Global Vaccine Safety Initiative
Hundreds of millions of doses of vaccines are used every year in developing countries. However, assessments of NRAs conducted by WHO demonstrate that few of these countries' programmes have the ability to monitor and assure the safe use of vaccines.
By studying the current performance of vaccine pharmacovigilance systems in low- and middle-income countries, and of existing inter-country and global support mechanisms, WHO has developed a Global Vaccine Safety Blueprint Strategy in an inclusive drafting process.
Key point
Global Vaccine Safety Blueprint is a strategic framework aiming at the establishment of effective vaccine pharmacovigilance systems in all countries.
It defines indicators of a minimal capacity for ensuring vaccine safety and proposes a strategic plan for enhancing global vaccine safety activities by combining the efforts of major pharmacovigilance stakeholders.
To implement the Global Vaccine Safety Blueprint strategy, a Global Vaccine Safety Initiative project has been initiated.
Global Vaccine Safety InitiativeThe Global Vaccine Safety Blueprint has three main goals:
- the first goal aims at assisting low- and middle-income countries to have at least minimal capacity for vaccine safety activities;
- the second goal aims to enhance capacity for vaccine safety assessment in countries: that introduce newly developed vaccines; that introduce vaccines in settings with novel characteristics; that both, manufacture and use prequalified vaccines
Prequalified vaccineA vaccine that has been approved as acceptable, in principle, for purchase by United Nations agencies, such as WHO, after full assessment of all procedures involved in its production. The purpose of the assessment is to verify that prequalified vaccines: (a) meet the specifications of the relevant UN agency; and (b) are produced and overseen in accordance with the principles and specifications recommended by WHO, for good manufacturing practice (GMP), and for good clinical practice (GCP). This is to ensure that vaccines used in national immunization services in different countries are safe and effective for the target population at the recommended schedules and that they meet particular operational specifications for packaging and presentation.;
- the third goal looks to establish a global vaccine safety support structure so that countries can benefit from international collaboration, training and information exchange.
The 3 main goals run through 8 Strategic Objectives which relate directly to vaccine systems, or are supporting elements to the effectiveness of vaccine safety systems:
