SARS-CoV-2 vaccine effectiveness in immunosuppressed kidney transplant recipients

  1. Hiam Chemaitelly
  2. Sawsan AlMukdad
  3. Jobin Paravila Joy
  4. Houssein H. Ayoub
  5. Hadi M. Yassine
  6. Fatiha M. Benslimane
  7. Hebah A. Al Khatib
  8. Patrick Tang
  9. Mohammad R. Hasan
  10. Peter Coyle
  11. Zaina Al Kanaani
  12. Einas Al Kuwari
  13. Andrew Jeremijenko
  14. Anvar Hassan Kaleeckal
  15. Ali Nizar Latif
  16. Riyazuddin Mohammad Shaik
  17. Hanan F. Abdul Rahim
  18. Gheyath K. Nasrallah
  19. Mohamed Ghaith Al Kuwari
  20. Adeel A. Butt
  21. Hamad Eid Al Romaihi
  22. Mohamed H. Al-Thani
  23. Mohamad M. Alkadi
  24. Omar Ali
  25. Muna Al-Maslamani
  26. Roberto Bertollini
  27. Hassan Al Malki
  28. Yousuf Almaslamani
  29. Laith J. Abu-Raddad
  30. Abdullatif Al Khal

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Abstract

COVID-19 vaccine protection against infection in immunosuppressed solid organ transplant recipients is unknown but possibly weak with the low proportion of these patients mounting a robust humoral and cellular immune response after vaccination. Using a retrospective cohort study design with cross-over, we assessed vaccine effectiveness among 782 kidney transplant recipients registered at Hamad Medical Corporation, the national public healthcare provider in Qatar, where the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines have been used in the national immunization campaign. Vaccine effectiveness against any SARS-CoV-2 infection was estimated at 46.6% (95% CI: 0.0-73.7%) ≥14 days after the second dose, 66.0% (95% CI: 21.3-85.3%) ≥42 days after the second dose, and 73.9% (95% CI: 33.0-89.9%) ≥56 days after the second dose. Vaccine effectiveness against any severe, critical, or fatal COVID-19 disease was estimated at 72.3% (95% CI: 0.0-90.9%) ≥14 days after the second dose, 85.0% (95% CI: 35.7-96.5%) ≥42 days after the second dose, and 83.8% (95% CI: 31.3-96.2%) ≥56 days after the second dose. Most vaccine breakthrough infections occurred in the first few weeks after receiving the first and/or second dose. Vaccine effectiveness reached considerable levels in kidney transplant recipients, but vaccine protection mounted slowly and did not reach a high level until several weeks after the second dose.

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  1. ScreenIT

    SciScore for 10.1101/2021.08.07.21261578: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: Statistical analyses were conducted in STATA/SE version 17.0.38 Ethical approval: The study was approved by the Hamad Medical Corporation and Weill Cornell Medicine-Qatar Institutional Review Boards with waiver of informed consent.
    Consent: Statistical analyses were conducted in STATA/SE version 17.0.38 Ethical approval: The study was approved by the Hamad Medical Corporation and Weill Cornell Medicine-Qatar Institutional Review Boards with waiver of informed consent.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    This was done using the STATA 17.038 stcrreg command to account further for potential bias arising from the competing risks of vaccination and death,33 as the duration of follow up coincided with the rapid scale-up of vaccination in Qatar.
    STATA
    suggested: (Stata, RRID:SCR_012763)
    Statistical analyses were conducted in STATA/SE version 17.0.38 Ethical approval: The study was approved by the Hamad Medical Corporation and Weill Cornell Medicine-Qatar Institutional Review Boards with waiver of informed consent.
    STATA/SE
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This study has limitations. With the relatively small cohort of transplant recipients (n=782), and the rapid scale-up of vaccination during the study duration, it was not possible to match vaccinated and unvaccinated persons by factors such as age, sex, nationality, comorbidity, and calendar time, while maintaining adequate sample sizes, time of follow-up, and statistical precision. However, cohorts of both vaccinated and unvaccinated were largely balanced by both demographic and clinical characteristics (Table 1). Moreover, the regression analyses adjusted for age, sex, and nationality group, with age being a proxy for comorbidity, and both the adjusted and unadjusted analyses reached similar results (not shown). Additionally, the majority of individuals in both vaccinated and unvaccinated cohorts were followed during similar times, starting from the first day of the study, February 1, 2021, or shortly thereafter, even in the additional analyses of vaccine effectiveness for those at ≥42 days and at ≥56 days after the second vaccine dose. Please note follow up times (results and Figure 1) and numbers at risk (Figures 2-4). We only assessed risk of documented infection, but other infections may have occurred and gone undocumented, perhaps because of minimal/mild or no symptoms. Unlike in blinded, randomized clinical trials, the investigated observational cohorts were not blinded nor randomized. Vaccine effectiveness estimates calculated in this study may not necessarily be gen...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  2. Version published to 10.1101/2021.08.07.21261578v1 on medRxiv