ii4sm and CIOMS/WHO collaborate on the Global Vaccine Safety Blueprint Project

WHO launched the Global Vaccine Safety Blueprint Project, a new initiative that aims at developing a concerted approach for a global, regional and country level vaccine safety assessment and response system.  This project addresses best practices and governance in providing support on vaccine safety for countries with emerging economies.

In most countries, the vaccine licensing process includes a requirement for manufacturers to communicate serious Adverse Events Following Immunization (AEFIs) captured through their notification systems.  Regulators and Industry are extremely interested to improve on the availability of vaccine safety information, in particular through the Public Sector, in order to optimize vaccine utilization.

With support from the CIOMS/WHO working group on vaccines pharmacovigilance, ii4sm is analyzing current Industry practices and expectations from large vaccine manufacturers - six of them are worldwide established companies  and the other six are large manufacturers active in countries with emerging economies.

ii4sm is providing analysis services from vaccine post-marketing surveillance data, highlighting the information flow between manufacturers, immunization programs and regulatory authorities and suggesting collaboration models between the Public Sector and the Industry. ii4sm is also analyzing potential risks and suggesting preventive actions which will be summarized in a report for the WHO/CIOMS scientific committee.