Neurodevelopmental outcomes of infants after in utero exposure to SARS-CoV-2 or mRNA COVID-19 vaccine compared to unexposed infants: a COVI-PREG prospective cohort study.

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 from 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 to infants without prenatal exposure to the virus and/or vaccine. Parents received a neurodevelopmental questionnaire (ASQ-3) at 12 months after birth assessing 5 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; 101 in the reference group). In utero exposure to SARS-CoV-2 or mRNA-COVID-19 vaccine were not associated with an increased risk of a low score for at least one subdomain compared to the reference group. The crude odds ratios were 1.16 (95% confidence interval [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 SARS-CoV-2 or mRNA-COVID-19 vaccine, compared to the reference group. The adjusted odds ratios 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 ASQ-3 subdomain at 12 months after birth. Additional studies are needed to confirm our results, especially longer-term evaluation of infant development.

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Copyright © 2024 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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Declaration of interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. Alice Panchaud received grants from the Swiss Federal Office of Public Health and the CHUV Foundation; she also received grants from Vifor, the European Medicine Agency (EMA/2017/09/PE and EMA/2017/09/PE/11), the Fonds Paritaire RBP IV and a H2020 grant (ConcePTION WP 3-4), outside the submitted work. All other authors declare no conflicts of interest.