Innogen  ·  Publications  ·  Consultation responses
Global vaccine safety blueprint; The landscape analysis (Survey of Regulators).

Very few public-health interventions have been as successful as immunizations in preventing untimely deaths. Over the past thirty-five years, vaccines have provided substantial and highly cost-effective improvements to human health, 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 programmes.

Although hundreds of millions 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’ programmes 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. WHO has therefore proposed developing a blueprint for a global, regional and country level vaccine safety assessment and response system.

This initial step of the global vaccine safety blueprint project included a set of studies that analysed the existing vaccine safety infrastructure in low-income countries. These studies have provided the foundations for the development of a strategic plan that defines the indicators of a minimal capacity for ensuring vaccine safety, and proposes a concerted approach to enhance global vaccine safety activities, with a focus on national capacity in the world's poorest countries up to the minimal capacity. In addition, the blueprint includes an illustrative workplan with a budget and management principles.

This report summarizes the findings of seven detailed studies conducted during the first phase of the global vaccine safety blueprint project. The studies provided the empirical basis for developing the blueprint strategies and work planning, and are referenced throughout the blueprint documents. Three stakeholder surveys (vaccine safety experts, industry and regulators), three systems analyses (national regulatory functions for post-marketing surveillance of vaccine adverse events, vaccine pharmacovigilance infrastructure in a sample of low- and middle-income countries, and existing international vaccine safety initiatives) and one financial analysis are presented here.