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Chronic Lymphocytic Leukemia
Safety and efficacy of the BNT162b mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia
Ohad Benjamini,1,2 Lior Rokach,3 Gilad Itchaki,4 Andrei Braester,5 Lev Shvidel,6 Neta Goldschmidt,7 Shirley Shapira,8 Najib Dally,9 Abraham Avigdor,1,2 Galia Rahav,10,2 Yaniv Lustig,11 Shirley Shapiro Ben David,8 Riva Fineman,12 Alona Paz,13,14 Osnat Bairey,4 Aaron Polliack,7 Ilana Levy15 and Tamar Tadmor14,15 on behalf of the Israeli CLL study group (ICLLSG)
1Hematology Division, Chaim Sheba Medical Center, Tel-Hashomer, 2Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv; 3Department of Software and Information Systems Engineering, Ben-Gurion University of the Negev, Beer-Sheva; 4Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva; 5Department of Hematology, Galilee Medical Center, Nahariya; 6Hematology Institute, Kaplan Medical Center, Rehovot; 7Hematology, Hadassah Medical Center, Jerusalem; 8Health Division, Maccabi Healthcare Services, Tel Aviv; 9Division of Hematology, Ziv Medical Center, Safed; 10The Infectious Disease Unit, Sheba Medical Center, Tel-Hashomer; 11Central Virology Laboratory, Ministry of Health and Sheba Medical Center, Tel-Hashomer; 12Department of Hematology and BMT, Rambam Health Care Campus, Haifa;
13Infectious Disease Unit, Bnai Zion Medical Center, Haifa; 14The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa and 15Hematology Unit, Bnai Zion Medical Center, Haifa, Israel.
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 immunocompe- tent 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 con- clusion, the BNT162b2 mRNA COVID-19 vaccine was found to be safe in patients with CLL, but its efficacy is limited, particularly in treated patients.
Introduction
The coronavirus disease 2019 (COVID-19) pandemic has become the main healthcare issue worldwide since its appearance at the end of 2019, with the disease affecting millions of people globally.1 International efforts generated a vaccine against the causative virus, severe acute respiratory syndrome coronavirus-2 (SARS-
Ferrata Storti Foundation
Haematologica 2022 Volume 107(3):625-634
Correspondence:
TAMAR TADMOR
Tamar.tadmor@b-zion.org.il
Received: May 11, 2021. Accepted: July 8, 2021. Pre-published: July 29, 2021.
https://doi.org/10.3324/haematol.2021.279196 ©2022 Ferrata Storti Foundation
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