美国疾病预防控制中心Tom T. Shimabukuro团队研究了mRNA Covid-19疫苗对孕妇的安全性。2021年4月21日，《新英格兰医学杂志》发表了该研究。

美国有许多孕妇正在接种mRNA Covid-19疫苗，但关于其妊娠安全性的数据很有限。2020年12月14日到2021年2月28日，研究组使用“疫苗接种后v-safe健康检查”监测系统、v-safe妊娠登记和疫苗不良事件报告系统（VAERS）的数据来描述mRNA Covid-19疫苗在孕妇中的初始安全性。

共有35691名16至54岁的v-safe参与者被确认怀孕。孕妇注射部位疼痛的发生率高于非孕妇，而头痛、肌痛、寒战和发热的发生率较低。在参加v-safe妊娠登记的3958名受试者中，827人已完成妊娠，其中115人（13.9%）流产，712人（86.1%）活产（大部分受试者在妊娠晚期接种疫苗）。

不良新生儿结局包括早产（9.4%）和小于胎龄儿（3.2%），无新生儿死亡报告。尽管没有直接可比性，但在接种Covid-19疫苗的孕妇中，已完成妊娠的不良妊娠和新生儿结局的计算比例，与Covid-19大流行前涉及孕妇的研究报告中的发生率相似。在向VAERS报告的221例妊娠相关不良事件中，最常报告的事件是自然流产（46例）。

研究结果表明，接种mRNA Covid-19疫苗的孕妇未发现明显安全问题。

附：英文原文

Title: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

Author: 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.

Issue&Volume: 2021-04-21

Abstract:

BACKGROUND

Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy.

METHODS

From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons.

RESULTS

A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases).

CONCLUSIONS

Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.

DOI: 10.1056/NEJMoa2104983

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2104983