WHO Informal Consultation on Recommendations to Assure the Quality, Safety and Efficacy of Enterovirus 71 Vaccines

Overview

Enterovirus A71 (EV71) is one of the major causative agents of hand, foot and mouth disease (HFMD) and is sometimes associated with severe central nervous system syndromes. Vaccines against EV71 infection have been developed or are in development in several countries and a few have been licensed in China. In response to requests from some of these countries, WHO convened a working group meeting in Shanghai, China, from 11 to 12 September 2019 to develop WHO Recommendations to assure the quality, safety and efficacy of Enterovirus 71 vaccines. Following the working group meeting, a drafting group prepared the first draft of the recommendations based on the consensus reached at the meeting. This draft document was posted on WHO’s website for public consultation and comments were received from relevant regulators, manufacturers and individual experts. To review the draft recommendations further, as well as the comments received through the public consultation, an informal consultation was convened in June 2020 via WebEx with participation by members of the drafting group, representatives of regulators and vaccine manufacturers. Following intense discussion, consensus was reached and a revised draft was finalized. It was agreed to submit the final draft to the Expert Committee on Biological Standardization (ECBS) for review and adoption this year.