Key points are not available for this paper at this time.
BACKGROUND The COVID-19 pandemic has claimed the lives of nearly 2 million people worldwide. Following rapid sequencing of SARSCoV-2, pharmaceutical companies and academic institutions rapidly generated vaccine candidates on the back of a variety of both established and novel vaccine platforms. Vaccines accelerated at unprecedented pace to phase 3 development, and in December 2020, two mRNA vaccines and one inactivated vaccine were authorised for use in a number of countries. Additional vaccine platforms and candidates are in late stages of phase 3 testing. Prioritisation of vaccine access is generally determined by regional health authorities on the basis of risk of SARSCoV-2 exposure and risk of developing complications from COVID-19 in order to equitably protect and promote global public wellbeing. IBD, including Crohn’s disease and ulcerative colitis, are characterised by chronic intestinal inflammation due to immune dysregulation. IBD is often treated with immunemodifying therapies including corticosteroids, immunomodulators, biologic agents including monoclonal antibody inhibitors of tumour necrosis factor (TNF) alpha, interleukin 12/23, integrins and small molecules such as Janus kinase (JAK) inhibitors. Prior studies have evaluated the safety and effectiveness of various vaccines in patients with IBD, with specific focus on the impact of immunemodifying therapies on serologic responses. In general, nonlive vaccines are considered safe in patients with IBD regardless of IBD therapy, although those on specific types of immunemodifying treatments at the time of vaccination may have reduced vaccine immune responses. In spite of decreased efficacy associated with immunemodifying medication, most vaccines are broadly recommended for those with IBD. Patients with immune conditions (including IBD) were excluded from the SARSCoV-2 vaccine clinical development programmes, and novel vaccine platforms not previously studied in IBD populations are now authorised in many countries. Therefore, many questions regarding the safety and effectiveness of SARSCoV-2 vaccination in patients with IBD have emerged with urgent clinical relevance. The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) is a global organisation of clinician researchers dedicated to the study and management of IBD. There are currently 60 active members and 32 senior members of IOIBD representing 27 countries. In March 2020, IOIBD rapidly developed recommendations for the clinical management of patients with IBD during the COVID-19 pandemic. Now that vaccinations are available, this group reconvened to develop specific recommendations pertaining to the use of SARSCoV-2 vaccines in IBD populations. METHODS We used the modified Delphi method to develop consensus statements regarding SARSCoV-2 vaccination for patients with IBD. The main characteristics of this technique include expert opinion with anonymous voting on statements, iteration with controlled feedback of group opinion and statistical aggregation of the group response. A consensus meeting was planned for 18 December 2020. The invitees for this meeting included the membership of IOIBD and additional content experts including an IBD specialist with expertise in vaccinations (GM) and a vaccinologist (FK) with expertise in vaccine development and immune responses to vaccines. Prior to this planned meeting, a questionnaire was developed by authors (CS, GM, MD, DM, MA, DR) to include statements in domains that impact clinical decisions around vaccination for the IBD population. The domains included general issues of vaccines and IBD; risk of COVID-19 to patients with IBD and need for SARSCoV-2 vaccination; efficacy and safety of the various SARSCoV-2 vaccines for patients with IBD; timing of when to receive SARSCoV-2 vaccination; the influence of IBD medications on the decision and timing for SARSCoV-2 vaccination and prioritisation of patients with IBD for SARSCoV-2 vaccination. Fortyfour statements were created and participants were asked to respond to each statement on a scale from 1 to 10 (1=do not agree at all and 10=agree completely). A priori rules determined that a statement would be accepted if at least 75% of participants scored the statement between 7 and 10. If a 75% consensus was not achieved, it would be discussed during the live meeting, followed by a second round of voting. Statements that were accepted in the first round but had a SD ≥2 or had a proportion of responses between 75% and 77% were also reviewed and voted on a second time if there was particular concern from the participants. If the second round of voting during the live meeting did not achieve consensus of 75% or higher of the respondents, then the statement was not accepted. The questionnaire was sent electronically using Google Forms (Menlo Park, California, USA) to all voting participants on 11 December 2020. A literature review was provided to the participants prior to the meeting including evidence directly relevant for proposed statements. These included Grading of Recommendations, Assessment, Development and Evaluations Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, DartmouthHitchcock Medical Center, Lebanon, New Hampshire, USA F Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars Sinai Medical Center, Los Angeles, California, USA University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA Department of Cellular and Molecular Physiology, Yale University, New Haven, Connecticut, USA Department of Microbiology, Icahn School of Medicine, Mount Sinai, New York, New York, USA Department of Medicine, Division of Gastroenterology, Crohn’s and Colitis Center, University of Miami Miller School of Medicine, Miami, Florida, USA Department of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, New York, USA
Siegel et al. (Wed,) studied this question.