Global vaccine safety stakeholders and services

International collaboration is essential to maintain the significant achievements of immunization to date and to prevent the spread of misinformation about safety concerns from paralysing and damaging immunization programmes. Vaccine safety is both a priority and a challenge to countries. Examples of challenges that countries need to address in differing priorities depending on their local contexts include:

  • continued prevalence of unsafe injections and injection practices;
  • mishandling of rumours and adverse events;
  • lack of access to new, safer technologies such as auto-disable syringes;
  • growing anti-immunization movements, including anti-vaccination websites;
  • inadequate AEFI surveillance;
  • globalization and the internet (greater impact of misinformation raising public concerns about harm from vaccines).

WHO and other partners are supporting various global initiatives that aim to strengthen and support national AEFI surveillance, investigation and response. The following graphic shows some of the initiatives at global level that support countries on vaccine safety issues. Move your mouse over each group to find out about its overall role.

The role of the organizations in this group is to ensure that unique and consistent definitions relating to vaccine safety are used globally. They provide standardized case definitions for adverse events. These organizations are involved in global analysis and response and provide scientific advice on vaccine safety issues of global importance. Product monitoring bodies have two roles. Firstly, they ensure the safety of products through the timely exchange of information. Secondly, they provide information on the quality and prequalification, or acceptability, of vaccine products. There are three roles for this group. Firstly, they support AEFI reporting and ensure the prompt evaluation of safety signals. Secondly, they ensure that reporting is standardised across countries. Thirdly, they support the exchange of data and research across countries through the Global Vaccine Safety DataLink. The role of a national AEFI surveillance system is to respond and investigate in a timely and appropriate way when an adverse event is reported. A national AEFI surveillance system is the responsibility of the national regulatory authority (NRA) and the national immunisation programme (NIP). In some countries it may also be linked to other support groups and to vaccine manufacturers.

Components of 21st century global vaccine systems39


The Global Advisory Committee on Vaccine safety (GACVS), established in 1999, advises advises WHO on vaccine-related safety issues and enables WHO to respond promptly, efficiently and with scientific rigour to issues of vaccine safety with potential global importance.

WHO and partners

Many partners support drug safety activities at global or regional levels, in particular non-governmental organizations, such as academic, clinical care and public-health institutions.

Brighton collaboration

The Brighton Collaboration, an international voluntary collaboration launched in 2000, provides globally accepted standard case definitions for assessing AEFIs so that safety data across trials and surveillance systems can be compared.

Council for International Organizations of Medical Sciences CIOMS/WHO working group

The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949. CIOMS includes technical working groups (e.g. vaccine pharmacovigilance).

WHO Programme for International Drug Monitoring (PIDM)

The WHO Programme for International Drug Monitoring (PIDM), established in 1968, consists of a network of NPCs, WHO headquarters in Geneva, and the WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Sweden.

Other support groups

Depending on the country, other groups such as academic institutions or technical agencies (e.g. national immunization technical advice groups, NITAGs) provide significant support to drug safety activities.

On the following pages we will introduce some of these initiatives and their respective areas of activity. Following this, we will introduce the Global Vaccine Safety Initiative, an implementation support mechanism that envisions effective vaccine pharmacovigilance systems to be established in all countries.