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Epidemiology
Efficacy of COVID-19 vaccines in patients taking immunosuppressants
  1. Chen Shen1,
  2. Malcolm Risk1,
  3. Elena Schiopu2,
  4. Salim S Hayek3,
  5. Tiankai Xie1,
  6. Lynn Holevinski4,
  7. Cem Akin5,
  8. Gary Freed6,
  9. Lili Zhao1
  1. 1 Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA
  2. 2 Department of Rheumatology, University of Michigan Michigan Medicine, Ann Arbor, Michigan, USA
  3. 3 Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA
  4. 4 Data Office for Clinical and Translational Research, University of Michigan Medical School, Ann Arbor, Michigan, USA
  5. 5 Division of Allergy, University of Michigan, Ann Arbor, Michigan, USA
  6. 6 Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA
  1. Correspondence to Dr Lili Zhao, Department of Biostatistics, University of Michigan, Ann Arbor, MI 48109, USA; zhaolili{at}med.umich.edu

Abstract

Objectives We intended to assess the effectiveness of all three US Food and Drug Administration approved COVID-19 vaccines at preventing SARS-CoV-2 infection and COVID-19 hospitalisation in a large cohort of individuals on immunosuppressants for a diverse range of conditions.

Methods We studied the effectiveness of BNT162b2 (Pfizer–BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Johnson & Johnson–Janssen) vaccines among individuals who take immunosuppressants (including disease-modifying antirheumatic drugs and glucocorticoids) by comparing vaccinated (n=97688) and unvaccinated (n=42094) individuals in the Michigan Medicine healthcare system from 1 January to 7 December 2021, using Cox proportional hazards modelling with time-varying covariates.

Results Among vaccinated and unvaccinated individuals, taking immunosuppressants increased the risk of SARS-CoV-2 infection (adjusted HR (aHR)=2.17, 95% CI 1.69 to 2.79 for fully vaccinated and aHR=1.40, 95% CI 1.07 to 1.83 for unvaccinated). Among individuals taking immunosuppressants, we found: (1) vaccination reduced the risk of SARS-CoV-2 infection (aHR=0.55, 95% CI 0.39 to 0.78); (2) the BNT162b2 and mRNA-1273 vaccines were highly effective at reducing the risk of SARS-CoV-2 infection (n=2046, aHR=0.59, 95% CI 0.38 to 0.91 for BNT162b2; n=2064, aHR=0.52, 95% CI 0.33 to 0.82 for mRNA-1273); (3) with a smaller sample size (n=173), Ad26.COV2.S vaccine protection did not reach statistical significance (aHR=0.34, 95% CI 0.09 to 1.30, p=0.17); and (4) receiving a booster dose reduced the risk of SARS-CoV-2 infection (aHR=0.42, 95% CI 0.24 to 0.76).

Conclusions The mRNA-1273 and BNT162b2 vaccines are effective in individuals who take immunosuppressants. However, individuals who are vaccinated but on immunosuppressants are still at higher risk of SARS-CoV-2 infection and COVID-19 hospitalisation than the broader vaccinated population. Booster doses are effective and crucially important for individuals on immunosuppressants.

  • COVID-19
  • vaccination
  • epidemiology
  • autoimmune diseases
  • autoimmunity

Data availability statement

No data are available. Not applicable.

This article is made freely available for personal use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

http://dx.doi.org/10.1136/annrheumdis-2021-222045

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    Footnotes

    • Handling editor Josef S Smolen

    • Contributors CS: manuscript writing, study design, statistical analysis and data preparation. MR: manuscript writing, statistical analysis and data preparation. ES: clinical advice, study design and manuscript editing. SSH: clinical advice, data preparation and manuscript editing. TX: data preparation. LH: data preparation. CA: clinical advice and study design. GF: clinical advice, study design and manuscript editing. LZ: data querying, manuscript writing, study design and statistical analysis and LZ is responsible for the overall content as guarantor.

    • Funding Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R01AI158543.

    • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

    • Competing interests None declared.

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

    • 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.