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DaVita Clinical Research Study Indicates Effectiveness Of MRNA COVID-19 Vaccines In Dialysis Patients

Research supports vaccination as an important clinical strategy to help protect vulnerable patients from virus infection.

Dialysis patients who received mRNA COVID-19 vaccines had a lower risk of COVID-19 diagnosis post-vaccination and were less likely to be hospitalized or die following breakthrough infection than unvaccinated patients, according to a DaVita Clinical Research (DCR) study published online ahead of print by the Journal of the American Society of Nephrology.

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“This is the first large study aimed at understanding the clinical effectiveness of COVID-19 vaccines in this highly vulnerable patient population,” said Dr. Steven Brunelli, MCSE, vice president for DCR. “Our observations provide reassurance that COVID-19 mRNA vaccination is an effective clinical strategy to help protect these patients from COVID-19 and from associated hospitalization and death.”

More than 500,000 Americans diagnosed with end stage kidney disease (ESKD) receive life-sustaining dialysis care. Despite being at high risk for COVID-19 due to underlying health conditions that compromise their immune systems, these patients were not represented in the Phase III clinical trials of BNT162b and mRNA-1273 SARS-CoV-2 vaccines.

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To assess COVID-19 vaccine effectiveness in this patient population, researchers evaluated electronic health records of 35,206 DaVita dialysis patients vaccinated with Pfizer/BioNTech or Moderna vaccines between Jan. 1 and Feb. 25, 2021. These patients were matched to unvaccinated controlled groups and followed over time to observe future COVID-19 infections and related clinical outcomes.

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Researchers observed that the Pfizer/BioNTech and Moderna vaccines were 78% and 73% effective in preventing COVID-19 infections, respectively. The study indicated that vaccinated dialysis patients who experienced a breakthrough COVID-19 infection were also less likely to be hospitalized or die from COVID-19 as compared to unvaccinated patients diagnosed with COVID-19. In addition, among vaccinated dialysis patients, SARS-CoV-2 antibodies were detected in rates similar to those seen in the broader Phase III clinical trials.

Since the onset of the COVID-19 pandemic, DCR has conducted several studies to better understand how the novel coronavirus behaves in medically vulnerable patients with ESKD. Related research efforts also include two prospective studies in ESKD patients: one investigating the influence of prior infection/ naturally acquired antibodies on the future risk of infection, and a second one (ongoing) studying the genetic basis for susceptibility to more severe cases of COVID-19.

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[To share your insights with us, please write to sghosh@martechseries.com]

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