developed a time limited Emergency Use Listing Procedure (EUL) to expedite the availability of medical products needed in public health emergency situations, to assist interested UN procurement agencies and Member States on the acceptability for use of specific products in the context of a public health emergency, based on an essential set of available quality, safety, and efficacy/immunogenicity/ performance data.

Both procedures include, for each product, the evaluation of data submitted contained in the Common Technical Document (CTD) format. The review of the quality, safety and efficacy/immunogenicity data is performed by WHO experts. Their recommendations are taken into account by WHO in the decision-making process for prequalification or EUL of each individual product. The WHO evaluation of vaccines either for EUL or PQ, considers the suitability for use in Lowand Middle-Income Countries (LMICs). In their reviews WHO focuses on information that may not be part of the NRA approval process, although in practice they also do at least a verification of what is expected to have been evaluated by the NRA. Any vaccine submitted for WHO assessment should have been authorized by the reference NRA (emergency use approval or equivalent or standard licensure/marketing authorization). This document should be read in conjunction with the following:

1. “Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies”, WHO Technical Report Series 978, Annex 6, 2013
2. WHO EUL document
3. “Guidelines on clinical evaluation of vaccines: regulatory expectations”, WHO Technical Report Series 1004, Annex 9, 2017 
4. COVAX SAGE Compendium of Covid-19 vaccine research questions
5. “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.
6. “Points to Consider for assuring the quality, safety and efficacy of RNA vaccines” (currently under development).

Based on the current status of development of Covid-19 vaccines candidate, the extent of the available quality, safety and efficacy data and regulatory approvals by relevant NRAs, WHO shall follow either EUL process or Prequalification. Once a product has been listed under the EUL procedure, the development of the product must contin

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