Kyuwon Kim, Erdenetuya Bolormaa, Eunseon Gwak, Ju-Young Shin, Nam-Kyong Choi, Young June Choe, Seung-Ah Choe
{"title":"母亲暴露于COVID-19疫苗和不良分娩结局：韩国国家人口研究","authors":"Kyuwon Kim, Erdenetuya Bolormaa, Eunseon Gwak, Ju-Young Shin, Nam-Kyong Choi, Young June Choe, Seung-Ah Choe","doi":"10.3346/jkms.2025.40.e63","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":16249,"journal":{"name":"Journal of Korean Medical Science","volume":"40 17","pages":"e63"},"PeriodicalIF":3.0000,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056060/pdf/","citationCount":"0","resultStr":"{\"title\":\"Maternal Exposures to COVID-19 Vaccine and Adverse Birth Outcomes: National Population Study in Korea.\",\"authors\":\"Kyuwon Kim, Erdenetuya Bolormaa, Eunseon Gwak, Ju-Young Shin, Nam-Kyong Choi, Young June Choe, Seung-Ah Choe\",\"doi\":\"10.3346/jkms.2025.40.e63\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":16249,\"journal\":{\"name\":\"Journal of Korean Medical Science\",\"volume\":\"40 17\",\"pages\":\"e63\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-05-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056060/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Korean Medical Science\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3346/jkms.2025.40.e63\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Korean Medical Science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3346/jkms.2025.40.e63","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Maternal Exposures to COVID-19 Vaccine and Adverse Birth Outcomes: National Population Study in Korea.
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.
期刊介绍：
The Journal of Korean Medical Science (JKMS) is an international, peer-reviewed Open Access journal of medicine published weekly in English. The Journal’s publisher is the Korean Academy of Medical Sciences (KAMS), Korean Medical Association (KMA). JKMS aims to publish evidence-based, scientific research articles from various disciplines of the medical sciences. The Journal welcomes articles of general interest to medical researchers especially when they contain original information. Articles on the clinical evaluation of drugs and other therapies, epidemiologic studies of the general population, studies on pathogenic organisms and toxic materials, and the toxicities and adverse effects of therapeutics are welcome.
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