Immunogenicity and Safety of a Two-Dose Regimen of the BNT162b2 Vaccine in Dialysis Patients

Abstract

[Introduction] Patients on maintenance hemodialysis are at a high risk of complication and death following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Vaccination is a critical step in fighting the disease；however, evidence on the reactogenicity of COVID-19 vaccines in hemodialysis patients is limited. [Methods] We chronologically determined antibody titers against the spike protein of SARS-CoV-2 in hemodialysis patients (N=34) and health care workers (N=166). We also assessed the solicited systemic reactions induced by BNT162b2 vaccine using a selfreported questionnaire survey and examined whether the immunological responses of dialysis patients differ from those of controls. [Results] Antibody titers were significantly lower in maintenance hemodialysis patients than in controls at two and six months after vaccination (p＜0. 001). Both groups had increased antibody titers at two months, then a decrease to six months after the first vaccination. The frequency of systemic adverse events after the second dose decreased in dialysis patients. [Conclusions] In patients undergoing chronic dialysis, the humoral response to BNT162b2 vaccination was significantly lower and the risk of breakthrough infection is suspected to be higher than that of healthy controls. The safety of vaccination was confirmed.