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孕妇接种mRNA COVID-19疫苗安全性的初步研究
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons


Tom T. Shimabukuro ... 传染病 呼吸系统疾病 妇产科和儿科 • 2021.06.17
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摘要


背景

美国许多孕妇正在接种mRNA COVID-19疫苗,但目前关于妊娠期安全性的数据有限

 

方法

从2020年12月14日至2021年2月28日,我们通过“v-safe疫苗接种后健康检查”监测系统、v-safe妊娠登记系统和疫苗不良事件报告系统(Vaccine Adverse Event Reporting System,VAERS)的数据确定了孕妇接种mRNA COVID-19疫苗的初始安全性。

 

结果

共计35,691名16~54岁的v-safe参与者被确定为孕妇。孕妇报告的注射部位疼痛发生率高于非妊娠女性,而孕妇报告的头痛、肌痛、寒战和发热发生率较低。在v-safe妊娠登记系统登记的3,958名参与者中,有827人完成妊娠,其中115人(13.9%)妊娠丢失,712人(86.1%)活产(大多数是在妊娠晚期接种疫苗的参与者)。新生儿不良结局包括早产(9.4%)和小于胎龄儿(3.2%);无关于新生儿死亡的报告。虽然不具有直接可比性,但在接种COVID-19疫苗且完成妊娠的人中,计算出的不良妊娠和新生儿结局比例与在COVID-19疫情前开展的孕妇研究报告的发生率相似。在向VAERS报告的221起妊娠相关不良事件中,最常报告的事件是自然流产(46例)。

 

结论

初步结果在接种mRNA COVID-19疫苗的孕妇中未显示明显的安全信号。然而,更多纵向随访(包括对在妊娠较早期接种疫苗的大量孕妇进行随访)对于了解孕产妇、妊娠和婴儿结局是必要的。





作者信息

Tom T. Shimabukuro, M.D., Shin Y. Kim, M.P.H., Tanya R. Myers, Ph.D., Pedro L. Moro, M.D., Titilope Oduyebo, M.D., Lakshmi Panagiotakopoulos, M.D., Paige L. Marquez, M.S.P.H., Christine K. Olson, M.D., Ruiling Liu, Ph.D., Karen T. Chang, Ph.D., Sascha R. Ellington, Ph.D., Veronica K. Burkel, M.P.H., Ashley N. Smoots, M.P.H., Caitlin J. Green, M.P.H., Charles Licata, Ph.D., Bicheng C. Zhang, M.S., Meghna Alimchandani, M.D., Adamma Mba-Jonas, M.D., Stacey W. Martin, M.S., Julianne M. Gee, M.P.H., and Dana M. Meaney-Delman, M.D. for the CDC v-safe COVID-19 Pregnancy Registry Team*
From the Immunization Safety Office, Division of Healthcare Quality Promotion (T.T.S., T.R.M., P.L. Moro, L.P., P.L. Marquez, C.K.O., C.L., B.C.Z., J.M.G.), and the Arboviral Diseases Branch, Division of Vector-Borne Diseases (S.W.M.), National Center for Emerging and Zoonotic Infectious Diseases, the Division of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities (S.Y.K., V.K.B., C.J.G., D.M.M.-D.), the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion (T.O., K.T.C., S.R.E., A.N.S.), the World Trade Center Health Program, National Institute for Occupational Safety and Health (R.L.), and the Epidemic Intelligence Service (K.T.C.) — all at the Centers for Disease Control and Prevention, Atlanta; and the Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD (M.A., A.M.-J.). Address reprint requests to Dr. Shimabukuro at the Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30329, or at tshimabukuro@cdc.gov. *The members of the CDC v-safe COVID-19 Pregnancy Registry Team are listed in the Supplementary Appendix, available at NEJM.org.

 

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