Abstract：
This US-based, prospective observational cohort study evaluated the safety of a quadrivalent inactivated influenza vaccine (IIV4; Afluria Quadrivalent) in pregnant persons immunized over four influenza seasons between 2017 and 2021. Pregnancy outcomes included live birth, stillbirth, spontaneous abortion, and elective termination. Infant events of interest were major congenital malformations (MCMs), preterm birth (<37 weeks gestational age), and low birth weight (LBW). Data were descriptive; prevalence point estimates were reported with 95% confidence intervals (CI). A total of 483 pregnant persons were given IIV4 and evaluated; 477 (98.8%) reported a live birth, and there were 2 stillbirths, 4 spontaneous abortions, and no elective terminations or maternal deaths. The prevalence rates of infant events were as follows: preterm birth, 7.2% (upper 95% CI, 9.6%); LBW, 5.4% (upper 95% CI, 7.4%); and MCMs, 0.8% (upper 95% CI, 1.9%). Point estimates and upper 95% CIs of the observed prevalence rates were lower than or similar to background prevalence in the general US population. Our findings suggest no evidence of a safety concern with vaccinating this group at high risk of influenza complications and are consistent with published data from databases and surveillance systems that monitor the safety of influenza vaccines in pregnant persons.
摘要：
这个以美国为基础的，前瞻性观察性队列研究评估了四价灭活疫苗(IIV4;Affluria四价)在2017年至2021年4个流感季节接种的孕妇中的安全性.妊娠结局包括活产，死产,自然流产,和选择性终止。感兴趣的婴儿事件是主要的先天性畸形（MCMs），早产（<37孕周），低出生体重（LBW）。数据是描述性的；患病率点估计以95%置信区间(CI)报告。共有483名孕妇接受了IIV4并进行了评估；477名（98.8％）报告了活产，有两个死胎，4次自然流产,没有选择性终止妊娠或产妇死亡。婴儿事件的患病率如下：早产，7.2%(95%置信区间上限，9.6%)；LBW，5.4%(95%CI上限，7.4%)；和MCM，0.8%（95%CI上限，1.9%）。在美国普通人群中，点估计值和观察到的患病率的95％CIs低于或类似于背景患病率。我们的研究结果表明，没有证据表明在流感并发症高风险人群中接种疫苗存在安全性问题，并且与来自监测孕妇流感疫苗安全性的数据库和监测系统的公开数据一致。
