Bioethics in MRNA vaccines and clinical trials against SARS-CoV-2

Authors

  • Juan Manuel Alba Bermúdez Universidad de Las Américas (Ecuador)

DOI:

https://doi.org/10.61243/calamo.15.124

Keywords:

Vaccine, SARS-CoV-2, Covid-19, Patients, Bioethics

Abstract

This paper aims to point out and analyze the main aspects of the debate around the development of vaccines against SARS-CoV-2, during the COVID-19 health crisis. With this objective, the corresponding implications will be analyzed in two fields of interest: bioethics and law. It will also allude to issues related to clinical trials and respect for bioethical principles. Cases such as mRNA vaccines and the use of alternative clinical trial methodologies are presented. Regarding the vaccines, issues such as approval, licenses, regulatory entities, are addressed, as well as the importance of science and law.

Author Biography

Juan Manuel Alba Bermúdez, Universidad de Las Américas (Ecuador)

Profesor titular e investigador en la Facultad de Derecho de la Universidad de Las Américas (Quito -Ecuador). Es doctor en Derecho, máster en Derechos Fundamentales con especialidad en Bioderecho, máster en Prácticas Jurídicas y Ejercicio de la Abogacía por el Centro Formación Abogados de Madrid, y máster en Estudios de Derechos Humanos por la Université Catholique de Lyon (Francia). También es miembro del grupo de investigación “Libertades Públicas y Derechos Fundamentales” de la Universidad de Cádiz (España) y miembro del grupo de investigación de JVS.CM Santarem (Portugal).

References

Abdelrahman, Z., Li, M. y Wang, X. 2020. “Comparative review of SARS-CoV-2, SARS-CoV, MERS-CoV, and influenza a respiratory viruses”. Frontiers in immunology, 11, 2309.

Acevedo Pérez. 2002. "Aspectos éticos en la investigación científica". Ciencia y enfermería 8 (1): 15-18.

Aguiló Regla, Josep. 2009. "Dos concepciones de la ética judicial". Doxa. Cuadernos de Filosofía del Derecho, 32: 525-539. DOI: https://doi.org/10.14198/DOXA2009.32.21

Alba Bermúdez. 2016. "Derechos del paciente: especial referencia a la legislación ecuatoriana". Revista de

Derecho UNED 19: 493-510.

Amanat y Krammer. 2020. "SARS-CoV-2 Vaccines: Status Report". Immunity 52: 583-589.

Atzrodt, Maknojia, McCarthy, Oldfield, Po, Stepp y Clements. 2020. "A Guide to COVID‐19: a Global Pandemic Caused by the Novel Coronavirus SARSCoV‐2". The FEBS Journal. Acceso el 3 de mayo de 2021. https://febs.onlinelibrary.wiley.com/doi/epdf/10.1111/febs.15375

Barratt, A., Olsen, I., Nezvalova, K., Kåsine, T., Lund, F., Hoel, H. y Aukrust, P. 2021. "Evaluation of the Effects of Remdesivir and Hydroxychloroquine on Viral Clearance in COVID-19: A Randomized Trial". Annals of Internal Medicine.

Bonsall, M., Huntingford, C. y Rawson, T. 2021. "Optimal Time to Return to Normality: Parallel Use of COVID-19 Vaccines and Circuit Breakers". MedRxiv.

Callaway. 2020. "Should Scientists Infect Healthy People With the Coronavirus to Test Vaccines?". Nature 580, n.° 7801: 17.

Chen, Strych, Hotez y Bottazzi. 2020. "The SARSCoV-2 Vaccine Pipeline: An Overview". Current Tropical Medicine Reports: 1-4.

Cox, Edmund, Kratz, Lockwood y Shankar. 2020. "Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways". Clinical and Translational Science 13, n.° 3: 451-461.

Ebola ça Suffit Ring Vaccination Trial Consortium. 2015. "The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola". British Medical Journal, 351: 3740.

Eyal y Lipsitch. 2020. "Ethical Comparators in Coronavirus Vaccine Trials". Harvard Business School.

Eyal, Lipsitch y Smith. 2020. "Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure". The Journal of Infectious Diseases 221, n.° 11: 1752-1756.

