Seasonal Influenza Vaccination During Pregnancy and the Risk of Major Congenital Malformations in Live-born Infants: A 2010–2016 Historical Cohort Study

Maria Peppa, Sara L. Thomas, Caroline Minassian, Jemma L. Walker, Helen I. McDonald, Nick J. Andrews, Stephen T. Kempley, Punam Mangtani

Research output: Contribution to journalArticlepeer-review

Abstract

Background. Available evidence indicates that seasonal inactivated influenza vaccination during pregnancy protects both the mother and her newborn and is safe. Nevertheless, ongoing safety assessments are important in sustaining vaccine uptake. Few studies have explored safety in relation to major congenital malformations (MCMs), particularly in the first trimester when most organogenesis occurs. Methods. Anonymized UK primary care data (the Clinical Practice Research Datalink), including a recently developed Pregnancy Register, were used to identify live-born singletons delivered between 2010 and 2016. Maternal influenza vaccination was determined using primary care records and stratified by trimester. Ascertainment of MCMs from infant primary care records was maximized by linkage to hospitalization data and death certificates. The relationship between vaccination and MCMs recorded in the year after delivery and in early childhood was then assessed using multivariable Cox regression. Results. A total of 78 150 live-birth pregnancies were identified: 6872 (8.8%) were vaccinated in the first trimester, 11 678 (14.9%) in the second, and 12 931 (16.5%) in the third. Overall, 5707 live births resulted in an infant with an MCM recorded in the year after delivery and the adjusted hazard ratio when comparing first-trimester vaccination to no vaccination was 1.06 (99% CI, .94–1.19; P = .2). Results were similar for second- and third-trimester vaccination and for analyses considering MCMs recorded beyond the first birthday. Conclusions. In this large, population-based historical cohort study there was no evidence to suggest that seasonal influenza vaccine was associated with MCMs when given in the first trimester or subsequently in pregnancy.

Original languageEnglish
Pages (from-to)E4296-E4304
JournalClinical Infectious Diseases
Volume73
Issue number11
Early online date23 Jun 2020
DOIs
Publication statusPublished - 1 Dec 2021
Externally publishedYes

Keywords

  • congenital malformations
  • influenza vaccine
  • pregnancy
  • safety

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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