Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension

Detalhes bibliográficos
Autor(a) principal: Mota-Filipe, Helder
Data de Publicação: 2021
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/816
Resumo: The pneumonia outbreak caused by a new species of coronavirus at the end of 2019 in Wuhan (China) led to a pandemic with more than 200 million people infected and about 4.5 million deaths worldwide and which continue to increase. Despite the short time elapsed (less than two years), much progress has been made in the management of the disease and patients and in the development of vaccines and other drugs for the prevention and treatment of COVID-19, associated with several ethical challenges. Many drugs approved for other therapeutic indications were used outside the formally approved indications, raising questions regarding the validity of results and observance of fundamental ethical principles. The World Health Organization has taken a clear position on the use of drugs without sufficient evidence for COVID-19 patients and has promoted the performance of randomized clinical trials. Currently, more than 6,000 clinical studies are registered with the aim of studying different therapeutic approaches for COVID-19. At the same time, the first safe and effective vaccines against COVID-19 were developed and approved. Vaccines and the vaccination process have also raised issues with an important ethical component. Today, it is no longer acceptable to experiment with potential therapies outside the context of clinical trials, and a strategy for discovering effective treatments for COVID-19 should be promoted. A discussion, including the ethical dimension, about the best use of these vaccines, considering the global fight against the pandemic, is also essential.
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spelling Discussion about vaccines and drugs for COVID-19: need to add an ethical dimensionDiscusión sobre vacunas y medicamentos para el COVID-19: necesidad de agregar una dimensión éticaDiscussão sobre vacinas e medicamentos para a COVID-19: necessidade de acrescentar uma dimensão éticaCOVID-19PandemiaVacunasMedicamentosÉticaCOVID-19PandemiaVacinasMedicamentosÉticaCOVID-19PandemicsVaccinesMedicinesEthicsThe pneumonia outbreak caused by a new species of coronavirus at the end of 2019 in Wuhan (China) led to a pandemic with more than 200 million people infected and about 4.5 million deaths worldwide and which continue to increase. Despite the short time elapsed (less than two years), much progress has been made in the management of the disease and patients and in the development of vaccines and other drugs for the prevention and treatment of COVID-19, associated with several ethical challenges. Many drugs approved for other therapeutic indications were used outside the formally approved indications, raising questions regarding the validity of results and observance of fundamental ethical principles. The World Health Organization has taken a clear position on the use of drugs without sufficient evidence for COVID-19 patients and has promoted the performance of randomized clinical trials. Currently, more than 6,000 clinical studies are registered with the aim of studying different therapeutic approaches for COVID-19. At the same time, the first safe and effective vaccines against COVID-19 were developed and approved. Vaccines and the vaccination process have also raised issues with an important ethical component. Today, it is no longer acceptable to experiment with potential therapies outside the context of clinical trials, and a strategy for discovering effective treatments for COVID-19 should be promoted. A discussion, including the ethical dimension, about the best use of these vaccines, considering the global fight against the pandemic, is also essential.El brote de neumonía provocado por una nueva especie de coronavirus a finales de 2019 en Wuhan (China) provocó una pandemia con la infección de más de 200 millones de personas infectadas y alrededor de 4,5 millones de muertes en todo el mundo y que siguen aumentando. A pesar del poco tiempo transcurrido (menos dos años), se ha avanzado mucho en el manejo de la enfermedad y los pacientes y en el desarrollo de vacunas y otros fármacos para la prevención y el tratamiento del covid-19, asociado a varios desafíos éticos. Muchos fármacos para otras indicaciones terapéuticas se utilizan fuera de las indicaciones aprobadas formalmente, lo que plantea dudas sobre la validez de los resultados y la observancia de los principios éticos fundamentales. La Organización Mundial de la Salud ha tomado una posición clara sobre el uso de medicamentos sin evidencia suficiente para pacientes con covid-19 y ha promovido la realización de ensayos clínicos aleatorizados. Actualmente, se registran más de 6000 estudios clínicos con el objetivo de estudiar diferentes enfoques terapéuticos para covid-19. Al mismo tiempo, se desarrollaron y aprobaron las primeras vacunas seguras y eficaces contra el covid-19. Las vacunas y el proceso de vacunación también han planteado problemas con un importante componente ético. Hoy en día, ya no es aceptable experimentar con terapias potenciales fuera del contexto de los ensayos clínicos, y se debe promover una estrategia para descubrir tratamientos efectivos para el covid-19. También es fundamental un debate, incluida la dimensión ética, sobre el mejor uso de estas vacunas, teniendo en cuenta la lucha mundial contra la pandemia.O surto de pneumonia provocado por uma nova espécie de coronavírus no final de 2019, em Wuhan (China) originou uma pandemia com a infeção de mais de 200 milhões de pessoas infetadas e cerca de 4,5 milhões de mortes em todo o mundo e que continuam a aumentar. Apesar do pouco tempo volvido (menos de dois anos), muitos progressos têm vindo a ser conseguidos na gestão da doença e dos doentes e no desenvolvimento de vacinas e outros medicamentos para prevenção e tratamento da COVID-19, associados a diversos desafios éticos. Muitos medicamentos aprovados para outras indicações terapêuticas usados fora