Impact of BNT162b2 mRNA Vaccination on the Development of Short and Long-Term Vaccine-Related Adverse Events in Inflammatory Bowel Disease: A Multi-Center Prospective Study

Mohammad Shehab; Fatema Alrashed; Israa Abdullah; Ahmad Alfadhli; Hamad Ali; Mohamed Abu-Farha; Arshad Mohamed Channanath; Jehad Ahmed Abubaker; Fahd Al-Mulla

doi:10.3389/fmed.2022.881027

Impact of BNT162b2 mRNA Vaccination on the Development of Short and Long-Term Vaccine-Related Adverse Events in Inflammatory Bowel Disease: A Multi-Center Prospective Study

Front Med (Lausanne). 2022 Jun 8:9:881027. doi: 10.3389/fmed.2022.881027. eCollection 2022.

Authors

Mohammad Shehab¹, Fatema Alrashed², Israa Abdullah³, Ahmad Alfadhli¹, Hamad Ali^{4

5}, Mohamed Abu-Farha⁶, Arshad Mohamed Channanath⁶, Jehad Ahmed Abubaker⁶, Fahd Al-Mulla⁶

Affiliations

¹ Division of Gastroenterology, Department of Internal Medicine, Mubarak Alkabeer University Hospital, Kuwait University, Jabriya, Kuwait.
² Department of Pharmacy Practice, Faculty of Pharmacy, Health Sciences Center (HSC), Kuwait University, Jabriya, Kuwait.
³ Clinical Pharmacy Unit, Department of Pharmacy, Kuwait Hospital, Sabah Al-Salem, Kuwait.
⁴ Department of Genetics and Bioinformatics, Dasman Diabetes Institute (DDI), Kuwait City, Kuwait.
⁵ Department of Medical Laboratory Sciences, Faculty of Allied Health Sciences, Health Sciences Center (HSC), Kuwait University, Kuwait City, Kuwait.
⁶ Department of Biochemistry and Molecular Biology, Dasman Diabetes Institute (DDI), Kuwait City, Kuwait.

Abstract

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has been effective in protecting against severe COVID-19 infections and related mortality. It is recommended for all individuals including patients with inflammatory bowel disease (IBD). However, safety data are lacking in this group of patients. Therefore, we aim to evaluate the short- and long-term vaccine related adverse events (AEs) in patients with IBD.

Methods: This is a prospective, observational cohort study investigating short- and long-term AEs related to the BNT162b2 vaccine in patients with IBD (study group) after the first and second dose compared to healthy participants (control group). Patients were recruited at the time of attendance to the clinic or infusion rooms. Short term (<3 weeks) localized and systemic AEs were assessed via questionnaire. Follow-up phone-based survey was made to collect data on long term (up to 24 weeks) AEs.

Results: A total of 408 patients answered the questionnaires, 204 patients in each group, the study and control group. No serious adverse events were reported in either the study or the control group after the first or the second dose. Participants in the control group reported more frequent pain at the injection site than those in the study group after the first dose [58 (57%) vs. 38 (37%) respectively, P = 0.005]. After the second dose, tiredness was reported more frequently in the control group [49 (48%)] compared to the study group [25 (24%) (P < 0.001)]. At 20-24 weeks post vaccination, 386 out of 408 (94.6%) patients were willing to participate in the follow-up phone based questionnaire [196 (96.1%) in the study group vs. 190 (93.1%) in the control group]. In both groups, none of the patients reported local, systemic, or severe adverse events (0 out of 386) at week 20-24 post second dose.

Conclusion: The BNT162b2 vaccine is safe in patients with IBD. No severe or long-term adverse events were reported in our study. The frequency of local and systemic adverse events after the second dose was generally higher among healthy participants compared to patients with IBD. Further studies including a larger cohort with a longer follow-up duration are needed to assess for possible rare adverse events.

Keywords: COVID-19; IBD; safety; symptoms; vaccine.