The Ohio State University 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) reported to the national pharmacovigilance system.
The team conducted the assessment in January with 33 participants, including the pharmacovigilance advisory committee members and the pharmacovigilance team from the EFDA.
Among the nine AEFI cases completed before the case investigation, the team assessed and classified six AEFIs with complete information for causality assessment. Three were from the Janssen COVID-19 vaccine; the rest were for Oral Cholera Vaccine (OCV), Human papillomavirus (HPV) and rabies vaccine.
Based on the assessment result, the team forwarded recommendations to the EFDA and the national immunization program to take appropriate regulatory and corrective measures to ensure safe immunization programs in Ethiopia.