Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Weill Cornell Medical College, New York, New York.
Department of Obstetrics and Gynecology, Weill Cornell Medical College, New York, New York.
JAMA Netw Open. 2024 Jul 1;7(7):e2419268. doi: 10.1001/jamanetworkopen.2024.19268.
IMPORTANCE: A nonadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF [Pfizer]) protein subunit vaccine was newly approved and recommended for pregnant individuals at 32 0/7 to 36 6/7 weeks' gestation during the 2023 to 2024 RSV season; however, clinical vaccine data are lacking. OBJECTIVE: To evaluate the association between prenatal RSV vaccination status and perinatal outcomes among patients who delivered during the vaccination season. DESIGN, SETTING, AND PARTICIPANTS: This retrospective observational cohort study was conducted at 2 New York City hospitals within 1 health care system among patients who gave birth to singleton gestations at 32 weeks' gestation or later from September 22, 2023, to January 31, 2024. EXPOSURE: Prenatal RSV vaccination with the RSVpreF vaccine captured from the health system's electronic health records. MAIN OUTCOME AND MEASURES: The primary outcome is preterm birth (PTB), defined as less than 37 weeks' gestation. Secondary outcomes included hypertensive disorders of pregnancy (HDP), stillbirth, small-for-gestational age birth weight, neonatal intensive care unit (NICU) admission, neonatal respiratory distress with NICU admission, neonatal jaundice or hyperbilirubinemia, neonatal hypoglycemia, and neonatal sepsis. Logistic regression models were used to estimate odds ratios (ORs), and multivariable logistic regression models and time-dependent covariate Cox regression models were performed. RESULTS: Of 2973 pregnant individuals (median [IQR] age, 34.9 [32.4-37.7] years), 1026 (34.5%) received prenatal RSVpreF vaccination. Fifteen patients inappropriately received the vaccine at 37 weeks' gestation or later and were included in the nonvaccinated group. During the study period, 60 patients who had evidence of prenatal vaccination (5.9%) experienced PTB vs 131 of those who did not (6.7%). Prenatal vaccination was not associated with an increased risk for PTB after adjusting for potential confounders (adjusted OR, 0.87; 95% CI, 0.62-1.20) and addressing immortal time bias (hazard ratio [HR], 0.93; 95% CI, 0.64-1.34). There were no significant differences in pregnancy and neonatal outcomes based on vaccination status in the logistic regression models, but an increased risk of HDP in the time-dependent model was seen (HR, 1.43; 95% CI, 1.16-1.77). CONCLUSIONS AND RELEVANCE: In this cohort study of pregnant individuals who delivered at 32 weeks' gestation or later, the RSVpreF vaccine was not associated with an increased risk of PTB and perinatal outcomes. These data support the safety of prenatal RSVpreF vaccination, but further investigation into the risk of HDP is warranted.
重要性:一种无佐剂的二价呼吸道合胞病毒(RSV)融合前 F(RSVpreF [辉瑞])蛋白亚单位疫苗最近获得批准,并建议在 2023 至 2024 年 RSV 季节期间,妊娠 32 0/7 至 36 6/7 周的孕妇接种;然而,目前缺乏临床疫苗数据。
目的:评估在疫苗接种季节分娩的患者中,产前 RSV 疫苗接种状况与围产期结局之间的关系。
设计、设置和参与者:这是一项在纽约市两家医院进行的回顾性观察性队列研究,在一个医疗系统内,纳入了 2023 年 9 月 22 日至 2024 年 1 月 31 日期间在 32 周妊娠或之后分娩的单胎妊娠患者。
暴露:产前 RSV 疫苗接种,使用医疗系统的电子健康记录捕获 RSVpreF 疫苗的数据。
主要结局和措施:主要结局是早产(PTB),定义为不足 37 周妊娠。次要结局包括妊娠高血压疾病(HDP)、死胎、小于胎龄出生体重、新生儿重症监护病房(NICU)入院、新生儿呼吸窘迫伴 NICU 入院、新生儿黄疸或高胆红素血症、新生儿低血糖和新生儿败血症。使用逻辑回归模型估计比值比(OR),并进行多变量逻辑回归模型和时间依赖协变量 Cox 回归模型。
结果:在 2973 名孕妇(中位数[IQR]年龄,34.9[32.4-37.7]岁)中,1026 名(34.5%)接受了产前 RSVpreF 疫苗接种。15 名患者在 37 周妊娠或之后不恰当地接种了疫苗,被纳入未接种组。在研究期间,有 60 名有产前疫苗接种证据(5.9%)的患者发生了 PTB,而未接种疫苗的患者中有 131 名(6.7%)。在调整了潜在混杂因素后(调整后的 OR,0.87;95%CI,0.62-1.20),产前接种疫苗与 PTB 风险增加无关,且可以解决“不死时间”偏倚(HR,0.93;95%CI,0.64-1.34)。在逻辑回归模型中,基于疫苗接种状态,妊娠和新生儿结局没有显著差异,但在时间依赖模型中观察到 HDP 风险增加(HR,1.43;95%CI,1.16-1.77)。
结论和相关性:在这项对妊娠 32 周或以上分娩的孕妇进行的队列研究中,RSVpreF 疫苗接种与 PTB 和围产期结局的风险增加无关。这些数据支持产前 RSVpreF 疫苗接种的安全性,但需要进一步研究 HDP 的风险。
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