Bioethical aspects involved in vaccine testing against SARS-COV-2 virus
DOI:
https://doi.org/10.33448/rsd-v9i12.10570Keywords:
Coronavirus infections; Bioethics; Vaccine-preventable diseases.Abstract
Objective: to analyze scientific productions that disagree about the relationship between bioethics and vaccine tests' performance against the SARS-CoV-2 virus. Methodology: This is an integrative review, where a bibliographic survey was carried out in the MEDLINE, SCIELO, and VHL databases, using two descriptors "bioethics", "COVID" and "vaccine" associated through the Boolean operator "AND". The analysis of two data was performed descriptively from the comprehensive reading of two articles, categorization, sitting, extraction, and interpretation of two data. Result: the research showed that the population used for our studies was: 68.2% of challenge studies with human beings (HCS), 9.1% of research with the general population and 22.7% of studies with specific populations (pregnant women, blacks, incarcerated population and children), Conclusion: not considered and notorious in the absence of consensus among the studies analyzed, two more studies argue in favor of carrying out two challenge studies, others are exhaustive in stating that the tests without bioethical protection .
References
Bambery, B., Selgelid, M., Weijer, C., Savulescu, J., & Pollard, A. J. (2016). Ethical Criteria for Human Challenge Studies in Infectious Diseases. Public Health Ethics, 9(1), 92-103. https://doi.org/10.1093/phe/phv026.
Bull, S., Jamrozik, E., Binik, A., & Parker, M. J. (2020). SARS-CoV-2 challenge studies: ethics and risk minimization. Journal of Medical Ethics. https://doi.org/10.1136/medethics-2020-106504.
Chang, L., Yan, Y., & Wang, L. (2020). Coronavirus disease 2019: coronaviruses and blood safety. Transfusion medicine reviews. https://doi.org/10.1016/j.tmrv.2020.02.003.
Concha, M., Gómez, P., Tuteleers, F., Arzola, M., & Duffau, G. (2020). Bioética en tiempos de pandemia COVID-19. Neumol. pediátr. (En línea), 358-361. Recuperado de: https://www.neumologia-pediatrica.cl/wp-content/uploads/2020/05/2020-15-2-11-es.pdf.
Eyal, N., Lipsitch, M., & Smith, P. G. (2020). Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure. The Journal of Infectious Diseases, 221(11), 1752–1756. https://doi.org/10.1093/infdis/jiaa152.
Eyal, N. (2020). Why Challenge Trials of SARS‐CoV‐2 Vaccines Could Be Ethical Despite Risk of Severe Adverse Events. Ethics & Human Research, 42: 24–34. https://doi.org/10.1002/eahr.500056.
Eyal, N., & Lipsitch, M. (2020). Opinion: It’s ethical to test promising coronavirus vaccines against less-promising ones. Proceedings of the National Academy of Sciences, 117(32), 18898-18901. https://doi.org/10.1073/pnas.2014154117.
Eyal, N., Lipsitch, M., & Smith, P. G. (2020). Human challenge studies to accelerate coronavirus vaccine licensure. The Journal of infectious diseases, 221(11), 1752-1756. https://doi.org/10.1093/infdis/jiaa152.
Farrell, R., Michie, M., & Pope, R. (2020). Pregnant Women in Trials of COVID‐19: A Critical Time to Consider Ethical Frameworks of Inclusion in Clinical Trials. Ethics & human research, 42(4), 17-23. https://doi.org/10.1002/eahr.500060.
Ghebreyesus/ Director Geral da OMS, T. A. (2020, January 13). Home Perspectiva Global Reportagens Humanas. ONU News. Retrieved September 30, 2020, Recovered from https://news.un.org/pt/story/2020/01/1700342.
Grady, C., Shah, S., Miller, F., Danis, M., Nicolini, M., Ochoa, J. & Rid, A. (2020). So much at stake: Ethical trade-offs in accelerating SARS-CoV-2 vaccine development. Vaccine. https://doi.org/10.1016/j.vaccine.2020.08.017.
Grimwade, O., Savulescu, J., Giubilini, A., Oakley, J., Osowicki, J., Pollard, A. J., & Nussberger, A. (2020). Payment in challenge studies: ethics, attitudes and a new payment for risk model. Journal of Medical Ethics. https://doi.org/10.1136 / medethics-2020-106438.
Gunnarsdóttir, H. D., Sinha, M. S., Gerke, S., & Minssen, T. (2020). Applying the proportionality principle to COVID-19 antibody testing. Journal of Law and the Biosciences, 7(1), lsaa058. https://doi.org/10.1093/jlb/lsaa058.
Holm, S. (2020). Controlled human infection with SARS-CoV-2 to study COVID-19 vaccines and treatments: bioethics in Utopia. Journal of Medical Ethics, 46(9), 569-573. http://dx.doi.org/10.1136/medethics-2020-106476.
