WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20–22 April 2021

ABSTRACT

This paper presents the key outcomes of the above WHO informal consultation with global stakeholders including regulatory authorities, vaccine developers and manufacturers, academia and other international health organizations and institutions involved in the development, evaluation and use of messenger RNA (mRNA) vaccines. The aim of the consultation was to further clarify the main principles to be presented in an upcoming WHO guidance document on the regulatory considerations in evaluating the quality, safety and efficacy of mRNA prophylactic vaccines for infectious diseases. This WHO guidance document is intended to facilitate global mRNA vaccine development and regulatory convergence in the assessment of such vaccines. The urgent need to develop such a document as a new WHO written standard is outlined in this report along with the key scientific and regulatory challenges. A number of key conclusions are provided at the end of this report along with an update on the steps taken following this meeting.

KEYWORDS:

• WHO
• mRNA vaccines
• prophylactic vaccines
• infectious diseases
• regulatory considerations
• COVID-19

Acknowledgements

The authors would like to acknowledge the critical input from the members of the drafting group: Dr Heidi Meyer (Paul-Ehrlich-Institut, Germany), Dr Margaret A. Liu (WHO consultant, USA), Dr Rebecca L. Sheets (WHO consultant, USA), Dr Keith Peden (Food & Drug Administration, USA), Dr Subin Sankarankutty (Health Sciences Authority, Singapore), and Dr Ka-Wai Wan (Medicines and Healthcare products Regulatory Agency, UK), and consultation meeting participants. M.L., T.Z.: drafted a manuscript and prepared the summary of discussion. T.Z.: designed and coordinated the work. R.S., H.M., I.K.: reviewed and edited the manuscript. I.K.: funding acquisition. The authors alone are responsible for the views expressed in this article and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated. The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Disclosure statement

M.A.L. owns Merck shares as part of her retirement; Merck is on record as developing mRNA for cancer therapy, which is not the subject of this manuscript although the technology is the same. The other authors declare no conflict of interest.

Additional information

Funding

This project was funded by the Center for Biologics Evaluation and Research (CBER)-US Food and Drug Administration through a cooperative agreement between US FDA/CBER and WHO and reference the FAIN number (U01 FD005959).