Department of Chemistry and Biochemistry, Faculty of Science, Section 1, Lebanese University, Beirut, Lebanon.
Quality Assurance of Pharmaceutical Products Department, Lebanese Ministry of Public Health, Beirut, Lebanon.
BMC Public Health. 2024 Oct 21;24(1):2905. doi: 10.1186/s12889-024-20297-z.
Continuous surveillance and risk assessment of inactivated Coronavirus Disease 2019 (COVID-19)) vaccines provide an understanding of their safety profiles, guide vaccination strategy and public health policy. This study aims to analyze the characteristics and prevalence of officially reported serious adverse events following immunization (AEFIs) with inactivated COVID-19 vaccines by System Organ Class (SOC), age, and sex.To achieve this aim, a retrospective observational study was conducted between February 14th, 2021, and June 30th, 2022. Reported AEFIs were evaluated for data completeness. Causality assessment adhered to the World Health Organization guidelines.Findings revealed that the AEFIs occurrence did not significantly differ between vaccines used (ChAdOx1 vs. BNT162b2), sex, or SOC. The most prevalent AEFIs were vascular disorders (37%), followed by cardiac (25%) and nervous system disorders (14%). The adverse events were predominantly reported post-vaccination with the BNT162b2 vaccine, mainly after the first dose. The mean age was highest for miscellaneous disorders (70 ± 21.7 years) and the lowest for nervous system (46 ± 22 years) and immune system disorders (45 ± 19 years). Age differences were statistically different for vascular disorders (p = 0.003) and immune system disorders (p = 0.012).In conclusion, ongoing surveillance and risk assessment of the vaccine's safety profile is crucial for detecting potential safety signals. Active surveillance of the reported serious AEFIs is highly needed to support evidence-based vaccination strategies and maintain public confidence in immunization programs.
对灭活的 2019 年冠状病毒病（COVID-19）疫苗进行持续监测和风险评估，可了解其安全性概况，指导疫苗接种策略和公共卫生政策。本研究旨在通过系统器官类别（SOC）、年龄和性别分析灭活 COVID-19 疫苗接种后报告的严重不良事件（AEFI）的特征和流行率。为实现这一目标，进行了一项回顾性观察研究，时间为 2021 年 2 月 14 日至 2022 年 6 月 30 日。对报告的 AEFIs 进行了数据完整性评估。因果关系评估遵循世界卫生组织指南。结果显示，疫苗使用（ChAdOx1 与 BNT162b2）、性别或 SOC 之间的 AEFIs 发生率无显著差异。最常见的 AEFIs 是血管疾病（37%），其次是心脏（25%）和神经系统疾病（14%）。不良事件主要在接种 BNT162b2 疫苗后报告，主要是在第一剂后。各种疾病的平均年龄最高（70±21.7 岁），神经系统疾病（46±22 岁）和免疫系统疾病（45±19 岁）最低。血管疾病（p=0.003）和免疫系统疾病（p=0.012）的年龄差异具有统计学意义。总之，持续监测和评估疫苗安全性概况对于检测潜在的安全信号至关重要。需要积极监测报告的严重 AEFIs，以支持基于证据的疫苗接种策略，并维护公众对免疫计划的信心。