Jaffe, E., Lyerly, A. D., & Goldfarb, I. T. (2020). Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials. Vaccine, 38(44), 6922-6929. https://doi.org/10.1016/j.vaccine.2020.08.059.
Jamrozik, E., Heriot, G. S., & Selgelid, M. J. (2020). Coronavirus human infection challenge studies: assessing potential benefits and risks. Journal of bioethical inquiry, 1-7. https://doi.org/10.1007/s11673-020-10030-x.
Jamrozik, E., & Selgelid, M. J. (2020). COVID-19 human challenge studies: ethical issues. The Lancet Infectious Diseases. https://doi.org/10.1016/S1473-3099(20)30438-2.
Jamrozik, E., & Selgelid, M. J. (2020). Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy. Journal of Medical Ethics.
Kamble, P. H., & Dubhashi, S. P. (2020). Expedited COVID-19 vaccine trials: a rat-race with challenges and ethical issues. The Pan African Medical Journal, 36. doi: 10.11604/pamj.2020.36.206.23977.
Kolber, A. J. (2020). Why We (Probably) Must Deliberately Infect. Journal of Law and the Biosciences, Forthcoming. doi:10.1093/jlb/lsaa024.
Monrad, J. T. (2020). Ethical considerations for epidemic vaccine trials. Journal of Medical Ethics. http://dx.doi.org/10.1136/medethics-2020-106235.
Oliveira, A. C. D., Lucas, T. C., & Iquiapaza, R. A. (2020). What has the COVID-19 pandemic taught us about adopting preventive measures? Texto & Contexto-Enfermagem, 29. https://doi.org/10.1590/1980-265x-tce-2020-0106.
Pang, J., Wang, M. X., Ang, I. Y. H., Tan, S. H. X., Lewis, R. F., Chen, J. I. P., & Ng, X. Y. (2020). Potential rapid diagnostics, vaccine and therapeutics for 2019 novel coronavirus (2019-nCoV): a systematic review. Journal of clinical medicine, 9(3), 623. https://doi.org/10.3390/jcm9030623.
Plotkin, S. A., & Caplan, A. (2020). Extraordinary diseases require extraordinary solutions. Vaccine, 38(24), 3987. doi: 10.1016/j.vaccine.2020.04.039.
Raabe, V. N., Lighter, J., Caplan, A. L., & Ratner, A. J. (2020). Importance of Pediatric Inclusion in COVID-19 Therapeutic Trials. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciaa656
Schaefer, G. O., Tam, C. C., Savulescu, J., & Voo, T. C. (2020). COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies? Available at SSRN 3568981. http://dx.doi.org/10.2139/ssrn.3568981.
Shah, S. K., Miller, F. G., Darton, T. C., Duenas, D., Emerson, C., Lynch, H. F., & Kimmelman, J. (2020). Unnecessary hesitancy on human vaccine tests-Response. Science (New York, NY), 369(6500). https://doi.org/10.1126/science.abc9380.
Spinola, S. M., Zimet, G. D., Ott, M. A., & Katz, B. P. (2020). Human Challenge Studies Are Unlikely to Accelerate Coronavirus Vaccine Licensure Due to Ethical and Practical Issues. The Journal of infectious diseases, 222(9), 1572-1574. https://doi.org/10.1093/infdis/jiaa457.
Steel, R., Buchak, L., & Eyal, N. (2020). Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines. Journal of Medical Ethics. http://dx.doi.org/10.1136/medethics-2020-106501.
Strassle, C., Jardas, E., Ochoa, J., Berkman, B., Danis, M., Rid, A., & Taylor, H. (2020). COVID-19 Vaccine Trials and Incarcerated People - The Ethics of Inclusion. The New England Journal of Medicine, 383, 1897-1899. https://doi.org/10.1056/NEJMp2025955.
Warren, R. C., Forrow, L., Hodge Sr, D. A., & Truog, R. D. (2020). Trustworthiness before Trust—COVID-19 Vaccine Trials and the Black Community. New England Journal of Medicine. doi: 10.1056/NEJMp2030033.
World Health Organization. (2020, September 13). Estrutura de valores da OMS SAGE para a alocação e priorização da vacinação COVID-19. Retrieved December 10, 2020, from https://www.who.int/publications/i/item/who-sage-values-framework-for-the-allocation-and-prioritization-of-COVID-19-vaccination.
World Health Organization. (2020, September 13). Estrutura de valores da OMS SAGE para a alocação e priorização da vacinação COVID-19. Retrieved December 10, 2020, from https://www.who.int/publications/i/item/who-sage-values-framework-for-the-allocation-and-prioritization-of-COVID-19-vaccination.
World Health Organization. (2020). Considerations for quarantine of individuals in the context of containment for coronavirus disease ( COVID-19): interim guidance, 19 March 2020 (No. WHO/2019-nCoV/IHR_Quarantine/2020.2). World Health Organization.
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