PMID- 35755075
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231102
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 9
DP  - 2022
TI  - 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.
PG  - 881027
LID - 10.3389/fmed.2022.881027 [doi]
LID - 881027
AB  - 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.
CI  - Copyright (c) 2022 Shehab, Alrashed, Abdullah, Alfadhli, Ali, Abu-Farha, 
      Channanath, Abubaker and Al-Mulla.
FAU - Shehab, Mohammad
AU  - Shehab M
AD  - Division of Gastroenterology, Department of Internal Medicine, Mubarak Alkabeer 
      University Hospital, Kuwait University, Jabriya, Kuwait.
FAU - Alrashed, Fatema
AU  - Alrashed F
AD  - Department of Pharmacy Practice, Faculty of Pharmacy, Health Sciences Center 
      (HSC), Kuwait University, Jabriya, Kuwait.
FAU - Abdullah, Israa
AU  - Abdullah I
AD  - Clinical Pharmacy Unit, Department of Pharmacy, Kuwait Hospital, Sabah Al-Salem, 
      Kuwait.
FAU - Alfadhli, Ahmad
AU  - Alfadhli A
AD  - Division of Gastroenterology, Department of Internal Medicine, Mubarak Alkabeer 
      University Hospital, Kuwait University, Jabriya, Kuwait.
FAU - Ali, Hamad
AU  - Ali H
AD  - Department of Genetics and Bioinformatics, Dasman Diabetes Institute (DDI), 
      Kuwait City, Kuwait.
AD  - Department of Medical Laboratory Sciences, Faculty of Allied Health Sciences, 
      Health Sciences Center (HSC), Kuwait University, Kuwait City, Kuwait.
FAU - Abu-Farha, Mohamed
AU  - Abu-Farha M
AD  - Department of Biochemistry and Molecular Biology, Dasman Diabetes Institute 
      (DDI), Kuwait City, Kuwait.
FAU - Channanath, Arshad Mohamed
AU  - Channanath AM
AD  - Department of Biochemistry and Molecular Biology, Dasman Diabetes Institute 
      (DDI), Kuwait City, Kuwait.
FAU - Abubaker, Jehad Ahmed
AU  - Abubaker JA
AD  - Department of Biochemistry and Molecular Biology, Dasman Diabetes Institute 
      (DDI), Kuwait City, Kuwait.
FAU - Al-Mulla, Fahd
AU  - Al-Mulla F
AD  - Department of Biochemistry and Molecular Biology, Dasman Diabetes Institute 
      (DDI), Kuwait City, Kuwait.
LA  - eng
PT  - Journal Article
DEP - 20220608
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC9215310
OTO - NOTNLM
OT  - COVID-19
OT  - IBD
OT  - safety
OT  - symptoms
OT  - vaccine
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/06/28 06:00
MHDA- 2022/06/28 06:01
PMCR- 2022/06/08
CRDT- 2022/06/27 03:45
PHST- 2022/02/22 00:00 [received]
PHST- 2022/05/03 00:00 [accepted]
PHST- 2022/06/27 03:45 [entrez]
PHST- 2022/06/28 06:00 [pubmed]
PHST- 2022/06/28 06:01 [medline]
PHST- 2022/06/08 00:00 [pmc-release]
AID - 10.3389/fmed.2022.881027 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2022 Jun 8;9:881027. doi: 10.3389/fmed.2022.881027. 
      eCollection 2022.