May 4, 2022

Global One Health LLC helps conduct causality assessment of AEFI

The Ohio State Global One Health LLC supported the Ethiopian Food and Drug Authority (EFDA) to undertake a causality assessment of adverse events following COVID-19 vaccines reported to the pharmacovigilance system. Experts from the national pharmacovigilance advisory committee, the EFDA pharmacovigilance team and 26 clinicians conducted the assessment.

The committee selected 13 adverse events following immunization (AEFI) to assess for causality. As part of this session, the committee also reviewed six AEFIs reported following the Oral (OPV) Novel Type 2 (NOPV2) vaccine. Causal associations between the vaccines and the reported vaccine reactions were assessed and determined.

Based on the assessment result, the team devised recommendations that support the system to take appropriate regulatory actions and corrective measures to ensure a safe immunization program in Ethiopia.