CBR Division, Defence Science and Technology Laboratory, Salisbury, Wiltshire, UK.
Clin Exp Immunol. 2019 Nov;198(2):170-183. doi: 10.1111/cei.13284. Epub 2019 Apr 11.
Globally, there are a number of emerging pathogens. For most, there are no licensed vaccines available for human use, although there is ongoing research and development. However, given the extensive and increasing list of emerging pathogens and the investment required to bring vaccines into clinical use, the task is huge. Overlaid on this task is the risk of anti-microbial resistance (AMR) acquisition by micro-organisms which can endow a relatively harmless organism with pathogenic potential. Furthermore, climate change also introduces a challenge by causing some of the insect vectors and environmental conditions prevalent in tropical regions to begin to spread out from these traditional areas, thus increasing the risk of migration of zoonotic disease. Vaccination provides a defence against these emerging pathogens. However, vaccines for pathogens which cause severe, but occasional, disease outbreaks in endemic pockets have suffered from a lack of commercial incentive for development to a clinical standard, encompassing Phase III clinical trials for efficacy. An alternative is to develop such vaccines to request US Emergency Use Authorization (EUA), or equivalent status in the United States, Canada and the European Union, making use of a considerable number of regulatory mechanisms that are available prior to licensing. This review covers the status of vaccine development for some of the emerging pathogens, the hurdles that need to be overcome to achieve EUA or an equivalent regional or national status and how these considerations may impact vaccine development for the future, such that a more comprehensive stockpile of promising vaccines can be achieved.
全球范围内存在许多新出现的病原体。对于大多数病原体而言，虽然目前正在进行研究和开发，但尚未有针对人类使用的许可疫苗。然而，鉴于新出现的病原体数量众多且不断增加，以及将疫苗投入临床使用所需的投资，这项任务艰巨。在此任务之上，微生物获得抗微生物药物耐药性（AMR）的风险也叠加在一起，这可能使相对无害的生物体具有致病性潜力。此外，气候变化也带来了挑战，导致一些昆虫媒介和热带地区流行的环境条件开始从这些传统地区传播开来，从而增加了人畜共患疾病传播的风险。接种疫苗可以预防这些新出现的病原体。然而，对于在地方性流行地区偶尔引起严重疾病暴发的病原体的疫苗，由于缺乏开发到临床标准（包括针对疗效的 III 期临床试验）的商业动力，因此一直受到影响。另一种选择是开发此类疫苗，以请求美国紧急使用授权（EUA）或在美国、加拿大和欧盟获得同等地位，利用在许可之前可用的大量监管机制。这篇综述涵盖了一些新出现的病原体的疫苗开发状况、为获得 EUA 或同等的地区或国家地位而需要克服的障碍，以及这些考虑因素如何影响未来的疫苗开发，以便能够实现更全面的有前途的疫苗储备。
