The Safety and Immunogenicity of the mRNA-BNT162b2 SARS-CoV-2 Vaccine in Hemodialysis Patients

Abstract

BackgroundHemodialysis patients are at high risk for severe COVID-19. SARS-CoV-2 vaccination related safety and immunogenicity data in these patients are rare.MethodsIn this observational study SARS-CoV-2-seronegative hemodialysis patients were vaccinated with two doses of the Pfizer/BioNTech mRNA-BNT162b2 vaccine (COMIRNATY® 30 µg) and followed for 90 days. Local and systemic side effects were assessed at every dialysis session during the first post-vaccination week after the first and second vaccine dose. Immunogenicity was determined four weeks after vaccination by quantifying anti-SARS-CoV-2 spike protein IgG antibodies (LIAISON® SARS-CoV-2-TrimericS IgG chemiluminescent immunoassay) expressed in binding activity units per milliliter (BAU/mL) adapted to the WHO International standard.ResultsFifty patients (32% women, 68% men) with a mean (SD) age of 67.6 (14.8) years were included. Mild local reactions occurred in 38% after the first injection, and in 29.2% with mild, in 2.1% with moderate and in 2.1% with severe degree after the second injection. Systemic reactive events occurred less often, with diarrhea (4% mild, 4% moderate) and fatigue (8% mild) being the most frequent ones. After the first injection 42% of the patients developed a positive response using the assay specific cut-off value of 33.8 binding activity units per milliliter (BAU/mL) with a median (Q1, Q3) anti-SARS-CoV-2 spike IgG concentration of 20.0 (11.7, 51.0) BAU/mL. After the second injection the percentage of seropositive patients increased to 97.9% with an anti-SARS-CoV-2 spike IgG concentration of 1075 (290.8, 1735) BAU/mL. Higher age and immunosuppression were associated with lower, calcitriol treatment and prior seroconversion to hepatitis B vaccination with significantly higher antibody concentration.ConclusionsThe mRNA-BNT162b2 SARS-CoV-2 vaccine appears to be safe and well-tolerated and shows a high immunogenicity in hemodialysis patients.

Waning humoral response 6 months after SARS-CoV-2 vaccination with the mRNA-BNT162b2 vaccine in hemodialysis patients: time for a boost

“…We and others have found a high short-term seroconversion rate between 71% and 98% in hemodialysis patients following a complete two-dose vaccination course with the mRNA-BNT162b2 vaccine. 1 , 2 After natural infection 76% of hemodialysis patients remained seropositive after a median time period of 124 days after infection. 3 However, to our knowledge there are no serial data available on the maintenance of the vaccine-induced SARS-CoV-2 humoral response in hemodialysis patients.…”

Anti-COVID-19 Vaccination in Patients with Autoimmune-Autoinflammatory Disorders and Primary/Secondary Immunodeficiencies: The Position of the Task Force on Behalf of the Italian Immunological Societies

“…A recent study confirmed the lack of antibody response in patients with X-linked agammaglobulinemia, compensated by the induction of an adaptive cellular response, whereas the response of patients with Common Variable Immunodeficiency was found to be unsatisfactory and non-protective at both cellular and humoral levels [ 100 ]. Safety and substantial immunogenicity were observed in patients with onco-hematological diseases [ 101 , 102 ] and in hemodialysis patients [ 103 ]. Despite the absence of comparative studies between mRNA and viral vector non-replicating vaccines, data from scientific studies and reports of regulatory authorities indicate better protection from mRNA vaccines.…”

“…This is a further consideration for prioritizing these patients in the access to vaccines to prevent the infection or, at least, a chronic infection. The Task Force does not consider it appropriate to interrupt/discontinue immunosuppressive therapy, excepting for high dosage CCS (≥10 mg of prednisone-equivalent [ 104 ]) and anti-CD20mAbs, such as rituximab [ 103 , 104 , 105 ] ( Table 3 ). Moreover, in the case of MTX [ 105 , 106 ], abatacept [ 105 , 106 ], JKI [ 105 , 106 ], and mycophenolate [ 106 ], the immunology specialist should evaluate the possible discontinuation based on the clinical patients’ characteristics.…”

“…The Task Force does not consider it appropriate to interrupt/discontinue immunosuppressive therapy, excepting for high dosage CCS (≥10 mg of prednisone-equivalent [ 104 ]) and anti-CD20 mAbs, such as rituximab [ 103 , 104 , 105 ] ( Table 6 ). Moreover, in the case of MTX [ 105 , 106 ], abatacept [ 105 , 106 ], JKI [ 105 , 106 ], and mycophenolate [ 106 ], the immunology specialist will evaluate the possible discontinuation based on the patients’ clinical characteristics.…”

“…Guide to using anti-COVID-19 vaccination in patients with AIAIDs under immunosuppressive treatment [from Ref [103]. modified].…”