Vaccine Safety Datalink project: A new tool for improving vaccine safety monitoring in the United States
Vaccine Safety Datalink project: A new tool for improving vaccine safety monitoring in the United States
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DOI：
10.1542/peds.99.6.765
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发表时间：
1997-06-01
期刊：
影响因子：
8
通讯作者：
Caserta, V
中科院分区：
文献类型：
--
作者：
Chen, RT;Glasser, JW;Caserta, V
目标。填补在医学研究所最近的综述中发现的罕见疫苗不良事件在当前科学知识中的巨大“空白和局限性”。在几个健康维护组织中，每年对50多万名0至6岁儿童的免疫、医疗结果和潜在混杂因素的计算机信息进行关联，以创建一个大型队列，用于疫苗安全性的多种流行病学研究。对3年随访数据的分析显示，对研究队列中的儿童接种了549 488剂白喉-破伤风-百日咳（DTP）和310 618剂麻疹-腮腺炎-风疹（MMR）疫苗。正在对疫苗与34种医疗结果之间的关系进行分析。自动数据筛选显示，癫痫发作与当天接受DTP（相对风险[RR]， 2.1； 95%可信区间[CI]， 1.1至4.0）和接受MMR后8至14天（RR 3.0; 95% CI， 2.1至4.2）相关。在这个大型队列中，疫苗接种暴露的多样性使我们能够证明，b型流感嗜血杆菌疫苗接种后8至14天癫痫发作的明显关联（RR, 1.6; 95% CI， 1.2至2.1）可归因于同时接种MMR疫苗的混淆；适当调整后，相关性消失（RR, 1.0; 95% CI, 0.7 ~ 1.4）。疫苗安全数据链项目的初步设计、数据收集和分析能力已通过复制以前已知的癫痫发作与百白破和MMR疫苗之间的关联得到验证。疫苗接种时间表的多样性使得同时接种疫苗和联合接种疫苗的影响有可能得到区分。除了为疫苗的安全性和其他研究提供良好的基础设施外，该项目还提供了公共卫生管理的保健合作模式。
Objective. To fill the large ''gaps and limitations'' in current scientific knowledge of rare vaccine adverse events identified in recent reviews of the Institute of Medicine.Methods. Computerized information on immunization, medical outcomes, and potential confounders on more than 500 000 children 0 to 6 years of age is linked annually at several health maintenance organizations to create a large cohort for multiple epidemiologic studies of vaccine safety.Results. Analysis of 3 years of follow-up data shows that 549 488 doses of diphtheria-tetanus-pertussis (DTP) and 310 618 doses of measles-mumps-rubella (MMR) vaccines have been administered to children in the study cohort. Analyses for associations between vaccines and 34 medical outcomes are underway. Screening of automated data shows that seizures are associated with receipt of DTP on the same day (relative risk [RR], 2.1; 95% confidence interval [CI], 1.1 to 4.0) and 8 to 14 days after receipt of MMR (RR 3.0; 95% CI, 2.1 to 4.2). The diversity of vaccination exposures in this large cohort permits us to show that an apparent association of seizures 8 to 14 days after Haemophilus influenzae type b vaccine (RR, 1.6; 95% CI, 1.2 to 2.1) was attributable to confounding by simultaneous MMR vaccination; the association disappears with appropriate adjustment (RR, 1.0; 95% CI, 0.7 to 1.4).Conclusion. Preliminary design, data collection, and analytic capability of the Vaccine Safety Datalink project has been validated by replication of previous known associations between seizures and DTP and MMR vaccines. The diversity in vaccine administration schedules permits potential disentangling of effects of simultaneous and combined vaccinations. The project provides a model of public health-managed care collaborations in addition to an excellent infrastructure for safety and other studies of vaccines.