COVID-19 대유행 속 백신 개발을 둘러싼 윤리적 쟁점
Ethical Debates Surrounding the Development of Vaccines During COVID-19 Pandemic
0
조회
0
다운로드
9
인용
0
참고문헌
키워드
초록
전 세계적 COVID-19 유행의 규모가 갈수록 심해지는 상황에서 백신은 COVID-19 유행으로부터 사회를 구할 수 있는 도구로 여겨지고 있다. 전통적으로 백신은 기획부터 개발까지 수년에서 수십 년이 걸리는 과정이었으나 COVID-19 유행 속에서는 백신 개발 과정을 압축하여 빠른 개발이 이루어져야 한다는 요구가 크다. 그러나 윤리적인 과정을 통해 안전하고 효과적인 백신이 개발되어야 백신은 적절하게 COVID-19에 대응할 수 있다. 본 논문은 백신 개발의 역사와 중요한 논란들, 백신 개발이 지니는 윤리적 고려 사항 등과 함께 현재 백신 개발 가속화 압력을 중심으로 한 윤리적 쟁점들을 다룬다. 백신 개발 방법을 혁신하기 위한 대안적 방법으로 인체 바이러스 주입 연구, 혁신적 설계, 오버래핑 방법 등 다양한 방법들이 제안된다. 향후 COVID-19뿐 아니라 전 세계적으로 감염병 대유행이 호발하리라고 예측된다. 감염병 유행이 빈번해짐에 따라 백신을 비롯한 기존의 면역 전략은 효과적인지, 안전한지, 효율적인지가 검토될 가능성이 높다. 현재 백신 개발에 대하여 새롭게 제안되는 전략들이 윤리적으로 적절하면서 안전한지, 백신 개발의 이익에 비추어 위험이 균형 잡혀 있는지 수용할 만한지 고려될 필요가 있다.
Abstract
As the COVID-19 pandemic worsens, vaccines are considered a tool to save society from the disaster. The development of vaccines typically takes years from planning to licensure. However, in the COVID-19 pandemic, there is a great demand to develop vaccines more rapidly. Nonetheless, only a safe, effective, and ethically developed vaccine can respond to COVID-19 appropriately. This paper deals with ethical issues focused on the current pressure to accelerate vaccine development, and historical affairs regarding vaccine ethics. Various designs are proposed to accelerate vaccine development, including human challenge studies, innovative designs, and overlapping models. Newly infectious disease pandemics besides COVID-19 are expected to hit the world periodically. Conventional immune strategies, including vaccines, will be reviewed and revised to achieve more efficiency and safety. We need to consider whether the newly proposed vaccine development strategies are ethically appropriate and safe while balancing the risks with the benefits.
참고문헌 (37)
- N.J. Willis, "Edward Jenner and the eradication of smallpox", Scottish Medical Journal, 42(4) (1997)
- E. Jenner, "An Inquiry into the Causes and Effects of the Variolae Vaccinae", ~
- K. Hoyt, "Vaccine innovation: lessons from World War II", Journal of Public Health Policy, 27(1) (2006)
- "clinical evaluation of vaccines"[URL]
- N. Durbach, "‘They might as well brand us’: working-class resistance to compulsory vaccination in Victorian England", Social History of Medicine, 13(1) (2000)
- M. Fitzpatrick, "The cutter incident: How america’s first polio vaccine led to a growing vaccine crisis", Journal of the Royal Society of Medicine, 99(3) (2006)
- Immunization Safety Review Committee, "Immunization safety review: influenza vaccines and neurological complications" (2004), National Academies Press
- R. Kwok, "The real issues in vaccine safety", Nature, 473(7348) (2011)
- "Coronavirus Vaccine Tracker"[URL]
- "Guidelines on clinical evaluation of vaccines: regulatory expections; TRS 1004, Annex 9" (2017)[URL]
- "Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry" (2020)[URL]
- Blueprint novel Coronavirus An international randomised trial of candidate vaccines against COVID-19, "WHO", ~ (2020)
- "NIH"[URL]
- "Sinovac’s Coronavirus Vaccine Candidate Approved for Emergency Use in China- Source" (2020)[URL]
- "COVID-19 Vaccines: Ex-FDA Leaders Urge High Bar For Emergency Use Authorization" (2020)[URL]
- "Operation Warp Speed on Track for End-of-Year Vaccine Delivery" (2020)[URL]
- Adaptive Platform Trials Coalition, "Adaptive platform trials: definition, design, conduct and reporting considerations", Nature Reviews. Drug Discovery, 18(10) (2019)
- "Immune responses and immunity to SARS-CoV-2" (2020)[URL]
- E. Jamrozik, "Human challenge studies in endemic settings: ethical and regulatory issues" (2020), Springer
- "Key criteria for the ethical acceptability of COVID-19 human challenge studies" (2020)[URL]
- N. Eyal, "Human challenge studies to accelerate coronavirus vaccine licensure", The Journal of infectious diseases, 221(11) (2020)
- G.M. Franklin, "The ethical challenge of infection-inducing challenge experiments", Clinical Infectious Diseases, 33(7) (2001)
- "Ethical Considerations for Zika Virus Human Challenge Trials-Report & Recommendations" (2017)[URL]
- D. B. Resnik, "Limits on risks for healthy volunteers in biomedical research", Theoretical medicine and bioethics, 33(2) (2012)
- G.O. Schaefer, "COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies?", Vaccine, 38(33) (2020)
- R. Verity, "Estimates of the severity of coronavirus disease 2019: a model-based analysis", The Lancet infectious diseases, 20(6) (2020)
- H. Salje, "Estimating the burden of SARS-CoV-2 in France", Science, 369(6500) (2020)
- "Human challenge trials with live coronavirus aren’t the answer to a Covid-19vaccine" (2020)[URL]
- "Finding a vaccine against the novel coronavirus: why challenge trials can be ethical even when a lot remains unknown" (2020)[URL]
- R. Steel, "Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines", Journal of Medical Ethics (2020)
- "Infect volunteers with Covid-19 in the name of research? A proposal lays bare a minefield of issues" (2020)[URL]
- E. Jamrozik, "COVID-19 human challenge studies: ethical issues", The Lancet Infectious Diseases, 20(8) (2020)
- S. K. Shah, "Ethics of controlled human infection to address COVID-19", Science, 368(6493) (2020)
- M.E. Deming, "Accelerating Development of SARS-CoV-2 Vaccines — The Role for Controlled Human Infection Models", The New England Journal of Medicine, 383(10) (2020)
- N. Lurie, "Developing Covid-19 Vaccines at Pandemic Speed", The New England Journal of Medicine, 382(21) (2020)
- A. Dawson, "Pandemic vaccine trials: expedite, but don’t rush", Research Ethics (2020)
- C. Grady, "So much at stake: Ethical tradeoffs in accelerating SARS CoV-2 vaccine development", Vaccine, 38(41) (2020)