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

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.

Real-World Use and Adverse Events of SARS-CoV-2 Vaccination in Greek Patients with Inflammatory Bowel Disease

“…This study aimed at reporting the experience on the acceptance and safety of vaccines against COVID-19 in IBD patients. Interestingly, it was highlighted that the occurrence of AEs after vaccination against COVID-19 in Greek IBD patients was similar to that reported in other ethnic IBD and non-IBD populations [7][8][9][10][11][12]. No severe disease relapse or serious AEs including hospitalizations for any reason, severe allergic reactions, thromboembolic events or myopericarditis were recorded.…”

“…The majority of studies emphasize that patients with immune-mediated inflammatory diseases receiving biologic therapies do not run any extra risk for AEs after COVID-19 vaccination [7][8][9]25,26] when compared with the general population. However, in the recently published PREVENT-COVID study anti-TNFa and vedolizumab use were associated with severe systemic reactions to D2 [10] while there is one report showing that the AE risk might even be reduced while on biologics [7]. The later can be partly explained by the fact that such agents (anti-TNFα) reduce the cytokine activation taking place after the inflammatory response to vaccination and therefore patients experience less AEs [3].…”

“…This applies both to mild and severe AEs or AEs of special interest, both topical and systemic. However, in certain reports, biologic agents in general or anti-TNFα agents in particular turned out to be either risk [10] or protective factors [7] for AE occurrence. Young age, female gender, vaccine type and prior COVID infection have all been associated with AEs in healthy controls as well as in the IBD subpopulation [7,10].…”

“…However, in certain reports, biologic agents in general or anti-TNFα agents in particular turned out to be either risk [10] or protective factors [7] for AE occurrence. Young age, female gender, vaccine type and prior COVID infection have all been associated with AEs in healthy controls as well as in the IBD subpopulation [7,10]. Regarding a possible impact of vaccines on disease activity, no correlation has been found as assessed by steroid need or changes in clinical disease activity scores [8,9].…”

Safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease: A systematic review and meta-analysis

“…Eventually, 9 studies (8 full texts and one abstract) with 16 cohorts were included in the final analysis. The details of the included studies are illustrated in Table 1 [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] . The details of the excluded studies with the reason for exclusion is shown in Supplementary Table 2 [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] .…”