Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study

  1. Gaetano Alfano
  2. Niccolò Morisi
  3. Francesco Fontana
  4. Roberta Scarmignan
  5. Laura Tonelli
  6. Camilla Ferri
  7. Martina Montani
  8. Silvia Giovanella
  9. Giulia Ligabue
  10. Giacomo Mori
  11. Erica Franceschini
  12. Giovanni Guaraldi
  13. Gianni Cappelli
  14. Riccardo Magistroni
  15. Gabriele Donati

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

Introduction

Some hemodialysis patients are reluctant to COVID-19 for the development of adverse events (AEs). The aim of this study was to verify the safety of mRNA-1273 vaccine in hemodialysis patients.

Methods

We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1 st to April 30 th , 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic.

Results

Overall, 126 patients on chronic maintenance dialysis without a prior COVID-19 diagnosis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥ 65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%).

The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of the vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem to be lower than in the general population.

Conclusion

RNA-1273 vaccine was associated with the development of transient AEs after the first (57.9%) and second doses (61.9%) in patients on chronic maintenance hemodialysis. Systemic AEs were more common after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae.

Article activity feed

  1. Version published to 10.1101/2021.11.21.21266561v2 on medRxiv
  2. ScreenIT

    SciScore for 10.1101/2021.11.21.21266561: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Anti-SARS-CoV-2 vaccination was performed in all patients without a prior COVID-19 diagnosis and without signs of ongoing infection who provided written consent from March 24th to April 30th, 2021.
    IRB: This study has been authorized by the local Ethical Committee of Emilia Romagna (n. 839/2020).
    Sex as a biological variablenot detected.
    RandomizationThis vaccine was found to be safe and efficacious (94.1%) in preventing symptomatic, laboratory-confirmed COVID-19 in a large, randomized-controlled trial7 and subsequent observational studies11,12.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical analyses were performed using SPSS 24® statistical software.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    Some limitations of the study should be enunciated. The retrospective nature of the analysis and the small sample size could lead to unintended bias in the correct estimation of vaccine-related AEs. Measure of AEs magnitude was not collected in our patients, albeit none required acute hospital in-patient care after the administration of vaccine. Lastly, our study provides key information for healthcare workers to plan active surveillance on hemodialysis patients.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04470427Active, not recruitingA Study to Evaluate Efficacy, Safety, and Immunogenicity of …

    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

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.11.21.21266561v1 on medRxiv