Safety and efficacy of the BNT162b mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia
Patients with chronic lymphocytic leukemia (CLL) have a suboptimal humoral response to vaccination. Recently, BNT162b2, an mRNA COVID-19 vaccine with a high efficacy of 95% in immunocompetent individuals, was introduced. We investigated the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine i...
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| Published in | Haematologica (Roma) Vol. 107; no. 3; pp. 625 - 634 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Italy
Fondazione Ferrata Storti
01.03.2022
Ferrata Storti Foundation |
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| Abstract | Patients with chronic lymphocytic leukemia (CLL) have a suboptimal humoral response to vaccination. Recently, BNT162b2, an mRNA COVID-19 vaccine with a high efficacy of 95% in immunocompetent individuals, was introduced. We investigated the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with CLL from nine medical centers in Israel, Overall 400 patients were included, of whom 373 were found to be eligible for the analysis of antibody response. The vaccine appeared to be safe and only grade 1-2 adverse events were seen in 50% of the patients. Following the second dose, an antibody response was detected in 43% of the cohort. Among these CLL patients, 61% of the treatment-na ve patients responded to the vaccine, while responses developed in only 18% of those with ongoing disease, 37% of those previously treated with a BTK inhibitor and 5% of those recently given an anti-CD20 antibody. Among patients treated with BCL2 as monotherapy or in combination with anti-CD20, 62% and 14%, respectively, developed an immune response. There was a high concordance between neutralizing antibodies and positive serological response to spike protein. Based on our findings we developed a simple seven-factor score including timing of any treatment with anti-CD20, age, treatment status, and IgG, IgA, IgM and hemoglobin levels. The sum of all the above parameters can serve as a possible estimate to predict whether a given CLL patient will develop sufficient antibodies. In conclusion, the BNT162b2 mRNA COVID-19 vaccine was found to be safe in patients with CLL, but its efficacy is limited, particularly in treated patients. |
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| AbstractList | Patients with chronic lymphocytic leukemia (CLL) have a suboptimal humoral response to vaccination. Recently, BNT162b2, an mRNA COVID-19 vaccine with a high efficacy of 95% in immunocompetent individuals, was introduced. We investigated the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with CLL from nine medical centers in Israel, Overall 400 patients were included, of whom 373 were found to be eligible for the analysis of antibody response. The vaccine appeared to be safe and only grade 1-2 adverse events were seen in 50% of the patients. Following the second dose, an antibody response was detected in 43% of the cohort. Among these CLL patients, 61% of the treatment-na ve patients responded to the vaccine, while responses developed in only 18% of those with ongoing disease, 37% of those previously treated with a BTK inhibitor and 5% of those recently given an anti-CD20 antibody. Among patients treated with BCL2 as monotherapy or in combination with anti-CD20, 62% and 14%, respectively, developed an immune response. There was a high concordance between neutralizing antibodies and positive serological response to spike protein. Based on our findings we developed a simple seven-factor score including timing of any treatment with anti-CD20, age, treatment status, and IgG, IgA, IgM and hemoglobin levels. The sum of all the above parameters can serve as a possible estimate to predict whether a given CLL patient will develop sufficient antibodies. In conclusion, the BNT162b2 mRNA COVID-19 vaccine was found to be safe in patients with CLL, but its efficacy is limited, particularly in treated patients. Patients with chronic lymphocytic leukemia (CLL) have a suboptimal humoral response to vaccination. Recently, BNT162b2, an mRNA COVID-19 vaccine with a high efficacy of 95% in immunocompetent individuals, was introduced. We investigated the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with CLL from nine medical centers in Israel, Overall 400 patients were included, of