Incidence of severe breakthrough SARS-CoV-2 infections in vaccinated kidney transplant and haemodialysis patients

Abstract

Introduction Given the increased COVID-19 observed in kidney transplant recipients (KTRs) and haemodialysis patients, several studies have tried to establish the efficacy of mRNA vaccines in these populations by evaluating their humoral and cellular responses. However, there is currently no information on clinical protection (deaths and hospitalizations), a gap that this study aims to fill. Methods Observational prospective study involving 1,336 KTRs and haemodialysis patients from three dialysis units affiliated to Hospital Clínic of Barcelona, Spain, vaccinated with two doses of mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) SARS-CoV-2 mRNA vaccines. The outcomes measured were SARS-CoV-2 infection diagnosed by a positive RT-PCR fourteen days after the second vaccine dose, hospital admissions derived from infection, and a severe COVID-19 composite outcome, defined as either ICU admission, invasive and non-invasive mechanical ventilation, or death. Results Six per cent (18/302) of patients on haemodialysis were infected, of whom four required hospital admission (1.3%), only one (0.3%) had severe COVID-19, and none of them died. In contrast, 4.3% (44/1034) of KTRs were infected, and presented more hospital admissions (26 patients, 2.5%), severe COVID-19 (11 patients, 1.1%) or death (4 patients, 0.4%). KTRs had a significantly higher risk of hospital admission than HD patients, and this risk increased with age and male sex (HR 3.37 and 4.74, respectively). Conclusions The study highlights the need for booster doses in KTRs. In contrast, the haemodialysis population appears to have an adequate clinical response to vaccination, at least up to four months from its administration. Graphical abstract

High Incidence of SARS-CoV-2 Variant of Concern Breakthrough Infections Despite Residual Humoral and Cellular Immunity Induced by BNT162b2 Vaccination in Healthcare Workers: A Long-Term Follow-Up Study in Belgium

“…Serological findings of this cohort were comparable with those described by other groups that studied serology up to 32 weeks after receiving the BNT162b2 vaccine [44][45][46][47][48][49][50][51][52]. Of note, many of these studies monitored vaccine-induced antibody responses in either patients with multiple pathologies (e.g., multiple sclerosis, hemodialysis) [44][45][46]53,54], SARS-CoV-2 convalescent patients [55][56][57] or between patients receiving one, two or three doses of the BNT162b2 vaccine [57,58]. These different set-ups complicate an accurate comparison between datasets.…”

Clinical Effectiveness of SARS-CoV-2 Vaccination in Renal Transplant Recipients. Antibody Levels Impact in Pneumonia and Death

“…Our results support the idea that it might be more appropriate to consider broader antibody ranges than to establish a single cutoff point. Indeed, according with other publications, 3,23,24 our results support that other factors such as a history of diabetes were associated with an increased risk of death, but early minimization of MPA was associated with a lower risk of mortality.…”

Heterologous vector versus homologous mRNA COVID-19 booster vaccination in non-seroconverted immunosuppressed patients: a randomized controlled trial

“…Patients without detectable anti-RBD antibody levels were included in our study, reflecting individuals at exceptionally high risk for severe COVID-19 disease courses. Although none of the patients seroconverted after primary vaccination, the heterogeneity of the patient cohort has to be considered since it has been reported that underlying disease-specific medication can contribute to vaccination response [34][35][36] . While antibody levels have been determined at multiple time points during clinical routine before booster vaccination, it cannot be ruled out that individual patients had developed transient antibodies prior to study inclusion.…”