Comparative Effectiveness of mRNA-based BNT162b2 Vaccine versus Adenovirus Vector–Based Ad26.COV2.S Vaccine for the Prevention of COVID-19 among Dialysis Patients

  1. Steven M. Brunelli
  2. Scott Sibbel
  3. Steph Karpinski
  4. Gilbert Marlowe
  5. Adam G. Walker
  6. Jeffrey Giullian
  7. David Van Wyck
  8. Tara Kelley
  9. Rachael Lazar
  10. Meredith L. Zywno
  11. Jeffrey J. Connaire
  12. Amy Young
  13. Francesca Tentori

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Abstract

Vaccination against SARS-CoV-2 is critically important for patients on maintenance dialysis, who are at high risk for COVID-19–related morbidity and mortality. Previous research has demonstrated that mRNA-based vaccines are highly effective in patients on dialysis. Because specific vaccines may be differentially available to patients, it is important to understand the comparative effectiveness of individual vaccines, including the adenovirus vector–based vaccine Ad26.COV2.S. In this retrospective study, the authors compared the real-world effectiveness of Ad26.COV2.S with that of an mRNA vaccine, BNT162b2, in a population of patients on dialysis. Their findings showed no difference in the effectiveness of these vaccines over the first 6 months postvaccination, and support the continued use of either in the population of patients on dialysis.

Background

Studies have demonstrated that mRNA-based SARS-CoV-2 vaccines are highly effective among patients on dialysis. Because individual vaccines may be differentially available or acceptable to patients, it is important to understand comparative effectiveness relative to other vaccines, such those on the basis of adenovirus technologies.

Methods

In this retrospective study, we compared the clinical effectiveness of adenovirus vector–based Ad26.COV2.S (Janssen/Johnson & Johnson) to mRNA-based BNT162b2 (Pfizer/BioNTech) in a contemporary cohort of patients on dialysis. Patients who received a first BNT162b2 dose were matched 1:1 to Ad26.COV2.S recipients on the basis of date of first vaccine receipt, US state of residence, site of dialysis care (in-center versus home), history of COVID-19, and propensity score. The primary outcome was the comparative rate of COVID-19 diagnoses starting in the 7th week postvaccination. In a subset of consented patients who received Ad26.COV2.S, blood samples were collected ≥28 days after vaccination and anti–SARS-CoV-2 immunoglobulin G antibodies were measured.

Results

A total of 2572 matched pairs of patients qualified for analysis. Cumulative incidence rates of COVID-19 did not differ for BNT162b2 versus Ad26.COV2.S. No differences were observed in peri–COVID-19 hospitalizations and deaths among patients receiving BNT162b2 versus Ad26.COV2.S, who were diagnosed with COVID-19 during the at-risk period. Results were similar when excluding patients with a history of COVID-19, in subgroup analyses restricted to patients who completed the two-dose BNT162b2 regimen, and in patients receiving in-center hemodialysis. SARS-CoV-2 antibodies were detected in 59.4% of 244 patients who received Ad26.COV2.S.

Conclusions

In a large real-world cohort of patients on dialysis, no difference was detected in clinical effectiveness of BNT162b2 and Ad26.COV2.S over the first 6 months postvaccination, despite an inconsistent antibody response to the latter.

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  1. Version published to 10.1681/asn.2021101395
  2. ScreenIT

    SciScore for 10.1101/2021.10.21.21265339: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: According to 45 Code of Federal Regulations part 46 from the US Department of Health and Human Services, this study was deemed exempt from institutional review board (IRB) or ethics committee approval.
    Consent: We adhered to the Declaration of Helsinki, and informed consent was not required.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisIn addition, because finite statistical power increases the likelihood of type 2 errors, we further consider a “worst case” scenario for Ad26.COV2.S based on the upper confidence bound, which is a conservative approach since statistical imprecision implicitly “counts against” Ad26.COV2.S under this approach.

    Table 2: Resources

    Antibodies
    SentencesResources
    Immunoglobulin G (IgG) was measured using an indirect chemiluminescence immunoassay for anti-SARS-CoV-2 IgG antibodies (Diazyme Laboratories, Inc), which detects antibodies against the SARS-CoV-2 spike and nucleocapsid proteins.
    anti-SARS-CoV-2 IgG
    suggested: None
    We previously used this assay for research purposes due to its selectivity for SARS-CoV-2 antibodies and low-levels of cross-reactivity to other coronaviruses or influenza viruses.9, 10 IgM levels were not measured based on pilot data demonstrating that measured IgM response was implausibly low in this population (<20% positive even in the 28-day period following documented SARS-CoV-2 infection).
    SARS-CoV-2
    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:
    The study should be viewed in light of the following limitations. As with any observational study, there is the possibility of residual confounding and bias (e.g., misclassification of exposure status for patients reporting vaccinations outside of the clinic). Data limitations precluded the ability to study COVID-19-related hospitalizations as we well as severity of illness and asymptomatic infections, or to study side effects of vaccines. Low case counts also precluded study of case fatality. Given the fluctuating nature of background COVID-19 rates in the US population over the course of follow-up, COVID-19 rates within an exposure group should not be compared across follow-up periods, but rather limited to within period comparisons across exposure groups. Finally, we could not compare the effectiveness of these vaccines against specific SARS-CoV-2 variants. In summary, our results demonstrate equivalent effectiveness of Ad26.COV2.S to an mRNA-based vaccine (BNT162b2) in dialysis patients. These results support the continued use of Ad26.COV2.S as a SARS-CoV-2 vaccine option in this vulnerable population.

    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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  3. Version published to 10.1101/2021.10.21.21265339v1 on medRxiv