Departments of Pediatrics, Obstetrics and Gynecology, and Epidemiology, University of Florida College of Medicine and College of Public Health and Health Professions, Gainesville, Florida; and the Division of Infectious Diseases and the Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, the Grady Healthcare System, Infectious Diseases Program, Atlanta, and the Hope Clinic of the Emory Vaccine Center, Decatur, Georgia.
Obstet Gynecol. 2021 Mar 1;137(3):408-414. doi: 10.1097/AOG.0000000000004290.
Coronavirus disease 2019 (COVID-19) vaccines have begun to be distributed across the United States and to be offered initially to priority groups including health care personnel and persons living in long-term care facilities. Guidance regarding whether pregnant persons should receive a COVID-19 vaccine is needed. Because pregnant persons were excluded from the initial phase 3 clinical trials of COVID-19 vaccines, limited data are available on their efficacy and safety during pregnancy. After developmental and reproductive toxicology studies are completed, some companies are expected to conduct clinical trials in pregnant persons. Until then, pregnant persons and their obstetricians will need to use available data to weigh the benefits and risks of COVID-19 vaccines. Issues to be considered when counseling pregnant persons include data from animal studies and inadvertently exposed pregnancies during vaccine clinical trials when available, potential risks to pregnancy of vaccine reactogenicity, timing of vaccination during pregnancy, evidence for safety of other vaccines during pregnancy, risk of COVID-19 complications due to pregnancy and the pregnant person's underlying conditions, and risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential for risk mitigation. The Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine have each issued guidance supportive of offering COVID-19 vaccine to pregnant persons. As additional information from clinical trials and from data collected on vaccinated pregnant persons becomes available, it will be critical for obstetricians to keep up to date with this information.
新型冠状病毒病 2019(COVID-19)疫苗已开始在美国分发,并初步提供给包括医护人员和长期护理机构人员在内的优先群体。需要就孕妇是否应接种 COVID-19 疫苗提供指导。由于孕妇被排除在 COVID-19 疫苗的初始 3 期临床试验之外,因此关于其在怀孕期间的疗效和安全性的数据有限。在完成发育和生殖毒理学研究后,一些公司预计将在孕妇中进行临床试验。在此之前,孕妇及其产科医生将需要利用现有数据权衡 COVID-19 疫苗的益处和风险。在为孕妇提供咨询时需要考虑的问题包括动物研究数据和疫苗临床试验中无意中暴露的妊娠数据,如果疫苗的不良反应对怀孕有潜在风险、怀孕期间接种疫苗的时间、其他疫苗在怀孕期间的安全性证据、因怀孕和孕妇的基础疾病而导致 COVID-19 并发症的风险,以及接触严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)的风险和潜在风险缓解措施。美国疾病控制与预防中心、美国妇产科医师学会和母胎医学学会都发布了支持为孕妇提供 COVID-19 疫苗的指南。随着临床试验和接种疫苗的孕妇数据的不断增加,产科医生及时了解这些信息至关重要。