Decker M D
Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Prim Care. 2001 Dec;28(4):739-61, vi. doi: 10.1016/s0095-4543(05)70039-7.
The biotechnology revolution has stimulated vaccine development, blessing us with new, safe, and effective vaccines, but burdening our vaccination schedule. The incorporation of multiple individual vaccines into combination vaccines can simplify vaccine administration programs and permit the inclusion of new antigens in the vaccine schedule. Although the development, evaluation, and implementation of combination vaccines pose numerous challenges and raise controversies that remain unresolved, there is a reasonable prospect of United States licensure within the next few years of several new combination vaccines for infant use. Approval in the United States of combination vaccines in use elsewhere might be speeded by improved vaccination tracking systems and post marketing efficacy surveillance, which would provide confidence that material reductions in efficacy could be detected following licensure, and thereby ease concerns regarding moderate, but perhaps immaterial, declines in immunogenicity seen with some combinations.
生物技术革命推动了疫苗的研发,为我们带来了新的、安全有效的疫苗,但也使我们的疫苗接种计划变得繁重。将多种单一疫苗整合为联合疫苗可以简化疫苗接种程序,并使新抗原能够纳入疫苗接种计划。尽管联合疫苗的研发、评估和应用带来了诸多挑战并引发了一些尚未解决的争议,但未来几年内,美国有合理的预期批准几种用于婴儿的新型联合疫苗。其他地区已投入使用的联合疫苗在美国的获批速度可能会因改进后的疫苗接种追踪系统和上市后疗效监测而加快,这将让人相信在疫苗获批后能够检测到效力的实质性降低,从而缓解对某些联合疫苗免疫原性出现适度但可能无关紧要下降的担忧。