First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring

Elyse Olshen Kharbanda; Gabriela Vazquez-Benitez; Paul A Romitti; Allison L Naleway; T Craig Cheetham; Heather S Lipkind; Nicola P Klein; Grace Lee; Michael L Jackson; Simon J Hambidge; Natalie McCarthy; Frank DeStefano; James D Nordin; Vaccine Safety Datalink

doi:10.1016/j.jpeds.2017.04.039

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First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring

Journal article

Peer reviewed

First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring

Elyse Olshen Kharbanda, Gabriela Vazquez-Benitez, Paul A Romitti, Allison L Naleway, T Craig Cheetham, Heather S Lipkind, Nicola P Klein, Grace Lee, Michael L Jackson, Simon J Hambidge, …

The Journal of pediatrics, Vol.187, pp.234-239.e4

08/2017

DOI: 10.1016/j.jpeds.2017.04.039

PMCID: PMC6506840

PMID: 28550954

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https://www.ncbi.nlm.nih.gov/pmc/articles/6506840View

Open Access

Abstract

To examine risks for major structural birth defects in infants after first trimester inactivated influenza vaccine (IIV) exposures. In this observational study, we used electronic health data from 7 Vaccine Safety Datalink sites to examine risks for selected major structural defects in infants after maternal IIV exposure. Vaccine exposures for women with continuous insurance enrollment through pregnancy who delivered singleton live births between 2004 and 2013 were identified from standardized files. Infants with continuous insurance enrollment were followed to 1 year of age. We excluded mother-infant pairs with other exposures that potentially increased their background risk for birth defects. Selected cardiac, orofacial or respiratory, neurologic, ophthalmologic or otologic, gastrointestinal, genitourinary and muscular or limb defects were identified from diagnostic codes in infant medical records using validated algorithms. Propensity score adjusted generalized estimating equations were used to estimate prevalence ratios (PRs). We identified 52 856 infants with maternal first trimester IIV exposure and 373 088 infants whose mothers were unexposed to IIV during first trimester. Prevalence (per 100 live births) for selected major structural birth defects was 1.6 among first trimester IIV exposed versus 1.5 among unexposed mothers. The adjusted PR was 1.02 (95% CI 0.94-1.10). Organ system-specific PRs were similar to the overall PR. First trimester maternal IIV exposure was not associated with an increased risk for selected major structural birth defects in this large cohort of singleton live births.

Congenital Abnormalities - epidemiology

Prenatal Exposure Delayed Effects - epidemiology

Humans

Congenital Abnormalities - etiology

Influenza Vaccines - adverse effects

Infant

Risk

Pregnancy Trimester, First

Pregnancy

Propensity Score

Adult

Female

Influenza, Human - prevention & control

Pregnancy Complications - epidemiology

Details

Title: Subtitle: First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring
Creators: Elyse Olshen Kharbanda - HealthPartners Institute, Minneapolis, MN. Electronic address: elyse.o.kharbanda@healthpartners.com
Gabriela Vazquez-Benitez - HealthPartners Institute, Minneapolis, MN
Paul A Romitti - University of Iowa, Iowa City, IA
Allison L Naleway - Center for Health Research, Kaiser Permanente Northwest, Portland, OR
T Craig Cheetham - Kaiser Permanente Southern California, Pasadena, CA
Heather S Lipkind - Yale University School of Medicine, New Haven, CT
Nicola P Klein - Kaiser Permanente Northern California, Oakland, CA
Grace Lee - Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Michael L Jackson - Kaiser Permanente Washington Health Research Institute, Seattle, WA
Simon J Hambidge - Institute for Health Research, Kaiser Permanente Colorado and Ambulatory Care Services, Denver Health, Colorado Springs, CO
Natalie McCarthy - Centers for Disease Control and Prevention, Atlanta, GA
Frank DeStefano - Centers for Disease Control and Prevention, Atlanta, GA
James D Nordin - HealthPartners Institute, Minneapolis, MN
Vaccine Safety Datalink
Resource Type: Journal article
Publication Details: The Journal of pediatrics, Vol.187, pp.234-239.e4
DOI: 10.1016/j.jpeds.2017.04.039
PMID: 28550954
PMCID: PMC6506840
NLM abbreviation: J Pediatr
ISSN: 1097-6833
eISSN: 1097-6833
Publisher: United States
Language: English
Date published: 08/2017
Academic Unit: Epidemiology; Biostatistics
Record Identifier: 9983996198602771

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