Global Vaccine Safety Initiative
In 2011, WHO and a group of partners developed the Global Vaccine Safety (GVS) Blueprint, a strategic document with a vision of establishing effective vaccine pharmacovigilance systems in all countries.6 The GVS Blueprint is a part of the Global Vaccine Action Plan, which was endorsed by the World Health Assembly in May 2012. The Global Vaccine Safety Initiative (GVSI) was set up to implement the Blueprint and is advised by the GVSI planning group. The Blueprint strategic goals, which GVSI is expected to achieve during 2012–2020, include: (1) ensuring minimal capacity in vaccine safety for all LMICs; (2) promoting enhanced vaccine pharmacovigilance activities in countries with specific needs; and (3) establishing a global technical support structure.
GACVS reviewed the development of the GVSI workplan and the display of its products through its website.7 The GVSI identified activities to cover the 8 strategic goals of the Blueprint through a broad network of stakeholders engaged in global vaccine pharmacovigilance. An activity portfolio has been developed as a management tool for implementing the Blueprint. In the portfolio, activities are prioritized based on their expected impact, feasibility and desirability. The portfolio provides initiators, managers and donors of each activity with due recognition for their respective roles. It is also a resource for all stakeholders in global pharmacovigilance to help identify ongoing efforts, allow for better synergies, minimize duplications and enable resource mobilization. The WHO regional offices lead country support in capacity building and in addressing vaccine safety concerns. Currently, the portfolio includes 94 activities, 31 of which have been identified in the first priority category.
GACVS examined areas of interactions between its mandate to advise on vaccine safety issues of global importance and that of the GVSI to support and strengthen global vaccine pharmacovigilance capacity. GACVS recognizes that the GVSI strategies are required to improve vaccine safety systems and develop networks to strengthen the monitoring, evaluation and response to vaccine safety issues. The rapid development of activities expected to be associated with the GVSI will also generate a complex network of stakeholders where roles and responsibilities should be defined as clearly as possible. The GVSI addresses many aspects that intersect with the work of other established groups. The complementarity of advice from vaccine safety bodies with that of other immunization and public health advisory groups requires particular attention, both at global and regional levels. GACVS identified several areas where the GVSI should clearly outline the leading role of WHO as a global convener in health monitoring and systems. In addition, efforts should include: involving regional and national immunization technical advisory groups with vaccine safety assessment and communication efforts; use of existing academic and educational institutions to expand vaccine safety training resources, engagement of vaccine producers in promoting information exchange; and active development of a roster of vaccine pharmacovigilance experts with appropriate cultural awareness and geographical proximity to support country demands.
The GVSI proposes solutions for a number of unmet needs in vaccine safety. The Blueprint framework has the potential to involve many new players in a broad collaborative effort. Yet the increased volume of activities and attention will generate competition and competency issues, requiring clear accountability and quality assurance. GACVS therefore proposed a thorough analysis of how the complex needs for vaccine safety can best be addressed and development of an accountability framework for all stakeholders participating in the GVSI. The role of GACVS with respect to the GVSI will remain at the consultancy and advisory level, providing independent evaluation of the evidence for the global vaccine safety issues identified by and for WHO. The rapidly increasing number of proposed activities will also require a more comprehensive system of prioritization with appropriate criteria. The committee is well positioned to help set those criteria, with a focus on ensuring that technical partners’ activities meet the needs of LMICs in strengthening their vaccine safety capacities.