Humoral Response to the Pfizer BNT162b2 Vaccine in Patients Undergoing Maintenance Hemodialysis

Grupper, Ayelet; Sharon, Nehama; Finn, Talya; Cohen, Regev; Israel, Meital; Agbaria, Amir; Rechavi, Yoav; Schwartz, Idit F.; Schwartz, Doron; Lellouch, Yonatan; Shashar, Moshe

doi:10.2215/cjn.03500321

Cited by 291 publications

(384 citation statements)

References 19 publications

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“…This agrees with recent data published by Terpos et al [ 22 ], who also found that the anti-Spike-RBD IgGs response was more sustained in female than in male octogenarians after vaccination with Pfizer BNT162b2 mRNA vaccine. In keeping with previous reports [ 23 , 24 , 25 , 26 ], we also observed a gradual reduction of total anti-SARS-CoV-2 RBD antibodies level in older individuals (i.e., aged 60 years or older). In particular, a significant difference by age (≤60 years vs. >60 years) could be noted after the first mRNA vaccine dose (~1.3-fold), which was magnified after the second dose (~1.9-fold).…”

Section: Discussionsupporting

confidence: 93%

Anti-SARS-CoV-2 Receptor-Binding Domain Total Antibodies Response in Seropositive and Seronegative Healthcare Workers Undergoing COVID-19 mRNA BNT162b2 Vaccination

et al. 2021

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Background: This study monitored total anti-SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) RBD (receptor-binding domain) antibodies levels in a large population of healthcare workers undergoing mRNA COVID-19 vaccination. Methods. The study population consisted of employees of Pederzoli Hospital of Peschiera del Garda (Verona, Italy), who underwent voluntary vaccination with two doses of COVID-19 mRNA BNT162b2 (Comirnaty; Pfizer Inc). Venous blood was drawn immediately before the first vaccine dose, as well as 21 days (immediately before second vaccine dose) and 50 days afterwards. Humoral response was assessed with Roche Elecsys Anti-SARS-CoV-2 S total antibodies, on Roche Cobas 6000 (Roche Diagnostics). Results: The final study population consisted of 925 subjects (mean age, 44 ± 13 years; 457 women), 206 (22.3%) anti-SARS-CoV-2 baseline seropositive. The increase of total anti-SARS-CoV-2 RBD antibodies levels 21 days after the first vaccine dose was ~3 orders of magnitude higher in seropositive than in seronegative individuals (11782 vs. 42 U/mL; p < 0.001). Total anti-SARS-CoV-2 RBD antibodies levels further increased by over 30-fold after the second vaccine dose in baseline seronegative subjects, while such increase was only ~1.3-fold in baseline seropositive subjects. In multivariate analysis, total anti-SARS-CoV-2 RBD antibodies level was inversely associated with age after both vaccine doses and male sex after the second vaccine dose in baseline seronegative subjects, while baseline antibodies value significantly predicted immune response after both vaccine doses in baseline seropositive recipients. Conclusion: Significant difference exists in post-mRNA COVID-19 vaccine immune response in baseline seronegative and seropositive subjects, which seems dependent on age and sex in seronegative subjects, as well as on baseline anti-SARS-CoV-2 antibodies level in seropositive patients.

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Section: Discussionsupporting

confidence: 93%

Anti-SARS-CoV-2 Receptor-Binding Domain Total Antibodies Response in Seropositive and Seronegative Healthcare Workers Undergoing COVID-19 mRNA BNT162b2 Vaccination

et al. 2021

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“…In comparison to these findings, the strong immunogenicity with the mRNA-BNT162b2 SARS-CoV-2 vaccine found in our study is encouraging and hopefully translates into the prevention of clinically important outcomes such as severe COVID-19, hospitalization and death. Our results confirm the recently published high antibody response rates from 90% to 96% in three dialysis cohorts from Israel (24)(25)(26), and show a better vaccine response compared to 56 French SARS-CoV-2 infection-naïve hemodialysis patients (82%) (27).…”

Section: Discussionsupporting

confidence: 91%

“…Age is a well-known key driver of vaccination response in hemodialysis patients with higher age being associated with a weaker antibody concentration as shown in the studies by Grupper at al ( 25 ). and Agur et al.…”

Section: Discussionmentioning

confidence: 98%

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

et al. 2021

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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.

