ABSTRACT
Background: Soon after the Italian Medicine Agency (AIFA) authorized the first mRNA COVID-19 vaccine, BNT162b2 (ComirnatyR), the Italian Ministry of Health launched a national vaccination campaign. Giving the high risk of mortality from COVID-19, cancer patients were considered a priority group. However, data about BNT162b2 safety in this population are still lacking and the impact on patients' psychological state and social life was not studied. Herein we describe the adverse events (AE) related to the vaccine and the subjective experience of cancer patients treated and vaccinated at San Luigi Gonzaga University Hospital. Materials and methods: All cancer patients who accepted to participate in our campaign were vaccinated with BNT162b2 and included in the descriptive analysis. Patients who tested positive for COVID-19 after January 1st, 2021 were not recruited. An anonymous questionnaire about AE and psycho-social impact of the vaccination was administered to the study population 21 days after the first dose. The short-term AE reported after the second dose were investigated via a telephone questionnaire. Results: A total of 997 patients were included in the study, of whom 618 were affected by advanced cancer. At the time of the vaccination, 223 patients were receiving chemotherapy and/or immunotherapy. 49 patients have been infected and recovered from COVID-19. AE were reported in 37.3% cases after the first dose and in 48.5% cases after the second dose. The most common AE were muscle pain (26.7% and 27.4%, after the first and second dose respectively) and fatigue (10.4% and 16.8%). No severe AE had been reported. Before receiving the vaccine, 18% patients felt fearful and/or insecure about the vaccination, while 76.4% felt hopeful and/or enthusiast. After the first dose, 57.5% patients changed their feelings positively and 79.5% patients stated to feel much more confident in their social life. Patients' opinion about the vaccination was mainly influenced by the specialist/family doctor (38.7%) and by mass-media (25.8%), and the information they were given was considered adequate by 86% patients. Conclusions: Our data support the short-term safety of BNT162b2 in cancer patients, regardless of the disease staging and the concurrent treatment. Before the vaccination, most of our patients consulted the specialist or the family doctor receiving adequate information and being reassured. Moreover, the vaccination showed a positive psychological and social impact.