背景:要正确评估疫苗与特定不良事件之间的关联,需要对观察到的发生率和背景发生率进行比较;然而,目前在韩国的研究有限。因此,在这项研究中,我们估计了过敏反应的背景发生率,心肌炎,心包炎,格林-巴利综合征(GBS)以及韩国的死亡率。
方法:使用国家样本队列(NSC)数据进行回顾性队列研究。使用NSC,背景发病率是通过将2009-2019年期间的发作次数除以按年份划分的总人口,然后乘以100,000来估算的.使用韩国统计数据,背景死亡率是通过除以死亡人数来估计的,在2009-2019年期间,按当年的标准人口计算,然后乘以100,000。使用背景死亡率,我们使用自回归综合移动平均模型预测了2021年的死亡率。Further,将预期死亡率与观察到的死亡率进行了比较.
结果:根据年龄调整的过敏反应发生率(AIR)从每100,000人4.28例增加到22.90例(p=0.003);心肌炎没有显着增加,从每100,000人口0.56例增加到1.26例(p=0.276);心包炎从每100,000人口0.94例增加到1.88例(p=0.005);GBS从每100,000人口0.78例增加到1.21例(p=0.013).年龄调整后的死亡率从每100,000人645.24降至475.70人(p<0.001)。2021年总体观察/预期死亡率(比率:1.08,95%置信区间[CI]:1.07-1.08),男性(比率:1.07,95%CI:1.07-1.08),和女性(比率:1.08,95%CI:1.07-1.09),都明显更高。当按年龄组分层时,年龄≥80岁(比率:1.16,95%CI:1.15-1.17),60-69(比率:1.11,95%CI:1.10-1.13),而20-29岁(比值:1.07,95%CI:1.02-1.13)也明显增高。
结论:通过评估与过敏反应相关的背景发生率,心肌炎,心包炎,GBS,和死亡率,我们建立了一个参考点,用于评估COVID-19疫苗接种后不良事件的潜在过度发生率.这一参考点是支持COVID-19疫苗安全性的实质性证据。
BACKGROUND: To properly assess an association between vaccines and specific adverse events requires a comparison between the observed and background rates; however, studies in South Korea are currently limited. Therefore, in this
study, we estimated the background incidence of anaphylaxis, myocarditis,
pericarditis, Guillain-Barré syndrome (GBS), and mortality in South Korea.
METHODS: A retrospective cohort
study was conducted using the National Sample Cohort (NSC) data. Using NSC, the background incidence rate was estimated by dividing the number of episodes during 2009-2019 by the total population by year and then multiplying by 100,000. Using Statistics Korea data, the background mortality rate was estimated by dividing the number of deaths, during 2009-2019 by the standard population for that year and then multiplying by 100,000. Using background mortality rates, we predicted mortality rates for 2021 using autoregressive integrated moving average models. Further, the expected mortality rates were compared with observed mortality rates.
RESULTS: The age-adjusted incidence rate (AIR) of anaphylaxis increased from 4.28 to 22.90 cases per 100,000 population (p = 0.003); myocarditis showed no significant increase, changing from 0.56 to 1.26 cases per 100,000 population (p = 0.276);
pericarditis increased from 0.94 to 1.88 cases per 100,000 population (p = 0.005); and GBS increased from 0.78 to 1.21 cases per 100,000 population (p = 0.013). The age-adjusted mortality rate decreased from 645.24 to 475.70 deaths per 100,000 population (p <0.001). The 2021 observed/expected mortality rates for overall (ratio: 1.08, 95% confidence interval [CI]: 1.07-1.08), men (ratio: 1.07, 95% CI: 1.07-1.08), and women (ratio: 1.08, 95% CI: 1.07-1.09), were all significantly higher. When stratified by age group, those aged ≥80 (ratio: 1.16, 95% CI: 1.15-1.17), 60-69 (ratio: 1.11, 95% CI: 1.10-1.13), and 20-29 years old (ratio: 1.07, 95% CI: 1.02-1.13) were also significantly higher.
CONCLUSIONS: Through the estimation of background rates related to anaphylaxis, myocarditis,
pericarditis, GBS, and mortality, we established a reference point for evaluating the potential excess occurrence of adverse events following COVID-19 vaccination. This reference point serves as substantive evidence supporting the safety profile of COVID-19 vaccines.