COVID-19新冠大流行已经将世界的关注点从经济和全球关系部分转向了医疗保健和疫苗生产。如此大规模的大流行病首次冲击了现代社会，确诊病例接近7亿。生命危在旦夕，时间与我们赛跑，科学家们正在全球范围内竭尽全力开发有效的治疗方法和疫苗。今天，我们将从表现和合法性的角度审视疫苗发展的快速过程。我们将深入探讨生物学进步背后的道德性，回顾过去一些臭名昭著的错误，并揭示导致我们现在的COVID-19疫苗的复杂过程。
The COVID-19 pandemic has turned the world’s attention partially away from economic and global relationships into healthcare and vaccine production. For the first time, such an extensive pandemic had crushed modern society, growing close to 700 million positive cases. With life hanging in the balance and time running against us, scientists are racing to develop effective treatment and vaccines has become a topic of global interest. Today, we question the rapid process of vaccine development under the scope of its performance and legality. We will delve into the ethicality behind advancement in biology, examining some infamous missteps from the past, and shedding light to the complex process that has led to our present-day COVID-19 vaccines.
人类临床试验：拯救生命的机会游戏 The Human Clinical Trials: A Lifesaving Game of Chance
人类临床试验是确定潜在新治疗方法是否安全有效的关键实验，遵循严格的多阶段过程。它们是任何新的医疗手段的最终检验场，虽然它们可能会带来拯救生命的突破，但有时也可能出错。两个例子生动地说明了这一点。
Human clinical trials, the crucial experiments that determine whether a potential new treatment is safe and effective, follow a rigorous, multi-phase process. They are the ultimate proving ground for any new medical intervention and, while they can lead to life-saving breakthroughs, they can sometimes go disastrously wrong. Two examples, one from the past and another more recent, illustrate this starkly.
大象人的悲剧故事 The Tragic Tale of the Elephant Man
可能在悲剧结果方面引发了最多关注的临床试验是使参与者变得畸形肿胀的试验，让他们看起来像约瑟夫·梅里克，人们通常称他为"大象人"。2006年，为治疗白血病开发的TGN1412药物的第一阶段临床试验导致了灾难性的结果。在接受药物几分钟后，参与的六名健康志愿者开始出现头痛，然后迅速进入严重疾病。这种药物触发了他们免疫系统的灾难性过度反应，这种反应在动物试验中未见，突显了早期临床试验的潜在不可预测性。
The clinical trial that has arguably garnered the most publicity in terms of tragic outcomes was the one that left participants with grotesque swelling, likening them to Joseph Merrick, famously known as the "Elephant Man". In 2006, a phase I clinical trial for the drug TGN1412, developed to treat leukemia, led to disastrous results. Within minutes of receiving the drug, the six healthy volunteers involved started experiencing headaches, followed by a rapid spiral into critical illness. The drug triggered a catastrophic overreaction of their immune systems, a reaction not seen in animal trials, highlighting the potential unpredictability of early-phase clinical trials.
现代警世故事：BIA 10-2474 A Modern-Day Cautionary Tale: BIA 10-2474
快进十年，我们在2016年遇到了另一个警世故事，这次是用于治疗一系列神经疾病的实验性药物BIA 10-2474。在法国进行的第一阶段试验中，一名参与者死亡，另外五人出现严重的神经症状。试验后的调查显示，在测试阶段采取的防范措施不足，进一步强调了人类临床试验中严格安全措施的重要性。
Fast forward a decade, and we encounter another cautionary tale from 2016, this time with the experimental drug BIA 10-2474, aimed to treat a range of neurological conditions. During a phase I trial in France, one participant died, and five others suffered severe neurological symptoms. The trial's subsequent investigation revealed insufficient precautions during the testing phase, further emphasizing the importance of rigorous safety measures in human clinical trials.
新冠时期的试验：平衡的艺术 Trials in the Time of COVID-19: A Balancing Act
随着COVID-19大流行的展开，对有效疫苗的迫切需要使临床试验的世界面临前所未有的压力。形势的紧迫性要求在速度和安全之间找到微妙的平衡。研究人员肩负了在不危害试验参与者安全的情况下寻找解决方案的任务。
As the COVID-19 pandemic unfurled, a desperate need for effective vaccines put the world of clinical trials under unprecedented pressure. The urgency of the situation demanded a delicate balance between speed and safety. Researchers were tasked with finding a solution without compromising the safety of trial participants.
为此，传统的试验阶段通常是连续进行的，但在保证安全标准的同时进行。在早期的小规模试验中表现出前景的疫苗候选者迅速转移到大规模试验，有时涉及数千名参与者。同时，进行了大规模生产的准备工作，这是一个通常会延迟到最后批准之后才进行的步骤，以避免如果疫苗证明无效而产生不必要的成本。
In response to this, traditional trial phases, typically sequential, were conducted simultaneously, while ensuring safety standards. Vaccine candidates that showed promise in early-phase small-scale trials were quickly moved to large-scale trials, sometimes with thousands of participants. Concurrently, preparations for mass production were set in motion, a step that normally would be delayed until after the final approval to avoid unnecessary costs if the vaccine proved ineffective.
这个加速过程的一个例子是辉瑞-生物NTech COVID-19疫苗。在涉及超过43,000名参与者的大型临床试验中，这种疫苗展示了约95%的效果。由于阶段重叠，COVID-19发病率高，需求紧迫，试验加速了。在仔细检查试验数据后，该疫苗在2020年12月被FDA授予紧急使用授权(EUA)，许多其他全球监管机构也做出了相同的决定。
One example of this expedited process was the Pfizer-BioNTech COVID-19 vaccine. Tested in a large clinical trial involving over 43,000 participants, the vaccine demonstrated an efficacy of around 95%. The accelerated trial was a result of overlapping phases, high COVID-19 incidence, and urgent need. After careful examination of trial data, the vaccine was granted emergency use authorization (EUA) by the FDA in December 2020, a decision mirrored by many other global regulatory bodies.
总结 Conclusion
从构思到部署的临床试验之旅，证明了科学的奉献精神，严谨性和无数志愿参与者的勇气。这是一条充满潜在陷阱的道路，正如TGN1412和BIA 10-2474的故事提醒我们的。然而，在COVID-19大流行中，我们实时看到了这个过程的展开，结果是我们恢复正常生活的最大希望的疫苗。尽管存在试验本身，但这些试验的胜利为我们在这个充满挑战的时期提供了希望的灯塔。
The journey of a clinical trial, from conception to deployment, is a testament to scientific dedication, rigor, and the courage of countless volunteer participants. It's a path fraught with potential pitfalls, as the stories of TGN1412 and BIA 10-2474 remind us. Yet, amid the COVID-19 pandemic, we've seen this process unfold in real-time, resulting in vaccines that are our best hope for returning to a sense of normalcy. The triumph of these trials, despite the trials themselves, offers a beacon of hope in these challenging times.
参考文献
1. National Institutes of Health (NIH) resources on clinical trials: Clinical Trials - NIH
2. The "Elephant Man" clinical trial case: “Elephant Man” Drug Trial Leaves Six Fighting for their Lives - The Guardian
3. The BIA 10-2474 clinical trial case: Death in France renews concerns about drug trial safety - Nature
4. The Pfizer-BioNTech COVID-19 vaccine development: Pfizer-BioNTech COVID-19 Vaccine - FDA
5. Bioethics and COVID-19 vaccine distribution: Fairly Prioritizing Groups for Access to COVID-19 Vaccines - JAMA
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