Craig Amanda M, Hughes Brenna L, Swamy Geeta K
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Duke University Health System, Durham, NC.
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Duke University Health System, Durham, NC.
Am J Obstet Gynecol MFM. 2021 Mar;3(2):100295. doi: 10.1016/j.ajogmf.2020.100295. Epub 2020 Dec 10.
As of December 1, 2020, nearly 64 million people have been infected with the severe acute respiratory syndrome coronavirus 2 worldwide with nearly 1.5 million global deaths. The impact of this virus has continued to overwhelm hospital infrastructure and demanded remodeling of healthcare systems. With rising concerns for a third, and possibly the largest, wave of individuals infected with the virus, national leaders are continuing to seek avenues by which we can further limit disease transmission and prevent infection with the use of vaccination. To our knowledge, no clinical trial evaluating vaccines to prevent coronavirus disease 2019 has included pregnant women. In December 2020, it was anticipated that the Food and Drug Administration will approve at least 1 or 2 mRNA-based coronavirus disease 2019 vaccine under the Emergency Use Authorization based on phase 3 clinical trial efficacy data. Both Pfizer and Moderna have manufactured mRNA-based vaccines with 95% and 94.1% efficacy against the severe acute respiratory syndrome coronavirus 2. AstraZeneca has manufactured a vaccine using a viral vector demonstrating early efficacy as well, and this next-generation platform has previously been utilized with the Ebola vaccine and safely administered during pregnancy with an acceptable safety profile. Approval of these vaccines will have a tremendous impact on the ongoing pandemic, yet there remains a lack of data for use of coronavirus disease 2019 vaccine in pregnant women. In this article, we seek to discuss the available data regarding treatment and prevention of coronavirus disease 2019 in pregnancy and address the growing questions regarding how best to approach vaccine access and administration in the pregnant population.
截至2020年12月1日，全球近6400万人感染了严重急性呼吸综合征冠状病毒2，全球死亡人数近150万。这种病毒的影响持续压垮医院基础设施，并要求对医疗系统进行重塑。随着人们对第三波、可能也是规模最大的一波病毒感染者的担忧加剧，各国领导人继续寻求途径，以便能够通过接种疫苗进一步限制疾病传播并预防感染。据我们所知，尚无评估预防2019冠状病毒病疫苗的临床试验纳入孕妇。2020年12月，预计美国食品药品监督管理局将根据3期临床试验疗效数据，在紧急使用授权下批准至少1种或2种基于信使核糖核酸的2019冠状病毒病疫苗。辉瑞和莫德纳公司均已生产出对严重急性呼吸综合征冠状病毒2有效率分别为95%和94.1%的基于信使核糖核酸的疫苗。阿斯利康公司生产了一种使用病毒载体的疫苗，也显示出早期疗效，而且这种新一代平台此前已用于埃博拉疫苗，并在孕期安全接种，安全性可接受。这些疫苗的获批将对当前的疫情产生巨大影响，但仍然缺乏2019冠状病毒病疫苗在孕妇中使用的数据。在本文中，我们试图讨论关于孕期2019冠状病毒病治疗和预防的现有数据，并解答有关如何最好地为孕妇提供疫苗接种途径及实施接种的越来越多的问题。
