Robinson Christopher, Van Boxmeer Josephine, Tilson Hugh, Scialli Anthony, Vanchiere John A, Ides Ellis, Sawlwin Daphne, Molrine Deborah, Hohenboken Matthew, Edelman Jonathan, Albano Jessica D
Charleston Maternal Fetal Medicine, Mount Pleasant, SC 29485, USA.
Seqirus Netherlands B.V., 1105 BJ Amsterdam, The Netherlands.
Vaccines (Basel). 2022 Sep 23;10(10):1600. doi: 10.3390/vaccines10101600.
Objective: To evaluate pregnancy and infant outcomes among persons immunized with a cell-based quadrivalent inactivated influenza vaccine (IIV4c) during routine pregnancy care. Design: Prospective observational cohort. Setting: US-based obstetrics/gynecology clinics. Population: Pregnant persons. This US-based, prospective observational cohort study evaluated the safety of quadrivalent inactivated influenza vaccine (IIV4c; Flucelvax® Quad) in pregnant persons immunized over 3 influenza seasons between 2017 and 2020. Pregnant persons were immunized with IIV4c as part of routine care, after which their health care provides HCPs with all observational data to a single coordinating center. Follow-up data were collected at the end of the second trimester and/or at the time of pregnancy outcome. A scientific advisory committee reviewed the data. Prevalence point estimates were reported with 95% confidence intervals (CIs). Pregnancy outcomes included: live birth, stillbirth, spontaneous abortion, elective termination, and maternal death. Infant outcomes included: preterm birth (<37 weeks gestational age), low birth weight (<2500 g), or major congenital malformations (MCMs). Of the 665 evaluable participants, 659 (99.1%) had a live birth. No stillbirths (0% [95% CI 0.0−0.6]), 4 spontaneous abortions (1.9% [0.5−4.8]), and 1 elective termination (0.5% [0.0−2.6]) were reported. Among 673 infants, 9.2% (upper 95% CI 11.5%) were born prematurely, 5.8% (upper 95% CI 7.6%) had low birth weight, and 1.9% (upper 95% CI 3.1%) were reported to have an MCM. No maternal deaths were reported. Of the 2 infants who died shortly after birth, one was adjudicated as not related to the vaccine; the other’s cause could not be determined due to maternal loss to follow-up. The prevalence of adverse pregnancy outcomes or preterm birth, low birth weight, or MCMs in newborns was similar in persons vaccinated with IIV4c compared to the rates observed in US surveillance systems. The safety profile of IIV4c in pregnant persons is consistent with previously studied influenza vaccines.
评估在常规孕期保健期间接种基于细胞的四价灭活流感疫苗（IIV4c）的人群的妊娠及婴儿结局。
前瞻性观察队列研究。
美国的妇产科诊所。
孕妇。
这项基于美国的前瞻性观察队列研究评估了2017年至2020年期间3个流感季节接种四价灭活流感疫苗（IIV4c；Flucelvax® Quad）的孕妇的安全性。孕妇作为常规保健的一部分接种IIV4c，之后其医疗保健提供者将所有观察数据提交给一个单一的协调中心。在孕中期结束时和/或妊娠结局时收集随访数据。一个科学咨询委员会对数据进行了审查。报告患病率点估计值及其95%置信区间（CI）。妊娠结局包括：活产、死产、自然流产、选择性终止妊娠和孕产妇死亡。婴儿结局包括：早产（孕周<37周）、低出生体重（<2500 g）或重大先天性畸形（MCM）。在665名可评估的参与者中，659名（99.1%）活产。未报告死产（0% [95% CI 0.0−0.6]），4例自然流产（1.9% [0.5−4.8]），1例选择性终止妊娠（0.5% [0.0−2.6]）。在673名婴儿中，9.2%（95% CI上限11.5%）早产，5.8%（95% CI上限7.6%）低出生体重，1.9%（95% CI上限3.1%）报告有MCM。未报告孕产妇死亡。在2例出生后不久死亡的婴儿中，1例判定与疫苗无关；另1例由于母亲失访，死因无法确定。与美国监测系统观察到的比率相比，接种IIV4c的人群中不良妊娠结局或新生儿早产、低出生体重或MCM的患病率相似。IIV4c在孕妇中的安全性概况与先前研究的流感疫苗一致。
