Post-marketing surveillance of rotavirus vaccine safety


This document provides background data regarding safety concerns of rotavirus vaccines and presents guidelines for routine post-marketing surveillance to assess the safety of rotavirus vaccines, with flexibility for adaptation at country level according to existing surveillance systems, health infrastructure and resources. A Technical Advisory Committee on post-marketing surveillance of rotavirus vaccine safety, established by IVB/IVR and the rotavirus subgroup of GACVS, is available to provide technical advice to enhance the quality of post-marketing surveillance activities aimed at assessing the safety and effectiveness of rotavirus vaccines.The primary targets for this document are regulatory authorities and national immunization programmes in developing countries, with responsibility for routine post-marketing surveillance systems, often linked to immunization or pharmacovigilance programmes. However, to adapt it to the local setting, fieldwork and operational procedure details should be added with input from healthcare workers with expertise in diarrhoeal and surgical conditions, in particular, intussusception. The surveillance system and the information collected will also need to meet the standards and format required by the relevant national regulatory authority.