Executive Summary: WHO Informal consultation on revision of guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines

Overview

The WHO Norms and Standards for Biologicals team of the Technical Standards and Specifications Unit within Health Product Policy and Standards Department, Access to Medicines and Health Products Division, organized an informal consultation meeting, held virtually during 15 - 17 November 2022. The purpose of the meeting was to (i) provide an update on global rotavirus epidemiology and on rotavirus vaccine development pipeline; (ii) share experiences and perspectives on quality, safety and efficacy aspects of rotavirus vaccines with a particular consideration of regulatory requirements for new vaccines and technologies, among researchers, manufacturers and regulators; and (iii) discuss the scope of a revision of the current WHO Guidelines (e.g., whether to include other types of rotavirus vaccines under development) and identify key issues that should be addressed in the revision and the possibilities for rotavirus vaccine standardization. The meeting was attended by around 60 participants from 22 countries across the six WHO regions, including experts and representatives of stakeholders from academic institutes, vaccine developers and manufacturers, regulatory authorities, and other international health agencies including the Bill & Melinda Gates Foundation and PATH