Immunogenicity and Safety of the BNT162b2 mRNA COVID-19 Vaccine Among Actively Treated Cancer Patients

Abstract

Background Activity and safety of the SARS-CoV2 BNT162b2 vaccine in actively treated patients with solid tumors is currently unknown. Methods We conducted a retrospective study of 326 patients with solid tumors treated with anti-cancer medications to determine the proportion of cancer patients with immunogenicity against SARS-CoV2, following two doses of the BNT162b2 vaccine. Control group was comprised of 164 vaccinated healthy adults. Anti-SARS-CoV-2 S IgG (Immunoglobulin G) antibodies (Abs) were measured, using level>50 AU/ml as cutoff for seropositivity. Adverse effects were collected using a questionnaire. All statistical tests were 2-sided. Results Most patients (205, 62.9%) were treated with chemotherapy, either alone or with additional therapy, 55 (16.9%) were treated with immune checkpoint inhibitors (ICI) and 38 (11.7%) with targeted therapy alone, 28 (8.6%) received other combinations. The vaccine was well tolerated and no severe side effects were reported. Among patients with cancer 39 (11.9%) were seronegative, compared to 5 (3.0%) of the control group (P=0.001). Median IgG titers were statistically significant lower among patients with cancer compared to control (931 AU/ml vs. 2817 AU/ml, P=0.003). Seronegativity proportions were higher in the chemotherapy treated group (19, 18.8%) compared to the ICI-treated patients (5, 9.1%) and to those treated with targeted therapy (1, 2.6%) (P=0.02. Titers were also statistically significant different among treatment types (P=0.002). Conclusion The BNT162b2 vaccine is safe and effective in actively treated patients with cancer. The relatively lower antibody titers and lower proportion of seropositive patients, especially among chemotherapy treated patients, call for continuing the use of personal protective measures in these patients, even following vaccination.

Safety and immunogenicity of the COVID-19 vaccine BNT162b2 in patients undergoing chemotherapy for solid cancer

“…Interestingly, anti-S1 antibody levels were significantly lower in not only the CC group but also in the ICI group. Because ICI is known to enhance the immune system, this result was unexpected, and similar results to ours were reported by other research group s [ 7 , 15 ]. It is possible that the effect of cytotoxic chemotherapy and/or RT before ICI therapy and the immunosuppressed state due to malignancy itself suppress antibody production.…”

“…Second, the third vaccination with the COVID-19 vaccines might be effective. The efficacy of three doses has been reported in patients with solid organ transplantation who also have impaired antibody production due to immunosuppressants [ 15 ]. We believe that it is important to continue to actively collect and offer information on vaccine efficacy for cancer patients .…”

Immunological and clinical efficacy of COVID-19 vaccines in immunocompromised populations: a systematic review

“…Forty-three studies reported immunogenicity in patients with haematological malignancy ( n = 6259, 79.9%) and cancer ( n = 1480, 18.9%) ( Table S3 ) [ 30 , 33 , 35 , 42 , 43 , 49 , 52 , 59 , 60 , 70 , 71 , 76 ], [ [83] , [84] , [85] , [86] , [87] , [88] , [89] , [90] , [91] , [92] , [93] , [94] , [95] , [96] , [97] , [98] , [99] , [100] , [101] , [102] , [103] , [104] , [105] , [106] , [107] , [108] , [109] , [110] , [111] , [112] , [113] ]. Twenty-three of these studies included a control population (overall n = 1931) [ 30 , 33 , 42 , 43 , 60 , 71 , 76 , [85] , [86] , [87] , [88] , [89] , 91 , 92 , 96 , 98 , 104 , [106] , [107] , [108] ...…”

“…Malignancy-specific treatments were repeatedly associated with non-responder status, whether taken as a whole or specific treatments such as cytotoxic chemotherapy, Bruton tyrosine kinase inhibitors, anti-CD20 treatment or daratumumab-based regimens [ 30 , 33 , 35 , 42 , 43 , 70 , 71 , 76 , 83 , 85 , 86 , [89] , [90] , [91] , [92] , 95 , 100 , [102] , [103] , [104] , [105] , [106] , 110 , 112 , 113 ] ( Table S3 ).…”

Immunogenicity and safety of BNT162b2 mRNA vaccine booster in actively treated patients with cancer

“…Although patients with cancer were excluded from the pivotal BNT162b2 vaccine trials, a series of studies examined the safety and efficacy of the vaccine in patients with solid tumours; all showed consistent data, 1 , 2 , 3 , 4 indicating the vaccine was safe and effective. At a median of 76 days after the second vaccine dose, 287 (88%) of 326 vaccine recipients who had cancer had protective antibody concentrations above the minimal threshold considered as seropositive, compared with 159 (97%) of 164 healthy individuals.…”