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Maternal COVID-19 Vaccination While Pregnant Not Associated With Neurodevelopmental Delay at 18 Months
Maternal vaccination against COVID-19 during pregnancy was found safe for offspring up to 18 months according to neurodevelopment measures. Results from the prospective cohort study were published in JAMA Pediatrics.
“As societies emerge from [the] acute phase [of the pandemic], there is a need to better understand the longer-term sequelae of both the virus and the interventions directed against it,” wrote Eleni G. Jaswa, MD, MSc, University of California, San Francisco, and co-authors.
Vaccine hesitancy persists for many reasons, most notably the exclusion of pregnant people from initial large-scale randomized clinical trials for the COVID-19 vaccines as well as “unknown risks to the fetus,” particularly regarding long-term developmental outcomes.
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The study, known as Assessing the Safety of Pregnancy During the Coronavirus Pandemic (ASPIRE), enrolled participants from May 2020 to August 2021. Eligible and included participants were pregnant individuals 18 or older and at 10 weeks’ gestation who completed the baseline demographics questionnaire upon study enrollment; completed the Age and Stages Questionnaire, third edition (ASQ-3), at 12 and/or 18 months postpartum; and completed the vaccination history questionnaire. The primary outcome under investigation was an abnormal screening on the ASQ-3, and the primary exposure was COVID-19 vaccination during pregnancy.
A total of 2487 pregnant individuals were included in the study, which yielded neurodevelopmental assessments from 2261 12-month infants and 1940 18-month infants. Initial, crude analyses demonstrated that 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).
Importantly, 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).
“We observed no difference in risk of developmental delay at 12 and 18 months for infants exposed to maternal COVID-19 vaccination vs those unexposed,” concluded Jaswa and co-authors. “To our knowledge, this represents the first meaningful evidence regarding the safety of maternal COVID-19 vaccination from the standpoint of early offspring neurodevelopment.” The authors also emphasized the need for ongoing follow-up study to bolster the limited existing data on long-term vaccination outcomes.
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