孕妇接种甲型流感（H1N1）2009 活疫苗的安全性。
Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women.
机构信息
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, the Birth Defects Branch, Division of Birth Defects & Developmental Disabilities, National Center on Birth Defects & Developmental Disabilities, the Epidemic Intelligence Service, Epidemiology Workforce Branch, Office of Public Health Scientific Services, and the Women's Health and Fertility Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, and the Department of Pediatrics, Emory School of Medicine, Atlanta, Georgia; and the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
出版信息
Obstet Gynecol. 2013 Dec;122(6):1271-8. doi: 10.1097/AOG.0000000000000010.
OBJECTIVE
To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events.
METHODS
We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 2009 to June 2010. We reviewed the initial reports and obtained pregnancy outcome and infant data through 6 months of age from medical records. We reviewed the numbers and characteristics of pregnancy complications and infant outcomes including major birth defects and medically important infant conditions. Rates of spontaneous abortion, preterm birth, and major birth defects and their 95% confidence intervals were calculated.
RESULTS
The Vaccine Adverse Event Reporting System received 113 reports stating receipt of live H1N1 vaccine during pregnancy with no adverse events reported. We obtained follow-up maternal records on 95 of the 113 (84%) live H1N1 reports (40.2% were vaccinated in the first trimester) and found: 87 live births (two twin pregnancies) and no maternal deaths occurred. Number and rates of pregnancy-specific adverse events included: 10 (10.5%, 5.8-18.3) spontaneous abortions; four (4.7%, 1.8-11.4) preterm deliveries at 35-36 weeks of gestation; three (3.4%, 1.2-9.7) infants had one or more major birth defects noted at birth: one cleft palate, one cleft lip, and one microtia (underdeveloped or absent external ear). Seven neonates and infants were hospitalized for medically important conditions. One infant death occurred in a 2.5-month-old boy as a result of pertussis.
CONCLUSION
Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified.
LEVEL OF EVIDENCE
: III.
目的
描述在没有报告不良事件的情况下，接受 H1N1 流感活疫苗的孕妇及其母婴结局。
方法
我们从 2009 年 10 月至 2010 年 6 月期间的疫苗不良事件报告系统（VAERS）中筛选出描述在妊娠期间接受 H1N1 活疫苗接种且在报告时未报告不良事件的报告。我们对初始报告进行了审查，并从医疗记录中获得了妊娠结局和婴儿 6 个月龄时的数据。我们对妊娠并发症和婴儿结局的数量和特征进行了回顾，包括重大出生缺陷和有医学重要意义的婴儿疾病。计算了自然流产、早产和重大出生缺陷的发生率及其 95%置信区间。
结果
VAERS 共收到 113 份报告，称在妊娠期间接种了 H1N1 活疫苗且无不良事件报告。我们获得了 113 份 H1N1 活疫苗报告中的 95 份（84%）随访产妇记录（40.2%在妊娠早期接种），发现 87 例活产（2 例双胞胎妊娠），没有产妇死亡。妊娠特异性不良事件的数量和发生率包括：10 例（10.5%，5.8-18.3）自然流产；4 例（4.7%，1.8-11.4）35-36 周早产；3 例（3.4%，1.2-9.7）婴儿出生时存在一种或多种重大出生缺陷：1 例腭裂，1 例唇裂，1 例小耳畸形（外耳发育不良或缺失）。7 名新生儿和婴儿因有医学重要意义的疾病住院。1 例 2.5 月龄的男孩因百日咳死亡。
结论
在接受 H1N1 流感活疫苗的孕妇中，自然流产、早产和重大出生缺陷的发生率与已发表的背景发生率相似或更低。未发现婴儿有令人担忧的疾病模式。
证据水平
III。
Zotero 插件