Gee Julianne, Sukumaran Lakshmi, Weintraub Eric
National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Vaccine. 2017 Oct 13;35(43):5756-5758. doi: 10.1016/j.vaccine.2017.09.009. Epub 2017 Sep 19.
Describe the Vaccine Safety Datalink's (VSD) Guillain Barré Syndrome (GBS) surveillance following quadrivalent HPV vaccine (4vHPV) from 2006 through 2015.
Among 4vHPV vaccinated persons aged 9-26, ICD-9 coded GBS was identified in VSD's electronic data. Medical records were reviewed and adjudicated to confirm GBS. We calculated incidence rates of confirmed GBS within 1-42days following 4vHPV with a one-sided 95% confidence interval.
Following 2,773,185 4vHPV doses, we confirmed 1 case of GBS in a male and no cases among females. The incidence rate of medical record confirmed GBS within 42days following 4vHPV vaccine was 0.36 cases per million 4vHPV doses administered (1-sided 95% CI 1.71), which was less than the background rate.
We found no evidence of an increased risk of GBS following 4vHPV. With an upper 95% confidence limit, we estimate that, if an increased risk exists, we would expect at most 1.08 additional cases of GBS per million people vaccinated with 4vHPV.
描述2006年至2015年期间四价人乳头瘤病毒疫苗(4vHPV)接种后疫苗安全数据链(VSD)对格林-巴利综合征(GBS)的监测情况。
在9至26岁接种4vHPV的人群中,通过VSD的电子数据识别出国际疾病分类第九版(ICD-9)编码的GBS。对医疗记录进行审查和判定以确诊GBS。我们计算了4vHPV接种后1至42天内确诊GBS的发病率,并给出单侧95%置信区间。
在接种2,773,185剂4vHPV后,我们确诊1例男性GBS病例,女性中无病例。4vHPV疫苗接种后42天内医疗记录确诊的GBS发病率为每接种百万剂4vHPV有0.36例(单侧95%置信区间为1.71),低于背景发病率。
我们未发现4vHPV接种后GBS风险增加的证据。通过95%置信上限,我们估计,如果存在风险增加情况,每百万接种4vHPV的人群中最多额外出现1.08例GBS病例。