The essence of a vaccine lies in its ability to elicit a set of immune responses specifically directed at a particular pathogen. Accordingly, vaccines were historically designed, developed, registered, recommended, procured, and administered as monopathogen formulations. Nonetheless, the control and elimination of an astonishing number of diseases was realised only after several once-separate vaccines were provided as combinations. Unfortunately, the current superabundance of recommended and pipeline vaccines is now at odds with the number of acceptable vaccine administrations and feasible health-care visits for vaccine recipients and health-care providers. Yet, few new combinations are in development because, in addition to the scientific and manufacturing hurdles intrinsic to coformulation, developers face a gauntlet of regulatory, policy, and commercialisation obstacles in a milieu still largely designed for monopathogen vaccines. We argue here that national policy makers and public health agencies should prospectively identify and advocate for the development of new multipathogen combination vaccines, and suggest ways to accelerate the regulatory pathways to licensure of combinations and other concrete, innovative steps to mitigate current obstacles.

中文翻译：

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促进急需的联合疫苗的开发

疫苗的本质在于其能够引发一系列专门针对特定病原体的免疫反应。因此，疫苗历来都是作为单病原体制剂来设计、开发、注册、推荐、采购和施用的。尽管如此，只有在几种曾经单独的疫苗作为组合提供后，才实现了对数量惊人的疾病的控制和消除。不幸的是，目前推荐和正在研发的疫苗数量过多，与可接受的疫苗接种数量以及疫苗接受者和医疗保健提供者可行的医疗保健就诊数量相矛盾。然而，正在开发的新组合很少，因为除了复合制剂固有的科学和制造障碍之外，开发商还面临着监管、政策和商业化障碍的挑战，而环境仍然主要是为单病原体疫苗设计的。我们在此认为，国家政策制定者和公共卫生机构应前瞻性地确定和倡导开发新的多病原体组合疫苗，并提出加速组合许可监管途径的方法以及其他具体的创新步骤，以减轻当前的障碍。