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BNT162b2 mRNA COVID-19 vaccine and booster in patients with autoimmune rheumatic diseases: a national cohort study
  1. Amir Bieber1,
  2. Iftach Sagy2,3,4,
  3. Lena Novack2,
  4. Shay Brikman1,5,
  5. Ran Abuhasira6,7,
  6. Snait Ayalon8,
  7. Irina Novofastovski1,
  8. Mahmoud Abu-Shakra3,4,
  9. Reuven Mader1,5
  1. 1 Rheumatology, Emek Medical Center, Afula, Northern, Israel
  2. 2 Clinical Research Center, Soroka University Medical Center, Beer Sheva, Israel
  3. 3 Rheumatology, Soroka Medical Center, Beer Sheva, Israel
  4. 4 Faculty of Medicine, Ben-Gurion University of the Negev, Beer-Sheva, Israel
  5. 5 Technion Israel Institute of Technology The Ruth and Bruce Rappaport Faculty of Medicine, Haifa, Israel
  6. 6 Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  7. 7 Department Medicine B, Rabin Medical Center Beilinson Hospital, Petah Tikva, Israel
  8. 8 Reseach Authority, Emek Medical Center, Afula, Northern, Israel
  1. Correspondence to Dr Amir Bieber, Rheumatology, Emek Medical Center, Afula, Northern, Israel; amir.bieber{at}


Introduction Emerging evidence supports the immunogenic response to mRNA COVID-19 vaccine in patients with autoimmune rheumatic diseases (ARD). However, large-scale data about the association between vaccination, and COVID-19 outcomes in patients with ARD is limited.

Methods We used data from Clalit Health Services, which covers more than half of the population in Israel. Patients with ARD older than 18 were included between 20 December 2020 and 30 September 2021, when the BNT162b2 mRNA COVID-19 vaccine, and later a third booster dose, were available. The primary outcome was a documented positive SARS-CoV-2 PCR test. We used a Cox regression models with vaccination status as time-dependent covariate and calculated the HR for the study outcome.

Results We included 127 928 patients with ARD, of whom, by the end of the study follow-up, there were 27 350 (21.3%) unvaccinated patients, 31 407 (24.5%) vaccinated patients and 69 171 (54.1%) patients who also received a third booster-dose. We identified 8470 (6.6%) patients with a positive SARS-CoV-2 PCR test during the study period. The HR for SARS-CoV-2 infection among the vaccination group was 0.143 (0.095 to 0.214, p<0.001), and among the booster group was 0.017 (0.009 to 0.035, p<0.001). Similar results were found regardless of the type of ARD group or antirheumatic therapy.

Conclusion Our results indicate that both the BNT162b2 mRNA COVID-19 vaccine and the booster are associated with better COVID-19 outcomes in patients with ARD.

  • Covid-19
  • Vaccination
  • Autoimmune Diseases

Data availability statement

No data are available. Owing to the Clalit Health Services data privacy regulations, the raw data for this study cannot be shared.

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.

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Data availability statement

No data are available. Owing to the Clalit Health Services data privacy regulations, the raw data for this study cannot be shared.

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  • AB and IS are joint first authors.

  • Handling editor Josef S Smolen

  • AB and IS contributed equally.

  • Correction notice This article has been corrected since it published Online First. The abstract has been corrected.

  • Contributors AB and IS designed the study, wrote the manuscript draft and coordinate all authors and reviewers comments IS, LN and RA contributed to the Statistical and epidemiological analysis. SB, SA and IN contributed to data extraction and modulation. MA-S and RM supervised and guided the project process. AB and IS are responsible for the overall content as guarantors.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement 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.

  • 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.