Lykins William R, Fox Christopher B
Access to Advanced Health Institute, Seattle, WA 98102, USA.
Pharmaceutics. 2023 Jun 29;15(7):1850. doi: 10.3390/pharmaceutics15071850.
Over the last several years, there has been increased interest from academia and the pharmaceutical/biotech industry in the development of vaccine adjuvants for new and emerging vaccine modalities. Despite this, vaccine adjuvant development still has some of the longest timelines in the pharmaceutical space, from discovery to clinical approval. The reasons for this are manyfold and range from complexities in translation from animal to human models, concerns about safety or reactogenicity, to challenges in sourcing the necessary raw materials at scale. In this review, we will describe the current state of the art for many adjuvant technologies and how they should be approached or applied in the development of new vaccine products. We postulate that there are many factors to be considered and tools to be applied earlier on in the vaccine development pipeline to improve the likelihood of clinical success. These recommendations may require a modified approach to some of the common practices in new product development but would result in more accessible and practical adjuvant-containing products.
在过去几年中，学术界以及制药/生物技术行业对开发用于新型和新兴疫苗模式的疫苗佐剂越来越感兴趣。尽管如此，从发现到临床批准，疫苗佐剂的开发在制药领域仍然有着一些最长的时间表。原因是多方面的，从动物模型到人类模型转化的复杂性、对安全性或反应原性的担忧，到大规模采购必要原材料的挑战。在这篇综述中，我们将描述许多佐剂技术的当前技术水平，以及它们在新疫苗产品开发中应如何应用。我们推测，在疫苗开发流程的早期有许多因素需要考虑，有许多工具需要应用，以提高临床成功的可能性。这些建议可能需要对新产品开发中的一些常见做法进行调整，但会带来更易获取和实用的含佐剂产品。
