Abstract
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.
Highlights
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 the off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures
The “real life” utilization may significantly differ from the one recommended by label indications so that the off-label use is realized and sometimes promoted by local national health system (NHS) recommendations (“off-label public health use”) [12]
Summary
The off-label use of medicines and vaccines does not have a unique definition and different interpretations of the subject are provided by national and international. Drug Regulatory Agencies as the Food and Drug Administration (FDA), the European. Medicines Agency (EMA), and the Italian Medicines Agency (AIFA) [1,2,3,4,5] (Table 1). Drug Regulatory Agency FDA [4,5]. This article is an open access article EMA [2,3]. Distributed under the terms and conditions of the Creative Commons AIFA [1].
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