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. 2021 Jun 16;39(27):3614-3620.
doi: 10.1016/j.vaccine.2021.05.032. Epub 2021 May 26.

Incidence of pediatric inflammatory bowel disease within the Vaccine Safety Datalink network and evaluation of association with rotavirus vaccination

Elizabeth Liles  1 , Stephanie A Irving  2 , Padma Dandamudi  3 , Edward A Belongia  4 , Matthew F Daley  5 , Frank DeStefano  6 , Lisa A Jackson  7 , Steven J Jacobsen  8 , Elyse Kharbanda  9 , Nicola P Klein  10 , Eric Weintraub  11 , Allison L Naleway  12
Affiliations

Incidence of pediatric inflammatory bowel disease within the Vaccine Safety Datalink network and evaluation of association with rotavirus vaccination

Elizabeth Liles et al. Vaccine. .

Abstract

Background: Recent studies have reported an increase in Inflammatory bowel disease (IBD) incidence in young children, highlighting the need to better understand risk factors for the development of IBD. Licensed for use in infants in 2006, the oral, live-attenuated rotavirus vaccine has biologic plausibility for instigating inflammation of the gut mucosa as a pathway to immune dysregulation.

Methods: Over a ten-year period, we evaluated incidence of IBD within a cohort of children under the age of ten, enrolled in seven integrated healthcare delivery systems. We conducted a nested case-control study to evaluate the association between rotavirus vaccination and IBD using conditional logistic regression. Cases were confirmed via medical record review and matched to non-IBD controls on date of birth, sex, and study site.

Results: Among 2.4 million children under the age of 10 years, 333 cases of IBD were identified with onset between 2007 and 2016. The crude incidence of IBD increased slightly over the study period (p-value for trend = 0.046). Of the 333 cases, 227 (68%) were born prior to 2007. Forty-two cases born in 2007 or later, with continuous enrollment since birth were included in the case-control study and matched to 210 controls. The adjusted odds ratio for any rotavirus vaccination in IBD cases, compared to matched controls, was 0.72 (95% confidence interval 0.19-2.65).

Conclusions: Data from this large pediatric cohort demonstrate a small overall increase in IBD incidence in young children over a ten-year period. The data suggest that rotavirus vaccination is not associated with development of IBD.

Keywords: Incidence; Inflammatory bowel disease; Pediatric; Rotavirus vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Liles received unrelated research funding from Merck, Pfizer, Epigenomics and Medial Solutions. Dr. Jackson received unrelated research funding from Pfizer. Dr. Jacobsen received unrelated research funding from Dynavax Technologies. Dr. Klein received unrelated research funding from Merck, GlaxoSmithKline, Pfizer, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur). Dr. Naleway received unrelated research funding from Pfizer.

Figures

Fig. 1.
Fig. 1.
Abbreviations: IBD – inflammatory bowel disease, CD – Crohn’s disease, UC – ulcerative colitis. Crude incidence and linear trends of inflammatory bowel disease among children <10 years of age from six Vaccine Safety Datalink sites, 2007-2016. Incidence rates are shown per 100,000 person-years; “overall IBD” rate includes cases of CD, UC, and indeterminate colitis. Trend lines for overall IBD, CD, and UC represent the linear incidence trends within those categories across the study period. P-values for linear trends were 0.046, 0.012, and 0.281 for overall IBD, CD, and UC, respectively.
Fig. 2.
Fig. 2.
Crude incidence of inflammatory bowel disease among children <10 years of age from six Vaccine Safety Datalink sites, by age group and sex, 2007-2016. Incidence rates are shown per 100,000 person-years and include all cases of Crohn’s disease, ulcerative colitis, and indeterminate colitis; ages represent age at first IBD diagnosis.
Fig. 3.
Fig. 3.
Identification and confirmation of inflammatory bowel disease cases from electronic medical records of approximately 2.4 million members of the Vaccine Safety Datalink network aged <10 years.
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