whom 373 were found to be eligible for the analysis of antibody response. The vaccine appeared to be safe and only grade 1-2 adverse events were seen in 50% of the patients. Following the second dose, an antibody response was detected in 43% of the cohort. Among these CLL patients, 61% of the treatment-na ve patients responded to the vaccine, while responses developed in only 18% of those with ongoing disease, 37% of those previously treated with a BTK inhibitor and 5% of those recently given an anti-CD20 antibody. Among patients treated with BCL2 as monotherapy or in combination with anti-CD20, 62% and 14%, respectively, developed an immune response. There was a high concordance between neutralizing antibodies and positive serological response to spike protein. Based on our findings we developed a simple seven-factor score including timing of any treatment with anti-CD20, age, treatment status, and IgG, IgA, IgM and hemoglobin levels. The sum of all the above parameters can serve as a possible estimate to predict whether a given CLL patient will develop sufficient antibodies. In conclusion, the BNT162b2 mRNA COVID-19 vaccine was found to be safe in patients with CLL, but its efficacy is limited, particularly in treated patients.Patients with chronic lymphocytic leukemia (CLL) have a suboptimal humoral response to vaccination. Recently, BNT162b2, an mRNA COVID-19 vaccine with a high efficacy of 95% in immunocompetent individuals, was introduced. We investigated the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with CLL from nine medical centers in Israel, Overall 400 patients were included, of whom 373 were found to be eligible for the analysis of antibody response. The vaccine appeared to be safe and only grade 1-2 adverse events were seen in 50% of the patients. Following the second dose, an antibody response was detected in 43% of the cohort. Among these CLL patients, 61% of the treatment-na ve patients responded to the vaccine, while responses developed in only 18% of those with ongoing disease, 37% of those previously treated with a BTK inhibitor and 5% of those recently given an anti-CD20 antibody. Among patients treated with BCL2 as monotherapy or in combination with anti-CD20, 62% and 14%, respectively, developed an immune response. There was a high concordance between neutralizing antibodies and positive serological response to spike protein. Based on our findings we developed a simple seven-factor score including timing of any treatment with anti-CD20, age, treatment status, and IgG, IgA, IgM and hemoglobin levels. The sum of all the above parameters can serve as a possible estimate to predict whether a given CLL patient will develop sufficient antibodies. In conclusion, the BNT162b2 mRNA COVID-19 vaccine was found to be safe in patients with CLL, but its efficacy is limited, particularly in treated patients. Patients with chronic lymphocytic leukemia (CLL) have a suboptimal humoral response to vaccination. Recently, BNT162b2, an mRNA COVID-19 vaccine with a high efficacy of 95% in immunocompetent individuals, was introduced. We investigated the safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with CLL from nine medical centers in Israel, Overall 400 patients were included, of whom 373 were found to be eligible for the analysis of antibody response. The vaccine appeared to be safe and only grade 1-2 adverse events were seen in 50% of the patients. Following the second dose, an antibody response was detected in 43% of the cohort. Among these CLL patients, 61% of the treatment-naïve patients responded to the vaccine, while responses developed in only 18% of those with ongoing disease, 37% of those previously treated with a BTK inhibitor and 5% of those recently given an anti-CD20 antibody. Among patients treated with BCL2 as monotherapy or in combination with anti-CD20, 62% and 14%, respectively, developed an immune response. There was a high concordance between neutralizing antibodies and positive serological response to spike protein. Based on our findings we developed a simple seven-factor score including timing of any treatment with anti-CD20, age, treatment status, and IgG, IgA, IgM and hemoglobin levels. The sum of all the above parameters can serve as a possible estimate to predict whether a given CLL patient will develop sufficient antibodies. In conclusion, the BNT162b2 mRNA COVID-19 vaccine was found to be safe in patients with CLL, but its efficacy is limited, particularly in treated patients. |
