Pickering Larry K, Orenstein Walter A, Sun Wellington, Baker Carol J
Emory University School of Medicine, Department of Pediatrics, Division of Pediatric Infectious Diseases, Atlanta, GA, United States.
Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, Atlanta, GA, United States; Emory Vaccine Center, Emory University, Atlanta, GA, United States.
Vaccine. 2017 Sep 5;35(37):5027-5036. doi: 10.1016/j.vaccine.2017.07.023. Epub 2017 Jul 29.
Many healthcare providers are not familiar with the Food and Drug Administration (FDA) vaccine licensure process, the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation process, and how FDA vaccine licensure and ACIP recommendations are related. Vaccines for use in the United States military and civilian populations are licensed by the FDA by several potential pathways but use of licensed vaccines in the civilian population should be based on recommendations made by the ACIP. In performing these distinct activities, FDA and ACIP function under different mandates. In this article, we discuss whether the FDA licensure pathways used to approve a vaccine impacts ACIP recommendation categories for vaccines licensed from 2006 to 2016.
许多医疗服务提供者并不熟悉美国食品药品监督管理局（FDA）的疫苗许可程序、免疫实践咨询委员会（ACIP）的疫苗推荐程序，以及FDA疫苗许可与ACIP推荐之间的关系。用于美国军队和平民的疫苗由FDA通过多种潜在途径进行许可，但民用许可疫苗的使用应基于ACIP的建议。在开展这些不同的活动时，FDA和ACIP依据不同的授权开展工作。在本文中，我们讨论了用于批准疫苗的FDA许可途径是否会影响2006年至2016年许可疫苗的ACIP推荐类别。
