DaVita Clinical Research study indicates mRNA COVID-19 vaccines effective in dialysis patients

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Dialysis patients who received mRNA COVID-19 vaccines had a lower risk of COVID-19 diagnosis post-vaccination, and were less likely to be hospitalised or die following breakthrough infection compared to unvaccinated patients. That is according to a study announced today by DaVita Clinical Research (DCR) and published online in the Journal of the American Society of Nephrology (JASN).

“This is the first large study aimed at understanding the clinical effectiveness of COVID-19 vaccines in this highly vulnerable patient population,” said DCR vice president Steven Brunelli. “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 hospitalisation and death.”

More than 500,000 Americans diagnosed with end stage renal disease (ESRD) receive life-sustaining dialysis care, a DCR press release notes. 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 the BNT162b2 (Pfizer/BioNTech) and mRNA-1273 (Moderna) SARS-CoV-2 vaccines, the release adds.

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 1 January and 25 February 2021. These patients were matched to unvaccinated controlled groups and followed over time to observe future COVID-19 infections as well as related clinical outcomes.

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 hospitalised 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 in an effort to better understand how the novel coronavirus behaves in medically vulnerable patients with ESRD. Related research efforts include two prospective studies in these patients—one investigating the influence of prior infection/naturally acquired antibodies on the future risk of infection, and another studying the genetic basis for susceptibility to more severe cases of COVID-19, which is currently ongoing.

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