Global Vaccine Safety

WHO guidance for vaccine safety presentations to GACVS


The Global Advisory Committee for Vaccine Safety (GACVS) has developed a template framework for presenters to provide information from multiple sources to assess vaccine safety. This template has been developed particularly for the presentation of pre-licensure clinical trials and post-licensure pharmacovigilance vaccine safety data. The template does not replace existing guidance which detail how clinical trials should be performed and what safety data should be collected. Even though the template will provide comprehensive and consistent presentation format for future safety information at GACVS, it is acknowledged that safety data and issues are unique to a particular product and thus, presentations may need to be adapted accordingly.