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新冠疫苗试验与伦理:延迟保护就是拒绝保护。

Covid-19 vaccine trials and ethics: Protection delayed is protection denied.

机构信息

Retired Professor, Christian Medical College, Vellore, Tamil Nadu 632 002 INDIA.

Consultant in Pediatric Infectious Diseases, Apollo Hospitals, CBD Belapur, Navi Mumbai. Maharashtra, INDIA.

出版信息

Indian J Med Ethics. 2021 Jan-Mar;VI(1):1-5. doi: 10.20529/IJME.2020.104.

DOI:10.20529/IJME.2020.104
PMID:34080997
Abstract

The Covid-19 pandemic is raging, taking heavy toll of lives and livelihoods. The need for safe and effective vaccine(s) is urgent. Vaccine research has progressed rapidly and a few vaccine candidates have passed trial Phases 1 and 2, confirming reasonable safety and immunogenicity parameters. They are ready for large scale Phase 3 trials to quantify protective efficacy, if any, and to detect uncommon but serious adverse effects, if any. These developments present unprecedented opportunities and challenges, scientific and ethical. Globally hundreds die every day due to Covid-19, and emergency/compassionate use of vaccine candidates that are ready for Phase 3 trials are likely to save lives. We perceive an ethical imperative to allow such vaccination for those at high risk of death and voluntarily make such informed choice - for them protection delayed will be tantamount to protection denied.

摘要

新冠疫情肆虐,导致大量生命和生计损失。急需安全有效的疫苗。疫苗研究进展迅速,少数疫苗候选者已通过试验的 1 期和 2 期,确认了合理的安全性和免疫原性参数。它们已准备好进行大规模 3 期试验,以量化任何保护效力,并检测任何罕见但严重的不良反应。这些进展带来了前所未有的科学和伦理机遇和挑战。全球每天都有数百人因新冠而死亡,紧急/同情使用已准备好进行 3 期试验的疫苗候选者可能会拯救生命。我们认为有一种道德义务,允许那些面临高死亡风险的人接种疫苗,并自愿做出这种知情选择——对他们来说,延迟保护无异于拒绝保护。

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