Impact of SARS-CoV-2 Vaccination on Inflammatory Bowel Disease Activity and Development of Vaccine-Related Adverse Events: Results From PREVENT-COVID

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  • Weaver, Kimberly N
    • Affiliation: School of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology
  • Zhang, Xian
    • Affiliation: School of Medicine, Department of Pediatrics
  • Dai, Xiangfeng
    • Affiliation: School of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology
  • Watkins, Runa
    • Other Affiliation: University of Maryland School of Medicine
  • Adler, Jeremy
    • Other Affiliation: University of Michigan
  • Dubinsky, Marla C
    • Other Affiliation: Icahn School of Medicine at Mount Sinai
  • Kastl, Arthur
    • Other Affiliation: University of Pennsylvania
  • Bousvaros, Athos
    • Other Affiliation: Boston Children's Hospital
  • Strople, Jennifer A
    • Other Affiliation: Ann and Robert H. Lurie Children's Hospital of Chicago
  • Cross, Raymond K
    • Other Affiliation: University of Maryland School of Medicine
  • Higgins, Peter D R
    • Other Affiliation: University of Michigan
  • Ungaro, Ryan C
    • Other Affiliation: Icahn School of Medicine at Mount Sinai
  • Bewtra, Meenakshi
    • Other Affiliation: University of Pennsylvania
  • Bellaguarda, Emanuelle
    • Other Affiliation: Northwestern University
  • Farraye, Francis A
    • Other Affiliation: Mayo Clinic
  • Boccieri, Margie E
    • Affiliation: School of Medicine, Department of Pediatrics
  • Firestine, Ann
    • Affiliation: School of Medicine, Department of Pediatrics
  • Kappelman, Michael D
    • Affiliation: School of Medicine, Department of Pediatrics
  • Long, Millie D
    • Affiliation: School of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology
Abstract
  • Severe acute respiratory syndrome coronavirus 2 vaccination is recommended for all individuals with inflammatory bowel disease (IBD), including those on immunosuppressive therapies; however, little is known about vaccine safety and efficacy in these patients or the impact of vaccination on IBD disease course.We evaluated coronavirus disease 2019 (COVID-19) vaccine–related adverse events (AEs) and the effect of vaccination on IBD disease course among participants in the PREVENT-COVID (Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID) study, a prospective, observational cohort study. Localized and systemic reactions were assessed via questionnaire. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Outcomes were stratified by vaccine type and IBD medication classes.A total of 3316 individuals with IBD received at least 1 COVID-19 vaccine. Injection site tenderness (68%) and fatigue (46% dose 1, 68% dose 2) were the most commonly reported localized and systemic AEs after vaccination. Severe localized and systemic vaccine-related AEs were rare. The mRNA-1273 vaccine was associated with significantly greater severe AEs at dose 2 (localized 4% vs 2%, systemic 15% vs 10%; P < .001 for both). Prior COVID-19 infection, female sex, and vaccine type were associated with severe systemic reactions to dose 1, while age <50 years, female sex, vaccine type, and antitumor necrosis factor and vedolizumab use were associated with severe systemic reactions to dose 2. Overall rates (2%) of IBD flare were low following vaccination.Our findings provide reassurance that the severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with IBD, which may help to combat vaccine hesitancy and increase vaccine confidence.The severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with inflammatory bowel disease (IBD). Severe localized and systemic vaccine-related adverse events were rare, and rates of IBD flare were low (2%) following severe acute respiratory syndrome coronavirus 2 vaccination in a cohort of 3316 participants with IBD.
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  • Article
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  • In Copyright
Journal title
  • Inflammatory Bowel Diseases
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  • 1
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  • 9
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  • English
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  • Postprint
ISSN
  • 1078-0998

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