Efficacy and safety of BNT162b2 vaccination in patients with solid cancer receiving anticancer therapy – a single centre prospective study

Abstract

Aim Patients with cancer are at an increased risk for severe coronavirus disease of 2019, thus data on the safety and efficacy of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted this prospective study of patients with cancer vaccinated with BNT162b2 and monitored for antibody response and safety. The aim was to evaluate the rate of seropositivity and define predictors for non-reactive immune response. Furthermore, we evaluated the frequency and the severity of adverse events. Methods The study included patients with solid tumours undergoing anticancer treatment and immunocompetent health-care workers serving as controls. Serum titres of the receptor-binding domain (RBD) immunoglobulin G (IgG) and neutralising antibodies were measured 2–4 weeks after each vaccine dose. Results The analysis included 129 patients, of which 70.5% patients were metastatic. Patients were treated with chemotherapy (55%), immunotherapy (34.1%), biological agents (24.8%), hormonal treatment (8.5%) and radiotherapy (4.6%), that were given either alone or in combinations. The seropositivity rate among patients with cancer and controls was 32.4% versus 59.8% (p < 0.0001) after the first dose and 84.1% versus 98.9% (p < 0.0001) after the second dose, respectively. Median RBD-IgG titre was lower among patients than controls (p < 0.0001). Patients who were seronegative after the second dose had significantly more comorbidities than that with patients with seropositivity (77.8% vs 41.1%, respectively, p = 0.0042). Conclusion Adequate antibody response after BNT162b2 vaccination was achieved after two doses but not after one dose, in patients with cancer vaccinated during anticancer therapy.

Impaired seroconversion after SARS-CoV-2 mRNA vaccines in patients with solid tumours receiving anticancer treatment

“…In accordance with previous studies 14 , 15 , 16 , 20 , 21 , 26 , 27 , our data in this specific population demonstrate a lower probability to obtain seroconversion after a complete course of SARS-CoV-2 mRNA vaccination. About 6% of cancer patients in treatment failed to develop an immune response after mRNA vaccination, as compared to only 0.2% in controls, accounting for a 30-fold higher probability.…”

“…As the spike-protein (S) retains a pivotal role in viral infection and pathogenesis of COVID-19, novel messenger ribonucleic acid (mRNA) vaccines (BNT162b2 by Pfizer/BioNTech, and mRNA-1273 by Moderna) were found able to induce adequate anti-S response in healthy patients, obtaining more than 90% efficacy in preventing a severe course of COVID-19 12 , 13 . Despite these promising results, cancer patients were mostly excluded from clinical trials, and their ability of seroconversion is now the main issue of a growing number of studies 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 . However, some of these studies assessed heterogeneous populations including both solid tumours and hematological malignancies.…”

Third dose of anti-SARS-CoV-2 vaccine for patients with cancer: Should humoral responses be monitored? A position article

“…This strategy is supported by several studies focused on the durability of vaccine-induced antibodies (Abs) levels and clinical studies conducted in the general population, as well ( 1 , 2 , 3 , 4 , 5 ). Nevertheless, to date, there are no recommendations allowing for a personalized prescription dedicated to immunocompromised people, including patients with cancer displaying lower anti-SARS-CoV-2 vaccine immune responses ( 6 , 7 , 8 , 9 , 10 ). Another issue is still unresolved, and it concerns the exact timing of the earlier waning immunity observed at post-vaccination in immunocompromised patients, such as patients with cancer undergoing immunosuppressive therapy.…”

“…The main data concerning humoral vaccine responses in solid cancer or HM patients can be summarized as follows: Low seroconversion rate after the first vaccine dose (D1) ( 6 , 7 , 8 , 9 , 10 ); Conversely, an overall high seroconversion rate in solid oncology patients after the second dose (D2), with more than 80-90% of them having developed anti-Spike (S) Abs ( 6 , 7 , 8 , 9 , 10 , 27 , 28 , 29 ); Lower median anti-S Abs levels compared with healthy control (HC) group, consisting of highly heterogeneous responses with patients classified from low-responders to high-responders, the latter displaying a similar humoral response than HC group ( 6 , 7 , 8 , 9 , 10 , 27 , 28 , 29 ); A much lower seroconversion rate in patients with HM ( 30 , 31 , 32 ), especially those exhibiting chronic lymphoid leukemia (CLL), even when left untreated ( 31 ), as well as patients with multiple myeloma and those with additional deleterious prognostic factors, including age ( 31 ); The poorest vaccine response rate was recorded in patients undergoing anti-CD20 therapy or having stopped it for less than 12 months, with virtually no humoral response at all after a full two-dose vaccination ( 32 , 33 ). …”

“…Conversely, an overall high seroconversion rate in solid oncology patients after the second dose (D2), with more than 80-90% of them having developed anti-Spike (S) Abs ( 6 , 7 , 8 , 9 , 10 , 27 , 28 , 29 );…”