Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.
Division of Congenital and Developmental Disorders, National Center on Birth Defects and Developmental Disabilities, CDC, Atlanta, Georgia.
Birth Defects Res. 2017 Jul 17;109(13):1057-1062. doi: 10.1002/bdr2.23622.
Major birth defects are important infant outcomes that have not been well studied in the postmarketing surveillance of vaccines given to pregnant women. We assessed the presence of major birth defects following vaccination in the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system used to monitor the safety of vaccines in the United States.
We searched VAERS for reports of major birth defects during January 1, 1990, through December 31, 2014. We excluded birth defects from vaccines that had been studied in pregnancy registries or other epidemiological studies (e.g., human papilloma virus, varicella, measles/mumps/rubella, and anthrax vaccines). Birth defects were categorized into trimester of vaccination and classified based on the organs and/or systems affected. If several birth defects affecting different systems were described, we classified those as multiple body systems. Empirical Bayesian data mining was used to assess for disproportionate reporting.
We identified 50 reports of major birth defects; in 28 reports, the vaccine was given during the first trimester; 25 were reports with single vaccines administered. Birth defects accounted for 0.03% of all reports received by VAERS during the study period and 3.2% of pregnancy reports; reported defects affected predominately the musculoskeletal (N = 10) or nervous (N = 10) systems. No unusual clusters or specific birth defects were identified.
This review of the VAERS database found that major birth defects were infrequently reported, with no particular condition reported disproportionally. Birth defects after routine maternal vaccination will continue to be monitored in VAERS for signals to prompt future studies. Birth Defects Research 109:1057-1062, 2017. © 2017 Wiley Periodicals, Inc.
重大出生缺陷是重要的婴儿结局，在给孕妇接种的疫苗上市后监测中研究得并不充分。我们评估了疫苗接种后在疫苗不良事件报告系统（VAERS）中出现的重大出生缺陷情况，VAERS 是一个用于监测美国疫苗安全性的全国性自发报告系统。
我们在 1990 年 1 月 1 日至 2014 年 12 月 31 日期间，在 VAERS 中搜索重大出生缺陷报告。我们排除了已在妊娠登记处或其他流行病学研究中进行研究的疫苗（例如，人乳头瘤病毒、水痘、麻疹/腮腺炎/风疹和炭疽疫苗）中的出生缺陷。出生缺陷分为疫苗接种的孕期阶段，并根据受影响的器官和/或系统进行分类。如果描述了几种影响不同系统的出生缺陷，则将这些缺陷归类为多个身体系统。经验贝叶斯数据挖掘用于评估不成比例的报告。
我们确定了 50 份重大出生缺陷报告；在 28 份报告中，疫苗在第一孕期接种；25 份报告是单一疫苗接种。出生缺陷占 VAERS 在研究期间收到的所有报告的 0.03%和妊娠报告的 3.2%；报告的缺陷主要影响肌肉骨骼（N=10）或神经系统（N=10）。没有发现不寻常的聚集或特定的出生缺陷。
对 VAERS 数据库的审查发现，重大出生缺陷报告频率较低，没有特定的情况报告不成比例。将继续在 VAERS 中监测常规产妇疫苗接种后的出生缺陷，以提示未来的研究。出生缺陷研究 109：1057-1062，2017。©2017 威利期刊公司
