1095. Increased Risk of COVID-19 Hospitalization and Death in Vaccinated Patients with End-Stage Renal Disease (ESRD) and Dialysis: Initial Results from INFORM, a Retrospective Health Database Observational Study in England
Authors: Dube Sabada , Lu Yi , McNulty Richard , Graham Sophie , Arnetorp Sofie , Justo Nahila , Yokota Renata , Evans Kathryn , Venkatesan Sudhir , Yates Mark , Taylor Sylvia , Quint Jennifer , Evans Rachael A 
Published: November 2023

Abstract

Background
Individuals with immunocompromised conditions (IC) have a higher risk of COVID-19 morbidity and death despite vaccination. Though patients (pts) with ESRD are considered immunocompromised and have a weaker antibody response to COVID-19 vaccination, some guidelines do not currently recommend pre-exposure prophylaxis (PrEP) for these pts. This is due to the fact that boosters are believed to increase seropositivity and antibody production in pts on dialysis. The INFORM study aimed to describe the health burden of severe COVID-19, and here initial results are presented for fully vaccinated pts with ESRD or dialysis (ESRD or D); fully vaccinated pts with ESRD receiving dialysis (ESRD+D), and the fully vaccinated overall population (OP) aged ≥ 12 years or a subgroup aged ≥ 65 years.

Methods
The proportions, rates per 100 person-years (PY), and risks of COVID-19–related outcomes (hospitalizations, intensive care unit admissions, and mortality) in fully vaccinated (≥ 3 doses) pts aged ≥ 12 years in England, UK were identified using the National Health Service (NHS) databases between Jan 1, 2022–Dec 31, 2022. Only outcomes with COVID-19 recorded as the primary diagnosis were included.

Results
A total of 19,450 (0.3%) pts with ESRD or D, including 8390 (0.1%) with ESRD+D, were identified from the OP of 7,180,205. The proportion of pts with ≥ 1 hospitalization was higher in pts with ESRD or D (2.4%) and with ESRD+D (3.1%) compared with the OP aged ≥ 12 years (0.2%) and pts aged ≥ 65 years (0.6%). Similarly, mortality for both pts with ESRD or D and those with ESRD+D was estimated at 0.5%; higher than the OP (0.05%). Incidence rates per 100 PY for hospitalization and COVID-19 deaths were ≥ 10× higher in both groups versus the OP aged ≥ 12 years, and ≥ 3.5× higher versus pts aged ≥ 65 years (Table 1).

Conclusion
Pts with IC mount inadequate responses to COVID-19 vaccines. In this study, pts with ESRD and/or receiving dialysis were also at an increased risk with higher rates of severe COVID-19 outcomes compared with the OP, despite vaccination. This risk is particularly elevated for pts with ESRD who are receiving dialysis. As a result, like pts with IC with an inadequate response to vaccines, pts with ESRD or D and ESRD with D may benefit from PrEP in addition to protection from vaccines against severe COVID-19.

Disclosures
Sabada Dube, PhD, AstraZeneca: Employee Yi Lu, PhD, Evidera: Employee Richard McNulty, MD, AstraZeneca: Employee Sophie Graham, MSc, Evidera: Employee Sofie Arnetorp, MS, AstraZeneca: Employee Nahila Justo, PhD, MBA, Evidera: Employee|Karolinska Institute: Employee Renata Yokota, PhD, AstraZeneca: Employee Kathryn Evans, MPH, Evidera: Employee Sudhir Venkatesan, MPH, PhD, AstraZeneca: Employee Mark Yates, PhD, Evidera: Employee Sylvia Taylor, PhD, MPH, MBA, AstraZeneca: Stocks/Bonds Jennifer Quint, PhD, AstraZeneca: Grant/Research Support|Evidera: Grant/Research Support|GlaxoSmithKline: Grant/Research Support|Insmed: Grant/Research Support Rachael A. Evans, PhD FRCP, AstraZeneca: Advisor/Consultant|Boehringer: Advisor/Consultant|Evidera: Advisor/Consultant