Favre Guillaume, Bromley Rebecca L, Bluett-Duncan Matthew, Maisonneuve Emeline, Pomar Léo, Daire Charlotte, Radan Anda-Petronela, Raio Luigi, Surbek Daniel, Blume Carolin, Kalimeris Stylianos, Madec Yoann, Schneider Juliane, Bickle Graz Myriam, Winterfeld Ursula, Panchaud Alice, Baud David
Materno-Fetal and Obstetrics Research Unit, Woman-Mother-Child Department, Centre Hospitalier Universitaire Vaudois (CHUV), University Hospital, Lausanne, Switzerland.
Division of Neuroscience, School of Biological Sciences, Faculty of Medicine, Biology and Health, University of Manchester, Manchester, United Kingdom.
Clin Microbiol Infect. 2025 Feb;31(2):266-273. doi: 10.1016/j.cmi.2024.10.019. Epub 2024 Oct 23.
Data are lacking regarding the long-term consequences of SARS-CoV-2 and COVID-19 mRNA vaccine on infants exposed in utero. We aimed to evaluate the neurodevelopment of infants exposed prenatally to SARS-CoV-2 or mRNA-COVID-19 vaccine during pregnancy at 12 months after birth.
Infants born to mothers exposed to SARS-CoV-2 or mRNA-COVID-19 vaccine during pregnancy, or unexposed to either the virus or the vaccine were enrolled from 2021 to 2023. Infants with prenatal exposure to the virus or vaccine were compared with infants without prenatal exposure to the virus and/or vaccine. Parents received a neurodevelopmental questionnaire (ages and stages questionnaire third edition) at 12 months after birth assessing five subdomains: communication, gross motor, fine motor, problem-solving, and personal social development. A low score was defined as <2 standard deviations below the normative mean in at least one of the subdomains.
A total of 330 infants were included (76 in the SARS-CoV-2 group, 153 in the mRNA-COVID-19 vaccine group, and 101 in the reference group). In utero exposure to the SARS-CoV-2 or mRNA-COVID-19 vaccine was not associated with an increased risk of a low score for at least one subdomain compared with the reference group. The crude ORs were 1.16 (95% CI, 0.59-2.28) and 1.04 (95% CI, 0.58-1.86), respectively. Results remained consistent in the multivariate analysis, showing no increased risk of a low score for at least one subdomain for infants exposed to the SARS-CoV-2 or mRNA-COVID-19 vaccine, compared with the reference group. The adjusted ORs were 1.74 (95% CI, 0.76-3.99) and 0.76 (95% CI, 0.39-1.49), respectively.
In utero exposure to SARS-CoV-2 or mRNA-COVID-19 vaccine was not associated with an increased risk of a low score for at least one ages and stages questionnaire third edition subdomain at 12 months after birth. Additional studies are needed to confirm our results, especially longer-term evaluation of infant development.
关于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）和新冠病毒疾病（COVID-19）mRNA疫苗对子宫内暴露婴儿的长期影响的数据尚缺。我们旨在评估孕期产前暴露于SARS-CoV-2或新冠病毒疾病mRNA疫苗的婴儿在出生后12个月时的神经发育情况。
纳入2021年至2023年出生的母亲在孕期暴露于SARS-CoV-2或新冠病毒疾病mRNA疫苗、或未暴露于病毒或疫苗的婴儿。将产前暴露于病毒或疫苗的婴儿与未产前暴露于病毒和/或疫苗的婴儿进行比较。父母在婴儿出生后12个月时收到一份神经发育问卷（年龄与阶段问卷第三版），评估五个子领域：沟通、大运动、精细运动、解决问题和个人社交发展。低分数定义为至少在一个子领域低于标准均值2个标准差。
共纳入330名婴儿（SARS-CoV-2组76名，新冠病毒疾病mRNA疫苗组153名，参照组101名）。与参照组相比，子宫内暴露于SARS-CoV-2或新冠病毒疾病mRNA疫苗与至少一个子领域低分数风险增加无关。粗比值比分别为1.16（95%置信区间，0.59 - 2.28）和1.04（95%置信区间，0.58 - 1.86）。多变量分析结果保持一致，表明与参照组相比，暴露于SARS-CoV-2或新冠病毒疾病mRNA疫苗的婴儿至少一个子领域低分数风险未增加。校正后的比值比分别为1.74（95%置信区间，0.76 - 3.99）和0.76（95%置信区间，0.39 - 1.49）。
出生后12个月时，子宫内暴露于SARS-CoV-2或新冠病毒疾病mRNA疫苗与年龄与阶段问卷第三版至少一个子领域低分数风险增加无关。需要更多研究来证实我们的结果，尤其是对婴儿发育的长期评估。
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