孕妇美国现役军人接种破伤风、白喉和无细胞百日咳疫苗的安全性。
Safety of tetanus, diphtheria, and acellular pertussis vaccination among pregnant active duty U.S. military women.
机构信息
Leidos, Inc., 140 Sylvester Road, San Diego, CA 92106, USA; Deployment Health Research Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, USA.
Leidos, Inc., 140 Sylvester Road, San Diego, CA 92106, USA; Deployment Health Research Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, USA.
出版信息
Vaccine. 2020 Feb 18;38(8):1982-1988. doi: 10.1016/j.vaccine.2020.01.009. Epub 2020 Jan 14.
BACKGROUND
The tetanus, diphtheria, and acellular pertussis (Tdap) vaccine was approved for U.S. adults in 2005 and recommended for administration in every pregnancy in 2012, with optimal timing between 27 and 36 weeks' gestation. In the military, however, a current Tdap vaccination status is compulsory for service, and active duty women may be inadvertently exposed in early pregnancy. Safety data in this population are limited.
OBJECTIVES
To assess safety of inadvertent (0-13 weeks' gestation) and recommended (27-36 weeks' gestation) exposure to the Tdap vaccine in pregnancy.
METHODS
Pregnancies and live births from Department of Defense Birth and Infant Health Research program data were linked with military personnel immunization records to determine pregnancy Tdap vaccine exposure among active duty women, 2006-2014. Multivariable Cox and generalized linear regression models estimated associations between Tdap vaccine exposure and adverse pregnancy or infant outcomes.
RESULTS
Of 145,883 pregnancies, 1272 were exposed to the Tdap vaccine in the first trimester and 9438 between 27 and 36 weeks' gestation. Neither inadvertent nor recommended vaccine exposure were associated with spontaneous abortion, preeclampsia, or preterm labor. Among 117,724 live born infants, 984 were exposed to the Tdap vaccine in the first trimester and 9352 between 27 and 36 weeks' gestation. First trimester exposure was not associated with birth defects, growth problems in utero, growth problems in infancy, preterm birth, or low birth weight. Tdap vaccine exposure between 27 and 36 weeks' gestation was not associated with any adverse infant outcome.
CONCLUSIONS
Among a population of active duty women in the U.S. military who received the Tdap vaccine during pregnancy, we detected no increased risks for adverse maternal, fetal, or infant outcomes. Our findings corroborate existing literature on the safety of exposure to the Tdap vaccine in pregnancy.
背景
百白破（Tdap）疫苗于 2005 年在美国获准用于成年人，并于 2012 年建议在每一次妊娠中使用，最佳时间是在 27 至 36 孕周之间。然而，在军队中，目前 Tdap 疫苗的接种状态是强制性的，现役女性可能会在怀孕早期无意中接触到该疫苗。该人群的安全性数据有限。
目的
评估妊娠期间无意中（0-13 孕周）和推荐（27-36 孕周）接触 Tdap 疫苗的安全性。
方法
通过国防部生育和婴儿健康研究计划的数据将妊娠和活产与军人免疫记录相关联，以确定 2006 年至 2014 年期间现役女性妊娠 Tdap 疫苗暴露情况。多变量 Cox 和广义线性回归模型估计了 Tdap 疫苗暴露与不良妊娠或婴儿结局之间的关联。
结果
在 145883 例妊娠中，有 1272 例在孕早期接触了 Tdap 疫苗，9438 例在 27 至 36 孕周之间接触了 Tdap 疫苗。无意中或推荐的疫苗暴露均与自然流产、子痫前期或早产无关。在 117724 例活产婴儿中，有 984 例在孕早期接触了 Tdap 疫苗，9352 例在 27 至 36 孕周之间接触了 Tdap 疫苗。孕早期接触 Tdap 疫苗与出生缺陷、宫内生长问题、婴儿期生长问题、早产或低出生体重无关。27 至 36 孕周之间的 Tdap 疫苗暴露与任何不良婴儿结局无关。
结论
在美国军队现役女性中，在妊娠期间接种 Tdap 疫苗的人群中，我们没有发现不良的母体、胎儿或婴儿结局风险增加。我们的研究结果与现有的关于妊娠期间接触 Tdap 疫苗安全性的文献相符。
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