Safety, Efficacy of COVID-19 Vaccine in IBD

Investigators performed a retrospective analysis to compare COVID-19 vaccine outcomes in patients with IBD against those without.

Among patients with inflammatory bowel disease (IBD), the benefits of COVID-19 vaccination may outweigh the minimal risks, even for patients with IBD using immunosuppressive medications, according to research results published in Gastroenterology.

While large clinical trials have been conducted to assess the efficacy and safety of the current messenger ribonucleic acid (mRNA) COVID-19 vaccines (namely, Pfizer-BioNTech and Moderna) there is still insufficient data surrounding clinical outcomes in patients with IBD, especially those on biologic therapies.

To better understand the effectiveness of COVID-19 vaccines in patients with IBD, a team of investigators conducted a retrospective analysis of patients with Crohn disease or ulcerative colitis who were administered the COVID-19 vaccine and compared the outcomes against individuals without IBD who received COVID-19 vaccination.

The researchers compared safety outcomes up to 30-days following any dose of COVID-19 vaccination, 30-day all cause hospitalization rates, and efficacy (new COVID-19 diagnosis any time after vaccination) between IBD and non-IBD groups. A subgroup analysis was also conducted based on type of IBD (Crohn disease vs ulcerative colitis) and medications used (biologics and/or immunomodulators).

A total of 5562 patients (mean age, 57.3 years; 59.67% women) with a previous diagnosis of IBD who received COVID-19 vaccinations were included in the analysis; 2933 patients had ulcerative colitis and 2629 patients had Crohn disease. Prior to vaccination, 52.84% of patients were on biologics or thiopurines. Of the patients with IBD, 1822 people were administered 1 vaccine dose and 3740 people were administered 2 doses. Although vaccine manufacturer data was unavailable for some, 3104 patients were administered the Pfizer vaccine and 762 patients were administered the Moderna vaccine.

Ten or fewer patients with IBD were reported to have immediate reactions upon vaccination. A total of 113 (2.03%) patients with IBD and 6992 (0.81%) participants without IBD developed Centers for Disease Control and Prevention (CDC)-reported adverse events of special interest (risk ratio [RR], 2.50). Following vaccination, 19 (0.36%) patients with IBD and 2277 (0.28%) participants without IBD were diagnosed with COVID-19 (RR, 1.3).

Upon 1:1 propensity score matching of IBD and non-IBD cohorts, there were no significant differences in adverse events of special interest (RR, 1.15), new diagnosis of COVID-19 (RR, 0.95), or 30-day hospitalization (RR, 1.49) between both groups. Steroid prescription rates were also not significantly different between the 2 groups.

Results of the subgroup analysis did not reveal any significant differences in 30-day adverse events of special interest in patients with IBD who used or did not use biologic and/or immunomodulators (RR, 1.32) or between patients with Crohn disease vs ulcerative colitis (RR, 1.04). Steroid use between these patient groups was also not significantly different.

“We found that the incidence of COVID-19 in IBD patients after vaccination is very low, including patients on immunosuppressive agents, and is similar to non-IBD population,” the authors noted. “Further studies including a larger cohort with longer follow-up duration are needed.”

“Our study findings are reassuring and support the continued use of these vaccines in patients with IBD,” concluded the researchers.


Hadi YB, Thakkar S, Shah-Khan SM, Hutson W, Sarwari A, Singh S. COVID-19 vaccination is safe and effective in patients with inflammatory bowel disease: analysis of a large multi-institutional research network in United States. Gastroenterol. Published online June 15, 2021. doi:10.1053/j.gastro.2021.06.014

This article originally appeared on Gastroenterology Advisor