Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective
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 COVID1...
| Principais autores: | , , , , , , , , , , |
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| Formato: | Artigo |
| Idioma: | English |
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MDPI AG
2021-04-01
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| coleção: | Vaccines |
| Assuntos: | |
| Acesso em linha: | https://www.mdpi.com/2076-393X/9/5/423 |
| _version_ | 1827694330312130560 |
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| author | Davide Ferorelli Lorenzo Spagnolo Maricla Marrone Serena Corradi Maria Silvestre Federica Misceo Francesco Paolo Bianchi Pasquale Stefanizzi Biagio Solarino Alessandro Dell’Erba Silvio Tafuri |
| author_facet | Davide Ferorelli Lorenzo Spagnolo Maricla Marrone Serena Corradi Maria Silvestre Federica Misceo Francesco Paolo Bianchi Pasquale Stefanizzi Biagio Solarino Alessandro Dell’Erba Silvio Tafuri |
| author_sort | Davide Ferorelli |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T12:03:34Z |
| format | Article |
| id | doaj.art-312c9d13162b416ababafb495136db70 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T12:03:34Z |
| publishDate | 2021-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-312c9d13162b416ababafb495136db702023-11-21T16:46:09ZengMDPI AGVaccines2076-393X2021-04-019542310.3390/vaccines9050423Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian PerspectiveDavide Ferorelli0Lorenzo Spagnolo1Maricla Marrone2Serena Corradi3Maria Silvestre4Federica Misceo5Francesco Paolo Bianchi6Pasquale Stefanizzi7Biagio Solarino8Alessandro Dell’Erba9Silvio Tafuri10Section of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalySection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalySection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalySection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalySection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalySection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalyDepartment of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, ItalyDepartment of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, ItalySection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalySection of Legal Medicine, Interdisciplinary Department of Medicine, University of Bari, 70121 Bari, ItalyDepartment of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, ItalyDuring 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.https://www.mdpi.com/2076-393X/9/5/423COVID-19SARS-CoV-2off-label usevaccineethicsforensic sciences |
| spellingShingle | Davide Ferorelli Lorenzo Spagnolo Maricla Marrone Serena Corradi Maria Silvestre Federica Misceo Francesco Paolo Bianchi Pasquale Stefanizzi Biagio Solarino Alessandro Dell’Erba Silvio Tafuri Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective Vaccines COVID-19 SARS-CoV-2 off-label use vaccine ethics forensic sciences |
| title | Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective |
| title_full | Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective |
| title_fullStr | Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective |
| title_full_unstemmed | Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective |
| title_short | Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective |
| title_sort | off label use of covid 19 vaccines from ethical issues to medico legal aspects an italian perspective |
| topic | COVID-19 SARS-CoV-2 off-label use vaccine ethics forensic sciences |
| url | https://www.mdpi.com/2076-393X/9/5/423 |
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