Safety and immunogenicity of the COVID-19 vaccine BNT162b2 for patients with breast and gynecological cancer on active anticancer therapy: Results of a prospective observational study

Abstract

BackgroundVaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are highly effective. Nevertheless, immunocompromised participants were excluded from randomized controlled clinical trials. This study evaluates the efficacy and safety of the Pfizer/BioNTech BNT162b2 (BNT162b2) vaccine in patients with breast and gynecological cancer treated with active anticancer therapy versus a control cohort of healthy participants.MethodsImmune responses to the BNT162b2 vaccine in patients with breast cancer (n = 44) or a gynecological malignancy (n = 6) on active anticancer therapy (28 on chemotherapy, mostly anthracycline- or taxane-based, and 22 on target therapy) and in a control cohort of participants without cancer (n = 67) were investigated by SARS-CoV-2 neutralizing antibody titers measured by S1-binding immunoglobulin G (IgG) concentrations assessed using the LIAISON XL tools (DiaSorin S.p.A.). Response was assessed after a second dose of the BNT162b2 vaccine administered before and at least 3 weeks after the vaccine dose.ResultsOverall, 43/50 (86%) patients of the cancer cohort (74% in the breast cancer group and 100% in the gynecological malignancy group) developed IgG antibodies after the second dose of the BNT162b2 vaccine. There were no statistically significant differences in responder rates between patients treated with chemotherapy and those on target therapy. The majority of patients who received chemotherapy with or without target therapy, 21/28 (75%), developed a reliable antibody titer after a vaccine. All seven non-responder patients were undergoing an anthracycline-based regimen. Based on IgG levels (0–400 AU/ml), patients were classified as negative (‘non-responders’), weakly positive, or strongly positive (‘responders’). No delay in cancer therapy schedule or reported side effects were recorded after BNT162b2 vaccine administration. All healthy participants were strongly positive. Responder rates differed significantly between the two study cohorts (p < 0.001).ConclusionsMost patients develop antibody titers after the second immunization. However, given the persistence of non-responders or weak responders, additional immunization booster seems to be required, along with proactive planning in the vaccination schedule, with vaccine administration spaced out over time with respect to chemotherapy.

Vaccine beliefs, adverse effects, and quality of life in patients with cancer undergoing routine COVID-19 vaccination

“…Concerns about delaying vaccination or interference with therapy schedules is reported as a driver of hesitancy in the cancer population 4 23 . Our finding of no delays attributable to vaccination should help allay concerns, supporting reports from smaller cohorts 7 8 .…”

“…However, many patients had prior COVID-19 exposure and most data were collected during the pandemic peak 6 . There is minimal information on interruptions to cancer care and to our knowledge, no reports regarding effects of vaccination on participant-reported quality of life (QoL) 7 8 .…”

mRNA Vaccines against SARS-CoV-2: Advantages and Caveats

“…Most studies highlight the induction of S-specific antibodies after mRNA vaccination in solid-tumor patients and oncohematological patients. This is especially true in the third week after the administration of the second dose, reaching similar numbers of antibody titers as healthy donor groups [ 54 , 55 , 56 , 57 , 58 , 59 , 60 ]. Some studies also detected CD4 and CD8 T cells specific for the S protein in solid-tumor patients up to 6 months post-vaccination.…”

COVID-19 in patients with thymic epithelial tumors with or without Good’s syndrome: a single-center retrospective study

“…SARS-Cov-2 vaccine have dramatically contributed to reduce COVID 19 occurrence, severity and mortality in both healthy individual and cancer patients [ 18 ]. A recent study carried out by our group showed safety of mRNA vaccine in TET patients, with no reported cases of worsening autoimmunity or other complications.…”