Understanding & Estimating Costs of Vaccine Development,Production and Pricing

理解

• 批准号: 7229176
• 负责人: Matthew M Davis
• 金额: $ 15万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2008-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7229176
• 关键词: clinical research; computer system design /evaluation; cooperative study; drug design /synthesis /production; health care cost /financing; health care policy; human subject; interview; mathematical model; pediatrics; vaccine development

DESCRIPTION (provided by applicant): Childhood vaccines have been identified as one of the top 10 greatest achievements in public health in the 20th century, and new vaccines recommended already in the 21st century promise additional reductions in morbidity and mortality for children and adults. However, the rapidly expanding immunization schedule and increasingly expensive vaccines threaten the fiscal stability of public vaccine financing at federal and state levels. In the fragile public-private partnership at the core of United States vaccination efforts, public officials negotiate with private vaccine manufacturers to set federal contract prices. Public officials prefer lower prices in order to provide as many recommended vaccines as possible to vulnerable children, whereas manufacturers prefer higher prices that yield sufficient return on investment and capital for future vaccine development. To minimize risk for both parties, there is a need for better symmetry of information about manufacturers' investments in vaccine development and commercialization [including responses to the Food and drug Administration (FDA) regulatory efforts], and about program officials' price expectations for newly recommended vaccines relative to previously recommended vaccines. The investigators propose a two-year research project with the following specific aims: (1) To develop and evaluate a conceptual model of observable factors that contribute to the costs of vaccine development, commercialization, and pricing, using expert primary sources; (2) To translate the conceptual model into a working model of development/commercialization costs and pricing for vaccines, using an array of confidential primary industry sources and publicly available secondary sources; (3) To operationalize the working model of vaccine costs and pricing as a user-friendly tool with observable inputs that can be used in the future by federal immunization program staff and manufacturers. This vaccine cost/price tool will be of great value in the ongoing partnership between public health and vaccine manufacturing interests. RELEVANCE OF RESEARCH TO PUBLIC HEALTH: The public-private partnership between public immunization programs and vaccine manufacturers is strained by increasing prices of vaccines. The government wants to understand better how the costs of developing and producing new vaccines inform prices. Manufacturers want the government to understand their level of investment in vaccine development. This research will yield a tool to help improve mutual understanding of these issues.

描述（由申请人提供）：儿童疫苗被认为是 20 世纪公共卫生领域十大最伟大成就之一，21 世纪推荐的新疫苗有望进一步降低儿童和成人的发病率和死亡率。然而，快速扩大的免疫计划和日益昂贵的疫苗威胁着联邦和州一级公共疫苗融资的财政稳定性。在美国疫苗接种工作核心的脆弱的公私伙伴关系中，公职人员与私营疫苗制造商谈判以确定联邦合同价格。政府官员倾向于较低的价格，以便为弱势儿童提供尽可能多的推荐疫苗，而制造商则倾向于较高的价格，以便为未来的疫苗开发带来足够的投资和资本回报。为了最大限度地减少双方的风险，需要使有关制造商在疫苗开发和商业化方面的投资（包括对食品和药物管理局（FDA）监管工作的反应）以及项目官员对新推荐疫苗相对于先前推荐疫苗的价格预期的信息更加对称。研究人员提出了一个为期两年的研究项目，其具体目标如下：（1）利用专家的主要来源，开发和评估影响疫苗开发、商业化和定价成本的可观察因素的概念模型； (2) 利用一系列保密的第一产业来源和公开的二手来源，将概念模型转化为疫苗开发/商业化成本和定价的工作模型； (3) 将疫苗成本和定价的工作模型作为一种用户友好的工具进行操作，提供可观察的输入，可供联邦免疫计划工作人员和制造商在未来使用。这种疫苗成本/价格工具对于公共卫生和疫苗生产利益之间的持续合作伙伴关系将具有巨大价值。研究与公共卫生的相关性：公共免疫计划和疫苗制造商之间的公私合作伙伴关系因疫苗价格上涨而紧张。政府希望更好地了解开发和生产新疫苗的成本如何影响价格。制造商希望政府了解他们在疫苗开发方面的投资水平。这项研究将产生一个工具来帮助增进对这些问题的相互理解。