Evidence map›Paper›PMID 40333305›Full record

ArticleVaccines2025

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.

Fabrizio Nelli, Enzo Maria Ruggeri, Antonella Virtuoso, Diana Giannarelli, Jona Barbuta, Fabrizio Chegai, Armando Raso, Valentina Panichi, Julio Rodrigo Giron Berrios, Marta Schirripa and 7 more

Abstract read
In one paragraph

Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Fabrizio NelliDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.ORCID 0000-0001-8374-1362
Enzo Maria RuggeriDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Antonella VirtuosoDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Diana GiannarelliBiostatistics Unit, Scientific Directorate, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00136 Rome, Italy.
Jona BarbutaDepartment of Medicine, Vascular Diagnostics, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Fabrizio ChegaiDepartment of Oncology and Hematology, Thoracic and Interventional Radiology, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Armando RasoDepartment of Oncology and Hematology, Thoracic and Interventional Radiology, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Valentina PanichiDepartment of Oncology and Hematology, Citofluorimetry Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Julio Rodrigo Giron BerriosDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.ORCID 0000-0003-2042-4006
Marta SchirripaDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Cristina FioreDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Francesco SchietromaDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Alessandro StrusiDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Carlo SignorelliDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.ORCID 0000-0001-9710-4962
Mario Giovanni ChilelliDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Francesca PrimiDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.
Agnese FabbriDepartment of Oncology and Hematology, Medical Oncology Unit, Central Hospital of Belcolle, 01100 Viterbo, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

(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 has explored the effects of this possible interaction in cancer patients undergoing active treatment. We leveraged prospective monitoring from the Vax-On-Third-Profile study to examine the development of venous thromboembolism (VTE) after the third dose of mRNA-BNT162b2 (tozinameran) and its association with antibody and lymphocyte responses. (2) Methods: Patients who had received a third dose of tozinameran and had not experienced any VTE in the previous 30 days were eligible. A serological evaluation was conducted before the booster vaccination (timepoint-1) and four weeks thereafter (timepoint-2) to measure antibody titers against the SARS-CoV-2 spike protein, as well as to determine the absolute counts of T-helper cells, T-cytotoxic cells, B cells, and NK cells. Data were acquired from November 2021 to October 2022 and analyzed from November 2022 to October 2023. (3) Results: The present study involved 429 patients who were given a third dose of tozinameran from 26 September to 30 October 2021. Among the active treatments of interest, 109 (25.4%) patients received targeted therapy, 111 (25.9%) received cytotoxic chemotherapy, 39 (9.1%) received immune checkpoint inhibitors, 21 (4.9%) received endocrine therapy, and 30 (7.0%) received a combination of chemotherapy and targeted agents in the eight weeks preceding the booster dosing. In addition, 119 (27.7%) patients who had discontinued any systemic therapy for at least 12 weeks accounted for the reference subgroup. After a median follow-up time of 10.6 (95% CI 8.1-11.7) months, we observed 31 venous thromboembolic events in the general population, for an overall incidence rate of 7.2% (95% CI 5.0-10.1). The median time to VTE development after booster immunization was 99 (95% CI 85-112) days. In a univariate comparison, patients exposed to targeted therapies (11.3% [95% CI 6.0-18.9];

Indexed as

active treatmentCOVID-19mRNA-BNT162b2 vaccineSARS-CoV-2solid tumorsthird dosevenous thromboembolism

Identifiers

PMID40333305
PMCPMC12031221

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.