Layton JB, McGrath LJ, Sahrmann JM, Ma Y, Dharnidharka VR, O'Neil C, Weber DJ, Butler AM. Comparative safety of high-dose versus standard-dose influenza vaccination in patients with end-stage renal disease. Poster presented at the 2020 36th ICPE International Virtual Conference on Pharmacoepidemiology & Therapeutic Risk Management; September 16, 2020.

BACKGROUND: High-dose influenza vaccine (HDV) is an option for patients with end-stage renal disease (ESRD), though the safety of HDV has not been evaluated in this population.

OBJECTIVES: The objective of this study was to estimate the relative occurrence of adverse reactions in patients with ESRD following vaccination with HDV compared with standard-dose influenza vaccine (SDV).

METHODS: Using data from the United States Renal Data System, patients with ESRD aged ≥ 65 years were identified on the date of influenza vaccination during yearly influenza seasons (2010-2016). In each outcome-specific analysis, patients were followed from vaccination to observe serious (anaphylaxis, angioedema, seizure, encephalopathy, Guillain-Barré syndrome, and short-term mortality) and milder (urticaria/hives, rash, pain in limb, cellulitis, myalgia/myositis, fever, nausea and vomiting, diarrhea, and syncope) events. Propensity score-weighted hazard ratios (HR) and 95% confidence intervals (CI) comparing recipients of HDV to SDV were estimated with Cox proportional hazards models.

RESULTS: Of 520,876 vaccinated patients (mean age = 74.7, standard deviation = 7.0; 63% white race), 7.4% received HDV. Crude incidence rates of serious events were low. HRs were inestimable for anaphylaxis, angioedema, and Guillain-Barré syndrome due to too few cases, and HRs for seizure, encephalopathy, and mortality were null. HRs for some minor events were increased in the HDV group: rash (HR = 1.86; 95% CI: 1.34-2.57), diarrhea (HR = 1.26; 95% CI: 1.07-1.50), pain in limb (HR = 1.23; 95% CI: 1.12-1.34), and myalgia/myositis (HR = 1.16; 95% CI: 1.04-1.30). This pattern was consistent in subgroup and sensitivity analyses.

CONCLUSIONS: HDV recipients had increased risks of several minor events, while the risks of severe events were generally low and similar between the treatment groups, consistent with clinical trials findings in the general population of older adults. The risk-benefit tradeoff of HDV versus SDV use in patients with ESRD should be carefully considered given these safety data, increases in national use of HDV, and high comorbidity burden in this population.

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