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

Kimberly N. Weaver, Xian Zhang, Xiangfeng Dai, Runa Watkins, Jeremy Adler, Marla C. Dubinsky, Arthur Kastl, Athos Bousvaros, Jennifer A. Strople, Raymond K. Cross, Peter D.R. Higgins, Ryan C. Ungaro, Meenakshi Bewtra, Emanuelle Bellaguarda, Francis A. Farraye, Margie E. Boccieri, Ann Firestine, Michael D. Kappelman, Millie D. Long

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Original languageEnglish (US)
Pages (from-to)1497-1505
Number of pages9
JournalInflammatory bowel diseases
Volume28
Issue number10
DOIs
StatePublished - Oct 3 2022

Keywords

  • COVID-19
  • Crohn’s disease
  • preventive care
  • ulcerative colitis
  • vaccination

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

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