Safety of COVID-19 Vaccination in Inflammatory Bowel Disease Patients on Biologic Therapy.

We read with great interest the manuscript by Wellens et al. reviewing the evidence on SARS-CoV-2 vaccination in patients with inflammatory bowel disease [IBD].[1] The authors highlight that IBD patients should receive vaccination against SARS-CoV-2. In fact, the International Organization for the Study of IBD has already recommended vaccinating all patients with IBD as soon as they are able to receive the vaccine, regardless of immune-modifying therapies or disease activity.[2]

Nevertheless, some articles have shown that a large percentage of IBD patients are unwilling to receive the COVID-19 vaccine due to fear of potential adverse events [AEs].[3,4] Moreover, individuals with IBD were excluded from safety and efficacy phase III vaccine trials, as well as those being treated with immunosuppressive therapies.

Thus, we performed a monocentric real-life survey to assess AEs of COVID-19 vaccination among IBD patients. All adult individuals with IBD undergoing biological treatment and followed at Centro Hospitalar Universitário de São João were included. Each patient answered a telephone questionnaire conducted by a gastroenterologist.

A total of 301 patients agreed to participate in the study, the majority being females [53.2%], with a median age of 42 years [interquartile range 32–54 years]. IBD diagnosis included Crohn’s disease [76.7%] and ulcerative colitis [23.3%]. The proportions of patients receiving tumour necrosis factor inhibitors, ustekinumab and vedolizumab were 75.4%, 13.0% and 11.6%, respectively.

This cohort included 239 vaccinated patients [59.0% Pfizer-BioNTech, 20.5% Moderna, 14.2% Janssen and 6.3% AstraZeneca], 173 [57.5%] of whom had complete vaccination. Of the remaining individuals, only 12 did not intend to be vaccinated. The main reasons were: fear of potential AEs [50.0%], lack of confidence in the vaccine development process [25.0%] and little information about vaccination in IBD patients [16.6%].

Among vaccinated patients, the overall AE frequency was 56.8% after dose 1 [D1] and 74.1% after dose 2 [D2]. The two most common symptoms were localized injection-site reactions and fatigue. The vast majority of AEs were mild and lasted only a few days. Only four [1.7%] patients had IBD exacerbation after the vaccine. No serious AEs were reported and no patient was hospitalized. The percentage of AEs was higher among patients younger than 50 years [77.6% vs 62.5% after D1, p = 0.011; 83.0% vs 58.8% after D2, p = 0.002]. No significant differences were seen based on sex, vaccine type, biologic drug or disease type. Compared to the general population, a lower percentage of IBD patients suffered from local or systemic reactions during the first week after vaccination [Figure 1].[5]

Figure 1.

Adverse reactions occurring within 7 days after vaccination in IBD patients compared with the general population.[5].

In conclusion, we found a high acceptance rate and a good safety profile of SARS-CoV-2 vaccination in IBD patients treated with biologics. Indeed, AEs were common but overall mild and transitory. These data support the prioritization and rapid vaccination of these individuals.