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Lack of inflammatory bowel disease flare-up following two-dose BNT162b2 vaccine: a population-based cohort study
  1. Xue Li1,2,3,
  2. Xinning Tong1,
  3. Ian Chi Kei Wong2,3,4,5,
  4. Kuan Peng2,
  5. Celine Sze Ling Chui6,7,
  6. Francisco Tsz Tsun Lai2,3,
  7. Eric Yuk Fai Wan2,3,8,
  8. Carlos King Ho Wong2,3,8,
  9. Wai Keung Leung1,
  10. Esther Wai Yin Chan2,3,9,10
  1. 1 Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China
  2. 2 Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China
  3. 3 Laboratory of Data Discovery for Health Limited (D²4H), Hong Kong Science Park, Hong Kong Special Administrative Region, People's Republic of China
  4. 4 Research Department of Practice and Policy, School of Pharmacy, University College London, London, UK
  5. 5 Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation, Department of Health, The Government of the Hong Kong Special Administrative Region, Hong Kong Special Administrative Region, People's Republic of China
  6. 6 School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China
  7. 7 School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China
  8. 8 Department of Family Medicine and Primary Care, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China
  9. 9 HKU-Shenzhen Hospital, Shenzhen, People's Republic of China
  10. 10 HKU-Shenzhen Institute of Research and Innovation, Shenzhen, People's Republic of China
  1. Correspondence to Dr Esther Wai Yin Chan, Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, People's Republic of China; ewchan{at}hku.hk

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We read with interest the recent paper by Cannatelli et al 1 describing the adverse events (AEs) following COVID-19 vaccination from a large inflammatory bowel disease (IBD) cohort, which showed that patients with IBD had a similar rate of reported AEs to the general population but with a slightly higher rate of self-limiting gastrointestinal symptoms. However, the effects of COVID-19 vaccine on IBD activity, particularly severe flare resulting in hospitalisation and the interplay with the use of immunotherapy remain unknown. To address these questions, we analysed the territory-wide electronic medical records with vaccination linkage database in Hong Kong2–7 to examine the association between BNT162b2 vaccination and IBD flare.

From 4 161 762 patient records with affirmed vaccination status between 6 March 2021 and 30 September 2021, we identified 941 patients with IBD with two completed doses of BNT162b2, and 1196 unvaccinated IBD controls (online supplemental figure 1). Vaccine recipients were younger and less likely to have pre-existing chronic diseases. Approximately half of these patients with IBD received immunosuppressants and more than 20% were treated with biologics in the recent year. After inverse propensity treatment weighting, all variables were well balanced between vaccinated and unvaccinated groups (online supplemental table 1).

Supplemental material

[gutjnl-2021-326860supp001.pdf]

During a median follow-up of 60 days among two-dose BNT162b2 recipients, six patients (onset time: 24 –103 days) had unplanned hospitalisation due to IBD (mean hospitalisation duration: 5.3±3.5 days). The number of unplanned IBD-related admissions in the unvaccinated group was 13 with a median follow-up of 69 days. Two-dose BNT162b2 vaccine was not associated with unplanned IBD hospitalisation (adjusted incidence rate ratio (aIRR): 0.69, 95% CI 0.35 to 1.36), all-cause hospitalisation (aIRR: 0.86, 95% …

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Footnotes

  • WKL and EWYC are joint senior authors.

  • XL and XT are joint first authors.

  • Twitter @CarlosWongHKU

  • XL and XT contributed equally.

  • Correction notice This article has been corrected since it published Online First. Reference 7 has been corrected.

  • Contributors Study concept and design: XL, WKL and EWC. Funding and data acquisition: IW. Data extractions, cleaning and analysis: XT. Data validation and cross-check: KP. Data interpretation: all authors. Drafting of the manuscript: XL and XT. Critical revision of the manuscript of significant intellectual contribution: all authors. Study supervision: IW, EWC and WKL.

  • Funding The project was funded by Research Grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (Ref. No.COVID19F01). FTTL (Francisco Tsz Tsun Lai) and ICKW (Ian Chi Kei Wong)’s posts were partly funded by D24H; hence this work was partly supported by AIR@InnoHK administered by Innovation and Technology Commission.

  • Competing interests XL received research grants from Research Fund Secretariat of the Food and Health Bureau (HMRF, HKSAR), Research Grants Council Early Career Scheme (RGC/ECS, HKSAR), Janssen and Pfizer; internal funding from the University of Hong Kong; consultancy fee from Merck Sharp & Dohme, unrelated to this work. IW reports research funding outside the submitted work from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK Novartis, the Hong Kong RGC, and the Hong Kong Health and Medical Research Fund, National Institute for Health Research in England, European Commission, National Health and Medical Research Council in Australia, and also received speaker fees from Janssen and Medice in the previous 3 years. He is also an independent non-executive director of Jacobson Medical in Hong Kong. CC has received grants from the Food and Health Bureau of the Hong Kong Government, Hong Kong Research Grant Council, Hong Kong Innovation and Technology Commission, Pfizer, IQVIA and Amgen; personal fee from Primevigilance; outside the submitted work. FTTL has been supported by the RGC Postdoctoral Fellowship under the Hong Kong Research Grants Council, and has received research grants from the Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, outside the submitted work. EYFW has received research grants from the Food and Health Bureau of the Government of the Hong Kong SAR, and the Hong Kong Research Grant Council, outside the submitted work. CKHW reports the receipt of General Research Fund, Research Grant Council, Government of Hong Kong SAR; EuroQol Research Foundation, all outside the submitted work. EWC reports honorarium from Hospital Authority, supports from the Health and Medical Research Fund (HMRF), grants from Research Grants Council (RGC, Hong Kong), grants from National Natural Science Fund of China, grants from Wellcome Trust, grants from Bayer, grants from Bristol-Myers Squibb, grants from Pfizer, grants from Janssen, grants from Amgen, grants from Takeda, grants from Narcotics Division of the Security Bureau of HKSAR, grants from Innovation and Technology Commission of the Government of the HKSAR, all outside the submitted work.

  • Patient and public involvement statement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data will not be available for others as the data custodians have not given permission.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.