Vaccine safety surveillance in South Africa through COVID-19: A journey to systems strengthening

IF 4.5 3区 医学 Q2 IMMUNOLOGY Vaccine Pub Date : 2025-02-06 DOI:10.1016/j.vaccine.2024.126535
Chenoa Sankar , Johanna C. Meyer , Marione Schönfeldt , Hannah Gunter , Halima Dawood , Victoria Sekiti , Naseera Pickard , Lawrence Mubaiwa , Dini Mawela , Sipho Dlamini , Jonny Peter , David Spencer , Clive Gray , Vinod Patel , Lesley Bamford , Tohlang Sehloho , Kerrigan McCarthy
{"title":"Vaccine safety surveillance in South Africa through COVID-19: A journey to systems strengthening","authors":"Chenoa Sankar ,&nbsp;Johanna C. Meyer ,&nbsp;Marione Schönfeldt ,&nbsp;Hannah Gunter ,&nbsp;Halima Dawood ,&nbsp;Victoria Sekiti ,&nbsp;Naseera Pickard ,&nbsp;Lawrence Mubaiwa ,&nbsp;Dini Mawela ,&nbsp;Sipho Dlamini ,&nbsp;Jonny Peter ,&nbsp;David Spencer ,&nbsp;Clive Gray ,&nbsp;Vinod Patel ,&nbsp;Lesley Bamford ,&nbsp;Tohlang Sehloho ,&nbsp;Kerrigan McCarthy","doi":"10.1016/j.vaccine.2024.126535","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"46 ","pages":"Article 126535"},"PeriodicalIF":4.5000,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vaccine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0264410X24012179","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
2019冠状病毒病期间南非疫苗安全监测:加强系统之旅
背景:用于监测和报告免疫后不良事件(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。对监测系统进行评价是加强系统的必要条件。我们对2018年建立的目前形式的南非AEFI监测系统进行了首次评估。方法:采用CDC监测系统评估指南,对系统属性进行横断面评估,包括对2021年5月17日至2022年12月31日期间的AEFI/AESI数据进行定量分析,并通过对AEFI监测人员进行半结构化访谈进行定性分析。调查结果被用来提出加强系统的建议。结果:该系统收集和管理AEFI数据,采用调查工具,并建立了AEFI审查委员会进行因果关系评估,从而满足世卫组织疫苗安全的最低能力。通过包含数字应用程序来调整系统,促进了公开报告,同时增加了数据库管理的复杂性。答复者通过叙述其在AEFI监督中的角色,表明了对该系统的参与。在2021年5月17日至2022年12月31日期间,共接种了37,537,009剂COVID-19疫苗(BNT162b2和Ad26.COV2·S),报告了与这些疫苗相关的3846例AEFI(报告率:10.2/100,000剂)。各省之间的AEFI报告率差异很大,从1.6至59.5 AEFI/100,000剂不等。在此期间,报告了283例与非covid -19疫苗相关的AEFI。到2022年12月31日,调查的严重病例中有73.5%进行了因果关系评估。结论:我们观察到一个功能齐全,有用,灵活的系统,具有较高的利益相关者和公众接受水平。系统挑战包括来自特定省份的低报告率、纸张和数字报告之间的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,以加强信号检测和消除数据重复,在省级提供专门的人力和财政资源,以及通过队列事件监测纳入主动的AEFI监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
Vaccine
Vaccine 医学-免疫学
CiteScore
8.70
自引率
5.50%
发文量
992
审稿时长
131 days
期刊介绍: Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.
期刊最新文献
Targeting the early life stages of SARS-CoV-2 using a multi-peptide conjugate vaccine Applying the health belief model (HBM) to understand COVID-19 vaccine uptake among youth and young adults: Findings from a 6-month follow-up study in the United States Association of serum anti-gbs2106 protein immunoglobulin G (IgG) in newborns and risk reduction of invasive group B streptococcus disease during early infancy. Generative AI for vaccine misbelief correction: Insights from targeting extraversion and pseudoscientific beliefs Acceptability of the gonorrhoea human challenge model to accelerate vaccine development in UK men
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1