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

doi:10.1093/ibd/izab302

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

Inflamm Bowel Dis. 2022 Oct 3;28(10):1497-1505. doi: 10.1093/ibd/izab302.

Authors

Kimberly N Weaver¹, Xian Zhang², Xiangfeng Dai¹, Runa Watkins³, Jeremy Adler⁴, Marla C Dubinsky⁵, Arthur Kastl⁶, Athos Bousvaros⁷, Jennifer A Strople⁸, Raymond K Cross⁹, Peter D R Higgins¹⁰, Ryan C Ungaro¹¹, Meenakshi Bewtra^{12

13}, Emanuelle Bellaguarda¹⁴, Francis A Farraye¹⁵, Margie E Boccieri², Ann Firestine², Michael D Kappelman^{2

16}, Millie D Long^{1

16}

Affiliations

¹ Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
² Division of Pediatric Gastroenterology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
³ Division of Pediatric Gastroenterology and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA.
⁴ Susan B. Meister Child Health Evaluation and Research Center and Division of Pediatric Gastroenterology, University of Michigan, Ann Arbor, MI, USA.
⁵ Susan and Leonard Feinstein IBD Center, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁶ Division of Gastroenterology, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁷ Department of Pediatrics, Boston Children's Hospital, Boston, MA, USA.
⁸ Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.
⁹ Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, Baltimore, MD, USA.
¹⁰ Division of Gastroenterology & Hepatology, University of Michigan, Ann Arbor, MI, USA.
¹¹ Susan and Leonard Feinstein IBD Center, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹² Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia PA, USA.
¹³ Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia PA, USA.
¹⁴ Division of Gastroenterology and Hepatology, Northwestern University, Chicago, IL, USAand.
¹⁵ Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA.
¹⁶ Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

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.

Keywords: COVID-19; Crohn’s disease; preventive care; ulcerative colitis; vaccination.

Plain language summary

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.

Publication types

Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

2019-nCoV Vaccine mRNA-1273
COVID-19 Vaccines* / adverse effects
COVID-19* / prevention & control
Female
Humans
Inflammatory Bowel Diseases*
Middle Aged
Prospective Studies
SARS-CoV-2
Vaccination / adverse effects

Substances

COVID-19 Vaccines
2019-nCoV Vaccine mRNA-1273