School of Global Health and Bioethics, Euclid University, Bangui, Central African Republic.
BMC Public Health. 2024 Oct 21;24(1):2906. doi: 10.1186/s12889-024-20356-5.
Despite the benefits of periodic evaluation of the vaccine safety surveillance system, no formal assessment, to our knowledge, has been conducted in Nigeria. Hence, this study evaluated the surveillance system for adverse events following immunization (AEFI) to ascertain the system's functionality to inform vaccine safety considerations and guide communication strategies for demand generation.
The study employed a mixed-method approach. Survey questionnaires were administered to 274 routine immunization service providers in Kebbi State, Northern Nigeria, and data were analyzed descriptively using SPSS. In this study, 10 Key Informant Interviews and two Focus Group Discussions were conducted with senior officers and managers at sub-national and national levels within the immunization and surveillance landscape in Nigeria. The interview recordings were cleaned minimally, transcribed, and manually analyzed thematically. Finally, methodological triangulation was done to improve research rigor and provide a better understanding of the phenomena under investigation.
Of the respondents, 201(73.4%) reported that the surveillance system can inform vaccine safety considerations while 170(62%) reported that the AEFI surveillance system can determine the magnitude of AEFI within the population. Further, 173(63%) reported that the surveillance system can provide timely feedback about causality assessment. However, 158(58%) of the respondents stated that the surveillance system is competent in informing communication strategies to improve immunization demand. Triangulation was done which showed dissonance in AEFI surveillance and vaccine safety considerations but partial agreement in immunization demand generation. Further, AEFI surveillance system attributes' triangulation revealed agreements (convergence) on simplicity and timeliness; partial agreements on acceptability, data quality, sensitivity, flexibility, and completeness; dissonance on representativeness and silence on stability, indicating a sub-optimal performance of the AEFI surveillance system in the study setting. Finally, the study unearthed some underlying health system factors impeding the AEFI surveillance system from fully fulfilling its objectives.
The AEFI surveillance system in Northern Nigeria is well established but functioning sub-optimally. Based on the study findings, the capacity to provide information on vaccine safety exists but it is not robust enough to generate sufficient and convincing vaccine safety data and guide communication strategies for vaccine demand generation, especially for new vaccines and those under emergency authorization use.
尽管定期评估疫苗安全监测系统有诸多益处，但据我们所知，在尼日利亚尚未进行过正式评估。因此，本研究评估了预防接种后不良事件（AEFI）监测系统，以确定该系统的功能，为疫苗安全性考虑提供信息，并为需求生成提供沟通策略。
本研究采用混合方法。在尼日利亚北部的凯比州，向 274 名常规免疫服务提供者发放了调查问卷，并使用 SPSS 进行了描述性分析。在本研究中，与尼日利亚免疫和监测领域的国家和次国家各级的高级官员和管理人员进行了 10 次关键知情人访谈和 2 次焦点小组讨论。访谈录音经过最小化清理、转录，并进行了手动主题分析。最后，进行了方法学三角测量，以提高研究严谨性，并更好地理解研究现象。
在受访者中，有 201 人（73.4%）报告称监测系统可以为疫苗安全性考虑提供信息，而有 170 人（62%）报告称 AEFI 监测系统可以确定人群中的 AEFI 规模。此外，有 173 人（63%）报告称监测系统可以提供关于因果关系评估的及时反馈。然而，有 158 人（58%）的受访者表示，监测系统能够胜任提供改善免疫需求的沟通策略。三角测量显示，AEFI 监测和疫苗安全性考虑之间存在差异，但在免疫需求产生方面存在部分一致。此外，AEFI 监测系统属性的三角测量显示，在简单性和及时性方面存在一致性（趋同）；在可接受性、数据质量、敏感性、灵活性和完整性方面存在部分一致；在代表性方面存在差异，在稳定性方面则保持沉默，表明 AEFI 监测系统在研究环境中的表现不佳。最后，研究揭示了一些阻碍 AEFI 监测系统充分实现其目标的潜在卫生系统因素。
尼日利亚北部的 AEFI 监测系统已经建立，但功能欠佳。根据研究结果，提供疫苗安全性信息的能力存在，但还不够强大，无法提供足够有说服力的疫苗安全性数据，并为疫苗需求产生提供沟通策略，特别是对于新疫苗和紧急授权使用的疫苗。
