The Impact of Vaccination on Incidence and Outcomes of SARS-CoV-2 Infection in Patients with Kidney Failure in Scotland

  1. Samira Bell
  2. Jacqueline Campbell
  3. Emilie Lambourg
  4. Chrissie Watters
  5. Martin O’Neil
  6. Alison Almond
  7. Katharine Buck
  8. Edward J. Carr
  9. Laura Clark
  10. Zoe Cousland
  11. Mark Findlay
  12. Nicola Joss
  13. Wendy Metcalfe
  14. Michaela Petrie
  15. Elaine Spalding
  16. Jamie P. Traynor
  17. Vinod Sanu
  18. Peter Thomson
  19. Shona Methven
  20. Patrick B. Mark

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Abstract

Patients with kidney failure requiring KRT are at high risk of poor outcomes following SARS-CoV-2 infection, with variable antibody responses to vaccination reported. Ninety-three percent of patients on KRT in Scotland received a SARS-CoV-2 vaccine. The effectiveness of two vaccine doses was only 33% (95% CI, 0 to 52) against SARS-CoV-2 infection and 38% (95% CI, 0 to 57) against hospitalization in patients requiring KRT. Within 28 days of a positive SARS-CoV-2 PCR test, 9.2% of fully vaccinated patients died (7% patients on dialysis and 10% transplant recipients). These data suggest that a primary vaccine course of two doses does not provide adequate protection in patients receiving KRT and highlight the urgent need for adjunctive strategies to reduce risk of both SARS-CoV-2 infection and its complications.

Background

Patients with kidney failure requiring KRT are at high risk of complications and death following SARS-CoV-2 infection, with variable antibody responses to vaccination reported. We investigated the effects of COVID-19 vaccination on the incidence of infection, hospitalization, and death from COVID-19 infection.

Methods

The study design was an observational data linkage cohort study. Multiple health care datasets were linked to ascertain all SARS-CoV-2 testing, vaccination, hospitalization, and mortality data for all patients treated with KRT in Scotland from the start of the pandemic over a period of 20 months. Descriptive statistics, survival analyses, and vaccine effectiveness were calculated.

Results

As of September 19, 2021, 93% ( n =5281) of the established KRT population in Scotland had received two doses of an approved SARS-CoV-2 vaccine. Over the study period, there were 814 cases of SARS-CoV-2 infection (15.1% of the KRT population). Vaccine effectiveness rates against infection and hospitalization were 33% (95% CI, 0 to 52) and 38% (95% CI, 0 to 57), respectively. Within 28 days of a SARS-CoV-2–positive PCR test, 9.2% of fully vaccinated individuals died (7% patients on dialysis and 10% kidney transplant recipients). This compares to <0.1% of the vaccinated general Scottish population admitted to the hospital or dying due to COVID-19 during that period.

Conclusions

These data demonstrate that a primary vaccine course of two doses has limited effect on COVID-19 infection and its complications in patients with KRT. Adjunctive strategies to reduce risk of both COVID-19 infection and its complications in this population are urgently required.

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  1. Version published to 10.1681/asn.2022010046
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    SciScore for 10.1101/2022.01.05.22268785: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: As the analysis used routinely collected and anonymized data, individual patient consent was not sought.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    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:
    Several limitations must be acknowledged. The numbers are too low to calculate vaccine effectiveness against death, or to separate by vaccine type. About 3% of the cohort had only received one dose of an approved vaccine at the time the data were analyzed. These were excluded from the analysis, resulting in a minor loss of statistical power. No SARS-CoV2 antibody testing was performed. Data on mortality was available until 21 September 2021 whilst SARS-CoV-2 test results were updated until 19 October 2021. Consequently, the proportion of patients dying within 28 days of their positive PCR test may be slightly underestimated. Finally, whilst it had been reported that antibody response varies according to age, degree of immunosuppression, and estimated glomerular filtration rate8, 11, 33, we did not conduct any adjusted analysis in this study and only report crude outcomes. Despite promising effects of COVID-19 vaccination at a population level, for vaccinated patients requiring KRT the risk of SARS-COV-2 infection and subsequent complications remains high. Two doses of approved vaccines fail to provide sufficient protection. Further strategies to mitigate risk are required which may include non-pharmacological interventions, optimization of vaccination regimens, prophylactic therapies, and improved COVID-19 treatment strategies.

    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.
    • Thank you for including a protocol registration statement.

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

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  3. Version published to 10.1101/2022.01.05.22268785v1 on medRxiv