ABSTRACT
Background: Healthcare authorities at National and Regional level have prioritized vaccinations for cancer patients. Patients with cancer are among the very high-risk groups for adverse outcomes including hospitalization and/or death from COVID-19. The Medical Oncology Unit in Florence encourage vaccination for all patients with cancer being actively treated, regardless of treatment type, performance status, or life expectancy. A COVID-19 vaccination campaign, with the support of the Health Departments, was launched on April 02. The Pfizer BNT162b2 mRNA or the Moderna mRNA-1273 vaccines, based on availability, were used. Data regarding the safety of the mRNA vaccines in patients with cancer were collected. Material (patients) and methods: Between April 02 and May 07, vaccination was offered to patients actively undergoing cancer treatment. Side effects were monitored via detailed telephone questionnaires. Results: 913 patients were offered the vaccine. 22 (2%) refused the vaccination, mostly due to fear of side-effects, 73 (8%) patients did not answer the call, while 181 (20%) patients were had already been vaccinated. 637 patients received the first vaccination dose, of whom 601 (94%) received the second dose. The second dose was omitted if the patient contracted SARS-CoV-2 infection between three and six months before the first dose. The most common side-effects after the first dose were local, with 126 (24%) of 523 evaluable patients reporting pain at the site of injection. Systemic side-effects included fatigue (34 [6%]), headache (18 [3%]), muscle pain (14 [2%]), fever (17 [3%] and chills (3 [1%]). Two of 523 patients were admitted to hospital for acute allergic reactions. Three patients died after the first dose due to disease progression and two patients refused the second dose. More systemic side-effects were observed after the second dose of vaccine. Pain at the injection site was reported in 18 [3%] of the 502 evaluable patient, whereas the most common systemic side effects were muscle pain (39 [34%]), fatigue (19 [34%]), headache (31 [16%]), fever (102 [10%]), chills (17 [10%]). None of the reported side-effects required admission to hospital or any other special intervention. Two patients developed asymptomatic SARS-CoV-2 infection after the first and the second dose of vaccine, respectively. Conclusions: The reassuring safety signal regarding the mRNA COVID-19 vaccines in patients with cancer support call for vaccination of cancer patients.