Sankar Chenoa, Meyer Johanna C, Schönfeldt Marione, Gunter Hannah, Dawood Halima, Sekiti Victoria, Pickard Naseera, Mubaiwa Lawrence, Mawela Dini, Dlamini Sipho, Peter Jonny, Spencer David, Gray Clive, Patel Vinod, Bamford Lesley, Sehloho Tohlang, McCarthy Kerrigan
National Institute for Communicable Diseases, Division of Public Health Surveillance and Response, Johannesburg, South Africa; Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.
Department of Public Health Pharmacy and Management, Sefako Makgatho Health Sciences University, Pretoria, South Africa; South African Vaccination and Immunisation Centre, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
Vaccine. 2025 Feb 6;46:126535. doi: 10.1016/j.vaccine.2024.126535. Epub 2024 Dec 6.
Surveillance systems for monitoring and reporting adverse events following immunisation (AEFI) and adverse events of special interest (AESI) are vital in understanding safety profiles of post-marketed vaccines. Evaluation of surveillance systems is necessary for systems strengthening. We conducted the first evaluation of the South African AEFI surveillance system in its current form, established in 2018.
Using CDC guidelines for evaluation of surveillance systems, we conducted a cross-sectional evaluation of system attributes, including quantitative analyses of AEFI/AESI data from 17 May 2021 to 31 December 2022 and qualitative analyses through semi-structured interviews with AEFI surveillance personnel. Findings were used to generate recommendations for system strengthening.
The system collects and manages AEFI data, employs investigative tools and has an established AEFI review committee conducting causality assessment, thus meeting WHO minimal capacity for vaccine safety. System adaptation through inclusion of digital applications facilitated public reporting, whilst increasing complexity of database management. Respondents demonstrated engagement with the system through accounts of their roles in AEFI surveillance. Between 17 May 2021 and 31 December 2022, 37,537,009 COVID-19 vaccine doses (BNT162b2 and Ad26.COV2·S) were administered, and 3846 AEFI reported in relation to these vaccines (reporting rate: 10.2/100,000 doses). AEFI reporting rates varied considerably across provinces, ranging from 1.6 to 59.5 AEFI/100,000 doses. In this time period 283 AEFI were reported in relation to non-COVID-19 vaccines. By 31 December 2022, 73.5 % of severe cases that were investigated were causality assessed.
We observed a functional, useful, flexible system with high reported stakeholder and public acceptability levels. System challenges included low reporting rates from particular provinces, weak co-ordination between paper and digital reporting and human resource constraints. Recommendations include integration of paper-based and digital surveillance reporting systems to enhance signal detection and eliminate data duplication, provision of dedicated human and financial resources at provincial level and inclusion of active AEFI surveillance through cohort event monitoring.
用于监测和报告免疫接种后不良事件（AEFI）和特殊关注不良事件（AESI）的监测系统对于了解上市后疫苗的安全性至关重要。对监测系统进行评估对于加强系统很有必要。我们对2018年建立的南非AEFI监测系统的当前形式进行了首次评估。
我们依据美国疾病控制与预防中心（CDC）的监测系统评估指南，对系统属性进行了横断面评估，包括对2021年5月17日至2022年12月31日期间AEFI/AESI数据的定量分析，以及通过对AEFI监测人员进行半结构化访谈进行定性分析。研究结果用于生成加强系统的建议。
该系统收集和管理AEFI数据，采用调查工具，并设有一个AEFI审查委员会进行因果关系评估，从而达到了世界卫生组织规定的疫苗安全最低能力要求。通过纳入数字应用程序进行系统调整，促进了公众报告，同时增加了数据库管理的复杂性。受访者通过讲述他们在AEFI监测中的角色，表明了对该系统的参与度。在2021年5月17日至2022年12月31日期间，共接种了37,537,009剂新冠疫苗（BNT162b2和Ad26.COV2.S），并报告了3846例与这些疫苗相关的AEFI（报告率：10.2/100,000剂）。AEFI报告率在各省之间差异很大，从1.6至59.5例AEFI/100,000剂不等。在此期间，报告了283例与非新冠疫苗相关的AEFI。截至2022年12月31日，经调查的严重病例中有73.5%进行了因果关系评估。
我们观察到一个功能齐全、实用且灵活的系统，利益相关者和公众对其接受度较高。系统面临的挑战包括特定省份报告率较低、纸质报告与数字报告之间协调不力以及人力资源限制。建议包括整合纸质和数字监测报告系统以增强信号检测并消除数据重复、在省级层面提供专门的人力和财力资源，以及通过队列事件监测纳入主动AEFI监测。
