Vaccines (Jun 2022)

Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

  • Amedeo Nuzzo,
  • Simona Manacorda,
  • Enrico Sammarco,
  • Andrea Sbrana,
  • Serena Bazzurri,
  • Federico Paolieri,
  • Fiorella Manfredi,
  • Chiara Mercinelli,
  • Marco Ferrari,
  • Giulia Massaro,
  • Adele Bonato,
  • Alessia Salfi,
  • Luca Galli,
  • Riccardo Morganti,
  • Andrea Antonuzzo,
  • Chiara Cremolini,
  • Gianluca Masi

DOI
https://doi.org/10.3390/vaccines10060892
Journal volume & issue
Vol. 10, no. 6
p. 892

Abstract

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Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.

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