COVID-19 Vaccination During Pregnancy and Major Structural Birth Defects
Pediatrics e2024069778 https://doi.org/10.1542/peds.2024-069778
Stacey L. Rowe, PhD, MPH, BSc(Hons) srowe3 at usfca.edu; Sheena G. Sullivan, PhD, MPH, MSc, BSc(Hons); Flor M. Muñoz, MD, MSc; Matthew M. Coates, MPH; Brianna Agnew, MPH; Onyebuchi A. Arah, MD, DSc, PhD, MPH, MSc; Annette K. Regan, PhD, MPH
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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4 major possible problems with this study:
- "Our study excluded pregnancies ending early (due to spontaneous or medical abortion, ectopic and trophoblastic implantation, and stillbirth) and thus may be affected by live-birth bias: a form of selection bias that occurs when an exposure affects both diagnosis of the outcome and fetal survival."
- They ignored possible reduction in conceptions due to vaccination
- They ignored possible problems with vaccination AFTER 20 weeks of pregnancy
- They ignored possible health problems in the infant which were notticed after birth
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