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“…This is consistent with previous studies showing that patients receiving hemodialysis may require higher or repeated doses of hepatitis B vaccine to elicit a response, 7 and 1 recent study showing that 94% of patients receiving hemodialysis developed detectable anti-spike IgG antibodies 30 days after 2 doses of BNT162b2. 24 To vaccinate Canada's population of patients receiving hemodialysis with a second dose at the recommended 3-week interval would entail early allocation of about 25 000 doses, which in our view is modest, considering the high risk of exposure and COVID-19 case fatality rate of this population.…”

Section: Discussionmentioning

confidence: 99%

Short-term antibody response after 1 dose of BNT162b2 vaccine in patients receiving hemodialysis

Goupil

Benlarbi

Beaubien‐Souligny

et al. 2021

CMAJ

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BACKGROUND: Patients receiving in-R E S U L T S : O u r s t u d y i n c l u d e d after vaccination.Among those with centre hemodialysis are at high risk of 154 patients receiving hemodialysis previous SARS-CoV-2 infection, median exposure to SARS-CoV-2 and death if (135 without and 19 with previous SARS-anti-RBD IgG levels at 8 weeks in infected. One dose of the BNT162b2 SARS-CoV-2 infection), 40 controls (20 without patients receiving hemodialysis were CoV-2 vaccine is eficacious in the general and 20 with previous SARS-CoV-2 infec-similar to controls at 3 weeks (p = 0.3) population, but responses in patients tion) and convalescent plasma from and to convalescent plasma (p = 0.8). receiving hemodialysis are uncertain. 16 patients. Among those without previous SARS-CoV-2 infection, anti-RBD IgG INTERPRETATION: A single dose of METHODS: We obtained serial plasma was undetectable at 4 weeks in 75 of BNT162b2 vaccine failed to elicit a from patients receiving hemodialysis and 131 (57%, 95% confidence interval [CI] humoral immune response in most health care worker controls before and 47% to 65%) patients receiving hemodipatients receiving hemodialysis without after vaccination with 1 dose of the alysis, compared with 1 of 20 (5%, 95% previous SARS-CoV-2 infection, even BNT162b2 mRNA vaccine, as well as con-CI 1% to 23%) controls (p < 0.001). No after prolonged observation. In those valescent plasma from patients receiving patient with nondetectable levels at with previous SARS-CoV-2 infection, the hemodialysis who survived COVID-19. We 4 weeks developed anti-RBD IgG by antibody response was delayed. We measured anti-receptor binding domain 8 weeks. Results were similar in nonadvise that patients receiving hemodi-(RBD) immunoglobulin G (IgG) levels and immunosuppressed and younger indialysis be prioritized for a second stratified groups by evidence of previous viduals. Three patients receiving hemo-BNT162b2 dose at the recommended SARS-CoV-2 infection. dialysis developed severe COVID-19 3-week interval. Patients with end-stage kidney disease receiving in-this population. Some hemodialysis centres have thus prioricentre hemodialysis have been uniquely vulnerable dur-tized these patients for vaccination. ing the COVID-19 pandemic. For these patients, unlikeTo facilitate wider vaccine distribution during current shortfor most other people, self-isolation to avoid exposure to SARS-ages, 3 the National Advisory Committee on Immunization of Can-CoV-2 is impossible. Most patients receiving hemodialysis must ada has recommended delaying the second dose of the leave their homes 3 times weekly to receive their life-saving BNT162b2 vaccine from 3 to 16 weeks. 4 In a randomized contreatments, ofen in shared spaces for hours at a time. COVID-19 trolled trial (RCT), the clinical efficacy of the BNT162b2 was case fatality rates are 20%-30% for patients receiving hemodireported to be greater than 80% at 3 weeks afer the first dose. 5 alysis -10 times higher than in the general population. 1,2 However, no patients receiving hemodial...

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Humoral Response to the Pfizer BNT162b2 Vaccine in Patients Undergoing Maintenance Hemodialysis

Cited by 291 publications

References 19 publications

Anti-SARS-CoV-2 Receptor-Binding Domain Total Antibodies Response in Seropositive and Seronegative Healthcare Workers Undergoing COVID-19 mRNA BNT162b2 Vaccination

Anti-SARS-CoV-2 Receptor-Binding Domain Total Antibodies Response in Seropositive and Seronegative Healthcare Workers Undergoing COVID-19 mRNA BNT162b2 Vaccination

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

Short-term antibody response after 1 dose of BNT162b2 vaccine in patients receiving hemodialysis

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