WHO AEFI: Global Pharmacovigilance

How the WHO coordinates global adverse event following immunization surveillance

The WHO's Adverse Events Following Immunization (AEFI) surveillance system coordinates global vaccine safety monitoring. Through international collaboration, the WHO helps member states detect, investigate, and respond to vaccine safety signals that may have international implications.

How WHO AEFI Surveillance Works

VigiBase: The Global Database

Managed by the Uppsala Monitoring Centre (Sweden), VigiBase contains over 30 million adverse event reports from more than 170 countries. Key features:

Classification of AEFIs

WHO classifies AEFIs into 5 categories:

Vaccine Product-Related Reaction

Caused or precipitated by the active component or another component of the vaccine.

Vaccine Quality Defect-Related Reaction

Caused by a vaccine that is defective in quality, including its administration device as provided by the manufacturer.

Immunization Error-Related Reaction

Caused by inappropriate vaccine handling, prescribing, or administration — preventable by nature.

Immunization Anxiety-Related Reaction

Arising from anxiety about the immunization, not from the vaccine itself. Examples include vasovagal episodes.

Coincidental Event

Caused by something other than the vaccine or immunization process. Would have occurred regardless of vaccination.

Global Signal Investigation Process

Key Global Investigations

Limitations

Sources & Citations

WHO. "Pharmacovigilance." World Health Organization. https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance

WHO. "AEFI Surveillance Guidelines." World Health Organization. https://www.who.int/publications/i/item/9789241507455

WHO. "Global Advisory Committee on Vaccine Safety (GACVS)." World Health Organization. https://www.who.int/groups/global-advisory-committee-on-vaccine-safety

Uppsala Monitoring Centre. "VigiBase." WHO Collaborating Centre for International Drug Monitoring. https://www.who-umc.org/vigibase/vigibase/