Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral)

This document provides guidance to national regulatory authorities and vaccine manufacturers on the production, quality control and evaluation of safety and efficacy of live attenuated rotavirus vaccines (oral) by outlining, in detail, international regulatory expectations for product characterization. It should be read in conjunction with the WHO guidelines on nonclinical evaluation of vaccines (1), and the WHO guidelines on clinical evaluation of vaccines: regulatory expectations (2), in order to understand the whole process of vaccine evaluation. Advice that is specific to the nonclinical or clinical evaluation of live attenuated rotavirus vaccines is provided to supplement these two generic documents. The following text is written in the form of guidelines instead of recommendations. Guidelines allow greater flexibility than recommendations with respect to expected future developments in the field.