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- Title
In Utero Exposure to Maternal COVID-19 Vaccination and Offspring Neurodevelopment at 12 and 18 Months.
- Authors
Jaswa, Eleni G.; Cedars, Marcelle I.; Lindquist, Karla J.; Bishop, Somer L.; Kim, Young-Shin; Kaing, Amy; Prahl, Mary; Gaw, Stephanie L.; Corley, Jamie; Hoskin, Elena; Cho, Yoon Jae; Rogers, Elizabeth; Huddleston, Heather G.
- Abstract
This cohort study investigates the association between previous exposure to maternal COVID-19 vaccination in utero and risk for neurodevelopmental impairment in infants aged 12 and 18 months. Key Points: Question: Is previous exposure to maternal COVID-19 vaccination in utero associated with increased risk for neurodevelopmental impairment in 12- and 18-month-old infants? Findings: In this cohort study including 2261 and 1940 infants aged 12 and 18 months, respectively, in utero exposure to COVID-19 vaccination was not associated with abnormal neurodevelopmental scores on the Ages and Stages Questionnaire, third edition, at 12 or 18 months of life. Meaning: Results suggest that maternal vaccination against COVID-19 during pregnancy was safe from the perspective of offspring neurodevelopment up to age 18 months. 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.
- Subjects
PREGNANCY; SELF-evaluation; MATERNAL exposure; RESEARCH funding; CAUSAL models; PREMATURE infants; NEURAL development; QUESTIONNAIRES; LOGISTIC regression analysis; COVID-19 vaccines; CHI-squared test; LONGITUDINAL method; RESEARCH; CONFIDENCE intervals; COVID-19; COVID-19 pandemic
- Publication
JAMA Pediatrics, 2024, Vol 178, Issue 3, p258
- ISSN
2168-6203
- Publication type
Article
- DOI
10.1001/jamapediatrics.2023.5743