Understanding & Estimating Costs of Vaccine Development,Production and Pricing

描述(申请人提供)：儿童疫苗被确定为20世纪公共卫生十大最伟大成就之一，21世纪已经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，迅速扩大的免疫计划和日益昂贵的疫苗威胁到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的核心是脆弱的公私伙伴关系中，公职人员与私营疫苗制造商谈判，设定联邦合同价格。政府官员喜欢较低的价格，以便为易受感染的儿童提供尽可能多的推荐疫苗，而制造商则喜欢较高的价格，以便为未来的疫苗开发带来足够的投资回报和资金。为了将双方的风险降到最低，需要更好地对称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)监管努力的回应]的信息，以及关于项目官员对新推荐疫苗相对于以前推荐疫苗的价格预期的信息。研究人员提出了一项为期两年的研究项目，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)利用一系列保密的主要行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用户友好的工具，具有可观察的输入，可供联邦免疫计划工作人员和制造商在未来使用。这一疫苗成本/价格工具将对公共卫生和疫苗制造利益之间正在进行的伙伴关系具有重要价值。研究与公共卫生的相关性：公共免疫项目和疫苗制造商之间的公私伙伴关系因疫苗价格上涨而紧张。政府想更好地了解研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。这项研究将产生一种工具，有助于增进对这些问题的相互理解。

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.