Ferorelli Davide, Spagnolo Lorenzo, Marrone Maricla, Corradi Serena, Silvestre Maria, Misceo Federica, Bianchi Francesco Paolo, Stefanizzi Pasquale, Solarino Biagio, Dell'Erba Alessandro, Tafuri Silvio
Section of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, Italy.
Department of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, Italy.
Vaccines (Basel). 2021 Apr 23;9(5):423. doi: 10.3390/vaccines9050423.
During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 vaccine), an authorization was issued by national and international Drug Regulatory Agencies in order to speed up their introduction on the market and their administration on a large scale. Despite the authorization, the off-label use of these vaccines may still be possible especially to answer specific concerns as the lack of vaccine doses, the delay in the delivery of planned doses or the pressure from public opinion and political influence also in relation to the evolution of the pandemic. This paper aims to assess the possible off-label use of COVID-19 vaccines and the ethical and medico-legal implications of this eventuality. The scope of this paper is to point out the possible consequences of off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures.
在新冠疫情爆发期间，由于缺乏关于治疗的官方建议，医护人员不得不使用多种未经专门针对这种新型隐匿性疾病进行测试和批准的药物。在首批新冠疫苗（辉瑞 - 生物科技公司的Comirnaty和莫德纳新冠疫苗）上市后，国家和国际药品监管机构发布了授权，以加快其上市和大规模接种。尽管有了授权，但这些疫苗的超说明书使用仍有可能，特别是为了应对一些具体问题，比如疫苗剂量短缺、计划剂量交付延迟，或者在疫情发展过程中来自公众舆论和政治影响的压力。本文旨在评估新冠疫苗可能的超说明书使用情况以及这种可能性所带来的伦理和医学法律影响。本文的范围是指出新冠疫苗超说明书使用可能产生的后果，以及参与疫苗接种程序的医护人员应采取的可能的缓解和预防措施。
