PMID- 34871388 OWN - NLM STAT- MEDLINE DCOM- 20221004 LR - 20221021 IS - 1536-4844 (Electronic) IS - 1078-0998 (Print) IS - 1078-0998 (Linking) VI - 28 IP - 10 DP - 2022 Oct 3 TI - Impact of SARS-CoV-2 Vaccination on Inflammatory Bowel Disease Activity and Development of Vaccine-Related Adverse Events: Results From PREVENT-COVID. PG - 1497-1505 LID - 10.1093/ibd/izab302 [doi] LID - izab302 AB - 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. CI - (c) 2021 Crohn's & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Weaver, Kimberly N AU - Weaver KN AUID- ORCID: 0000-0002-7407-370X AD - Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. FAU - Zhang, Xian AU - Zhang X AD - Division of Pediatric Gastroenterology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. FAU - Dai, Xiangfeng AU - Dai X AD - Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. FAU - Watkins, Runa AU - Watkins R AD - Division of Pediatric Gastroenterology and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA. FAU - Adler, Jeremy AU - Adler J AD - Susan B. Meister Child Health Evaluation and Research Center and Division of Pediatric Gastroenterology, University of Michigan, Ann Arbor, MI, USA. FAU - Dubinsky, Marla C AU - Dubinsky MC AUID- ORCID: 0000-0003-4968-5795 AD - Susan and Leonard Feinstein IBD Center, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA. FAU - Kastl, Arthur AU - Kastl A AD - Division of Gastroenterology, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. FAU - Bousvaros, Athos AU - Bousvaros A AD - Department of Pediatrics, Boston Children's Hospital, Boston, MA, USA. FAU - Strople, Jennifer A AU - Strople JA AD - Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA. FAU - Cross, Raymond K AU - Cross RK AUID- ORCID: 0000-0001-9766-5196 AD - Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, Baltimore, MD, USA. FAU - Higgins, Peter D R AU - Higgins PDR AD - Division of Gastroenterology & Hepatology, University of Michigan, Ann Arbor, MI, USA. FAU - Ungaro, Ryan C AU - Ungaro RC AD - Susan and Leonard Feinstein IBD Center, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA. FAU - Bewtra, Meenakshi AU - Bewtra M AD - Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia PA, USA. AD - Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia PA, USA. FAU - Bellaguarda, Emanuelle AU - Bellaguarda E AD - Division of Gastroenterology and Hepatology, Northwestern University, Chicago, IL, USAand. FAU - Farraye, Francis A AU - Farraye FA AD - Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA. FAU - Boccieri, Margie E AU - Boccieri ME AD - Division of Pediatric Gastroenterology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. FAU - Firestine, Ann AU - Firestine A AD - Division of Pediatric Gastroenterology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. FAU - Kappelman, Michael D AU - Kappelman MD AD - Division of Pediatric Gastroenterology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. AD - Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. FAU - Long, Millie D AU - Long MD AD - Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. AD - Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't PL - England TA - Inflamm Bowel Dis JT - Inflammatory bowel diseases JID - 9508162 RN - 0 (COVID-19 Vaccines) RN - EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273) SB - IM CIN - Inflamm Bowel Dis. 2022 Jun 06;:. PMID: 35666245 MH - 2019-nCoV Vaccine mRNA-1273 MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - Female MH - Humans MH - *Inflammatory Bowel Diseases MH - Middle Aged MH - Prospective Studies MH - SARS-CoV-2 MH - Vaccination/adverse effects PMC - PMC8822409 OAB - 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. OABL- eng OTO - NOTNLM OT - COVID-19 OT - Crohn's disease OT - preventive care OT - ulcerative colitis OT - vaccination EDAT- 2021/12/07 06:00 MHDA- 2022/10/05 06:00 PMCR- 2021/12/06 CRDT- 2021/12/06 17:28 PHST- 2021/09/30 00:00 [received] PHST- 2021/12/07 06:00 [pubmed] PHST- 2022/10/05 06:00 [medline] PHST- 2021/12/06 17:28 [entrez] PHST- 2021/12/06 00:00 [pmc-release] AID - 6454297 [pii] AID - izab302 [pii] AID - 10.1093/ibd/izab302 [doi] PST - ppublish SO - Inflamm Bowel Dis. 2022 Oct 3;28(10):1497-1505. doi: 10.1093/ibd/izab302.