Manufacturing costs of HPV vaccines for developing countries

Manufacturing costs of HPV vaccines for developing countries
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DOI:
10.1016/j.vaccine.2016.09.042
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发表时间:
2016-11-21
期刊:
影响因子:
5.5
通讯作者:
Light, Donald W.
Light, Donald W.
中科院分区:
医学3区
文献类型:
--
作者:
Clendinen, Chaevia;Zhang, Yapei;Light, Donald W.

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背景:50万新宫颈癌病例和27万死亡病例几乎全部发生在中低收入国家。然而,最流行的两种HPV疫苗对大多数人来说负担不起。一旦失去Gavi的补贴,就连Gavi(疫苗联盟)的价格也是毕业国家负担不起的。默克和葛兰素史克(GlaxoSmithKline)声称,他们向Gavi支付的价格等于制造成本;但这些成本仍未披露。我们进行了这项调查,以估计这些成本。方法:在出版的和商业文献中搜索有关这些疫苗制造的信息。对疫苗生产专家的采访。发现:根据现有的最佳证据,这项详细的敏感性分析发现,在面向富裕市场的第一批疫苗之后,发展中国家的Gardasil的制造成本在每剂0.48美元到0.59美元之间,与其声称的4.50美元的成本相比,这只是一个零头。由于Cervarx的销量很低,它的单位成本要高得多,尽管在可比的销量下,它的成本将是相似的。解释:考虑到固定成本和年度成本从富裕市场的销售中收回,默克对Gavi的盈亏平衡价格可能是0.50-0.60美元,而不是4.50美元。这些节省下来的资金可以支持Gavi计划,以加强交付和扩大覆盖范围。在Gavi之外,向中低收入国家提供有利可图的价格也可以降低,并向数百万处于危险中的青少年提供。这些估计及其政策影响值得进一步讨论。(C)2016年提交人。爱思唯尔有限公司出版。
Background: Nearly all of the 500,000 new cases of cervical cancer and 270,000 deaths occur in middle or lower income countries. Yet the two most prevalent HPV vaccines are unaffordable to most. Even prices to Gavi, the Vaccine Alliance, are unaffordable to graduating countries, once they lose Gavi subsidies. Merck and Glaxosmithkline (GSK) claim their prices to Gavi equal their manufacturing costs; but these costs remain undisclosed. We undertook this investigation to estimate those costs.Methods: Searches in published and commercial literature for information about the manufacturing of these vaccines. Interviews with experts in vaccine manufacturing.Findings: This detailed sensitivity analysis, based on the best available evidence, finds that after a first set of batches for affluent markets, manufacturing costs of Gardasil for developing countries range between $0.48 and $0.59 a dose, a fraction of its alleged costs of $4.50. Because volume of Cervarix is low, its per unit costs are much higher, though at comparable volumes, its costs would be similar.Interpretation: Given the recovery of fixed and annual costs from sales in affluent markets, Merck's breakeven price to Gavi could be $0.50-$0.60, not $4.50. These savings could support Gavi programs to strengthen delivery and increase coverage. Outside Gavi, prices to lower- and middle-income countries, with profit, could also be lowered and made available to millions more adolescents at risk. These estimates and their policy implications deserve further discussion. (C) 2016 The Authors. Published by Elsevier Ltd.