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The risk of PTB, CSAs and sPPH was not statistically different between NVX-CoV2373 and BNT162b2 recipients during pregnancy and COVID-19-unvaccinated women, reinforcing the antepartum safety of NVX-CoV2373 and COVID-19 vaccines in general.
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BACKGROUND: Information on maternal and neonatal outcomes following NVX-CoV2373 coronavirus disease 2019 (COVID-19) vaccination in pregnant women is limited. METHODS: This retrospective cohort study utilized National Health Insurance Service data, linking maternal and neonatal records with COVID-19 vaccination registries in South Korea. Eligible pregnancies included those with recorded births among 20-49-year-old women between February 1 and December 31, 2022, excluding pregnancies with first-trimester severe acute respiratory syndrome coronavirus 2 infections. Pregnant women who received NVX-CoV2373 during pregnancy were matched, 1:4, with COVID-19-unvaccinated women using propensity score methods to account for demographic and clinical variables. Adjusted risk ratios (aRR) and 95% confidence intervals (95% CIs) for preterm birth (PTB), congenital structural anomalies (CSAs) and severe postpartum hemorrhage (sPPH) were estimated using log-binomial regression models. To further characterize NVX-CoV2373 safety, a separate analysis estimated aRRs and 95% CIs comparing women who exclusively received either NVX-CoV2373 or BNT162b2 during pregnancy. RESULTS: Among 484 NVX-CoV2373 recipients during pregnancy and their matched sample of 1930 COVID-19-unvaccinated women, there was no observed difference in risk of PTB (aRR = 0.95, 95% CI: 0.75-1.21), CSAs (aRR = 0.57, 0.30-1.09) or sPPH (aRR = 0.65, 0.15-2.90) between groups. Between 476 NVX-CoV2373 and their matched sample of 1497 BNT162b2 recipients during pregnancy, there were no significant differences in risk of PTB (aRR = 1.01, 0.75-1.34), CSAs (aRR = 0.74, 0.42-1.29) or sPPH (aRR = 0.45, 0.10-1.97). CONCLUSIONS: The risk of PTB, CSAs and sPPH was not statistically different between NVX-CoV2373 and BNT162b2 recipients during pregnancy and COVID-19-unvaccinated women, reinforcing the antepartum safety of NVX-CoV2373 and COVID-19 vaccines in general.
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@article{Gwak2026Risk,
title = {Risk of Preterm Birth, Congenital Structural Anomalies and Severe Postpartum Hemorrhage After Receipt of NVX-CoV2373 Vaccine During Pregnancy},
author = {Eunseon Gwak and Young June Choe and Ju-Young Shin and Smita Shah and Sarah Sellers and Seung‐Ah Choe and Jonathan Fix},
journal = {The Pediatric Infectious Disease Journal},
year = {2026},
doi = {10.1097/inf.0000000000005455},
url = {https://doi.org/10.1097/inf.0000000000005455}
}
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