SARS-CoV-2 vaccination for patients with inflammatory bowel disease: a British Society of Gastroenterology Inflammatory Bowel Disease section and IBD Clinical Research Group position statement

Alexander, James L; Moran, Gordon W; Gaya, Daniel R; Raine, Tim; Hart, Ailsa; Kennedy, Nicholas A.; Lindsay, James O; Macdonald, Jonathan; Segal, Jonathan P.; Sebastian, Shaji; Selinger, Christian P; Parkes, Miles; Smith, Philip J; Dhar, Anjan; Subramanian, Sreedhar; Arasaradnam, Ramesh Pulendran; Lamb, Christopher A; Ahmad, Tariq; Lees, Charlie W.; Dobson, Liz; Wakeman, Ruth; Iqbal, Tariq H; Arnott, Ian; Powell, Nick

doi:10.1016/S2468-1253(21)00024-8

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SARS-CoV-2 vaccination for patients with inflammatory bowel disease: a British Society of Gastroenterology Inflammatory Bowel Disease section and IBD Clinical Research Group position statement

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Author(s): James L Alexander , PhD ^a ^, ^b , Gordon W Moran , PhD ^c , Daniel R Gaya , MD ^d ^, ^e , Tim Raine , PhD ^f , Ailsa Hart , Prof, PhD ^a ^, ^g , Nicholas A Kennedy , PhD ^h ^, ⁱ , James O Lindsay , Prof, PhD ^j ^, ^k , Jonathan MacDonald , BM ^e ^, ^l , Jonathan P Segal , PhD ^a ^, ^m , Shaji Sebastian , Prof, MD ⁿ , Christian P Selinger , MD ^o , Miles Parkes , DM ^f , Philip J Smith , MRCP ^p , Anjan Dhar , Prof, DM ^q , Sreedhar Subramanian , MD ^p , Ramesh Arasaradnam , Prof, PhD ^r , Christopher A Lamb , PhD ^s ^, ^t , Tariq Ahmad , PhD ^h ^, ⁱ , Charlie W Lees , Prof, PhD ^u ^, ^v , Liz Dobson , MSc ^w , Ruth Wakeman , PGDip ^x , Tariq H Iqbal , Prof, MD ^y ^, ^z , Ian Arnott , MD ^v , Nick Powell , PhD ^a ^, ^b ^, ^* , Inflammatory Bowel Disease section of the British Society of Gastroenterology and the the Inflammatory Bowel Disease Clinical Research Group

Publication date (Electronic): 26 January 2021

Journal: The Lancet. Gastroenterology & Hepatology

Publisher: Elsevier Ltd.

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Abstract

SARS-CoV-2 has caused a global health crisis and mass vaccination programmes provide the best opportunity for controlling transmission and protecting populations. Despite the impressive clinical trial results of the BNT162b2 (Pfizer/BioNTech), ChAdOx1 nCoV-19 (Oxford/AstraZeneca), and mRNA-1273 (Moderna) vaccines, important unanswered questions remain, especially in patients with pre-existing conditions. In this position statement endorsed by the British Society of Gastroenterology Inflammatory Bowel Disease (IBD) section and IBD Clinical Research Group, we consider SARS-CoV-2 vaccination strategy in patients with IBD. The risks of SARS-CoV-2 vaccination are anticipated to be very low, and we strongly support SARS-CoV-2 vaccination in patients with IBD. Based on data from previous studies with other vaccines, there are conceptual concerns that protective immune responses to SARS-CoV-2 vaccination may be diminished in some patients with IBD, such as those taking anti-TNF drugs. However, the benefits of vaccination, even in patients treated with anti-TNF drugs, are likely to outweigh these theoretical concerns. Key areas for further research are discussed, including vaccine hesitancy and its effect in the IBD community, the effect of immunosuppression on vaccine efficacy, and the search for predictive biomarkers of vaccine success.

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Most cited references 38

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Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

Chaolin Huang, Yeming Wang, Xingwang Li … (2020)

Summary Background A recent cluster of pneumonia cases in Wuhan, China, was caused by a novel betacoronavirus, the 2019 novel coronavirus (2019-nCoV). We report the epidemiological, clinical, laboratory, and radiological characteristics and treatment and clinical outcomes of these patients. Methods All patients with suspected 2019-nCoV were admitted to a designated hospital in Wuhan. We prospectively collected and analysed data on patients with laboratory-confirmed 2019-nCoV infection by real-time RT-PCR and next-generation sequencing. Data were obtained with standardised data collection forms shared by WHO and the International Severe Acute Respiratory and Emerging Infection Consortium from electronic medical records. Researchers also directly communicated with patients or their families to ascertain epidemiological and symptom data. Outcomes were also compared between patients who had been admitted to the intensive care unit (ICU) and those who had not. Findings By Jan 2, 2020, 41 admitted hospital patients had been identified as having laboratory-confirmed 2019-nCoV infection. Most of the infected patients were men (30 [73%] of 41); less than half had underlying diseases (13 [32%]), including diabetes (eight [20%]), hypertension (six [15%]), and cardiovascular disease (six [15%]). Median age was 49·0 years (IQR 41·0–58·0). 27 (66%) of 41 patients had been exposed to Huanan seafood market. One family cluster was found. Common symptoms at onset of illness were fever (40 [98%] of 41 patients), cough (31 [76%]), and myalgia or fatigue (18 [44%]); less common symptoms were sputum production (11 [28%] of 39), headache (three [8%] of 38), haemoptysis (two [5%] of 39), and diarrhoea (one [3%] of 38). Dyspnoea developed in 22 (55%) of 40 patients (median time from illness onset to dyspnoea 8·0 days [IQR 5·0–13·0]). 26 (63%) of 41 patients had lymphopenia. All 41 patients had pneumonia with abnormal findings on chest CT. Complications included acute respiratory distress syndrome (12 [29%]), RNAaemia (six [15%]), acute cardiac injury (five [12%]) and secondary infection (four [10%]). 13 (32%) patients were admitted to an ICU and six (15%) died. Compared with non-ICU patients, ICU patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα. Interpretation The 2019-nCoV infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. Major gaps in our knowledge of the origin, epidemiology, duration of human transmission, and clinical spectrum of disease need fulfilment by future studies. Funding Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission.

