Venous Thromboembolic Risk Does Not Increase After a Third Dose of SARS-CoV-2 mRNA-BNT162b2 Vaccine in Cancer Patients Receiving Active Systemic Therapies: Updated Results from the Vax-On-Third-Profile Study DOI Creative Commons
Fabrizio Nelli, Enzo Maria Ruggeri, Antonella Virtuoso

et al.

Vaccines, Journal Year: 2025, Volume and Issue: 13(4), P. 392 - 392

Published: April 8, 2025

(1) Background: Clinical evidence has raised concerns regarding a potential link between COVID-19 mRNA-based vaccines and the occurrence of thromboembolic events. So far, no research explored effects this possible interaction in cancer patients undergoing active treatment. We leveraged prospective monitoring from Vax-On-Third-Profile study to examine development venous thromboembolism (VTE) after third dose mRNA-BNT162b2 (tozinameran) its association with antibody lymphocyte responses. (2) Methods: Patients who had received tozinameran not experienced any VTE previous 30 days were eligible. A serological evaluation was conducted before booster vaccination (timepoint-1) four weeks thereafter (timepoint-2) measure titers against SARS-CoV-2 spike protein, as well determine absolute counts T-helper cells, T-cytotoxic B NK cells. Data acquired November 2021 October 2022 analyzed 2023. (3) Results: The present involved 429 given 26 September 2021. Among treatments interest, 109 (25.4%) targeted therapy, 111 (25.9%) cytotoxic chemotherapy, 39 (9.1%) immune checkpoint inhibitors, 21 (4.9%) endocrine (7.0%) combination chemotherapy agents eight preceding dosing. In addition, 119 (27.7%) discontinued systemic therapy for at least 12 accounted reference subgroup. After median follow-up time 10.6 (95% CI 8.1-11.7) months, we observed 31 events general population, an overall incidence rate 7.2% 5.0-10.1). immunization 99 85-112) days. univariate comparison, exposed therapies (11.3% [95% 6.0-18.9]; p = 0.030) or inhibitors (16.2% 6.2-32.0]; 0.012) significantly higher than cohort (3.4% 0.9-8.5]). Univariate analysis responses showed that only dynamic changes pertaining cell distributions correlated occurrence. Multivariate regression confirmed high-level response (OR 6.10 [9% 2.16-17.21]; 0.001), history 9.81 [3.99-24.13]; < presence central catheter 5.02 1.84-13.67]; 0.002) independently associated increased risk VTE. (4) Conclusions: This provides unprecedented have developing tozinameran, regardless type therapy. specific pattern appears increase risk, underlying dysregulation causal cofactor. These findings emphasize need additional periodic patients.

Language: Английский

Venous Thromboembolic Risk Does Not Increase After a Third Dose of SARS-CoV-2 mRNA-BNT162b2 Vaccine in Cancer Patients Receiving Active Systemic Therapies: Updated Results from the Vax-On-Third-Profile Study DOI Creative Commons
Fabrizio Nelli, Enzo Maria Ruggeri, Antonella Virtuoso

et al.

Vaccines, Journal Year: 2025, Volume and Issue: 13(4), P. 392 - 392

Published: April 8, 2025

(1) Background: Clinical evidence has raised concerns regarding a potential link between COVID-19 mRNA-based vaccines and the occurrence of thromboembolic events. So far, no research explored effects this possible interaction in cancer patients undergoing active treatment. We leveraged prospective monitoring from Vax-On-Third-Profile study to examine development venous thromboembolism (VTE) after third dose mRNA-BNT162b2 (tozinameran) its association with antibody lymphocyte responses. (2) Methods: Patients who had received tozinameran not experienced any VTE previous 30 days were eligible. A serological evaluation was conducted before booster vaccination (timepoint-1) four weeks thereafter (timepoint-2) measure titers against SARS-CoV-2 spike protein, as well determine absolute counts T-helper cells, T-cytotoxic B NK cells. Data acquired November 2021 October 2022 analyzed 2023. (3) Results: The present involved 429 given 26 September 2021. Among treatments interest, 109 (25.4%) targeted therapy, 111 (25.9%) cytotoxic chemotherapy, 39 (9.1%) immune checkpoint inhibitors, 21 (4.9%) endocrine (7.0%) combination chemotherapy agents eight preceding dosing. In addition, 119 (27.7%) discontinued systemic therapy for at least 12 accounted reference subgroup. After median follow-up time 10.6 (95% CI 8.1-11.7) months, we observed 31 events general population, an overall incidence rate 7.2% 5.0-10.1). immunization 99 85-112) days. univariate comparison, exposed therapies (11.3% [95% 6.0-18.9]; p = 0.030) or inhibitors (16.2% 6.2-32.0]; 0.012) significantly higher than cohort (3.4% 0.9-8.5]). Univariate analysis responses showed that only dynamic changes pertaining cell distributions correlated occurrence. Multivariate regression confirmed high-level response (OR 6.10 [9% 2.16-17.21]; 0.001), history 9.81 [3.99-24.13]; < presence central catheter 5.02 1.84-13.67]; 0.002) independently associated increased risk VTE. (4) Conclusions: This provides unprecedented have developing tozinameran, regardless type therapy. specific pattern appears increase risk, underlying dysregulation causal cofactor. These findings emphasize need additional periodic patients.

Language: Английский

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