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. 2022 Mar 1;107(3):625-634.
doi: 10.3324/haematol.2021.279196.

Safety and efficacy of the BNT162b mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia

Ohad Benjamini  1 , Lior Rokach  2 , Gilad Itchaki  3 , Andrei Braester  4 , Lev Shvidel  5 , Neta Goldschmidt  6 , Shirley Shapira  7 , Najib Dally  8 , Abraham Avigdor  1 , Galia Rahav  9 , Yaniv Lustig  10 , Shirley Shapiro Ben David  7 , Riva Fineman  11 , Alona Paz  12 , Osnat Bairey  3 , Aaron Polliack  6 , Ilana Levy  13 , Tamar Tadmor  14
Affiliations

Safety and efficacy of the BNT162b mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia

Ohad Benjamini et al. Haematologica. .

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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Figures

Figure 1.
Figure 1.
Side effects of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia. Side effects were scored on a 0-5 scale with 0=no side effect.
Figure 2.
Figure 2.
Correlation between neutralizing antibodies and COVID-19 IgG titer. NEUT Ab: neutralizing antibodies.
Figure 3.
Figure 3.
Vaccine efficacy according to treatment. Vaccine response rate by treatment status, by treatment type and treatment timing and response to vaccine in patients who were treated or are currently being treated with BKT inhibitors or BCL2 inhibitors. mo: months; BKTi: BKT inhibitor; BCL2i: BCL2 inhibitor.
Figure 4.
Figure 4.
A simple scoring model to predict response to the BNT162b2 mRNA COVID-19 vaccine in individual patients with chronic lymphocytic leukemia. IgM, IgA and IgM levels in mg/dL; Hgb: hemoglobin.
See this image and copyright information in PMC

Comment in

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