Maternal Exposures to COVID-19 Vaccine and Adverse Birth Outcomes: National Population Study in Korea
Kyuwon Kim1, Erdenetuya Bolormaa1, Eunseon Gwak2
1Department of Public Health, Korea University School of Public Health, Seoul, Korea.
Insights
COVID-19 vaccination during pregnancy showed no increased risk of preterm birth or congenital malformations. Both mRNA vaccines (BNT162b2 and mRNA-1273) demonstrated similar safety profiles for these outcomes.
Area of Science:
- Obstetrics and Gynecology
- Vaccinology
- Public Health
Background:
- Maternal vaccination against COVID-19 (coronavirus disease 2019) is crucial for protecting pregnant individuals and neonates.
- Concerns exist regarding potential risks of mRNA vaccines during pregnancy, specifically preterm birth and congenital malformations.
Purpose of the Study:
- To assess the association between mRNA COVID-19 vaccination during pregnancy and the risks of preterm birth and congenital malformations.
- To compare the safety profiles of BNT162b2 and mRNA-1273 vaccines regarding these adverse outcomes.
Main Methods:
- Retrospective cohort study utilizing South Korean National Health Insurance System data.
- Inclusion of live births between February and December 2022, with COVID-19 vaccination status linked to maternal and infant records.
- Analysis compared vaccinated pregnant individuals with matched unvaccinated controls, adjusting for multiple confounding factors.
Main Results:
- Among 106,692 births, 8.4% involved maternal COVID-19 vaccination during pregnancy.
- No significant association was found between vaccination and increased risk of preterm birth (OR, 1.03) or congenital malformations (OR, 0.90).
- Risks for preterm birth and congenital malformations were comparable between BNT162b2 and mRNA-1273 vaccines.
Conclusions:
- mRNA COVID-19 vaccination during pregnancy is not associated with an increased risk of preterm birth or congenital malformations.
- Both BNT162b2 and mRNA-1273 vaccines exhibit similar safety profiles in pregnant individuals.
- Findings support the safety of COVID-19 vaccination for pregnant populations.
Background:
This study aimed to estimate the association between mRNA coronavirus disease 2019 (COVID-19) vaccine exposure during pregnancy and the risks of preterm birth and congenital malformations leveraging a national population data.
Methods:
This retrospective cohort study utilized national data from the National Health Insurance System, linking maternal and infant records with COVID-19 vaccination registries. Newborns with congenital malformations were identified using diagnosis codes. The analysis included women aged 20-49 who gave live births between February 2022 and December 2022. Odds ratios (ORs) for preterm birth and any congenital malformation per COVID-19 vaccination during pregnancy compared to 1:4 matched unvaccinated controls, adjusted for maternal age, residential area, employment, income, disability, month of conception, pre-pregnancy obesity, smoking, and severe acute respiratory syndrome coronavirus 2 infection prior to pregnancy, were calculated. We compared the risk of two outcomes between BNT162b2 and mRNA-1273.
Results:
Among 106,692 women who gave birth during the study period, 8,966 (8.4%) received a COVID-19 vaccination during pregnancy. Of the newborns, 7,039 (6.6%) were preterm births and 7,658 (7.2%) had congenital malformations. COVID-19 vaccination during pregnancy was associated with a comparable risk of preterm birth (OR, 1.03; 95% confidence interval [CI], 0.77-1.36) and a similar risk of congenital malformations (0.90; 95% CI, 0.72-1.12) compared to non-vaccinees. The ORs of preterm birth (1.02; 95% CI, 0.77-1.36) and congenital malformation (0.91; 95% CI, 0.73-1.14) for mRNA-1273 were comparable to those for BNT162b2.
Conclusion:
COVID-19 vaccines during pregnancy poses no increased risk of preterm birth and congenital malformations compared to those not exposed to the vaccine, with similar risk levels observed between the two mRNA vaccines. This finding provides additional evidence supporting the safety of COVID-19 vaccines.
Related Concept Videos
02:07Oogenesis
01:07Teratogenicity
01:22Development of Immunocompetence
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...