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Causality assessment of Adverse Events Following Immunizations

The Global One Health initiative (GOHi) collaborated with the Ethiopian Food and Drug Authority (EFDA) to undertake a causality assessment of adverse events following immunizations (AEFI) that were reported to the national pharmacovigilance unit at EFDA.

Members of the national pharmacovigilance advisory committee and pharmacovigilance experts and advisors from EFDA conducted the assessment. The team reviewed 11 cases of AEFIs following COVID-19 vaccines and the Novel Oral Polio Type 2 (NOPV2) vaccine for causality assessment and causal association determined.

Based on its findings, the team recommended taking appropriate regulatory actions and corrective measures to ensure a safe immunization program in Ethiopia.