FAO. 2020. "Considerations for Regulatory Oversight of Clinical Trials in the Covid-19 Pandemic". Acceso el 2 de mayo de 2021. https://iris.paho.org/handle/10665.2/52266

González Calisto, Patarroyo Durá y Carreño Bodensiek. 2017. "Principio de justiciar en el aula y responsabilidad moral del docente frente a los estilos de aprendizaje". Revista de investigación, Desarrollo e inovación, 7 (2): 241-253.

Gorbalenya, Baker, Baric, Groot, Drosten, Gulyaeva y Penzar. 2020. "Severe acute respiratory syndromerelated

coronavirus: The species and its viruses - A statement of the Coronavirus Study Group". BioRxiv. Acceso el 1 de abril de 2021. https://digital.csic.es/handle/10261/212994

Hendaus. 2020. "Remdesivir in the Treatment of Coronavirus Disease 2019 (COVID-19): A Simplified Summary". Journal of Biomolecular Structure and Dynamics: 1-10.

Hunt, Saenz y Littler. 2019. "The global forum on bioethics in research meeting, “ethics of alternative clinical trial designs and methods in low -and middle- income country research: emerging themes and outputs». Trials 20, n.° 701: 1-7.

Jamrozik y Selgelid. 2020. "COVID-19 Human Challenge Studies: Ethical Issues". The Lancet Infectious Diseases 1-6.

Jiang, H., Zhang, L., Li, J. y Zhu, F. 2021. "Next Steps for Efficacy Evaluation in Clinical Trials of COVID-19 Vaccines". Engineering 7(7): 903-907.

Johnson y Bailey. 2020. "Urgent Legal Lessons From a Very Fast Problem: COVID-19". Stanford Law Review Online, Forthcoming: 1-12. Acceso el 15 de abril de 2021. https://ssrn.com/abstract=3567412

Khuroo, Khuroo, Sofi y Khuroo. 2020. "COVID-19 Vaccines: A Race Against Time in the Middle of Death and Devastation!". India: Preprints-ResearchGate. DOI: https://doi.org/10.1016/j.jceh.2020.06.003

Landwirth. 1990. "Medical-legal Aspects of Immunization. Policy and Practices". Pediatric clinics of North America 37, n.° 3: 771-784.

Lyngbakken, M., Berdal, J., Eskesen, A., Kvale, D., Olsen, I., Rueegg, C. y Dalgard, O. 2020. "A Pragmatic Randomized Controlled Trial Reports Lack of Efficacy of Hydroxychloroquine on Coronavirus Disease 2019 Viral Kinetics. Nature communications, 11(1), 1-6. DOI: https://doi.org/10.1038/s41467-020-19056-6

Maciorowski, D., Idrissi, S., Gupta, Y., Medernach, B., Burns, M., Becker, D., Durvasula, R. y Kempaiah, P. 2020. “A review of the preclinical and clinical efficacy of Remdesivir, Hydroxychloroquine, and Lopinavir-Ritonavir treatments against COVID-19”. SLAS DISCOVERY: Advancing the Science of Drug Discovery, 25(10), 1108-1122. DOI: https://doi.org/10.1177/2472555220958385

Manheim, D., Więcek, W., Schmit, V., Morrison, J. y 1Day Sooner Research Team. 2021. “Exploring Risks of Human Challenge Trials For COVID‐19”. Risk Analysis, 41(5), 710-720. DOI: https://doi.org/10.1101/2020.11.19.20234658

Maschke y Gusmano. 2020. "Ethics and Evidence in the Search for a Vaccine and Treatments for Covid-19". Acceso el 2 de abril de 2021. https://www.thehastingscenter.org/ethics-and-evidencein-the-search-for-a-vaccine-and-treatments-forcovid-19/

National Institute of Allergy and Infectious Diseases. 2020. "Safety and Immunogenicity Study of 2019-

nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)". Acceso el 22 de abril de 2021. https://clinicaltrials.gov/ct2/show/NCT04283461

Nichol, A. 2020. "Potential Implications of Testing an Experimental mRNA-based Vaccine During an Emerging Infectious Disease Pandemic". The American Journal of Bioethics, 20(7), W2-W3. DOI: https://doi.org/10.1080/15265161.2020.1763696

