Pediatrics. 1997 Dec;100(6):1015-20. doi: 10.1542/peds.100.6.1015.
In the last 20 years, two thirds of all new vaccines provided worldwide have been produced by a US network of independent industrial, governmental, and academic partners engaged in vaccine research and development. Vaccines are complex products and the science of vaccinology is difficult. To achieve the full promise of modern science and technology to prevent and treat disease by immunization, the delicate fabric of America's cooperative and collaborative vaccine research relationships must be sustained and strengthened. The major partners are the federal government; four large companies--two US-headquartered (Wyeth-Lederle Biologics and Vaccines and Merck & Co), two foreign firms (SmithKline Beecham and Pasteur Mérieux Connaught); and academia. Of the $1.4 billion that fund US vaccine research and development annually, 46% comes from vaccine sales, 36% from taxpayers, and 18% from risk capital. Vaccine innovation could be strengthened by improved public and policy maker understanding of the vaccine development network; declarations of partnership; interactive dialog with federal advisory bodies; public forums for government and industry to listen to patients, providers and researchers; sabbatical assignments between partners; mechanisms to share industries' market research with public immunization programs; continued active industry participation in the Advisory committee on Immunization Practices and the National Vaccine Advisory committee; increased collaboration between industry and the National Institutes of Health for clinical research; harmonization of the Advisory Committee on Immunization Practices vaccine recommendations and the Food and Drug Administration package inserts; and public policies to foster the partnership's collaboration and robustness. The optimal size and configuration of the US vaccine enterprise should be debated only in the context of a full understanding of how the current system works and its record of effectiveness. These National Vaccine Advisory Committee recommendations are directed at developing public policies to foster and sustain vaccine innovation and ensure the timely introduction and supply of new vaccines needed by this nation and the world.
在过去20年里，全球提供的所有新疫苗中有三分之二是由美国一个由独立的工业、政府和学术伙伴组成的疫苗研发网络生产的。疫苗是复杂的产品，疫苗学是一门艰深的科学。为了充分实现现代科学技术通过免疫预防和治疗疾病的前景，美国合作与协作的疫苗研究关系的微妙架构必须得到维持和加强。主要合作伙伴包括联邦政府；四家大公司——两家总部设在美国的公司（惠氏-莱德勒生物制品和疫苗公司以及默克公司）、两家外国公司（史克必成公司和巴斯德梅里厄康诺公司）；以及学术界。在美国每年用于疫苗研发的14亿美元资金中，46%来自疫苗销售，36%来自纳税人，18%来自风险资本。可以通过以下方式加强疫苗创新：提高公众和政策制定者对疫苗研发网络的了解；宣布合作伙伴关系；与联邦咨询机构进行互动对话；为政府和行业设立听取患者、提供者和研究人员意见的公共论坛；合作伙伴之间的休假安排；将行业市场研究与公共免疫计划分享的机制；行业继续积极参与免疫实践咨询委员会和国家疫苗咨询委员会；加强行业与国立卫生研究院在临床研究方面的合作；统一免疫实践咨询委员会的疫苗建议和食品药品管理局的包装说明书；以及制定促进该伙伴关系合作与稳健性的公共政策。只有在充分了解当前系统如何运作及其有效性记录的背景下，才应讨论美国疫苗企业的最佳规模和结构。这些国家疫苗咨询委员会的建议旨在制定公共政策，以促进和维持疫苗创新，并确保及时推出和供应美国及世界所需的新疫苗。
