Evidence map›Paper›PMID 40081452›Full record

ArticlePediatrics2025

COVID-19 Vaccination During Pregnancy and Major Structural Birth Defects.

Stacey L Rowe, Sheena G Sullivan, Flor M Muñoz, Matthew M Coates, Brianna Agnew, Onyebuchi A Arah, Annette K Regan

Abstract read
In one paragraph

Article in Pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Stacey L RoweSchool of Nursing and Health Professions, University of San Francisco, San Francisco, CA.
Sheena G SullivanDepartment of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Flor M MuñozDepartments of Pediatrics, Division of Infectious Diseases, and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX.
Matthew M CoatesDepartment of Epidemiology, Fielding School of Public Health, University of California, Los Angeles (UCLA), Los Angeles, CA.
Brianna AgnewSchool of Nursing and Health Professions, University of San Francisco, San Francisco, CA.
Onyebuchi A ArahDepartment of Epidemiology, Fielding School of Public Health, University of California, Los Angeles (UCLA), Los Angeles, CA.
Annette K ReganSchool of Nursing and Health Professions, University of San Francisco, San Francisco, CA.

Funding

Scientific and Technical CoreP2CHD041022 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI HIRAM BELTRAN-SANCHEZ · 2016 to 2026
$6.9M
UCLA CANCER EPIDEMIOLOGY TRAINING PROGRAMT32CA009142 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ZHANG, ZUO-FENG · 1986 to 2024
$6.3M
Uptake, Safety and Effectiveness of COVID‐19 Vaccines during PregnancyR01AI169239 · NIAID · UNIVERSITY OF SAN FRANCISCO · PI REGAN, ANNETTE KARENA · 2022 to 2024
$1.3M
NCI NIH HHS T32 CA009142NIAID NIH HHS L40 AI178819NIAID NIH HHS R01 AI169239NICHD NIH HHS P2C HD041022
6 · The paper itself

Abstract

BACKGROUND AND

objectivesCOVID-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).

methodsA 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.

resultsAmong 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).

conclusionsCOVID-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.

Indexed as

Congenital AbnormalitiesCOVID-19COVID-19 VaccinesPregnancy Complications, InfectiousVaccinationAdultBNT162 VaccineCohort StudiesFemaleHumansInfant, NewbornPregnancyPrevalenceUnited StatesYoung AdultBNT162 VaccineCOVID-19 Vaccines

Identifiers

PMID40081452
PMCPMC12139448

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.