疫苗临床试验的伦理挑战

有效的疫苗作为应对传染病大流行的重要工具，在公共卫生中作出了重大贡献。为应对新发传染病流行，需要研发新的疫苗，但在传染病大流行的紧急公共卫生危机情况下，疫苗临床试验面临着重要的伦理挑战。如果尚不存在已证明安全有效的疫苗，处在均衡状态的多种有希望的候选疫苗，应在随机对照试验中进行验证。即使存在已证明安全有效获准使用的疫苗，基于效力、反应原性、运输储存等方面的考虑可能也需要研发新的疫苗。人体挑战试验必须在受试者个人风险处在可接受的界限之内的前提之下，平衡期望的社会受益。应采取措施避免“预防误解”风险。

The Ethical Challenges of Vaccine Clinical Trials

Vaccines make a major contribution to public health as an important tool in response to pandemics. New vaccines need to be developed in response to emerging infectious disease epidemics, but vaccine clinical trials face important ethical challenges in the context of emergency public health crises of pandemics. If no vaccine has been proven to be safe and effective, multiple promising vaccine candidates in equilibrium should be validated in randomized controlled trials. Even if a vaccine with proven safety and efficacy is available and approved for use, new vaccines may need to be developed based on reasons of efficacy, reactogenicity, transport and storage, and other considerations. Human challenge trials must balance the desired societal benefit with the premise that the risk to the individual subject is within acceptable limits. Measures should be taken to avoid the risk of "prophylactic misinterpretation".