Medical Oncology Unit - Florence, Department of Oncology, Azienda USL Toscana Centro, Italy.
School of Human Health Sciences, University of Florence, Italy.
Eur J Cancer. 2022 Jul;170:149-157. doi: 10.1016/j.ejca.2022.04.008. Epub 2022 Apr 20.
International and national oncology societies had released recommendations in favor of COVID-19 vaccination in cancer patients. In the context of the national vaccination campaign targeting the so called extremely vulnerable, we aimed to assess the safety and efficacy of the mRNA vaccines in a cohort of 623 patients.
Between March 26 and April 04, 2021, the Pfizer and BioNTech BNT162b2 mRNA and the Moderna mRNA-1273 vaccines were given as a two-dose prime-boost regimen. Starting on September 25th 2021 a third dose was offered to patients in whom a suboptimal immunogenicity with COVID-19 vaccination could be expected. Safety assessments were performed by phone call 7 days after each dose. Electronic health records were accessed to review demographic information, disease history, treatment detail, and outcome events of participants patients'.
No toxicities were reported in 63.7%, 54%, and in 48.7% patients with cancer after each dose. Mild-to-moderate pain at the injection site was the most commonly adverse event. After the second dose, 46% of the 610 patients reported toxicity, with more systemic side-effects observed. Fever was reported in 45% of patients, with a temperature ≥ 38 °C in 21.4% of them. Of the 335 patients receiving a third vaccine dose, 51% reported toxicity, with 13% of patients reporting more than one effect. Logistic regression analysis reported mixed results, with limited variables or categories reporting a significant odd ratio. The type of vaccine reported a significant value at first dose (OR = 0.12; CI 0.52, 0.26; p = 0.00). Thirty-four cases of COVID-19 infection were reported with only one patient requiring a short-term hospitalization for monitoring.
The safety profile of the mRNA vaccines does not raise any specific concerns and support prioritization of vaccination for cancer patients.
国际和国家肿瘤学会发布了建议，支持癌症患者接种 COVID-19 疫苗。在针对所谓的极度脆弱人群的全国疫苗接种运动的背景下，我们旨在评估 623 例患者队列中 mRNA 疫苗的安全性和有效性。
在 2021 年 3 月 26 日至 4 月 04 日期间，使用辉瑞和 BioNTech BNT162b2 mRNA 和 Moderna mRNA-1273 疫苗进行两剂初免-加强接种。自 2021 年 9 月 25 日起，对于预期 COVID-19 疫苗免疫原性不佳的患者，将提供第三剂疫苗。每次接种后 7 天通过电话进行安全性评估。访问电子健康记录，以回顾参与者患者的人口统计学信息、疾病史、治疗细节和结果事件。
在每剂疫苗后，63.7%、54%和 48.7%的癌症患者报告无毒性。最常见的不良反应是轻度至中度注射部位疼痛。在第二剂后，610 例患者中有 46%报告了毒性，观察到更多的全身副作用。45%的患者报告发烧，其中 21.4%的患者体温≥38°C。在接受第三剂疫苗的 335 例患者中，51%报告了毒性，13%的患者报告了一种以上的不良反应。逻辑回归分析报告结果不一致，有限的变量或类别报告了显著的比值比。报告的疫苗类型在第一剂时具有显著价值（OR=0.12；95%CI 0.52，0.26；p=0.00）。报告了 34 例 COVID-19 感染病例，只有 1 例患者因监测需要短期住院。
mRNA 疫苗的安全性概况没有引起任何具体关注，并支持为癌症患者接种疫苗的优先级。
