Global vaccine safety blueprint project
Very few public health interventions have been as successful as immunizations to prevent untimely deaths. Over the past thirty-five years, vaccines have provided substantial and highly cost-effective improvements to human health, and particularly to that of children. As immunization systems mature, immunization safety has become pivotal in determining the success or failure of national vaccine-preventable disease control programs. Although, hundreds of million of doses of vaccine are used every year in developing countries, assessments of regulatory authorities conducted by WHO demonstrate that few of the developing countries programs have the ability to monitor and assure the safe use of vaccines. Now more than ever, it is clear that vaccine safety issues are not merely a developing or developed country phenomenon, but a global phenomenon. It is in this context that we propose to develop a blueprint for a global, regional and country level vaccine safety assessment and response system. This project will include a set of studies that will analyze the existing vaccine safety infrastructure in low-income countries. These studies will be followed by the development of a draft document (the "blueprint") that will define the indicators of a minimal capacity for ensuring vaccine safety (based on the findings from the infrastructure analysis) and propose a strategic plan for enhancing global vaccine safety activities, with a focus on national capacity in the world poorest countries up to the minimal capacity through a coordinated effort of the major stakeholders in vaccine safety. In addition, the blueprint will include a budget, definitions of roles and responsibilities and will explore possible funding options. In the final stages of the project the blueprint will be reviewed by a broad group of the main stakeholders. This will be followed by revisions of the document, endorsement by stakeholders and WHO advisory bodies (Strategic Advisory Group of Experts (SAGE), Global Advisory Committee on Vaccine Safety (GACVS)and regional Technical Advisory Groups (TAGs)), initial fundraising efforts and launch of a global consortium.