Abstract
Since inflammatory bowel disease (IBD) patients were excluded from vaccine authorization studies, limited knowledge exists regarding perceptions and unfavorable effects of COVID-19 vaccination in this group. We aimed to investigate the real-world use and adverse events (AEs) of COVID-19 vaccines in Greek IBD patients. Fully vaccinated IBD patients followed in Greek centers were invited to participate. All patients filled out an anonymous online survey concerning the vaccination program, which included information regarding demographics, clinical characteristics, treatment, vaccination perceptions and potential AEs. Overall, 1007 IBD patients were included. Vaccine hesitancy was reported by 49%. Total AEs to vaccination were reported by 81% after dose 1 (D1) and 76% after dose 2 (D2), including isolated injection site reactions (36% and 24% respectively). Systemic AEs were more common after D2 (51%, D2 vs. 44%, D1, p < 0.0001). Very few patients reported new onset abdominal symptoms (abdominal pain 4% (D1), 6% (D2) and diarrhea 5% (D1), 7% (D2)). There were no serious AEs leading to emergency room visit or hospitalization. In multivariate analysis, AEs occurrence was positively associated with young age and female gender (p < 0.0005 for both doses), whereas inactive disease was negatively associated with AE in D1 (p = 0.044). SARS-CoV-2 vaccination in Greek IBD patients demonstrated a favorable and reassuring safety profile.
Highlights
The severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) was first reported at Wuhan, China in late 2019
A total of 1128 inflammatory bowel disease (IBD) patients responded to the online survey
This study aimed at reporting the experience on the acceptance and safety of vaccines against COVID-19 in IBD patients
Summary
The severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) was first reported at Wuhan, China in late 2019. It became apparent that it was a highly contagious virus spreading rapidly, alerting the majority of health authorities worldwide. The World Health Organization declared the coronavirus associated disease (COVID-19) a pandemic in March 2020. COVID-19 is characterized by severe illness and high mortality, which has raised concerns in the medical community and accelerated vaccination procedures, as the only effective and rapid intervention with which to confront the pandemic. Since December 2020, when vaccines against COVID-19 became available, a growing number of doses have been administered worldwide. Four vaccines against COVID-19 have received emergency use authorization (EUA) in Europe. They have been manufactured either with the mRNA or the viral vector vaccine technologies that are theoretically safe for immunosuppressed patients
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