Division of Pediatric Infectious Diseases, Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.
Department of Pediatrics, Tufts Medical Center, Tufts University School of Medicine, Boston, MA.
Mayo Clin Proc. 2020 Mar;95(3):600-608. doi: 10.1016/j.mayocp.2019.11.002. Epub 2020 Feb 13.
The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. For FDA-licensed vaccines, the product label includes indications, contraindications, and precautions for each vaccine. Package inserts do not include recommendations for vaccine use from the Advisory Committee on Immunization Practices (ACIP). The ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the director of the Centers for Disease Control and Prevention on the use of vaccines and related agents for control of vaccine preventable diseases in the civilian and military populations of the United States. As an external advisory committee to the Centers for Disease Control and Prevention, the ACIP has no regulatory authority but the committee does have responsibility for approving vaccines to be covered under the Vaccines for Children program. To implement ACIP vaccine recommendations in the public and private sectors, a collaboration of federal, state, and local governments as well as private organizations dealing with public health, vaccine supply, vaccine administration, vaccine finance, outcomes monitoring, public perception, and public trust and support must work together. Issues including vaccine misinformation, declining community immunity (herd protection), and need for risk communication add stress to this complex and fragile system. This study describes the functions of and interactions between FDA and ACIP.
疫苗的许可和推荐程序较为复杂。在美国，疫苗制造商向美国食品和药物管理局（FDA）提交生物制品许可申请，经审核后可为平民和军人接种疫苗。对于获得 FDA 许可的疫苗，产品标签包含了疫苗的适应证、禁忌证和注意事项。但包装说明书中不包括免疫实践咨询委员会（ACIP）对疫苗使用的建议。ACIP 是一个联邦咨询委员会，其职责是为美国疾病控制与预防中心主任提供有关疫苗和相关制剂在平民和军人中的使用的专业外部建议和指导，以控制可通过疫苗预防的疾病。作为疾病预防控制中心的一个外部咨询委员会，ACIP 没有监管权，但委员会负责批准疫苗纳入儿童疫苗计划。为了在公共和私营部门实施 ACIP 的疫苗建议，联邦、州和地方政府以及涉及公共卫生、疫苗供应、疫苗接种、疫苗融资、结果监测、公众认知和公众信任与支持的私营组织必须协同合作。疫苗错误信息、社区免疫水平下降（群体保护）以及风险沟通的需求等问题给这个复杂而脆弱的系统带来了压力。本研究描述了 FDA 和 ACIP 的功能和相互作用。
