Faherty Emily A G, Wilkins Kenneth J, Jones Sara, Challa Anup, Qin Qiuyuan, Chan Lauren E, Olson-Chen Courtney, Tarleton Jessica L, Liebman Michael N, Mariona Federico, Hill Elaine L, Patel Rena C
Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN 55455, USA.
Biostatistics Program, Office of the Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 20892, USA.
Vaccines (Basel). 2024 Mar 11;12(3):289. doi: 10.3390/vaccines12030289.
COVID-19 vaccines have been shown to be effective in preventing severe illness, including among pregnant persons. The vaccines appear to be safe in pregnancy, supporting a continuously favorable overall risk/benefit profile, though supportive data for the U.S. over different periods of variant predominance are lacking. We sought to analyze the association of adverse pregnancy outcomes with COVID-19 vaccinations in the pre-Delta, Delta, and Omicron SARS-CoV-2 variants' dominant periods (constituting 50% or more of each pregnancy) for pregnant persons in a large, nationally sampled electronic health record repository in the U.S. Our overall analysis included 311,057 pregnant persons from December 2020 to October 2023 at a time when there were approximately 3.6 million births per year. We compared rates of preterm births and stillbirths among pregnant persons who were vaccinated before or during pregnancy to persons vaccinated after pregnancy or those who were not vaccinated. We performed a multivariable Poisson regression with generalized estimated equations to address data site heterogeneity for preterm births and unadjusted exact models for stillbirths, stratified by the dominant variant period. We found lower rates of preterm birth in the majority of modeled periods (adjusted incidence rate ratio [aIRR] range: 0.42 to 0.85; -value range: <0.001 to 0.06) and lower rates of stillbirth (IRR range: 0.53 to 1.82; -value range: <0.001 to 0.976) in most periods among those who were vaccinated before or during pregnancy compared to those who were vaccinated after pregnancy or not vaccinated. We largely found no adverse associations between COVID-19 vaccination and preterm birth or stillbirth; these findings reinforce the safety of COVID-19 vaccination during pregnancy and bolster confidence for pregnant persons, providers, and policymakers in the importance of COVID-19 vaccination for this group despite the end of the public health emergency.
COVID-19疫苗已被证明在预防包括孕妇在内的严重疾病方面是有效的。这些疫苗在孕期似乎是安全的,总体风险/收益状况持续良好,不过缺乏美国在不同变异株占主导时期的支持数据。我们试图在美国一个全国抽样的大型电子健康记录库中,分析在Delta变异株出现前、Delta变异株和Omicron变异株占主导时期(占每次妊娠的50%或更多),孕妇接种COVID-19疫苗与不良妊娠结局之间的关联。我们的总体分析纳入了2020年12月至2023年10月期间的311,057名孕妇,当时每年约有360万例分娩。我们比较了孕期接种疫苗的孕妇与产后接种疫苗或未接种疫苗的孕妇的早产和死产率。我们使用广义估计方程进行多变量泊松回归,以处理早产数据的站点异质性,并对死产使用未调整的精确模型,按主导变异株时期进行分层。我们发现,在大多数建模时期,孕期接种疫苗的孕妇早产率较低(调整后的发病率比[aIRR]范围:0.42至0.85;P值范围:<0.001至0.06),大多数时期死产率也较低(发病率比[IRR]范围:0.53至1.82;P值范围:<0.001至0.976),与产后接种疫苗或未接种疫苗的孕妇相比。我们在很大程度上未发现COVID-19疫苗接种与早产或死产之间存在不良关联;这些发现强化了孕期接种COVID-19疫苗的安全性,并增强了孕妇、医护人员和政策制定者对这一群体接种COVID-19疫苗重要性的信心,尽管公共卫生紧急状态已经结束。
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