COVID-19 Vaccine Effectiveness in Pregnant Women and their Infants

摘要： 冠状病毒病2019年(新冠肺炎)由严重急性呼吸窘迫综合征冠状病毒2引起 (SARS-CoV-2)于2019年12月出现，自那以来已导致一场前所未有的全球大流行 发病率和死亡率都很高。 目前授权的SARS-CoV-2疫苗在临床试验中显示出70%-95%的疗效，但 紧急使用授权所依据的关键疗效试验不包括孕妇。 因此，在一场大规模的疫苗接种运动中，新冠肺炎疫苗在孕妇中有效 他们的婴儿也是未知的。孕妇感染新冠肺炎和住院的风险增加， 但目前没有强烈建议或反对在怀孕期间接种新冠肺炎疫苗。 此外，孕妇对新冠肺炎疫苗的接受率以及与接种疫苗相关的因素 或未接种疫苗的人是未知的。 我们建议1)评估新冠肺炎疫苗预防实验室确认的新冠肺炎的有效性 孕妇感染或新冠肺炎住院，2)决定新冠肺炎疫苗接种效果 在孕期预防新冠肺炎感染或在一岁内住院的婴儿； 并确定有效性是否因接种三个月而异，以及3)估计新冠肺炎疫苗接种 随着时间的推移，孕妇和未接种疫苗的孕妇的发病率，确定 与未接种疫苗相关的社会人口、地理集群和医疗保健利用模式。 我们在北加州Kaiser Permanente处于有利地位，这是一家大型集成医疗系统，拥有 稳定、多样化的成员和全面的纵向电子健康记录(EHR)，以解决 研究目的。通过使用EHR数据，这项研究将具有成本效益和及时性；提供关于COVID的信息- 19孕妇接种疫苗的有效性和评估产妇接种疫苗是否能提供 保护目前没有资格接种新冠肺炎疫苗的婴儿。 拟议的研究可以导致关于在中国接种新冠肺炎疫苗的循证建议 并将提供有关未接种疫苗的孕妇特征的重要信息 未来制定有针对性的干预措施以提高疫苗覆盖率所必需的妇女 在怀孕的妇女中。

Abstract: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2) which emerged in December 2019 and has since led to an unprecedented global pandemic with high morbidity and mortality. Current authorized vaccines against SARS-CoV-2 demonstrated 70 – 95% efficacy in clinical trials, but the pivotal efficacy trials on which the emergency use authorizations are based did not include pregnant women. Thus, in the midst of a massive vaccination campaign, COVID-19 vaccine effectiveness in pregnant women and their infants is unknown. Pregnant women are at increased risk of COVID-19 infection and hospitalization, but currently there is no strong recommendation for or against COVID-19 vaccination during pregnancy. Additionally, COVID-19 vaccine uptake among pregnant women and factors associated with being vaccinated or unvaccinated are unknown. We propose to 1) estimate COVID-19 vaccine effectiveness for preventing laboratory-confirmed COVID-19 infection or COVID-19 hospitalization in pregnant women, 2) determine effectiveness of COVID-19 vaccination during pregnancy in preventing COVID-19 infection or hospitalization among infants during the first year of life; and determine whether effectiveness varies by trimester of vaccination and 3) estimate COVID-19 vaccination rates among pregnant women over time and among unvaccinated pregnant women, identify sociodemographic, geographic clusters and healthcare utilization patterns associated with being unvaccinated. We are well-positioned at Kaiser Permanente Northern California, a large integrated healthcare system with stable, diverse membership and comprehensive longitudinal electronic health records (EHR), to address the research aims. By using EHR data, the study will be cost effective and timely; providing information on COVID- 19 vaccine effectiveness among pregnant women and assessing whether maternal vaccination provides protection for their infants who are currently ineligible to receive COVID-19 vaccine. The proposed research can lead to evidence-based recommendations regarding COVID-19 vaccination in pregnant women and will provide critical information regarding characteristics of unvaccinated pregnant women that will be necessary for future development of targeted interventions to improve vaccine coverage among pregnant women.