Department of Gynecology and Obstetrics, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Liver Disease Center, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
Front Immunol. 2024 Jan 16;14:1303058. doi: 10.3389/fimmu.2023.1303058. eCollection 2023.
Large sample of pregnant women vaccinated with COVID-19 vaccine has not been carried out in China. The objective of this study was to evaluate the safety and effectiveness of COVID-19 inactivated vaccine in pregnant women infected with the SARS-CoV-2 Omicron variant.
A total of 1,024 pregnant women and 120 newborns were enrolled in this study. 707 pregnant women received one to three doses of the inactivated COVID-19 vaccine, and 317 unvaccinated patients served as the control group. A comparison was made between their clinical and laboratory data at different stages of pregnancy.
The incidence rate of patients infected with Omicron variant in the first, the second, and the third trimesters of pregnancy was 27.5%, 27.0%, and 45.5% in patients during, respectively. The corresponding length of hospital stay was 8.7 ± 3.3 days, 9.5 ± 3.3 days, and 11 ± 4.3 days, respectively. The hospitalization time of pregnant women who received 3 doses of vaccine was (8.8 ± 3.3) days, which was significantly shorter than that of non-vaccinated women (11.0 ± 3.9) days. (P<0.0001). The positive rate of SARS-CoV-2 IgG in patients in the early stage of pregnancy was 28.8%, while that in patients in the late stage of pregnancy was 10.3%. However, three-doses of vaccination significantly increased the SARS-CoV-2 IgG positive rate to 49.5%. The hospitalization time of SARS-CoV-2 IgG-positive patients was shorter than that of negative patients (9.9 ± 3.5 days), which was 7.4 ± 2.0 days. 12.2% of vaccinated women experienced mild adverse reactions, manifested as fatigue (10.6%) and loss of appetite (1.6%). The vaccination of mother did not affect her choice of future delivery mode and the Apgar score of their newborn. All newborns tested negative for SARS-CoV-2 nucleic acid, as well as for IgG and IgM antibodies.
Women in the third trimester of pregnancy are highly susceptible to infection with the Omicron strain. The vaccination of pregnant women with COVID-19 vaccine can accelerate the process of eliminating SARS-CoV-2 virus, and is considered safe for newborns. The recommended vaccination includes three doses.
中国尚未对大量孕妇接种 COVID-19 疫苗进行研究。本研究旨在评估 COVID-19 灭活疫苗在感染 SARS-CoV-2 奥密克戎变异株的孕妇中的安全性和有效性。
本研究共纳入 1024 名孕妇及其 120 名新生儿。707 名孕妇接受了 1-3 剂灭活 COVID-19 疫苗，317 名未接种疫苗的患者作为对照组。比较了不同孕期孕妇的临床和实验室数据。
妊娠第一、二、三孕期感染奥密克戎变异株的患者发生率分别为 27.5%、27.0%和 45.5%，相应住院时间分别为 8.7±3.3 天、9.5±3.3 天和 11±4.3 天。接种 3 剂疫苗的孕妇住院时间为（8.8±3.3）天，明显短于未接种疫苗的孕妇（11.0±3.9）天（P<0.0001）。妊娠早期患者 SARS-CoV-2 IgG 阳性率为 28.8%，妊娠晚期患者为 10.3%。然而，接种 3 剂疫苗可显著提高 SARS-CoV-2 IgG 阳性率至 49.5%。SARS-CoV-2 IgG 阳性患者的住院时间短于阴性患者（9.9±3.5 天），为 7.4±2.0 天。12.2%的接种妇女出现轻度不良反应，表现为乏力（10.6%）和食欲不振（1.6%）。母亲的接种未影响其对未来分娩方式的选择及其新生儿的 Apgar 评分。所有新生儿的 SARS-CoV-2 核酸、IgG 和 IgM 抗体均为阴性。
妊娠晚期妇女极易感染奥密克戎株。COVID-19 疫苗接种可加速 SARS-CoV-2 病毒清除过程，对新生儿安全。推荐的疫苗接种包括 3 剂。
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