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

Author:

Weaver Kimberly N1ORCID,Zhang Xian2,Dai Xiangfeng1,Watkins Runa3,Adler Jeremy4,Dubinsky Marla C5ORCID,Kastl Arthur6,Bousvaros Athos7,Strople Jennifer A8,Cross Raymond K9ORCID,Higgins Peter D R10,Ungaro Ryan C11,Bewtra Meenakshi1213,Bellaguarda Emanuelle14,Farraye Francis A15,Boccieri Margie E2,Firestine Ann2,Kappelman Michael D216,Long Millie D116

Affiliation:

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

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.

Funder

Leona M. and Harry B. Helmsley Charitable Trust

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology,Immunology and Allergy

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