本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2023.26945

摘要内容如下：

重要性

更好地了解妊娠期COVID-19疫苗接种后的新生儿不良事件有助于解决疫苗安全性问题。

目的

评估孕期接触COVID-19疫苗后新生儿不良事件的风险。

设计、设置和参与者

基于人群的队列研究，包括瑞典和挪威2021年6月至2023年1月出生的所有婴儿。使用唯一的个人身份号码将来自不同国家登记册的个人信息联系起来。

曝光

在怀孕期间接种任何针对COVID-19的mRNA疫苗，而不考虑以前的疫苗接种、怀孕期间的剂量或疫苗制造商。

主要成果和措施

结果为新生儿出血/血栓形成或炎症/感染；中枢神经系统疾病；循环、呼吸或胃肠道问题；和新生儿死亡率。统计方法包括对怀孕个体的特征进行调整的逻辑回归，以及额外的限制和分层分析。

结果

在纳入的196470名新生儿（51.3%为男性，93.8%为足月出生，62.5%出生于瑞典）中，有94303名（48.0%）在怀孕期间接种了Covid-19疫苗。暴露的婴儿没有表现出新生儿不良结局的几率增加，并且他们表现出新生儿非创伤性颅内出血的几率较低（事件发生率，1.7比3.2/1000；调整后的比值比[AOR]，0.78[95%CI，0.61-0.99]），缺氧缺血性脑病（1.8 vs 2.7/1000；AOR，0.73[95%CI，0.55-0.96]）和新生儿死亡率（0.9 vs 1.8/1000；AOR，0.68[95%CI，0.50-0.91]）。亚组分析发现，孕期接种疫苗与较低的新生儿死亡率之间也存在类似的关联。亚组仅限于怀孕前未接种疫苗的个体、怀孕前接种疫苗的个体、发布孕期接种疫苗的一般建议后接种疫苗的个体以及孕期未感染COVID-19的个体所产婴儿。仅限于足月儿、单胎出生或无出生缺陷的婴儿的分析得出了类似的结果。按疫苗制造商对分析进行分层并没有减弱疫苗接种与低新生儿死亡率之间的联系。

结论和相关性

在这项基于大规模人群的研究中，孕妇接种mRNA Covid-19疫苗与其婴儿发生新生儿不良事件的风险增加无关。

英文原文如下：

Abstracts

Importance  Better knowledge about neonatal adverse events after COVID-19 vaccination during pregnancy could help address concerns about vaccine safety.

Objective  To evaluate the risks of neonatal adverse events after exposure to COVID-19 vaccination during pregnancy.

Design, Setting, and Participants  Population-based cohort study including all infants in Sweden and Norway born from June 2021 to January 2023. Unique personal identity numbers were used to link individual information from different national registers.

Exposure  Administration of any mRNA vaccine against COVID-19 during pregnancy, irrespective of previous vaccination, number of doses during pregnancy, or vaccine manufacturer.

Main Outcomes and Measures  Outcomes were neonatal conditions with bleeding/thrombosis or inflammation/infection; disorders of the central nervous system; circulatory, respiratory, or gastrointestinal problems; and neonatal mortality. Statistical methods included logistic regression adjusted for characteristics of the pregnant individuals, with additional restricted and stratified analyses.

Results  Of 196 470 newborn infants included (51.3% male, 93.8% born at term, 62.5% born in Sweden), 94 303 (48.0%) were exposed to COVID-19 vaccination during pregnancy. Exposed infants exhibited no increased odds of adverse neonatal outcomes, and they exhibited lower odds for neonatal nontraumatic intracranial hemorrhage (event rate, 1.7 vs 3.2/1000; adjusted odds ratio [aOR], 0.78 [95% CI, 0.61-0.99]), hypoxic-ischemic encephalopathy (1.8 vs 2.7/1000; aOR, 0.73 [95% CI, 0.55-0.96]), and neonatal mortality (0.9 vs 1.8/1000; aOR, 0.68 [95% CI, 0.50-0.91]). Subgroup analyses found a similar association between vaccination during pregnancy and lower neonatal mortality; subgroups were restricted to infants delivered by individuals unvaccinated before pregnancy, individuals vaccinated before pregnancy, individuals vaccinated after a general recommendation of vaccination during pregnancy was issued, and individuals without COVID-19 infection during pregnancy. Analyses restricted to term infants, singleton births, or infants without birth defects yielded similar results. Stratifying the analysis by vaccine manufacturer did not attenuate the association between vaccination and low neonatal mortality.

Conclusions and Relevance  In this large population-based study, vaccination of pregnant individuals with mRNA COVID-19 vaccines was not associated with increased risks of neonatal adverse events in their infants.

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