{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T23:59:08Z","timestamp":1788307148782,"version":"build-2803163510"},"reference-count":51,"publisher":"American Medical Association (AMA)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Pediatr"],"published-print":{"date-parts":[[2024,3,1]]},"abstract":"<jats:sec id=\"ab-poi230088-4\"><jats:title>Importance<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-poi230088-5\"><jats:title>Objective<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-poi230088-6\"><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-poi230088-7\"><jats:title>Exposure<\/jats:title><jats:p>In utero exposure of the fetus to maternal COVID-19 vaccination during pregnancy was compared with those unexposed.<\/jats:p><\/jats:sec><jats:sec id=\"ab-poi230088-8\"><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"ab-poi230088-9\"><jats:title>Results<\/jats:title><jats:p>A total of 2487 pregnant individuals (mean [SD] age, 33.3 [4.2] years) enrolled at less than 10 weeks\u2019 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%; \u03c7<jats:sup>2<\/jats:sup> = 1.32; <jats:italic>P<\/jats:italic>\u2009=\u2009.25); the corresponding prevalences at 18 months were 262 of 1301 (20.1%) vs 148 of 639 (23.2%), respectively (\u03c7<jats:sup>2<\/jats:sup> = 2.35; <jats:italic>P<\/jats:italic>\u2009=\u2009.13). 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).<\/jats:p><\/jats:sec><jats:sec id=\"ab-poi230088-10\"><jats:title>Conclusions and Relevance<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamapediatrics.2023.5743","type":"journal-article","created":{"date-parts":[[2024,1,22]],"date-time":"2024-01-22T16:32:16Z","timestamp":1705941136000},"page":"258","source":"Crossref","is-referenced-by-count":17,"title":["In Utero Exposure to Maternal COVID-19 Vaccination and Offspring Neurodevelopment at 12 and 18 Months"],"prefix":"10.1001","volume":"178","author":[{"given":"Eleni G.","family":"Jaswa","sequence":"first","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Reproductive Endocrinology and Infertility, University of California, San Francisco, San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelle I.","family":"Cedars","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology and 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