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Establishment of pandemic influenza vaccine production capacity at Bio Farma, Indonesia

机译：在印度尼西亚Bio Farma建立大流行性流感疫苗生产能力

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In Indonesia, avian influenza A(H5N1) virus started to spread in humans in June 2005, with an alarming case-fatality rate of more than 80%. Considering that global influenza vaccine production capacity would barely have covered 10% of the world's pandemic vaccine needs, and that countries with no production facilities or prearranged contracts would be without access to a vaccine, the Government of Indonesia embarked on a programme to increase its readiness for a future influenza pandemic. This included the domestic production of influenza vaccine, which was entrusted to Bio Farma.This health security strategy consists of developing trivalent influenza vaccine production capacity in order to be able to convert immediately to monovalent production of up to 20 million pandemic doses for the Indonesian market upon receipt of the seed strain from the World Health Organization (WHO). For this purpose, a dedicated production facility is being constructed within the Bio Farma premises in Bandung.As an initial stage of influenza vaccine development, imported seasonal influenza bulk has been formulated and filled in the Bio Farma facility. Following three consecutive batches and successful clinical trials, the product was licensed by the Indonesian National Regulatory Authority and distributed commercially for the Hajj programme in 2009. With continued support from its technology transfer partners, Bio Farma is now advancing with the development of upstream processes to produce its own bulk for seasonal and pandemic use
机译：在印度尼西亚，禽流感A（H5N1）病毒于2005年6月开始在人类中传播，令人震惊的病死率超过80％。考虑到全球流感疫苗的生产能力几乎无法满足世界大流行疫苗的需求的10％，并且没有生产设施或没有预先安排的合同的国家将无法获得疫苗，印度尼西亚政府着手实施一项计划，以提高其准备水平对于未来的流感大流行。其中包括由Bio Farma委托的国内流感疫苗生产。此健康安全战略包括发展三价流感疫苗生产能力，以便能够立即转换为印尼市场上高达2000万大流行剂量的单价生产收到世界卫生组织（WHO）的种子株后。为此，在万隆Bio Farma厂房内正在建设专用的生产设施，作为流感疫苗开发的初始阶段，已配制进口的季节性流感大宗药品并填充到Bio Farma设施中。经过连续三批次的试验和成功的临床试验，该产品已获得印度尼西亚国家监管局的许可，并于2009年为朝j计划进行了商业销售。在其技术转让合作伙伴的不断支持下，Bio Farma现在正在推进上游工艺的开发，以生产自己的散装产品以供季节性和大流行使用

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