A comprehensive evaluation of the AEFI surveillance system in Ethiopia: An insight from a national study

Background Adverse Events Following Immunization (AEFI) surveillance remains underdeveloped in Ethiopia, impeding efforts to promote vaccine uptake and reduce vaccine preventable diseases. This study aims to comprehensively evaluate the effectiveness of AEFI surveillance system in Ethiopia and assess the magnitude of AEFI cases in the community. Methods All health system levels including the ministry of health, Ethiopian Food and Drug Authority (EFDA), and health facilities were studied. AEFI data were collected from children aged 12-35 months who received routine vaccinations, individuals who received COVID-19, and adolescent girls who were vaccinated for HPV. Key informant interviews were conducted with key actors of the program. Data were analyzed categorizing AEFI cases by region, facility type and location. Quantitative data were triangulated with qualitative findings. Results A significant majority (88%) of facilities reported no AEFI cases within the year preceding the survey, with only 4% reporting more than 10 cases. Reported AEFI cases varied across different groups, with household surveys (59.1%), exit interviews (46.6%), COVID-19 vaccine recipients (44.9%), and HPV recipients (36.2%) experiencing adverse events. About 51 vaccinated individuals experienced serious AEFI. Lack of collaboration among the various stakeholders involved in immunization activities, and ambiguity in roles in the response to adverse events were the major challenges reported. Conclusions Significant majority of the health facilities do not report AEFI cases and have suboptimal surveillance system. The absence of a robust AEFI surveillance system coupled with insufficient measures to counter AEFI-related misinformation poses a challenge to the immunization program. The different actors should work together including the EFDA and ministry of health to effectively identify adverse events and improve the AEFI surveillance system.