Global Pharmacovigilance and Epidemiology, Sanofi Pasteur, Toronto, Ontario, Canada.
Global Pharmacovigilance and Epidemiology, Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Hum Vaccin Immunother. 2021 Dec 2;17(12):5325-5333. doi: 10.1080/21645515.2021.1915038. Epub 2021 Dec 29.
The "Adacel (Tdap5) Pregnancy Registry" was used to identify 1182 women who received the tetanus, diphtheria, acellular pertussis [5 components] (Tdap5) vaccine during pregnancy from 2005 to 2016. To evaluate the safety and use of prenatal Tdap5, we calculated the rate of maternal, obstetrical, pregnancy and neonatal outcomes following Tdap5 pregnancy exposure and assessed vaccine uptake by year and trimester of exposure. The most commonly reported maternal adverse events included injection site reactions (2.6%; 95% Confidence Interval 1.8%, 3.7%), nervous system events (1.3%; 0.8%, 2.1%) and musculoskeletal events (1.1%; 0.6%, 1.9%). The most commonly reported complications of pregnancy were hypertension/preeclampsia (5.5%; 3.3%, 8.9%) and gestational diabetes (2.5%; 1.1%, 5.3%), while those for labor and delivery were premature labor (2.9%; 1.4%, 5.7%) and premature membrane rupture (1.5%; 0.4%, 3.8%). These rates were similar to, or lower than those reported for the general population of pregnant women. Among pregnancies with known birth outcomes (N = 275), 90.4% (86.2%, 93.4%) resulted in a live birth, 5.9% (3.6%, 9.5%) in spontaneous abortion, 3.0% (1.4%, 5.8%) in stillbirth, and 0.7% (0.0%, 2.8%) in ectopic pregnancies. Most newborns had normal APGAR scores and birth weights (98.1% and 93.0%, respectively), and only two reported a congenital anomaly (0.7%; 0.0%, 2.8%). An influx of reports in 2012 with third trimester Tdap5 exposure coincided with the 2012 updated Advisory Committee on Immunization Practices recommendations. This analysis did not identify any safety concerns across the continuum of maternal, obstetrical, pregnancy, and neonatal outcomes in women who received Tdap5 vaccination during pregnancy.
“Adacel（Tdap5）妊娠登记处”用于识别 2005 年至 2016 年间 1182 名在怀孕期间接受破伤风、白喉、无细胞百日咳[5 种成分]（Tdap5）疫苗的女性。为了评估产前 Tdap5 的安全性和使用情况，我们计算了 Tdap5 妊娠暴露后产妇、产科、妊娠和新生儿结局的发生率，并按暴露年度和妊娠三季评估疫苗接种率。报告的最常见母体不良事件包括注射部位反应（2.6%；95%置信区间 1.8%，3.7%）、神经系统事件（1.3%；0.8%，2.1%）和肌肉骨骼事件（1.1%；0.6%，1.9%）。报告的最常见妊娠并发症为高血压/先兆子痫（5.5%；3.3%，8.9%）和妊娠期糖尿病（2.5%；1.1%，5.3%），而分娩和分娩并发症为早产（2.9%；1.4%，5.7%）和胎膜早破（1.5%；0.4%，3.8%）。这些发生率与一般孕妇人群报告的发生率相似或较低。在已知分娩结局的妊娠中（N=275），90.4%（86.2%，93.4%）为活产，5.9%（3.6%，9.5%）为自然流产，3.0%（1.4%，5.8%）为死产，0.7%（0.0%，2.8%）为异位妊娠。大多数新生儿的 APGAR 评分和出生体重正常（分别为 98.1%和 93.0%），仅报告了两例先天性异常（0.7%；0.0%，2.8%）。2012 年，随着第三孕期 Tdap5 暴露量的增加，恰逢 2012 年更新的免疫实践咨询委员会建议。本分析未发现孕妇接受 Tdap5 疫苗接种后，在产妇、产科、妊娠和新生儿结局的连续过程中存在任何安全性问题。
