PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: To evaluate the association between prenatal RSV vaccination status and perinatal outcomes among patients who delivered during the vaccination season.
UNASSIGNED: 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.
UNASSIGNED: Prenatal RSV vaccination with the RSVpreF vaccine captured from the health system\'s electronic health records.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: To evaluate the association between prenatal RSV vaccination status and perinatal outcomes among patients who delivered during the vaccination season.
UNASSIGNED: 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.
UNASSIGNED: Prenatal RSV vaccination with the RSVpreF vaccine captured from the health system\'s electronic health records.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
摘要：
■新批准了非佐剂二价呼吸道合胞病毒（RSV）预融合F（RSVpreF[Pfizer]）蛋白亚单位疫苗，并推荐用于在2023年至2024年RSV季节妊娠320/7至366/7周的孕妇；但是，缺乏临床疫苗数据。
■评估在疫苗接种季节期间分娩的患者的产前RSV疫苗接种状态与围产期结局之间的关联。
这项回顾性观察性队列研究是在1个医疗保健系统内的2家纽约市医院中进行的，这些患者从2023年9月22日至2024年1月31日在妊娠32周或更晚出生了单胎妊娠。
■使用从卫生系统的电子健康记录中捕获的RSVpreF疫苗进行产前RSV疫苗接种。
■主要结局是早产（PTB），定义为妊娠少于37周。次要结局包括妊娠高血压疾病（HDP），死产,小于胎龄出生体重，新生儿重症监护病房（NICU）入院，新生儿呼吸窘迫与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。Logistic回归模型用于估计比值比(OR)，并进行了多变量逻辑回归模型和时间依赖性协变量Cox回归模型。
■2973名孕妇（中位[IQR]年龄，34.9[32.4-37.7]年)，1026人(34.5%)接受产前RSVpreF疫苗接种。15名患者在妊娠37周或更晚不适当地接种了疫苗，并被纳入未接种组。在学习期间,有产前疫苗接种证据的60例患者（5.9％）经历了PTB，而没有经历的患者为131例（6.7％）。在调整潜在的混杂因素后，产前接种疫苗与PTB风险增加无关(调整后的OR，0.87；95%CI，0.62-1.20)和解决不朽的时间偏差(危险比[HR]，0.93；95%CI，0.64-1.34）。在logistic回归模型中，基于疫苗接种状态的妊娠和新生儿结局没有显着差异。但在时间依赖模型中观察到HDP的风险增加(HR，1.43；95%CI，1.16-1.77）。
在这项针对妊娠32周或更晚分娩的孕妇的队列研究中，RSVpreF疫苗与PTB风险增加和围产期结局无关.这些数据支持产前RSVpreF疫苗接种的安全性，但有必要对HDP的风险进行进一步调查。
■评估在疫苗接种季节期间分娩的患者的产前RSV疫苗接种状态与围产期结局之间的关联。
这项回顾性观察性队列研究是在1个医疗保健系统内的2家纽约市医院中进行的，这些患者从2023年9月22日至2024年1月31日在妊娠32周或更晚出生了单胎妊娠。
■使用从卫生系统的电子健康记录中捕获的RSVpreF疫苗进行产前RSV疫苗接种。
■主要结局是早产（PTB），定义为妊娠少于37周。次要结局包括妊娠高血压疾病（HDP），死产,小于胎龄出生体重，新生儿重症监护病房（NICU）入院，新生儿呼吸窘迫与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。Logistic回归模型用于估计比值比(OR)，并进行了多变量逻辑回归模型和时间依赖性协变量Cox回归模型。
■2973名孕妇（中位[IQR]年龄，34.9[32.4-37.7]年)，1026人(34.5%)接受产前RSVpreF疫苗接种。15名患者在妊娠37周或更晚不适当地接种了疫苗，并被纳入未接种组。在学习期间,有产前疫苗接种证据的60例患者（5.9％）经历了PTB，而没有经历的患者为131例（6.7％）。在调整潜在的混杂因素后，产前接种疫苗与PTB风险增加无关(调整后的OR，0.87；95%CI，0.62-1.20)和解决不朽的时间偏差(危险比[HR]，0.93；95%CI，0.64-1.34）。在logistic回归模型中，基于疫苗接种状态的妊娠和新生儿结局没有显着差异。但在时间依赖模型中观察到HDP的风险增加(HR，1.43；95%CI，1.16-1.77）。
在这项针对妊娠32周或更晚分娩的孕妇的队列研究中，RSVpreF疫苗与PTB风险增加和围产期结局无关.这些数据支持产前RSVpreF疫苗接种的安全性，但有必要对HDP的风险进行进一步调查。
