Blauvelt Christine A, Zeme Molly, Natarajan Aishwarya, Epstein Adrienne, Roh Michelle E, Morales Amayrani, Bourdoud Nadia, Flaherman Valerie J, Prahl Mary K, Gaw Stephanie L
Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.
School of Medicine, University of California, San Francisco.
JAMA Netw Open. 2025 Feb 3;8(2):e2460735. doi: 10.1001/jamanetworkopen.2024.60735.
Two interventions to prevent severe respiratory syncytial virus (RSV) in infants were approved in 2023-a bivalent prenatal RSV prefusion F protein-based (RSVpreF) vaccine and an infant monoclonal antibody (nirsevimab). Understanding their uptake and clinical outcomes is essential for public health planning.
To describe uptake of the prenatal RSVpreF vaccine and infant nirsevimab.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted at a single academic center among 647 pregnant individuals eligible for RSVpreF vaccination (32-36 weeks' gestation between October 15, 2023, and January 31, 2024) and infants eligible for nirsevimab (no prenatal RSVpreF vaccination >14 days before delivery).
Pregnancy or birth during the 2023-2024 RSV season.
RSVpreF vaccination among eligible pregnant individuals and nirsevimab administration prior to hospital discharge among eligible infants.
Of 647 eligible pregnant individuals (mean [SD] age, 34.6 [6.2] years; 355 nulliparous [54.9%]; 558 privately insured [86.2%]), 414 (64.0%) received the RSVpreF vaccine. Factors associated with higher RSVpreF uptake included older birthing parent age (adjusted odds ratio [AOR], 1.09; 95% CI, 1.05-1.12), nulliparity (AOR, 1.84; 95% CI, 1.31-2.60), private insurance (AOR, 2.19; 95% CI, 1.27-3.80), non-Hispanic ethnicity (AOR, 2.36; 95% CI 1.57-3.55; reference: Hispanic), receipt of any COVID-19 vaccine (AOR, 7.12; 95% CI, 3.91-13.70), 2023-2024 formula COVID-19 booster vaccine (AOR, 5.62; 95% CI, 3.80-8.48), influenza vaccine (AOR, 8.14; 95% CI, 5.38-12.50), or tetanus-diphtheria-pertussis vaccine (AOR, 6.86; 95% CI, 3.79-13.10). Factors associated with lower RSVpreF uptake included non-English language preference (AOR, 0.24; 95% CI, 0.10-0.52), Black race (AOR, 0.30; 95% CI, 0.16-0.57; reference: Asian), other or unknown race (AOR, 0.48; 95% CI, 0.30-0.76), and multiple gestation (AOR, 0.27; 95% CI, 0.07-0.88). Nirsevimab was administered to 183 of 261 eligible infants (70.1%) prior to hospital discharge. Among those who did not receive RSVpreF or standard prenatal vaccines, 40.4% of their neonates (19 of 47) received nirsevimab; among those who declined infant hepatitis B vaccination, 34.0% of their neonates (17 of 50) received nirsevimab. Respiratory syncytial virus coverage exceeded 80% during all months of the study period except October 2023, the first month during which prenatal RSV vaccination and infant nirsevimab were available. Preterm delivery occurred in 35 of 414 RSVpreF-vaccinated individuals (8.5%) and 43 of 233 unvaccinated individuals (18.5%). In a nested case-control analysis with preterm birth as the outcome, there was no significant association between RSVpreF vaccination and preterm birth (AOR, 1.03; 95% CI, 0.55-1.93).
In this cohort study, uptake of the RSVpreF vaccine and infant nirsevimab was high. Nirsevimab uptake was high even among individuals who did not receive routine prenatal or infant vaccines. There was no significant association between RSVpreF vaccination and preterm birth. This study suggests that an RSV prevention strategy that included both prenatal vaccination and infant monoclonal antibody administration had high uptake and reassuring perinatal outcomes.
2023年批准了两种预防婴儿严重呼吸道合胞病毒(RSV)的干预措施——一种基于二价产前RSV预融合F蛋白的(RSVpreF)疫苗和一种婴儿单克隆抗体(nirsevimab)。了解它们的使用情况和临床结果对于公共卫生规划至关重要。
描述产前RSVpreF疫苗和婴儿nirsevimab的使用情况。
设计、背景和参与者:这项回顾性队列研究在一个学术中心进行,研究对象为647名符合RSVpreF疫苗接种条件的孕妇(2023年10月15日至2024年1月31日期间妊娠32 - 36周)以及符合nirsevimab使用条件的婴儿(分娩前>14天未接种产前RSVpreF疫苗)。
2023 - 2024年RSV流行季期间怀孕或分娩。
符合条件的孕妇接种RSVpreF疫苗情况以及符合条件的婴儿在出院前接受nirsevimab治疗的情况。
在647名符合条件的孕妇中(平均[标准差]年龄为34.6[6.2]岁;355名初产妇[54.9%];558名有私人保险[86.2%]),414名(64.0%)接种了RSVpreF疫苗。与较高RSVpreF疫苗接种率相关的因素包括产妇年龄较大(调整后的优势比[AOR]为1.09;95%置信区间为1.05 - 1.12)、初产(AOR为1.84;95%置信区间为1.31 - 2.60)、私人保险(AOR为2.19;95%置信区间为1.27 - 3.80)、非西班牙裔种族(AOR为2.36;95%置信区间为1.57 - 3.55;参照组:西班牙裔)、接种过任何新冠疫苗(AOR为7.12;95%置信区间为3.91 - 安全套避孕13.70)、2023 - 2024年配方新冠加强疫苗(AOR为5.62;95%置信区间为3.80 - 8.48)、流感疫苗(AOR为8.14;95%置信区间为5.38 - 12.50)或破伤风 - 白喉 - 百日咳疫苗(AOR为6.86;95%置信区间为3.79 - 13.10)。与较低RSVpreF疫苗接种率相关的因素包括偏好非英语(AOR为0.24;95%置信区间为0.10 - 0.52)、黑人种族(AOR为0.30;95%置信区间为0.16 - 0.57;参照组:亚洲人)、其他或未知种族(AOR为0.48;95%置信区间为0.30 - 在医院怎么避孕0.76)以及多胎妊娠(AOR为0.27;95%置信区间为0.07 - 0.88)。261名符合条件的婴儿中有183名(70.1%)在出院前接受了nirsevimab治疗。在未接种RSVpreF或标准产前疫苗的人群中,其新生儿有40.4%(47名中的19名)接受了nirsevimab治疗;在拒绝给婴儿接种乙肝疫苗的人群中,其新生儿有34.0%(50名中的17名)接受了nirsevimab治疗。除了2023年10月(产前RSV疫苗和婴儿nirsevimab首次可用的第一个月)外,在研究期间的所有月份呼吸道合胞病毒感染率均超过80%。414名接种RSVpreF疫苗的个体中有35名(8.5%)发生早产,233名未接种疫苗的个体中有43名(18.5%)发生早产。在以早产为结局的巢式病例对照分析中,RSVpreF疫苗接种与早产之间无显著关联(AOR为1.03;95%置信区间为0.55 - 1.93)。
在这项队列研究中,RSVpreF疫苗和婴儿nirsevimab的使用率较高。即使在未接受常规产前或婴儿疫苗接种的人群中,nirsevimab的使用率也较高。RSVpreF疫苗接种与早产之间无显著关联。这项研究表明,一种包括产前疫苗接种和婴儿单克隆抗体给药的RSV预防策略具有较高的使用率和令人放心的围产期结局。