BNT162b2 mRNA COVID-19 vaccine is safe in a setting of patients on biologic therapy with inflammatory bowel diseases: a monocentric real-life study

ABSTRACT

Objectives

Patients with inflammatory bowel disease were excluded from trials that led to the approval of anti-COVID-19 vaccines and are worthy of real-life studies providing information on the safety of these vaccines in this clinical setting.

Methods

A prospective observational study was performed to estimate BNT162b2 mRNA COVID-19 Vaccine local and systemic adverse events (AEs) incidence related to administration in patients with inflammatory bowel disease through a questionnaire administered at the first, second, and third doses. Disease activity by Mayo Partial Score and Harvey-Bradshaw Index was also evaluated.

Results

Eighty patients with a median age of 47.5 years were initially enrolled. The local AEs rate was 26.25%, 58.75%, and 28.37% at the first, second, and third doses of the vaccine, respectively. In contrast, the systemic AEs rate was 52.2%, 48.75%, and 43.24%. Clinic-demographic predictor variables for AEs were not identified. Vaccination did not affect disease activity and no statistically significant difference in disease activity index scores was observed between the three doses. No serious adverse events were observed.

Conclusion

This vaccine was safe in a population of patients with inflammatory bowel disease and, therefore, could be safely administered in this clinical setting.

KEYWORDS:

• BNT162b2
• COVID-19
• crohn’s disease
• IBD
• safety
• SARS-Cov-2
• ulcerative colitis
• vaccine

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

R Pellegrino and AG Gravina contributed equally to the study conceptualization and execution as well as to the analysis and interpretation of the data and the writing of the draft and final version of the article. R Pellegrino, G Pellino, F Selvaggi, A Federico, M Romano, and AG Gravina contributed to data acquisition and data interpretation as well as in the writing of the article. All authors reviewed the intellectual content of the work and approved the final version.

Data availability statement

The data that support the findings of this study are available from the corresponding author, AGG, upon reasonable request.