Evidence map›Paper›PMID 40418866›Full record

ArticleVaccine2025

Influenza vaccination during early pregnancy and risk of major birth defects, US Birth Defects Study To Evaluate Pregnancy exposureS, 2014-2019.

Veronica Malange, Tasnim Mohaissen, Kristin M Conway, Anthony Rhoads, Joan K Morris, Elizabeth C Ailes, Paula L Hedley, Janet D Cragan, Eirini Nestoridi, Eleni A Papadopoulos and 5 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

15 authors.

Veronica MalangeDepartment for Congenital Disorders, Danish National Biobank and Biomarkers, Statens Serum Institut, Copenhagen, Denmark.
Tasnim MohaissenDepartment for Congenital Disorders, Danish National Biobank and Biomarkers, Statens Serum Institut, Copenhagen, Denmark; Jagiellonian University, Jagiellonian Center for Experimental Therapeutics (JCET), Krakow, Poland.
Kristin M ConwayDepartment of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA.
Anthony RhoadsDepartment of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA.
Joan K MorrisSchool of Health & Medical Sciences, City St George's University of London, London, UK.
Elizabeth C AilesDivision of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Paula L HedleyDepartment for Congenital Disorders, Danish National Biobank and Biomarkers, Statens Serum Institut, Copenhagen, Denmark; Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA.
Janet D CraganDivision of Birth Defects and Infant Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Eirini NestoridiCenter for Birth Defects Research and Prevention, Massachusetts Department of Public Health, Boston, MA, USA.
Eleni A PapadopoulosBirth Defects Registry, New York State Department of Health, Albany, New York, USA.
Thomas D ScholzDivision of Pediatric Cardiology, The Stead Family Department of Pediatrics, University of Iowa Health Care, Iowa City, Iowa, USA.
Alpa SidhuDivision of Medical Genetics and Genomics, The Stead Family Department of Pediatrics, University of Iowa Health Care, Iowa City, Iowa, USA.
Michael ChristiansenDepartment for Congenital Disorders, Danish National Biobank and Biomarkers, Statens Serum Institut, Copenhagen, Denmark; Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
Paul A RomittiDepartment for Congenital Disorders, Danish National Biobank and Biomarkers, Statens Serum Institut, Copenhagen, Denmark; Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA. Electronic address: paul-romitti@uiowa.edu.
Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)

Funding

Intramural CDC HHS CC999999NCBDD CDC HHS U01 DD001227NCBDD CDC HHS U01 DD001304NCBDD CDC HHS U01 DD001307
6 · The paper itself

Abstract

purposeStudies of influenza vaccination during pregnancy and major birth defects generally provide reassuring findings. To maintain public confidence, it is important to continue evaluating the safety of maternal vaccination using well characterized, population-based data. This study extended previous research to examine associations between maternal influenza vaccination and selected birth defects using data from the Birth Defects Study To Evaluate Pregnancy exposureS, a US, multisite case-control study.

methodsMothers of case children (diagnosed with a birth defect) and control children (without a birth defect diagnosis) were identified from population-based birth defect surveillance programs and recruited to complete a telephone interview. Data from 2675 case and 1575 control mothers (participants) with deliveries during 2014-2019 were analyzed. Influenza vaccination exposure during the critical exposure period (one month before pregnancy through the first pregnancy month [B1P1] for spina bifida or through the third pregnancy month [B1P3] for other selected birth defects) was assessed controlling for several participant covariates. Logistic regression with propensity score adjustment was used to estimate adjusted odds ratios (aORs) and 95 % confidence intervals (CIs). Several secondary analyses were conducted. A probabilistic bias analysis examined the effect of exposure misclassification.

resultsThe aOR observed between B1P1 influenza vaccination exposure and spina bifida was 0.9 (95 % CI: 0.4-2.0). The aORs for B1P3 exposure and other selected birth defects examined ranged from 0.4 to 1.3, with 95 % CIs including the null except those for cleft lip ± cleft palate (aOR: 0.6; 95 % CI: 0.4-0.9) and gastroschisis (aOR: 0.4; 95 % CI: 0.2-0.7). Results from secondary analyses were similar to the primary analyses, and those from probabilistic bias analysis were similar to respective primary and secondary analyses.

conclusionFindings showed no statistically significant positive associations between influenza vaccination and the selected birth defects, supporting public health efforts to promote optimal vaccination coverage among pregnant women.

Indexed as

Congenital AbnormalitiesInfluenza, HumanInfluenza VaccinesPregnancy Complications, InfectiousVaccinationAdultCase-Control StudiesFemaleHumansInfant, NewbornPregnancyUnited StatesYoung AdultInfluenza VaccinesBirth defectsCongenital abnormalitiesInfluenza vaccinesPregnancySpina bifida

Identifiers

PMID40418866
PMCPMC12990147

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.