Goss Mary Ann, Lievano Fabio, Buchanan Karyn M, Seminack Margaret M, Cunningham Michael L, Dana Adrian
Merck Research Laboratories, West Point, PA, USA.
Merck Research Laboratories, West Point, PA, USA.
Vaccine. 2015 Jun 26;33(29):3422-8. doi: 10.1016/j.vaccine.2015.04.014. Epub 2015 Apr 11.
To better describe the safety profile of pregnancy exposures to the qHPV vaccine by acquiring and analyzing post-marketing data on pregnancy outcomes.
This is a voluntary, post-marketing prenatal vaccine exposure registry. Enrollment criteria included an identifiable patient and health care provider from the United States, France, or Canada and exposure within 1 month before the date of onset of the last menstrual period or at any time during pregnancy. Outcomes of interest were pregnancy outcomes and birth defects. Prospectively reported cases were used for rate calculations.
For the 1752 prospective reports with known outcome, 1518 (86.6%) were live births, including ten twin pregnancies. Of 1527 neonates, 1444 (94.6%) had no congenital anomalies. The overall rate of spontaneous abortion was 6.7 per 100 outcomes (95% confidence interval [CI] 5.5-8.2). The prevalence of major birth defects was 2.4 per 100 live-born neonates (95% CI 1.7-3.3). There were 12 fetal deaths (0.8 per 100 outcomes, 95% CI 0.4-1.4).
Rates of spontaneous abortions and major birth defects were not greater than the general population rates. Although no adverse signals have been identified to date, the qHPV vaccine is not recommended for use in pregnant women.
通过获取和分析妊娠结局的上市后数据，更好地描述妊娠期间暴露于四价人乳头瘤病毒（qHPV）疫苗的安全性。
这是一项自愿的上市后产前疫苗暴露登记研究。纳入标准包括来自美国、法国或加拿大的可识别患者和医疗保健提供者，以及在末次月经开始日期前1个月内或妊娠期间任何时间的暴露情况。感兴趣的结局是妊娠结局和出生缺陷。前瞻性报告的病例用于率的计算。
对于1752份已知结局的前瞻性报告，1518例（86.6%）为活产，包括10例双胎妊娠。在1527例新生儿中，1444例（94.6%）无先天性异常。自然流产的总体发生率为每100例结局6.7例（95%置信区间[CI]5.5 - 8.2）。主要出生缺陷的患病率为每100例活产新生儿2.4例（95%CI 1.7 - 3.3）。有12例胎儿死亡（每100例结局0.8例，95%CI 0.4 - 1.4）。
自然流产率和主要出生缺陷率不高于一般人群的发生率。尽管迄今为止尚未发现不良信号，但不推荐在孕妇中使用qHPV疫苗。