| Author | Itchaki, Gilad Rokach, Lior Braester, Andrei Dally, Najib Fineman, Riva Polliack, Aaron Rahav, Galia Bairey, Osnat Shapira, Shirley Benjamini, Ohad Tadmor, Tamar Lustig, Yaniv Avigdor, Abraham Ben David, Shirley Shapiro Shvidel, Lev Levy, Ilana Paz, Alona Goldschmidt, Neta |
| AuthorAffiliation | 3 Department of Software and Information Systems Engineering, Ben-Gurion University of the Negev , Beer-Sheva 7 Hematology, Hadassah Medical Center , Jerusalem 14 The Ruth and Bruce Rappaport Faculty of Medicine , Technion, Haifa 2 Sackler Faculty of Medicine, Tel-Aviv University , Tel-Aviv 1 Hematology Division, Chaim Sheba Medical Center , Tel-Hashomer 15 Hematology Unit , Bnai Zion Medical Center , Haifa, Israel 12 Department of Hematology and BMT, Rambam Health Care Campus , Haifa 5 Department of Hematology, Galilee Medical Center , Nahariya 13 Infectious Disease Unit , Bnai Zion Medical Center , Haifa 4 Institute of Hematology , Davidoff Cancer Center, Rabin Medical Center, Petah Tikva 10 The Infectious Disease Unit , Sheba Medical Center , Tel-Hashomer 6 Hematology Institute , Kaplan Medical Center, Rehovot 9 Division of Hematology, Ziv Medical Center , Safed 8 Health Division, Maccabi Healthcare Services , Aviv 11 Central Virology Laboratory , Ministry of Health and Sheba Medical Center , Tel |
| AuthorAffiliation_xml | – name: 8 Health Division, Maccabi Healthcare Services , Aviv – name: 10 The Infectious Disease Unit , Sheba Medical Center , Tel-Hashomer – name: 7 Hematology, Hadassah Medical Center , Jerusalem – name: 4 Institute of Hematology , Davidoff Cancer Center, Rabin Medical Center, Petah Tikva – name: 5 Department of Hematology, Galilee Medical Center , Nahariya – name: 11 Central Virology Laboratory , Ministry of Health and Sheba Medical Center , Tel-Hashomer – name: 12 Department of Hematology and BMT, Rambam Health Care Campus , Haifa – name: 15 Hematology Unit , Bnai Zion Medical Center , Haifa, Israel – name: 1 Hematology Division, Chaim Sheba Medical Center , Tel-Hashomer – name: 13 Infectious Disease Unit , Bnai Zion Medical Center , Haifa – name: 14 The Ruth and Bruce Rappaport Faculty of Medicine , Technion, Haifa – name: 9 Division of Hematology, Ziv Medical Center , Safed – name: 2 Sackler Faculty of Medicine, Tel-Aviv University , Tel-Aviv – name: 6 Hematology Institute , Kaplan Medical Center, Rehovot – name: 3 Department of Software and Information Systems Engineering, Ben-Gurion University of the Negev , Beer-Sheva |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34320789$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1056/NEJMoa2001017 10.1016/j.vaccine.2021.01.001 10.1016/j.eclinm.2020.100651 10.1056/NEJMoa2034577 10.1016/j.vaccine.2018.05.012 10.1007/s10928-007-9057-1 10.1182/blood.2020008758 10.1038/s41375-020-0959-x 10.1038/s41375-020-01074-4 10.1182/blood-2017-09-806398 10.1182/blood.2020009966 10.1056/NEJMoa2101765 10.1080/17474086.2018.1407645 10.1038/s41586-020-2814-7 10.14366/usg.16045 10.1038/s41375-020-0941-7 10.1016/j.cell.2020.12.015 10.1182/blood.2020006965 10.1016/j.chom.2020.06.020 10.1007/s10875-012-9813-x 10.1182/blood.2021011568 10.1093/clinchem/hvaa198 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Disclosures Contributions TT and OB designed, organized and wrote the manuscript. LR performed the statistical and machine learning analysis including the seven-parameter models, and was involved in writing the manuscript. APol helped to write the manuscript. GI, AB, LS, NG, SS, ND, AA, GRYL, SSBD, RF, APaz, and IL contributed patients’ data. No conflicts of interest to disclose. |
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| References | 33780 33765 33776 33766 33777 33774 33785 33775 33786 33772 33783 33773 33784 33770 33781 33771 33782 33769 33767 33778 33768 33779 34320792 - Haematologica. 2022 Mar 01;107(3):572-573 |
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| SubjectTerms | Antibodies, Viral BNT162 Vaccine COVID-19 - prevention & control COVID-19 Vaccines - adverse effects Humans Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy RNA, Messenger - genetics SARS-CoV-2 |
| Title | Safety and efficacy of the BNT162b mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia |
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