Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.
复制标题
DOI：
10.1056/nejmoa2104983
复制
发表时间：
2021-06-17
期刊：
影响因子：
--
通讯作者：
CDC v-safe COVID-19 Pregnancy Registry Team
中科院分区：
文献类型：
--
作者：
Shimabukuro TT;Kim SY;Myers TR;Moro PL;Oduyebo T;Panagiotakopoulos L;Marquez PL;Olson CK;Liu R;Chang KT;Ellington SR;Burkel VK;Smoots AN;Green CJ;Licata C;Zhang BC;Alimchandani M;Mba-Jonas A;Martin SW;Gee JM;Meaney-Delman DM;CDC v-safe COVID-19 Pregnancy Registry Team
美国的许多孕妇正在接受2019冠状病毒病（Covid-19）疫苗的信使RNA（mRNA），但有关其妊娠安全性的数据有限。从2020年12月14日至2021年2月28日，我们使用了来自“v-safe接种后健康检查员”监测系统、v-safe妊娠登记系统和疫苗不良事件报告系统（VAERS）的数据，以表征mRNA Covid-19疫苗在孕妇中的初始安全性。共有35，691名16至54岁的v-safe参与者被确定为妊娠。注射部位疼痛在妊娠患者中的报告频率高于非妊娠女性，而头痛、肌痛、寒战和发热的报告频率较低。在入组v-safe妊娠登记研究的3958例受试者中，827例完成妊娠，其中115例（13.9%）导致流产，712例（86.1%）导致活产（主要是在妊娠晚期接种疫苗的受试者）。不良新生儿结局包括早产（9.4%）和小于胎龄儿（3.2%）;未报告新生儿死亡。尽管没有直接可比性，但计算出的接种COVID-19疫苗并已完成妊娠的人的不良妊娠和新生儿结局比例与在COVID-19大流行之前进行的涉及孕妇的研究中报告的发生率相似。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例病例）。初步研究结果显示，在接种mRNA Covid-19疫苗的孕妇中没有明显的安全信号。然而，更多的纵向随访，包括大量妇女在怀孕早期接种疫苗的后续行动，是必要的，以告知产妇，怀孕和婴儿的结果。
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. 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. 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). 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.