Safety of covid-19 mrna vaccines in patients with cancer enrolled in early-phase clinical trials

Pamela Trillo Aliaga, Dario Trapani, José Luis Sandoval, Edoardo Crimini, Gabriele Antonarelli, Grazia Vivanet, Stefania Morganti, Chiara Corti, Paolo Tarantino, Alex Friedlaender, Carmen Belli, Ida Minchella, Marzia Locatelli, Angela Esposito, Carmen Criscitiello, Giuseppe Curigliano

Research output: Contribution to journalArticlepeer-review


Pivotal trials of COVID-19 vaccines did not include cancer patients, with questions remaining about their safety and efficacy in this population. Patients enrolled in early-phase clinical trials receive novel treatments with unknown efficacy and safety profiles. Studies on the safety of COVID-19 vaccines in these patients are urgently required. This is a retrospective, real-world, cohort study of patients receiving anticancer treatments and COVID-19 vaccines between 1 February and 25 June 2021 at the Division of New Drugs Development for Innovative Therapies of the European Institute of Oncology. One hundred thirteen patients were enrolled, 40 in early-phase clinical trials, and 20 under novel immunotherapy agents. Nearly three-quarters of the patients experienced at least one adverse event (AE) after the first dose (1D) (74.3%) and second dose (2D) (72.6%). Most of the AEs were local (67.3% 1D and 61.9% after 2D), while 31.8% (1D) and 38.1% (2D) of the patients had systemic AEs. No AEs above grade 2 were observed. Therefore, COVID-19 vaccines appear to be safe in patients enrolled in early-phase clinical trials, including patients receiving novel immunotherapy compounds. All cancer patients should be prioritized for COVID-19 vaccination, regardless of ongoing treatments or enrollment in early-phase trials.

Original languageEnglish
Article number5829
Issue number22
Publication statusPublished - Nov 1 2021


  • COVID and cancer
  • COVID-19
  • COVID-19 vaccine
  • Early-phase clinical trials
  • Novel im-munotherapy
  • Phase one trial
  • SARS-CoV-2
  • Solid tumors
  • Targeted therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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