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

Vaccines

Andrea Sbrana¹  Riccardo Morganti²  Andrea Antonuzzo³  Luca Galli⁴  Adele Bonato⁴  Chiara Cremolini⁴  Amedeo Nuzzo⁴  Chiara Mercinelli⁴  Alessia Salfi⁴  Fiorella Manfredi⁴  Marco Ferrari⁴  Simona Manacorda⁴  Federico Paolieri⁴  Giulia Massaro⁴  Enrico Sammarco⁴  Serena Bazzurri⁴  Gianluca Masi⁴ 

[1] Department of Surgical, Medical and Molecular Pathology and Critical Area Medicine, Azienda Ospedaliero-Universitaria Pisana, 56125 Pisa, Italy;Section of Statistics, University Hospital of Pisa, 56125 Pisa, Italy;Unit of Medical Oncology 1, Azienda Ospedaliero-Universitaria Pisana, Santa Chiara Hospital, 56125 Pisa, Italy;Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Santa Chiara Hospital, 56125 Pisa, Italy;

关键词: COVID-19;    COVID-19 vaccines;    cancer patients;    COVID-19 vaccine safety;   

DOI  :  10.3390/vaccines10060892

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown