Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Ppublish 12 citations
PubMed: 38252445 DOI: 10.1001/jamapediatrics.2023.5743
In Utero Exposure to Maternal COVID-19 Vaccination and Offspring Neurodevelopment at 12 and 18 Months.
JAMA Pediatr 178(3):258-265
Authors: Eleni G Jaswa, Marcelle I Cedars, Karla J Lindquist, Somer L Bishop, Young-Shin Kim, Amy Kaing, Mary Prahl, Stephanie L Gaw, Jamie Corley, Elena Hoskin, Yoon Jae Cho, Elizabeth Rogers, Heather G Huddleston
Affiliations
- Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Reproductive Endocrinology and Infertility, University of California, San Francisco, San Francisco.
- Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco.
- Department of Psychiatry, University of California, San Francisco, San Francisco.
- Department of Pediatrics, Division of Pediatric Infectious Disease and Global Health, University of California, San Francisco, San Francisco.
- Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Maternal Fetal Medicine, University of California, San Francisco, San Francisco.
- Department of Pediatrics, Division of Neonatology, University of California, San Francisco, San Francisco.
Abstract
Importance
Uptake of COVID-19 vaccines among pregnant individuals was hampered by safety concerns around potential risks to unborn children. Data clarifying early neurodevelopmental outcomes of offspring exposed to COVID-19 vaccination in utero are lacking.
Objective
To determine whether in utero exposure to maternal COVID-19 vaccination was associated with differences in scores on the Ages and Stages Questionnaire, third edition (ASQ-3), at 12 and 18 months of age.
Design, Setting, and Participants
This prospective cohort study, Assessing the Safety of Pregnancy During the Coronavirus Pandemic (ASPIRE), enrolled pregnant participants from May 2020 to August 2021; follow-up of children from these pregnancies is ongoing. Participants, which included pregnant individuals and their offspring from all 50 states, self-enrolled online. Study activities were performed remotely.
Exposure
In utero exposure of the fetus to maternal COVID-19 vaccination during pregnancy was compared with those unexposed.
Main Outcomes and Measures
Neurodevelopmental scores on validated ASQ-3, completed by birth mothers at 12 and 18 months. A score below the established cutoff in any of 5 subdomains (communication, gross motor, fine motor, problem solving, social skills) constituted an abnormal screen for developmental delay.
Results
A total of 2487 pregnant individuals (mean [SD] age, 33.3 [4.2] years) enrolled at less than 10 weeks' gestation and completed research activities, yielding a total of 2261 and 1940 infants aged 12 and 18 months, respectively, with neurodevelopmental assessments. In crude analyses, 471 of 1541 exposed infants (30.6%) screened abnormally for developmental delay at 12 months vs 203 of 720 unexposed infants (28.2%; χ2 = 1.32; P = .25); the corresponding prevalences at 18 months were 262 of 1301 (20.1%) vs 148 of 639 (23.2%), respectively (χ2 = 2.35; P = .13). In multivariable mixed-effects logistic regression models adjusting for maternal age, race, ethnicity, education, income, maternal depression, and anxiety, no difference in risk for abnormal ASQ-3 screens was observed at either time point (12 months: adjusted risk ratio [aRR], 1.14; 95% CI, 0.97-1.33; 18 months: aRR, 0.88; 95% CI, 0.72-1.07). Further adjustment for preterm birth and infant sex did not affect results (12 months: aRR, 1.16; 95% CI, 0.98-1.36; 18 months: aRR, 0.87; 95% CI, 0.71-1.07).
Conclusions and Relevance
Results of this cohort study suggest that COVID-19 vaccination was safe during pregnancy from the perspective of infant neurodevelopment to 18 months of age. Additional longer-term research should be conducted to corroborate these findings and buttress clinical guidance with a strong evidence base.
MeSH
Pregnancy, Parturition, Vaccines, Cohort Studies, Vaccination, Covid-19, Research, Pediatrics, Child, Infant, Neurodevelopment