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Vaccine Safety1 November 2026

Vaccine Safety Workshop Reviews Evidence and Identifies Priorities for Action

Participants at the vaccine safety workshop in Addis Ababa

On 24 September 2026, OHGA Institute, the Ethiopian Food and Drug Authority (EFDA) and the U.S. Centers for Disease Control and Prevention (CDC) convened a workshop in Addis Ababa to share findings from a desk review of serious adverse events following immunization (AEFI) and an assessment of AEFI data management.

A total of 86 participants attended the workshop, representing the Ministry of Health (MOH), the Ethiopian Public Health Institute (EPHI), regional immunization programs, regulatory authorities, EFDA branch offices and partner organizations.

The assessments found that 90% of verified serious AEFI cases had completed investigation and were presented for causality assessment, while AEFI focal persons were established across most administrative levels, providing a foundation for vaccine safety surveillance. However, persistent gaps were identified in data quality, delays in investigation and causality assessment, limited utilization of electronic reporting systems, weak coordination among stakeholders, and inadequate feedback mechanisms, which constrained effective monitoring and use of AEFI data for decision-making. To strengthen AEFI surveillance and data use, stakeholders called for coordinated action to enhance capacity through training and mentorship, improve supervision, feedback, and data reconciliation processes and routine data review mechanisms, and establish an integrated national AEFI information system.

In keynote addresses, representatives of CDC, EPHI and MOH emphasized coordinated surveillance, evidence-informed decisions and transparent communication about vaccine safety. Discussions also addressed timely responses to safety concerns, efforts to integrate AEFI indicators into the District Health Information Software 2 (DHIS2) platform, and possible no-fault compensation and fee exemption arrangements.

Participants reviewed the findings, discussed gaps in AEFI surveillance and data management, and identified priorities for improvement. The workshop provided an opportunity to validate the findings and develop recommendations for coordinated action.

This training is part of the Global Health Security Cooperative Agreement between the U.S. Centers for Disease Control and Prevention and The Ohio State University.