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Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study

Nanshan Chen, Min Zhou, Xuan Dong … (2022)

Summary Background In December, 2019, a pneumonia associated with the 2019 novel coronavirus (2019-nCoV) emerged in Wuhan, China. We aimed to further clarify the epidemiological and clinical characteristics of 2019-nCoV pneumonia. Methods In this retrospective, single-centre study, we included all confirmed cases of 2019-nCoV in Wuhan Jinyintan Hospital from Jan 1 to Jan 20, 2020. Cases were confirmed by real-time RT-PCR and were analysed for epidemiological, demographic, clinical, and radiological features and laboratory data. Outcomes were followed up until Jan 25, 2020. Findings Of the 99 patients with 2019-nCoV pneumonia, 49 (49%) had a history of exposure to the Huanan seafood market. The average age of the patients was 55·5 years (SD 13·1), including 67 men and 32 women. 2019-nCoV was detected in all patients by real-time RT-PCR. 50 (51%) patients had chronic diseases. Patients had clinical manifestations of fever (82 [83%] patients), cough (81 [82%] patients), shortness of breath (31 [31%] patients), muscle ache (11 [11%] patients), confusion (nine [9%] patients), headache (eight [8%] patients), sore throat (five [5%] patients), rhinorrhoea (four [4%] patients), chest pain (two [2%] patients), diarrhoea (two [2%] patients), and nausea and vomiting (one [1%] patient). According to imaging examination, 74 (75%) patients showed bilateral pneumonia, 14 (14%) patients showed multiple mottling and ground-glass opacity, and one (1%) patient had pneumothorax. 17 (17%) patients developed acute respiratory distress syndrome and, among them, 11 (11%) patients worsened in a short period of time and died of multiple organ failure. Interpretation The 2019-nCoV infection was of clustering onset, is more likely to affect older males with comorbidities, and can result in severe and even fatal respiratory diseases such as acute respiratory distress syndrome. In general, characteristics of patients who died were in line with the MuLBSTA score, an early warning model for predicting mortality in viral pneumonia. Further investigation is needed to explore the applicability of the MuLBSTA score in predicting the risk of mortality in 2019-nCoV infection. Funding National Key R&D Program of China.

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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Author and article information

Journal

Journal ID (nlm-ta): Lancet Gastroenterol Hepatol

Journal ID (iso-abbrev): Lancet Gastroenterol Hepatol

Title: The Lancet. Gastroenterology & Hepatology

Publisher: Elsevier Ltd.

ISSN (Electronic): 2468-1253

Publication date PMC-release: 26 January 2021

Publication date (Electronic): 26 January 2021

Affiliations

[a ]Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK

[b ]Department of Gastroenterology, Imperial College Healthcare NHS Trust, London, UK

[c ]NIHR Nottingham Biomedical Research Centre at Nottingham University Hospitals and The University of Nottingham, Nottingham, UK

[d ]Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK

[e ]Department of Medicine, University of Glasgow, Glasgow, UK

[f ]Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK

[g ]Department of Gastroenterology, St Mark's Hospital, London, UK

[h ]Department of Gastroenterology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK

[i ]Exeter Inflammatory Bowel Disease and Pharmacogenetics Research Group University of Exeter, Exeter, UK

[j ]Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK

[k ]Department of Gastroenterology, The Royal London Hospital, Barts Health NHS Trust, London, UK

[l ]Department of Gastroenterology, Queen Elizabeth University Hospital, Glasgow, UK

[m ]Department of Gastroenterology, The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK

[n ]IBD Unit, Hull University Teaching Hospitals NHS Trust, Hull, UK

[o ]Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UK

[p ]Department of Gastroenterology, Liverpool University Hospitals NHS Foundation Trusts, Liverpool, UK

[q ]Department of Gastroenterology, County Durham & Darlington NHS Foundation Trust, Durham, UK

[r ]Department of Gastroenterology, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK

[s ]Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK

[t ]Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

[u ]Institute of Genetic and Molecular Medicine, University of Edinburgh, Edinburgh, UK

[v ]Department of Gastroenterology, Western General Hospital, Edinburgh, UK

[w ]IBD Registry Limited, London, UK

[x ]Crohn's & Colitis UK, Hatfield, UK

[y ]Institute of Translational Medicine, University of Birmingham, Birmingham, UK

[z ]Department of Gastroenterology, University Hospitals Birmingham, Birmingham, UK

Author notes

[* ]Correspondence to: Dr Nick Powell, 10th Floor Commonwealth Building, Hammersmith Hospital Campus, Imperial College London, Du Cane Road, London W12 0NN, UK

[†]

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Publisher Item ID: S2468-1253(21)00024-8

DOI: 10.1016/S2468-1253(21)00024-8

PMC ID: 7834976

PubMed ID: 33508241

SO-VID: 71782d74-36c2-48a2-b69d-537751c19279

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Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

SARS-CoV-2 vaccination for patients with inflammatory bowel disease: a British Society of Gastroenterology Inflammatory Bowel Disease section and IBD Clinical Research Group position statement

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Novel Coronavirus Disease COVID-19

Most cited references 38

Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

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