COVID-19 Vaccination During Pregnancy and Major Structural Birth Defects

Stacey L Rowe^{1

2

3

4}, Sheena G Sullivan^{5

6}, Flor M Muñoz⁷, Matthew M Coates^{3

4}, Brianna Agnew¹, Onyebuchi A Arah^{3

4

8

9}, Annette K Regan^{1

3

4

10}

Affiliations

¹ School of Nursing and Health Professions, University of San Francisco, San Francisco, CA.
² School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
³ Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles (UCLA), Los Angeles, CA.
⁴ Practical Causal Inference Lab, University of California, Los Angeles (UCLA), Los Angeles, CA.
⁵ Department of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
⁶ School of Clinical Sciences, Monash University, Melbourne, Australia.
⁷ Departments of Pediatrics, Division of Infectious Diseases, and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX.
⁸ Department of Statistics and Data Science, University of California, Los Angeles (UCLA), Los Angeles, California.
⁹ Department of Public Health, Research Unit for Epidemiology, Aarhus University, Aarhus, Denmark.
¹⁰ Department of Research & Evaluation, Kaiser Permanente, Pasadena, CA.

PMID: 40081452
PMCID: PMC12139448 (available on 2026-04-01)
DOI: 10.1542/peds.2024-069778

COVID-19 Vaccination During Pregnancy and Major Structural Birth Defects

Stacey L Rowe et al. Pediatrics. 2025.

. 2025 Apr 1;155(4):e2024069778.

doi: 10.1542/peds.2024-069778.

Authors

Stacey L Rowe^{1

2

3

4}, Sheena G Sullivan^{5

6}, Flor M Muñoz⁷, Matthew M Coates^{3

4}, Brianna Agnew¹, Onyebuchi A Arah^{3

4

8

9}, Annette K Regan^{1

3

4

10}

Affiliations

¹ School of Nursing and Health Professions, University of San Francisco, San Francisco, CA.
² School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
³ Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles (UCLA), Los Angeles, CA.
⁴ Practical Causal Inference Lab, University of California, Los Angeles (UCLA), Los Angeles, CA.
⁵ Department of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
⁶ School of Clinical Sciences, Monash University, Melbourne, Australia.
⁷ Departments of Pediatrics, Division of Infectious Diseases, and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX.
⁸ Department of Statistics and Data Science, University of California, Los Angeles (UCLA), Los Angeles, California.
⁹ Department of Public Health, Research Unit for Epidemiology, Aarhus University, Aarhus, Denmark.
¹⁰ Department of Research & Evaluation, Kaiser Permanente, Pasadena, CA.

PMID: 40081452
PMCID: PMC12139448 (available on 2026-04-01)
DOI: 10.1542/peds.2024-069778

Abstract

Background and objectives: COVID-19 vaccination is recommended during pregnancy; however, evidence on the prevalence of major structural birth defects born to people vaccinated early in pregnancy (≤20 weeks of gestation) is limited. We compared the prevalence of major structural birth defects by COVID-19 vaccination status and key strata: insurance provider, clinically diagnosed SARS-CoV-2 infection during pregnancy, and concomitant administration of other maternal vaccines. We also compared, head-to-head, the prevalence of birth defects by brand (Moderna mRNA-1273 vs Pfizer-BioNTech BNT162b2).

Methods: A claims-based cohort study captured pregnancies ending in a live birth among people with an estimated last menstrual period between August 15, 2021, and December 24, 2021. Prevalence ratios comparing birth defects by exposure to COVID-19 vaccines were estimated using binomial regression with inverse probability treatment weights.

Results: Among 78 052 pregnancies, we identified 1248 major structural birth defects (1049 [160.6 per 10 000 live births] among unvaccinated people and 199 [156.4 per 10 000 live births] among vaccinated people). No differences in the prevalence of major structural birth defects were observed given COVID-19 vaccination (adjusted prevalence ratio [aPR], 0.96; 95% CI, 0.81-1.13). Findings were unchanged by insurance provider, SARS-CoV-2 infection during pregnancy, and concomitant of other maternal vaccines. No differences in the prevalence of birth defects were observed among vaccinated people by brand (aPR, 1.02; 95% CI, 0.77-1.37).

Conclusions: COVID-19 vaccination during early pregnancy is not associated with an increased prevalence of major structural birth defects in infants. These results support the safety of COVID-19 vaccination in early pregnancy.

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Conflict of interest statement

Conflict of interest and disclosure statements:

Sheena G Sullivan reports paid consulting and/or advisory board participation from CSL Seqirus, Evo Health, Moderna, Novavax and Pfizer, but declares no non-financial competing interests. All other authors declare no financial or non-financial competing interests.

Flor M Muñoz is an investigator of pediatric studies of COVID-19 vaccines for Pfizer and Moderna, and for a pediatric remdesivir study conducted by Gilead Sciences, Inc.; serves as investigator on projects supported by an NIH contract for a Vaccine Treatment and Evaluation Unit (VTEU), serves as member of the DSMB for clinical trials conducted by Pfizer, Moderna, Meissa Vaccines, Virometix, and the NIH; and is a member of the American Academy of Pediatrics Committee of Infectious Diseases (COID), the Immunization Expert Group of the American College of Obstetrics and Gynecology (ACOG), and Co-Chair of the COVAX Maternal Immunization Working Group.

Matthew M Coates is supported by the National Cancer Institute, grant number NIH/NCI T32 CA009142.

Anette K Regan is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R01AI169239.

The remaining authors have indicated they have no conflicts of interest relevant to this article to disclose.

References

1. Wang H et al. The association between pregnancy and COVID-19: A systematic review and meta-analysis. The American Journal of Emergency Medicine 56, 188–195, doi:10.1016/j.ajem.2022.03.060 (2022). - DOI - PMC - PubMed
1. Allotey J et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ 370, m3320, doi:10.1136/bmj.m3320 (2020). - DOI - PMC - PubMed
1. The American College of Obstetricians and Gynecologists. COVID-19 vaccines and pregnancy: Key recommendations and messaging for clinicians, <https://www.acog.org/covid-19/covid-19-vaccines-and-pregnancy-conversati...> (2022).
1. Fu W et al. Systematic review of the safety, immunogenicity, and effectiveness of COVID-19 vaccines in pregnant and lactating individuals and their infants. International Journal of Gynecology & Obstetrics 156, 406–417, doi:10.1002/ijgo.14008 (2022). - DOI - PMC - PubMed
1. Watanabe A et al. Peripartum Outcomes Associated With COVID-19 Vaccination During Pregnancy: A Systematic Review and Meta-analysis. JAMA Pediatrics 176, 1098–1106, doi:10.1001/jamapediatrics.2022.3456 (2022). - DOI - PMC - PubMed

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COVID-19 Vaccination During Pregnancy and Major Structural Birth Defects

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COVID-19 Vaccination During Pregnancy and Major Structural Birth Defects

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