Pickering Larry K, Walton L Reed
Pediatr Ann. 2013 Aug;42(8):146-52. doi: 10.3928/00904481-20130723-08.
New vaccines in the United States go through a complex process on their path from development to the domestic market involving an intricate partnership of public and private agencies and organizations. This process includes licensure by the US Food and Drug Administration, the development of recommendations by the Advisory Committee on Immunization Practices, and safety oversight post-licensure. This article examines the roles of the US Food and Drug Administration and the Centers for Disease Control and Prevention as well as certain professional organizations in governing the testing, marketing, and usage of new vaccines. Vaccines currently in development to treat numerous infectious and noninfectious diseases are also examined and compared with frameworks of domestic vaccine development prioritization, past and present, as assessed by the Institute of Medicine.
在美国，新疫苗从研发到进入国内市场要经历一个复杂的过程，涉及公共和私人机构及组织之间错综复杂的合作关系。这个过程包括美国食品药品监督管理局的许可、免疫实践咨询委员会制定建议，以及许可后的安全监督。本文探讨了美国食品药品监督管理局、疾病控制与预防中心以及某些专业组织在管理新疫苗的测试、营销和使用方面所扮演的角色。还对目前正在研发用于治疗多种传染病和非传染病的疫苗进行了研究，并与医学研究所评估的过去和现在国内疫苗研发优先级框架进行了比较。
