COVID-19 Vaccine Effectiveness in Pregnant Women and their Infants

摘要： 2019冠状病毒病（COVID-19）是由严重急性呼吸窘迫综合征冠状病毒2引起的 （SARS-CoV-2）于2019年12月出现，此后导致了前所未有的全球大流行 发病率和死亡率高。 目前批准的SARS-CoV-2疫苗在临床试验中显示出70 - 95%的有效性，但 紧急使用授权所依据的关键疗效试验不包括孕妇。 因此，在大规模疫苗接种运动中，COVID-19疫苗对孕妇的有效性 他们的孩子是未知的。孕妇感染COVID-19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COVID-19疫苗。 此外，孕妇的COVID-19疫苗接种率以及与接种疫苗相关的因素 或未接种疫苗的情况不明。 我们建议1）评估COVID-19疫苗预防实验室确诊COVID-19的有效性 孕妇感染或COVID-19住院，2）确定COVID-19疫苗接种的有效性 怀孕期间预防COVID-19感染或婴儿在出生后第一年住院; 并确定有效性是否因疫苗接种的三个月而异，以及3）估计COVID-19疫苗接种 孕妇和未接种疫苗的孕妇的接种率， 与未接种疫苗相关的社会人口统计学、地理集群和医疗保健利用模式。 我们在北方加州的凯撒医疗机构有着良好的定位，这是一个大型的综合医疗保健系统， 稳定、多样化的会员和全面的纵向电子健康记录（EHR），以解决 研究目的。通过使用电子健康记录数据，研究将具有成本效益和及时性;提供有关COVID的信息- 19.孕妇接种疫苗的有效性，并评估孕妇接种疫苗是否能提供 为目前没有资格接种COVID-19疫苗的婴儿提供保护。 这项拟议的研究可以为中国提供关于COVID-19疫苗接种的循证建议。 孕妇，并将提供有关未接种疫苗的孕妇的特征的关键信息 为今后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 在孕妇中。

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.