Global Vaccine Safety

A software to guide AEFI causality assessment


In 2013, WHO revised the methodology for causality assessment of individual Adverse Events Following Immunization (AEFI). The new method proposed by WHO was published in the WHO User manual for the revised WHO classification for causality assessment of AEFI. It uses a paper based tool that allows evaluators to review AEFI cases and guide them on their causality.

A companion electronic software application of the tool is now available for computers, IPads and tablets. The software provides step by step guidance in the assessment and reduces the chances of making errors. This tool will facilitate use of the revised methodology and help conducting research.

E-learning course on Vaccine Safety Basics

As part of its mandate of building, maintaining and strengthening capacity for vaccine pharmacovigilance, the WHO developed an online course addressed to health professionals. This course addresses the origin and nature of adverse events following immunization and at promoting good communication practices in handling risks and crises situations. Its content, compiled by international vaccine experts, takes on account different national contexts and is available in 4 different languages. Broad dissemination of this course is encouraged for building a common core knowledge base of vaccine safety issues, and for improving vaccine safety practices in countries in a cost effective manner.

Building capacity and enhancing vaccine pharmacovigilance in Pakistan

At the request of the MoH Pakistan, WHO organized an AEFI surveillance and monitoring workshop in Islamabad from 23rd to 26th August 2016. The 27 participants included professionals from the Drug Regulatory Authority of Pakistan, the National Program on Immunization and Pakistan Paediatric Association.

Inter-country workshop for the development of the « Adverse events following immunization surveillance manual »

From 25-28 July 2016, Benin, Burkina Faso, Burundi, Cameroon, Mali, Mauritania, Niger and Togo met in Ouagadougou, under the auspices of WHO to develop their « National adverse events following immunization (AEFI) surveillance manual ». National guidelines on vaccines pharmacovigilance will be validated by the authorities of each country by the end of the year. This workshop represents an important step forward to strenghten vaccines pharmacovigilance in the African region.

Fifth Global Vaccine Safety Initiative meeting, 26-27 October 2016, Addis Ababa, Ethiopia

GVSI 2015

The Global Vaccine Safety Initiative is the annual forum for Member States and key stakeholders in vaccine safety. Over two days, immunization program managers and pharmacovigilance staff of national regulatory authorities from more than 30 countries gather with representatives from UN agencies, academic institutions, pharmaceutical company umbrella organizations, partner and funding agencies to interact and exchange information on progress with implementation of national and global vaccine pharmacovigilance activities, share experiences, facilitate further partnerships and inter-sectorial collaborations, and define plans for further development.

For its fifth edition, the meeting will be organized in collaboration with the African Union Commission on 26-27 October 2016. The 5th GVSI will facilitate discussion pertaining to regulatory harmonization initiatives for pharmacovigilance of vaccines, vaccine safety communication and safety issues related to priority new vaccines.


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