The Ohio State University Global One Health initiative (GOHi) supported the Ethiopian Food and Drug Authority (EFDA) in undertaking a performance review of the National Causality Assessment process. Thirty participants, including members of the National Pharmacovigilance advisory committee, experts from the National Immunization Program and the pharmacovigilance team from the EFDA, attended the assessment.
EFDA experts presented the last five years of performance data from the National Causality Assessment, and committee members discussed the overall challenges and a path to move forward. The EFDA organized and facilitated the review and recommended ways to analyze available data and share the evidence with the global community.
Following the review meeting, the committee assessed the causality of seven serious adverse events following immunizations reported from different health facilities.
The committee determined causal associations between the vaccines and reported vaccine reactions. They also presented recommendations to support the system in appropriate regulatory actions, ensuring safe immunization programs in Ethiopia.