Signal Monitoring for Adverse Events Following Immunisation with COVID-19 Vaccines During the SARS-CoV-2 Pandemic: An Evaluation of the South African Surveillance System.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2025-04-16 DOI:10.1007/s40264-025-01547-4

Chenoa Sankar, Stephen Evans, Johanna Catharina Meyer, Hannah May Gunter, Victoria Sekiti, Kerrigan McCarthy

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引用次数: 0

Abstract

Introduction: Monitoring of adverse events following immunisation (AEFI) is recommended for post-licensure surveillance. We investigated whether the South African surveillance system could detect signals of disproportionate reporting and whether these signals aligned with globally identified AEFI and adverse events of special interest (AESI) post-coronavirus disease-2019 (COVID-19) vaccination.

Methods: This retrospective pharmacovigilance study undertook disproportionality analysis of the National Department of Health AEFI database from the start of the COVID-19 vaccine rollout on 17 May 2021 to 31 December 2022. We complemented this with AEFI reports for vaccines not on the routine Expanded Programme on Immunisation schedule, to address potential masking of signals due to the high reporting rate of COVID-19 vaccine AEFI.

Results: During the study period, 3846 AEFI were reported for 37,537,009 doses of COVID-19 vaccines (BNT162b2 and Ad26.COV2.S) administered. The overall reporting rate was 10.2 per 100,000 doses, 18.1/100,000 and 7.9/100,000 for Ad26.COV2.S and BNT162b2, respectively. Comparison with other countries suggests underreporting. Disproportionate reporting signals were obtained for three and seven AEFI following BNT162b2 and Ad26.COV2.S vaccines, respectively. An additional three AEFI signals from Ad26.COV2.S emerged in the augmented dataset, indicating masking. All Ad26.COV2.S signals, and one BNT162b2 signal, appear in the vaccines' product information. Among nine AESI evaluated, myocarditis/pericarditis presented as a signal of disproportionate reporting following BNT162b2 vaccination.

Conclusions: This study is one of the first from a lower-middle-income country, using a spontaneous reporting system for signal detection post-COVID-19 vaccination. Signals aligned with those reported globally. The study highlights the need to further investigate underreporting, masking, and system attributes for system strengthening.

查看原文本刊更多论文

SARS-CoV-2大流行期间接种COVID-19疫苗后不良事件的信号监测：对南非监测系统的评估

推荐在许可后监测中监测免疫接种后不良事件（AEFI）。我们调查了南非监测系统是否能够检测到不成比例报告的信号，以及这些信号是否与全球确定的冠状病毒病-2019 （COVID-19）疫苗接种后的AEFI和特殊关注不良事件（AESI）一致。方法：本回顾性药物警戒研究对2021年5月17日至2022年12月31日开始推广COVID-19疫苗的国家卫生部AEFI数据库进行了歧化分析。我们补充了未列入常规扩大免疫规划计划的疫苗的AEFI报告，以解决由于COVID-19疫苗AEFI报告率高而可能掩盖信号的问题。结果：在研究期间，报告了37,537,009剂COVID-19疫苗（BNT162b2和Ad26.COV2.S）的3846例AEFI。Ad26.COV2的总报告率为10.2 /10万剂，18.1/10万剂和7.9/10万剂。S和BNT162b2。与其他国家的比较表明少报。BNT162b2和Ad26.COV2后的3个和7个AEFI获得不成比例的报告信号。S疫苗。Ad26.COV2附加3个AEFI信号。S出现在增强数据集中，表示屏蔽。所有Ad26.COV2。S信号和一个BNT162b2信号出现在疫苗的产品信息中。在评估的9个AESI中，接种BNT162b2疫苗后，心肌炎/心包炎被认为是不成比例报告的信号。结论：本研究是第一批来自中低收入国家的研究之一，在covid -19疫苗接种后使用自发报告系统进行信号检测。信号与全球报告的一致。该研究强调了进一步调查漏报、掩盖和系统属性以加强系统的必要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.