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; Thomas D Scholz; Alpa Sidhu; Michael Christiansen; Paul A Romitti; Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)

doi:10.1016/j.vaccine.2025.127297

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

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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, …

Vaccine, Vol.59, 127297

05/25/2025

DOI: 10.1016/j.vaccine.2025.127297

PMCID: PMC12990147

PMID: 40418866

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Abstract

Studies 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. Mothers 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. The 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. Findings 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.

Pregnancy

Influenza vaccines

Spina bifida

Congenital abnormalities

Birth defects

Details

Title: Subtitle: Influenza vaccination during early pregnancy and risk of major birth defects, US Birth Defects Study To Evaluate Pregnancy exposureS, 2014-2019
Creators: Veronica Malange - Statens Serum Institut
Tasnim Mohaissen - Jagiellonian University
Kristin M Conway - University of Iowa, Epidemiology
Anthony Rhoads - University of Iowa
Joan K Morris - St George's, University of London
Elizabeth C Ailes - National Center on Birth Defects and Developmental Disabilities
Paula L Hedley - Statens Serum Institut
Janet D Cragan - National Center on Birth Defects and Developmental Disabilities
Eirini Nestoridi - Massachusetts Department of Public Health
Eleni A Papadopoulos - New York State Department of Health
Thomas D Scholz - University of Iowa
Alpa Sidhu - University of Iowa
Michael Christiansen
Paul A Romitti - Statens Serum Institut
Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)
Resource Type: Journal article
Publication Details: Vaccine, Vol.59, 127297
DOI: 10.1016/j.vaccine.2025.127297
PMID: 40418866
PMCID: PMC12990147
NLM abbreviation: Vaccine
ISSN: 0264-410X
eISSN: 1873-2518
Publisher: ELSEVIER SCI LTD
Grant note: US Centers for Disease Control and Prevention (CDC) cooperative: 96043, 02081, DD09-001, DD13-003, DD18-001, DD23-001 National Birth Defects Prevention Study: U01 DD001035, U01 DD001223, U01 DD001307 Polish National Agency for Academic Exchange: BPN/BEK/2023/1/00226
This project was supported through US Centers for Disease Control and Prevention (CDC) cooperative agreements under PA #96043, PA #02081, FOA #DD09-001, FOA #DD13-003, NOFO #DD18-001, and NOFO #DD23-001 to the Centers for Birth Defects Research and Prevention participating in the National Birth Defects Prevention Study and/or the Birth Defects Study To Evaluate Pregnancy exposureS, grants (U01 DD001035, U01 DD001223, and U01 DD001307) awarded to the Iowa Center for Birth Defects Research and Prevention (P.A.R.), and the Polish National Agency for Academic Exchange (BPN/BEK/2023/1/00226) (T.M.). The CDC contributed to the design and conduct of the study; collection, management, and interpretation of the data; and approval of the manuscript. The Polish National Agency for Academic Exchange was not involved in any of the study activities.
Language: English
Date published: 05/25/2025
Academic Unit: Cardiology; Stead Family Department of Pediatrics; Epidemiology; Biostatistics; Medical Genetics and Genomics; Fraternal Order of Eagles Diabetes Research Center; Child and Community Health
Record Identifier: 9984824175402771

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