The Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia.
Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
Pediatrics. 2022 Dec 1;150(6). doi: 10.1542/peds.2022-058789.
Temporal associations between Kawasaki disease (KD) and childhood vaccines have been reported. Limited data on KD following 13-valent pneumococcal conjugate (PCV13) and rotavirus vaccines are available.
We conducted a self-controlled risk interval study using Vaccine Safety Datalink electronic health record data to investigate the risk of KD following PCV13 and rotavirus vaccines in children <2 years of age who were born from 2006 to 2017. All hospitalized KD cases identified by International Classification of Diseases diagnosis codes that fell within predefined risk (days 1-28 postvaccination) and control (days 29-56 for doses 1 and 2, and days 43-70 for doses 3 and 4) intervals were confirmed by manual chart review.
During the study period, 655 cases of KD were identified by International Classification of Diseases codes. Of these, 97 chart-confirmed cases were within risk or control intervals. In analyses, the age-adjusted relative risk for KD following any dose of PCV13 was 0.75 (95% confidence interval, 0.47-1.21). Similarly, the age-adjusted relative risk for KD following any dose of rotavirus vaccine was 0.66 (95% CI, 0.40-1.09). Overall, there was no evidence of an elevated risk of KD following PCV13 or rotavirus vaccines by dose. In addition, no statistically significant temporal clustering of KD cases was identified during days 1 to 70 postvaccination.
PCV13 and rotavirus vaccination were not associated with an increased risk of KD in children <2 years of age. Our findings provide additional evidence for the overall safety of PCV13 and rotavirus vaccines.
已有报道称川崎病（KD）与儿童疫苗之间存在时间关联。关于 13 价肺炎球菌结合疫苗（PCV13）和轮状病毒疫苗接种后发生 KD 的有限数据。
我们使用疫苗安全数据链接电子健康记录数据进行了自我对照风险间隔研究，以调查 2006 年至 2017 年期间出生的<2 岁儿童接种 PCV13 和轮状病毒疫苗后发生 KD 的风险。通过国际疾病分类诊断代码确定的所有住院 KD 病例均落入预设风险（接种后 1-28 天）和对照（第 1 剂和第 2 剂为 29-56 天，第 3 剂和第 4 剂为 43-70 天）间隔内，并通过手动图表审查进行了确认。
在研究期间，通过国际疾病分类代码确定了 655 例 KD 病例。其中，97 例经图表确认的病例在风险或对照间隔内。在分析中，任何剂量的 PCV13 接种后 KD 的年龄调整相对风险为 0.75（95%置信区间，0.47-1.21）。同样，任何剂量的轮状病毒疫苗接种后 KD 的年龄调整相对风险为 0.66（95%置信区间，0.40-1.09）。总体而言，没有证据表明 PCV13 或轮状病毒疫苗接种后 KD 的风险增加。此外，在接种后 1 至 70 天期间，没有发现 KD 病例的统计学上显著时间聚集。
PCV13 和轮状病毒疫苗接种与<2 岁儿童 KD 风险增加无关。我们的发现为 PCV13 和轮状病毒疫苗的总体安全性提供了额外证据。
