Ohio State’s Global One Health initiative (GOHi) is supporting the Ethiopian Food and Drug Authority (EFDA) in undertaking a causality assessment of adverse events following immunizations (AEFI), mainly with COVID-19 vaccines, that were reported to the pharmacovigilance system. As part of GOHi’s continued support to the EFDA, 30 participants – including members of the pharmacovigilance advisory committee, experts of the pharmacovigilance team at EFDA and advisors – conducted the assessment on July 19 and 20.
Among the 13 selected adverse events reported to different health facilities, nine were from COVID-19 vaccines, three were from Novel Oral Polio Type 2 (NOPV2) vaccines and one was from the Tetanus Toxoid (TT) vaccine. The team assessed these adverse events for causality and classified them.
Based on the assessment result, the team forwarded recommendations to the EFDA and the Federal Ministry of Health to take appropriate regulatory and corrective measures to ensure safe immunization programs and protocols in Ethiopia.