A new CIOMS Working Group (WG) has been established to address issues related to the information exchange between stakeholders on vaccine safety. The formation of the new WG is linked to the activities of the Global Vaccine Safety Blueprint of WHO and its implementation plan, the Global Vaccine Safety Initiative (GVSI). It is a global strategic plan that aims at assisting low- and middle-income countries (LMIC) in their work with vaccine safety surveillance.
The importance of close collaboration between stakeholders is well recognized in vaccine pharmacovigilance activities, and guidance has been developed, in industrialized countries, for jointly planning these activities.
The new CIOMS working group on vaccine safety is established in order to provide a forum for information exchange and active interaction between industry and other stakeholders for the GVS Initiative as well as a “think-tank” that will develop and propose new concepts to the GVS Initiative and other global harmonization efforts in the field. The main objectives are:
- To promote a more efficient and rapid collection and exchange of information between NRAs, multilateral agencies and vaccine manufacturers (this should ideally be achieved through mutual publications).
- To develop and endorse harmonized tools and methods for vaccine safety monitoring activities between national regulatory agencies, multilateral agencies and manufacturers.
- To propose mechanisms for vaccine safety monitoring in difficult settings i.e. those with minimal infrastructure.
The initial duration of the Working Group is for three years but in order to align with that of the WHO GVS Initiative, this period may be considered for extension to 2020.