NEJM:孕妇接种mRNA新冠疫苗的安全性
创作:Epi汪 审核:Epi汪 05月14日
  • 对在美国接种了mRNA的新冠疫苗的孕妇(35691名)进行分析;
  • 相比于非孕妇,孕妇报告注射部位疼痛的风险更高,而头痛、肌痛、寒战和发烧的频率较低;
  • 对于完成妊娠的827人中,有13.9%发生流产;
  • 早产的发生率为9.4%,小于胎龄儿发生率是3.2%,没有新生儿死亡的报告;
  • 虽不具可比性,但疫苗接种者不良妊娠结局的发生率与疫情前的发生率是相似的;
  • 没有数据显示妊娠期接种mRNA疫苗会对孕妇和新生儿结局产生损伤。
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Epi汪
发表在《新英格兰医学杂志》的研究数据表明,对于在孕期接种美国mRNA疫苗的孕妇来说,并不会增加不良妊娠结局的发生率。这弥补了临床试验过程中孕妇数据的缺失问题,是一个比较重要的发现。
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Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

孕妇mRNA Covid-19疫苗安全性的初步发现

10.1056/NEJMoa2104983

04-21, Article

Abstract & Authors:展开

Abstract:收起
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.

First Authors:
Tom T Shimabukuro

Correspondence Authors:
Tom T Shimabukuro

All Authors:
Tom T Shimabukuro,Shin Y Kim,Tanya R Myers,Pedro L Moro,Titilope Oduyebo,Lakshmi Panagiotakopoulos,Paige L Marquez,Christine K Olson,Ruiling Liu,Karen T Chang,Sascha R Ellington,Veronica K Burkel,Ashley N Smoots,Caitlin J Green,Charles Licata,Bicheng C Zhang,Meghna Alimchandani,Adamma Mba-Jonas,Stacey W Martin,Julianne M Gee,Dana M Meaney-Delman,for the CDC v-safe COVID-19 Pregnancy Registry Team

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