Immune response and adverse events after vaccination against <scp>SARS‐CoV</scp>‐2 in adult patients with transfusion‐dependent thalassaemia

Delaporta, Polyxeni; Terpos, Evangelos; Solomou, Elena E.; Gumeni, Sentiljana; Nitsa, Evangelia; Apostolakou, Filia; Kyriakopoulou, Dimitra; Ntanasis‐Stathopoulos, Ioannis; Papassotiriou, Ioannis; Trougakos, Ioannis P.; Dimopoulos, Meletios Α.; Kattamis, Antonis

doi:10.1111/bjh.18146

Cited by 7 publications

(4 citation statements)

References 17 publications

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“…According to the protocol shown in Figure 1 A and Figure 2 , all the enrolled β-thalassemia patients received two doses of either the BNT162b2 (Pfizer–BioNTech) or the mRNA-1273 (Moderna) vaccines before starting with the daily intake of 2 mg of sirolimus as described by Gamberini et al [ 32 ] and by Zuccato et al [ 19 ]. The anti-SARS-CoV-2 IgG levels ( Figure 2 ) were found to be comparable to those reported elsewhere of β-thalassemia patients (not treated with sirolimus) [ 43 , 44 , 45 ].…”

Section: Discussionsupporting

confidence: 85%

Effects of Sirolimus Treatment on Fetal Hemoglobin Production and Response to SARS-CoV-2 Vaccination: A Case Report Study

et al. 2023

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The β-thalassemias are a group of monogenic hereditary hematological disorders caused by deletions and/or mutations of the β-globin gene, leading to low or absent production of adult hemoglobin (HbA). For β-thalassemia, sirolimus has been under clinical consideration in two trials (NCT03877809 and NCT04247750). A reduced immune response to anti-SARS-CoV-2 vaccination has been reported in organ recipient patients treated with the immunosuppressant sirolimus. Therefore, there was some concern regarding the fact that monotherapy with sirolimus would reduce the antibody response after SARS-CoV-2 vaccination. In the representative clinical case reported in this study, sirolimus treatment induced the expected increase of fetal hemoglobin (HbF) but did not prevent the production of anti-SARS-CoV-2 IgG after vaccination with mRNA-1273 (Moderna). In our opinion, this case report should stimulate further studies on β-thalassemia patients under sirolimus monotherapy in order to confirm the safety (or even the positive effects) of sirolimus with respect to the humoral response to anti-SARS-CoV-2 vaccination. In addition, considering the extensive use of sirolimus for the treatment of other human pathologies (for instance, in organ transplantation, systemic lupus erythematosus, autoimmune cytopenia, and lymphangioleiomyomatosis), this case report study might be of general interest, as large numbers of patients are currently under sirolimus treatment.

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Section: Discussionsupporting

confidence: 85%

Effects of Sirolimus Treatment on Fetal Hemoglobin Production and Response to SARS-CoV-2 Vaccination: A Case Report Study

et al. 2023

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“…Delaporta et al tested the efficacy of vaccination by measuring neutralizing antibody levels in patients with thalassemia and controls. It was observed that there was a significant increase in neutralizing antibody levels at 3 and 7 weeks postvaccination, with no difference between the patient and control groups [18]. Sgherza et al performed a prospective case-control study on 65 TDT patients and compared them with 63 healthy controls for a serological response after receiving two doses of the Pfizer-BioNTech vaccine.…”

Section: Discussionmentioning

confidence: 99%

Adverse Effects of COVID-19 Vaccination in Patients with Transfusion-Dependent Thalassemia: An Observational Study from a Tertiary Care Center in Punjab, India

Kakkar¹,

Jain²,

Jain³

et al. 2023

Acta Haematol

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Vaccination against SARS-CoV2 is the most important weapon in the arsenal in the battle against COVID-19. There is concern about an increased risk of adverse effects in patients with transfusion-dependent thalassemia (TDT), which affects vaccine acceptance. A predesigned questionnaire was used to evaluate adverse effects (local/systemic within 90 days after vaccination) in participants >18 years of age with TDT. A total of 100 patients received 129 vaccine doses. The mean age of the patients was 24.3 ± 5.7 years and M: F ratio of 1.6:1. Covishield (Serum Institute of India) was administered to 89% of the participants and Covaxin (Bharat Biotech Limited) to 11% of the participants. Adverse effects were documented in 62% of the respondents and were more pronounced after the first dose (52%) compared to the second dose (9%). The most frequent adverse effects were pain at the injection site (43%) and fever (37%). All adverse effects were mild and none of the participants required hospitalization. There were no differences in adverse effects among different vaccines, the presence or absence of comorbidities, blood groups, or ferritin levels. The SARS-CoV2 vaccine appears to be safe in patients with TDT.

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“…Furthermore, we found that patients with β-TM in general had higher anti-SARS-CoV-2 IgG antibody levels following infection or vaccination as compared to the control group. Previous studies have examined the immune responses following SARS-CoV-2 vaccination in patients with hemoglobinopathy, including thalassemia, 21 , 22 , 23 but the current study specifically concerns a cohort of patients with severely iron-overloaded, transfusion-dependent β-TM. This is interesting, as iron availability is crucial for B and T cell differentiation, 24 and iron deficiency has been associated with reduced responses to vaccines.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcome and humoral immune responses of β-thalassemia major patients with severe iron overload to SARS-CoV-2 infection and vaccination: a prospective cohort study

Ghoti,

Zreid,

Ghoti

et al. 2023

eClinicalMedicine

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Immune response and adverse events after vaccination against SARS‐CoV‐2 in adult patients with transfusion‐dependent thalassaemia

Cited by 7 publications

References 17 publications

Effects of Sirolimus Treatment on Fetal Hemoglobin Production and Response to SARS-CoV-2 Vaccination: A Case Report Study

Effects of Sirolimus Treatment on Fetal Hemoglobin Production and Response to SARS-CoV-2 Vaccination: A Case Report Study

Adverse Effects of COVID-19 Vaccination in Patients with Transfusion-Dependent Thalassemia: An Observational Study from a Tertiary Care Center in Punjab, India

Clinical outcome and humoral immune responses of β-thalassemia major patients with severe iron overload to SARS-CoV-2 infection and vaccination: a prospective cohort study

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