Understanding & Estimating Costs of Vaccine Development,Production and Pricing

理解

• 批准号: 7282371
• 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/7282371
• 关键词: Understanding; Estimating; Costs; 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）：童年疫苗已被确定为20世纪公共卫生中十大最大成就之一，而21世纪推荐的新疫苗有望降低儿童和成人的发病率和死亡率。但是，迅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，公职人员与私人疫苗制造商进行谈判，以确定联邦合同价格。公职人员更喜欢价格较低的价格，以便为弱势儿童提供尽可能多的推荐疫苗，而制造商更喜欢更高的价格，这些价格可以产生足够的投资回报和资本回报率，以进行未来的疫苗开发。为了最大程度地降低双方的风险，需要更好地对称有关制造商在疫苗开发和商业化方面投资的信息（包括对食品和药物管理局（FDA）监管工作的反应），以及有关相对于先前推荐的疫苗相对于新推荐的疫苗的计划官员对新推荐的疫苗的价格期望。研究人员提出了一个为期两年的研究项目，其特定目的是：（1）使用专家主要来源开发和评估可观察因素的概念模型，这些模型可观察到的可观察因素的概念模型，这些模型有助于疫苗开发，商业化和定价成本； （2）使用一系列机密的主要行业来源和公开可用的二级资源，将概念模型转化为开发/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用于用户友好的工具，并使用可观察到的投入，将来可以在未来由联邦免疫计划人员和制造商使用。这种疫苗成本/价格工具在公共卫生和疫苗制造业权益之间的持续合作伙伴关系中将具有很高的价值。研究与公共卫生的相关性：公共免疫计划与疫苗制造商之间的公私合作伙伴关系因疫苗价格上涨而受到影响。政府希望更好地了解开发和生产新疫苗的成本如何为价格提供信息。制造商希望政府了解他们在疫苗开发中的投资水平。这项研究将产生一种工具，以帮助提高对这些问题的相互了解。