Guidance
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.
Authors
Languages
- English
Publication year
2009
Publisher
WHO
Type
Guidance
Categories
- Programme management
Diseases
- Rotavirus
Organisations
- World Health Organisation (WHO)
Tags
- Disease surveillance
Topic references
EPI-CORE-ROTA
Title | Author | Year | Type | Language |
---|---|---|---|---|
Change in vaccine vial monitor (VVM) assignment for GlaxoSmithKline Rotarix product | World Health Organization (WHO) | 2017 | Guidance | English |
Generic protocol for monitoring impact of rotavirus vaccination on gastroenteritis disease burden and viral strains | World Health Organization (WHO) | 2009 | Guidance | English |
Manual of rotavirus detection and characterization methods | World Health Organization (WHO) | 2009 | Guidance | English |
Post-marketing surveillance of rotavirus vaccine safety | World Health Organization (WHO) | 2009 | Guidance | English |
Rotavirus vaccines: WHO position paper | World Health Organization (WHO) | Guidance | Arabic, Chinese, English, French, Russian, Spanish |