Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project

Abstract

Background and Objectives: The Pfizer-BioNTech (BNT162b2) COVID-19 mRNA vaccine has demonstrated excellent efficacy and safety in phase 3 trials. However, no dialyzed patients were included, and therefore safety data for this patient group is lacking. The aim of the study was to assess the safety and tolerances of vaccinations with BNT162b2 performed in chronically dialyzed patients. Materials and Methods: We performed a prospective cohort study including a group of 190 dialyzed patients (65% male) at median age 68.0 (55–74) years. 169 (89.0%) patients were treated with hemodialysis and 21 (11.0%) with peritoneal dialysis. The control group consisted of 160 people (61% male) without chronic kidney disease at median age 63 (range 53–77) years. Both groups were vaccinated with BNT162b2 with a 21-day interval between the first and the second dose. Solicited local and systemic reactogenicity, unsolicited adverse events and antipyretic and pain medication use were assessed with a standardized questionnaire. The toxicity grading scales were derived from the FDA Center for Biologics Evaluation and Research guidelines. Results: 59.8% (dose 1), 61.4% (dose 2) and 15.9% (dose 1), 29.4% (dose 2) dialyzed patients reported at least one local and one systemic reaction respectively within seven days after the vaccination. Many local and systemic solicited reactions were observed less frequently in dialyzed patients than in the age and sex matched control group and much less frequently than reported in the pivotal study. They were mostly mild to moderate, short-lived, and more frequently reported in younger individuals and women. No related unsolicited adverse events were observed. Conclusions: We have shown here that BNT162b2, an mRNA vaccine from Pfizer-BioNTech against SARS-COV-2 is safe and well-tolerated by dialyzed patients. The results can be useful for the nephrological community to resolve patients’ doubts and reduce their vaccine hesitancy.

Antibody Response and Safety After mRNA-1273 SARS-CoV-2 Vaccination in Peritoneal Dialysis Patients – the Vienna Cohort

“…These results could be explained by the fact that our study cohort consisted of 66.7% male participants compared to the 52.7% reported by Baden et al. Other studies have reported that women show a higher rate of adverse events in response to mRNA vaccines ( 52 ). Furthermore, the incidence of local and systemic adverse events in our study population was higher than in HD patients receiving the BNT162b2 vaccine ( 42 , 52 ).…”

“…Other studies have reported that women show a higher rate of adverse events in response to mRNA vaccines ( 52 ). Furthermore, the incidence of local and systemic adverse events in our study population was higher than in HD patients receiving the BNT162b2 vaccine ( 42 , 52 ). The fact that our study participants were treated with PD, were on average 13 years younger than the participants of the other studies and received a different vaccine may explain these differences.…”

Humoral and Cellular Vaccination Responses against SARS-CoV-2 in Hematopoietic Stem Cell Transplant Recipients

“…However, this point is still controversial. One study on SARS-CoV-2 mRNA vaccination showed lower local and systemic side effects in chronically dialyzed patients, who are immunosuppressed due to impaired renal function [ 7 ]. Another group reported a number and severity of side effects in HSCT recipients similar to published data from healthy controls [ 8 ].…”

Systemic COVID-19 vaccination also enhances the humoral immune response after SARS CoV-2 infection. An approach to criteria for COVID-19 re-immunization is needed. Do we need a third dose?

“…The same question can be asked about immunosuppression, people with immunode ciency syndromes, post transplantation patients, or oncologic or dialysis patients. Many published papers prove the safety of BNT162b2 vaccination in dialysis patients 18 , patients after lymphoma therapy 19 , and the safety of a third dose in kidney transplant recipients 20 . In healthy individuals, partial seroprotection, a mean of approximately 53% (32-68%, con dence interval 95%), is reached 14 days after the rst dose of BNT162b2 vaccine.…”