Shehab Mohammad, Alrashed Fatema, Abdullah Israa, Alfadhli Ahmad, Ali Hamad, Abu-Farha Mohamed, Channanath Arshad Mohamed, Abubaker Jehad Ahmed, Al-Mulla Fahd
Division of Gastroenterology, Department of Internal Medicine, Mubarak Alkabeer University Hospital, Kuwait University, Jabriya, Kuwait.
Department of Pharmacy Practice, Faculty of Pharmacy, Health Sciences Center (HSC), Kuwait University, Jabriya, Kuwait.
Front Med (Lausanne). 2022 Jun 8;9:881027. doi: 10.3389/fmed.2022.881027. eCollection 2022.
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.
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 questionnaire. Follow-up phone-based survey was made to collect data on long term (up to 24 weeks) AEs.
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, = 0.005]. After the second dose, tiredness was reported more frequently in the control group [49 (48%)] compared to the study group [25 (24%) ( < 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.
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.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗接种已有效预防严重的2019冠状病毒病（COVID-19）感染及相关死亡。建议所有个体包括炎症性肠病（IBD）患者接种。然而，这组患者缺乏安全性数据。因此，我们旨在评估IBD患者与疫苗相关的短期和长期不良事件（AE）。
这是一项前瞻性观察性队列研究，调查IBD患者（研究组）与BNT162b2疫苗相关的短期和长期AE，在接种第一剂和第二剂疫苗后与健康参与者（对照组）进行比较。患者在就诊于诊所或输液室时被招募。通过问卷调查评估短期（<3周）局部和全身AE。通过电话随访调查收集长期（长达24周）AE的数据。
共有408名患者回答了问卷，研究组和对照组各204名患者。在接种第一剂或第二剂疫苗后，研究组和对照组均未报告严重不良事件。对照组参与者在接种第一剂疫苗后报告注射部位疼痛的频率高于研究组[分别为58例（57%）和38例（37%），P = 0.005]。接种第二剂疫苗后，对照组报告疲劳的频率高于研究组[49例（48%）对25例（24%），P < 0.001]。在接种疫苗后20 - 24周，408名患者中有386名（94.6%）愿意参与基于电话的随访问卷[研究组196名（96.1%），对照组190名（93.1%）]。在两组中，在接种第二剂疫苗后第20 - 24周，没有患者报告局部、全身或严重不良事件（386例中0例）。
BNT162b2疫苗在IBD患者中是安全的。在我们的研究中未报告严重或长期不良事件。与IBD患者相比，健康参与者在接种第二剂疫苗后局部和全身不良事件的发生率通常更高。需要进一步开展包括更大队列和更长随访时间的研究，以评估可能的罕见不良事件。