Nuffield Bioethics. 2020. "Fair and Equitable Access to COVID-19 Treatments and Vaccines". Acceso el 30 de abril de 2021. https://www.nuffieldbioethics.org/assets/pdfs/Fair-and-equitable-access-to-COVID-19-treatments-and-vaccines.pdf

Olaya, García, Torres, Ferro y Torres. 2006. "Caracterización de proceso productivo, logístico y regulatorio de los medicamentos". Vitae, Vol. 13, Núm. 2: 69-82. https://www.researchgate.net/publication/220034939_CARACTERIZACION_DEL_PROCESO_PRODUCTIVO_LOGISTICO_Y_REGULATORIO_DE_LOS_MEDICAMENTOS

Organización Mundial de la Salud-OMS. 2020. "Q&A: Ethics and COVID-19: Resource Allocation and Priority Setting". Acceso el 2 de abril de 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/ethicsand-covid-19

Pacheco, de Souza, de Lima y Longo. 2020. "Panorama mundial de estudos com a hidroxicloroquina para o tratamento da COVID-19". Journal of Health & Biological Sciences 8, n.° 1: 1-4. DOI: https://doi.org/10.12662/2317-3076jhbs.v8i1.3288.p1-4.2020

Prompetchara, Ketloy y Palaga. 2020. "Immune Responses in COVID-19 and Potential Vaccines: Lessons Learned from SARS and MERS Epidemic". Asian Pac J Allergy Immunol 38, n.° 11: 1-9. DOI: https://doi.org/10.12932/ap-200220-0772

Rabaan, A., Al-Ahmed, S., Haque, S., Sah, R., Tiwari, R., Malik, Y. y Rodríguez, A. 2020. "SARS-CoV-2, SARS-CoV, and MERS-COV: a Comparative Overview". Infez Med, 28(2), 174-184. https://pubmed.ncbi.nlm.nih.gov/32275259/

Rawl, John. 1995. De la justicia. Fondo de Cultura Económica, México.

Sáenz, Luna, Salas, Canario, Chamorro, Palacios, Quiroz, Saidón y Villela. 2018. "La ética de los diseños y métodos alternativos de ensayos clínicos. Una reflexión sobre el Foro Global de Bioética en Investigación del 2017". Revista Panamericana de Salud Pública, 42: 38. DOI: https://doi.org/10.26633/RPSP.2018.38

Scavone, Brusco, Bertini, Sportiello, Rafaniello, Zoccoli, Berrino, Racagni, Rossi y Capuano. 2020. "Current Pharmacological Treatments for COVID‐19: What’s Next?". British Journal of Pharmacology, 177(21): 4813-4824. DOI: https://doi.org/10.1111/bph.15072

Stern, Ariel y Sarah Mehta. 2018. "Adaptive Platform Trials: The Clinical Trial of the Future?". Harvard Business

School. https://hbsp.harvard.edu/product/622012-PDF-ENG

Tietze, Vimalnath, Aristodemou y Molloy. 2020. "Crisis-Critical Intellectual Property: Findings from the COVID-19 Pandemic". Centre for Technology Management Working Paper Series 2: 1-19. Acceso el 10 de abril de 2021. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3569282

Wang, Kream y Stefano. 2020. "An evidence based perspective on mRNA-SARS-CoV-2 vaccine development". Medical Science Monitor: International Medical Journal of Experimental and Clinical Research, 26. DOI: https://doi.org/10.12659/msm.924700

Xie y Chen. 2020. "Insight Into 2019 Novel Coronavirus - An Updated Intrim Review and Lessons From SARS-CoV and MERS-CoV". International Journal of Infectious Diseases, 94: 119-124. DOI: https://doi.org/10.1016/j.ijid.2020.03.071

Yánez. 2020. "Bioética animal como respuesta al cartesianismo distópico". Revista Bioética y Derecho 50: 425-438. DOI: https://doi.org/10.1344/rbd2020.50.31834

Published

2023-09-11

How to Cite

Alba Bermúdez, J. M. (2023). Bioethics in MRNA vaccines and clinical trials against SARS-CoV-2. Cálamo, Journal of Legal Studies, (15), 34–45. https://doi.org/10.61243/calamo.15.124

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Dossier