Woestenberg Petra J, Maas Veronique Y F, Vissers Lieke C M, Oliveri Nadia M B, Kant Agnes C, de Feijter Maud
Netherlands Pharmacovigilance Centre Lareb 's-Hertogenbosch the Netherlands.
Department of Clinical Pharmacology and Toxicology Leiden University Medical Centre Leiden the Netherlands.
Pediatr Investig. 2024 Nov 7;9(1):41-51. doi: 10.1002/ped4.12456. eCollection 2025 Mar.
Pregnant women have a higher risk of severe illness or complications due to a severe acute respiratory syndrome coronavirus 2 infection. To reduce these risks, pregnant women are advised to coronavirus disease 2019 (COVID-19) vaccination. Continued monitoring of the safety of maternal COVID-19 vaccination remains important.
To evaluate the association between maternal COVID-19 vaccination and neonatal health.
Data from the Dutch Pregnancy Drug Register were used. In this prospective cohort study, pregnant women self-reported COVID-19 vaccination and neonatal health outcomes. We included women with a due date between January 15, 2021, and May 15, 2022, and a singleton live birth after at least 24 weeks gestation. Using log-binomial regression analysis we studied the association between COVID-19 vaccination during pregnancy and the health outcomes; small for gestational age (SGA), large for gestational age (LGA), and neonatal health problems. We corrected for potential confounders using inverse probability of treatment weighting.
In total, 3655 participants were included (92.1% COVID-19 vaccinated during pregnancy). Of all participants, 8.9% reported SGA, 11.1% reported LGA, and 16.4% reported neonatal health problems. Maternal COVID-19 vaccination was not statistically significantly associated with SGA (adjusted prevalence ratio [aPR]: 0.90; 95% confidence interval [CI]: 0.59-1.36), LGA (aPR: 1.07; 95% CI: 0.70-1.63), or neonatal health problems (aPR: 0.84; 95% CI: 0.63-1.11).
This study indicates that COVID-19 vaccination during pregnancy is not associated with self-reported adverse neonatal health outcomes. These findings contribute to the growing body of evidence on the safety of COVID-19 vaccination during pregnancy.
孕妇因感染严重急性呼吸综合征冠状病毒2而患重病或出现并发症的风险更高。为降低这些风险,建议孕妇接种2019冠状病毒病(COVID-19)疫苗。持续监测孕产妇COVID-19疫苗接种的安全性仍然很重要。
评估孕产妇COVID-19疫苗接种与新生儿健康之间的关联。
使用了荷兰孕期药物登记处的数据。在这项前瞻性队列研究中,孕妇自行报告COVID-19疫苗接种情况和新生儿健康结局。我们纳入了预产期在2021年1月15日至2022年5月15日之间、妊娠至少24周后单胎活产的妇女。我们使用对数二项回归分析研究孕期COVID-19疫苗接种与健康结局之间的关联;小于胎龄儿(SGA)、大于胎龄儿(LGA)和新生儿健康问题。我们使用治疗权重的逆概率对潜在混杂因素进行校正。
总共纳入了3655名参与者(92.1%在孕期接种了COVID-19疫苗)。在所有参与者中,8.9%报告为小于胎龄儿,11.1%报告为大于胎龄儿,16.4%报告有新生儿健康问题。孕产妇COVID-19疫苗接种与小于胎龄儿(校正患病率比[aPR]:0.90;95%置信区间[CI]:0.59 - 1.36)、大于胎龄儿(aPR:1.07;95% CI:0.70 - 1.63)或新生儿健康问题(aPR:0.84;95% CI:0.63 - 1.11)之间无统计学显著关联。
这项研究表明,孕期COVID-19疫苗接种与自行报告的不良新生儿健康结局无关。这些发现为孕期COVID-19疫苗接种安全性的证据积累做出了贡献。