British Society of Gastroenterology Inflammatory Bowel Disease Section and IBD Clinical Research Group position statement on SARS-CoV2 Vaccination
The Inflammatory Bowel Disease (IBD) Section of the BSG and the IBD Clinical Research Group have agreed the following key recommendations:
RECOMMENDATION 1: We strongly support SARS-CoV2 vaccination for patients with IBD.
RECOMMENDATION 2: The risks of SARS-CoV2 vaccination in IBD patients are anticipated to be very low.
RECOMMENDATION 3: In IBD patients taking immunosuppressive drugs, including biologics and small molecule inhibitors, the key concerns are related to the theoretical risk of sub-optimal vaccine responses rather than vaccine side effects.
RECOMMENDATION 4: We recommend that IBD patients accept whichever approved SARS-CoV2 vaccination is offered to them, in accordance with UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA)
RECOMMENDATION 5: It is important that patients with IBD are offered consistent and unbiased advice. This will be disseminated through the BSG and Crohn’s & Colitis UK.
Position Statement Review
On 30/12/2020, the Oxford/AstraZeneca ChAdOx1 nCoV-19 vaccine was given MHRA approval for deployment in the UK. It is anticipated that other vaccines may receive approval in the coming weeks and guidance may change accordingly. Consequently, this Position Statement will be reviewed frequently. The next date for review is 6th January 2021.
- The COVID-19 pandemic has caused significant mortality across the globe, with wide-ranging impacts across all sectors of society.
- Patients with IBD may have increased susceptibility to infectious diseases.
- The introduction of SARS-CoV2 vaccines is the first opportunity to suppress the virus over the long term and to protect individual patients from COVID-19.
- Several SARS-CoV2 vaccines are in advanced clinical development, and currently there are three that are approved/awaiting approval in the UK (see table 1). It is likely that additional vaccines will become available in the future.
- The BNT162b2 vaccine (Pfizer/BioNTech)1 and the ChAdOx1 nCoV-19 (Oxford/AstraZeneca)2 have been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency under Regulation 174 of the Human Medicine Regulations 2012a,b,c.
- The mRNA-1273 (Moderna)3 vaccine is currently under review by the MHRA and an authorisation decision is imminently anticipated.
Table 1: Overview of SARS-CoV2 vaccines
|Dosing schedule||2 doses, between 3 weeks and 12 weeks apart||2 doses, between 4 weeks and 12 weeks apart||2 doses, between 4 weeks and 12 weeks apart|
|Mechanism||mRNA encoding a genetically modified SARS-CoV2 spike protein||mRNA encoding a genetically modified SARS-CoV2 spike protein||Non-replicating adenovirus vector, containing SARS-CoV-2 spike protein
|Storage (long term)||-80°C to -60°C||-20°C||+2°C to +8°C|
|Safety||No serious concerns. Two anaphylactoid reactions since MHRA approval and roll-out.||No serious concerns||No serious concerns|
*pooled data from two trials – 62% efficacy in one study and 90% in another study in which first vaccination was given at half dose.
The full position statement is available to download below.
Position statement developed by:
James L. Alexander1,2, Gordon Moran3, Daniel R. Gaya4,5, Tim Raine6, Ailsa Hart1,7, Nicholas A. Kennedy8,9, James O. Lindsay10,11, Jonathan MacDonald12, Jonathan P. Segal1,13, Shaji Sebastian14, Christian Selinger15, Miles Parkes6, Phillip J. Smith16, Anjan Dhar17, Sreedhar Subramanian18, Ramesh Arasaradnam19, Christopher A. Lamb20,21, Tariq Ahmad8,9, Charlie Lees22,23, Liz Dobson24, Ruth Wakeman25, Ian Arnott23, Nick Powell1,2 on behalf of the IBD section of the British Society of Gastroenterology and the CRG.
- Imperial College London, London, UK
- Imperial College Healthcare NHS Trust, London, UK
- University of Nottingham, Nottingham, UK
- Glasgow Royal Infirmary, Glasgow, UK
- University of Glasgow, Glasgow, UK
- Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
- St Mark’s Hospital, London, UK
- Royal Devon and Exeter NHS Foundation Trust, Exeter, UK
- University of Exeter, Exeter, UK
- Barts and the London School of Medicine and Dentistry, London, UK
- The Royal London Hospital, Barts Health NHS Trust, London, UK
- Queen Elizabeth University Hospital, Glasgow, UK
- The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK
- Hull University Teaching Hospitals NHS Trust, Hull, UK
- Leeds Teaching Hospitals NHS Trust, Leeds, UK
- Liverpool University Hospitals NHS Foundation Trusts, Liverpool, UK
- County Durham & Darlington NHS Foundation Trust, Durham, UK
- The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
- University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK
- Newcastle University, Newcastle upon Tyne, UK
- Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
- University of Edinburgh, Edinburgh, UK
- Western General Hospital, Edinburgh, UK
- IBD Registry Limited, London, UK
- Crohn’s & Colitis UK, Hatfield, UK