das indicações formalmente aprovadas, levantando questões relativamente à validade dos resultados e à observância de princípios éticos fundamentais. A Organização Mundial de Saúde tomou uma posição clara sobre utilização de medicamentos sem evidência suficiente a doentes COVID-19 e promoveu a realização de ensaios clínicos randomizados. Atualmente estão registados mais de 6 mil estudos clínicos com o objetivo de estudar diferentes abordagens terapêuticas para a COVID-19. Ao mesmo tempo, foram desenvolvidas e aprovadas as primeiras vacinas contra a COVID-19, seguras e eficazes. As vacinas e o processo de vacinação têm também levantado questões com uma componente ética importante. Hoje, não é aceitável a experimentação de potenciais terapêuticas fora do contexto de ensaios clínicos, devendo ser fomentada uma estratégia para a descoberta de tratamentos eficazes para a COVID-19. É também fundamental uma discussão, incluindo a dimensão ética sobre a melhor utilização dessas vacinas tendo em consideração o combate global à pandemia.Fundação Oswaldo Cruz Brasília2021-09-16info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/81610.17566/ciads.v10i3.816Iberoamerican Journal of Health Law; Vol. 10 No. 3 (2021): (JUL./SEPT. 2021); 191-198Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 10 Núm. 3 (2021): (JUL./SEPT. 2021); 191-198Cadernos Ibero-Americanos de Direito Sanitário; v. 10 n. 3 (2021): (JUL./SET. 2021); 191-1982358-18242317-839610.17566/ciads.v10i3reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/816/842Copyright (c) 2021 Helder Mota-Filipe (Autor)https://creativecommons.org/licenses/by-nc/4.0info:eu-repo/semantics/openAccessMota-Filipe, HelderMota-Filipe, HelderMota-Filipe, Helder2023-03-08T15:03:18Zoai:ojs.cadernos.prodisa.fiocruz.br:article/816Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2023-03-08T15:03:18Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
Discusión sobre vacunas y medicamentos para el COVID-19: necesidad de agregar una dimensión ética
Discussão sobre vacinas e medicamentos para a COVID-19: necessidade de acrescentar uma dimensão ética
title Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
spellingShingle Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
Mota-Filipe, Helder
COVID-19
Pandemia
Vacunas
Medicamentos
Ética
COVID-19
Pandemia
Vacinas
Medicamentos
Ética
COVID-19
Pandemics
Vaccines
Medicines
Ethics
title_short Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
title_full Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
title_fullStr Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
title_full_unstemmed Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
title_sort Discussion about vaccines and drugs for COVID-19: need to add an ethical dimension
author Mota-Filipe, Helder
author_facet Mota-Filipe, Helder
author_role author
dc.contributor.author.fl_str_mv Mota-Filipe, Helder
Mota-Filipe, Helder
Mota-Filipe, Helder
dc.subject.por.fl_str_mv COVID-19
Pandemia
Vacunas
Medicamentos
Ética
COVID-19
Pandemia
Vacinas
Medicamentos
Ética
COVID-19
Pandemics
Vaccines
Medicines
Ethics
topic COVID-19
Pandemia
Vacunas
Medicamentos
Ética
COVID-19
Pandemia
Vacinas
Medicamentos
Ética
COVID-19
Pandemics
Vaccines
Medicines
Ethics
description The pneumonia outbreak caused by a new species of coronavirus at the end of 2019 in Wuhan (China) led to a pandemic with more than 200 million people infected and about 4.5 million deaths worldwide and which continue to increase. Despite the short time elapsed (less than two years), much progress has been made in the management of the disease and patients and in the development of vaccines and other drugs for the prevention and treatment of COVID-19, associated with several ethical challenges. Many drugs approved for other therapeutic indications were used outside the formally approved indications, raising questions regarding the validity of results and observance of fundamental ethical principles. The World Health Organization has taken a clear position on the use of drugs without sufficient evidence for COVID-19 patients and has promoted the performance of randomized clinical trials. Currently, more than 6,000 clinical studies are registered with the aim of studying different therapeutic approaches for COVID-19. At the same time, the first safe and effective vaccines against COVID-19 were developed and approved. Vaccines and the vaccination process have also raised issues with an important ethical component. Today, it is no longer acceptable to experiment with potential therapies outside the context of clinical trials, and a strategy for discovering effective treatments for COVID-19 should be promoted. A discussion, including the ethical dimension, about the best use of these vaccines, considering the global fight against the pandemic, is also essential.
publishDate 2021
dc.date.none.fl_str_mv 2021-09-16
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/816
10.17566/ciads.v10i3.816
url https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/816
identifier_str_mv 10.17566/ciads.v10i3.816
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/816/842
dc.rights.driver.fl_str_mv Copyright (c) 2021 Helder Mota-Filipe (Autor)
https://creativecommons.org/licenses/by-nc/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2021 Helder Mota-Filipe (Autor)
https://creativecommons.org/licenses/by-nc/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
dc.source.none.fl_str_mv Iberoamerican Journal of Health Law; Vol. 10 No. 3 (2021): (JUL./SEPT. 2021); 191-198
Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 10 Núm. 3 (2021): (JUL./SEPT. 2021); 191-198
Cadernos Ibero-Americanos de Direito Sanitário; v. 10 n. 3 (2021): (JUL./SET. 2021); 191-198
2358-1824
2317-8396
10.17566/ciads.v10i3
reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos Ibero-Americanos de Direito Sanitário (Online)
collection Cadernos Ibero-Americanos de Direito Sanitário (Online)
repository.name.fl_str_mv Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos.direitosanitario@fiocruz.br
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