Public consultation for review of draft Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO

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Public consultation for review of draft Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO
Organizations and individuals are invited to review and provide comments/suggestions on the draft Document “Considerations for the assessment of Covid-19 vaccines”

 

Please provide your comments in writing to WHO no later than 08 October 2020, 18:00 CEST by email at the following address WHOEUL@who.int.

:: CONSIDERATIONS FOR EVALUATION OF COVID19 VACCINES – Points to consider for manufacturers of COVID19 vaccines pdf, 406kb
:: Comments Form doc, 136kb

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 (1)
:: WHO EUL document (2)
:: “Guidelines on clinical evaluation of vaccines: regulatory expectations”, WHO Technical Report Series 1004, Annex 9, 2017 (3)
:: COVAX SAGE Compendium of Covid-19 vaccine research questions (4)
:: “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. (5)
:: “Points to Consider for assuring the quality, safety and efficacy of RNA vaccines” (6)
:: “WHO Target Product Profiles for COVID-19 Vaccines” (7)

(1) http://www.who.int/immunization_standards/vaccine_quality/TRS_978_61st_report_Annex_6_PQ_vaccine_procedure.pdf
(2) https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/EUL_PQ_Vaccines/en/
(3) http://www.who.int/biologicals/expert_committee/WHO_TRS_1004_web_Annex_9.pdf
(4) COVAX SAGE Compendium of Covid-19 vaccine research questions
(5) https://www.who.int/publications/m/item/DNA-post-ECBS-1-sept-2020
(6) Currently under development and to be published at https://www.who.int/biologicals
(7) https://www.who.int/publications/m/item/who-target-product-profiles-for-covid-19-vaccines