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中国新疫苗质量标准或增大乙肝疫苗短缺风险

  1. GMP
  2. 中国
  3. 乙肝疫苗供应短缺

来源:生物谷 2014-01-04 21:21

2014年1月4日讯 /生物谷BIOON/ --最近中国发生的婴儿接种乙肝疫苗死亡事件在中国国内引起轩然大波。迫于此次事件的压力,中国政府也开始加紧制定相关疫苗质量新标准。而受此次疫苗死亡事件的影响,大连汉信生物技术有限公司、深圳康泰生物技术有限公司和北京天坛生物技术有限公司都没有在此次中国药品生产质量管理规范(GMP)认证名单上。自2013年12月31日起,未通过此次认证的公司将不能进行新产品的生产和销售,但是仍然可以销售旧有批次产品。由于上述三家公司的乙肝疫苗产品占据了中国市场近80%的份额,这就使得新标准实施后中国政府面临着乙肝疫苗紧缺的窘境。根据最新消息显示,中国有关部门的检验部门消息,此次婴儿死亡事件与康泰等公司产品质量可能没有直接关系。不过即使如此,显然康泰公司等也无法在短时间内申请通过新标准认证。(生物谷Bioon.com)

详细英文报道:

China's push to raise manufacturing standards was always likely to result in a few hiccups as companies raced to bring production plants into line with new regulations. And with the deadline for producers of injectables now having passed, it appears the hepatitis B vaccine market faces a tricky few months.

Dalian Hissen BioPharm, Shenzhen BioKangtai and Beijing Tiantan Biological Products are all missing from the latest list of companies with good manufacturing practice (GMP) certification. Companies that failed to obtain GMP clearance by Dec. 31, 2013, are banned from producing new products, but they can continue selling old stock. As of October the three companies reportedly supplied 80% of hepatitis B vaccines sold in China, Global Times states, with each holding a little more than one quarter of the sector.

This figure is contradicted by a UPI article that reports BioKangtai alone controls 60% of the sector. Either way, the cessation of production has big implications for China. "There is huge demand for hepatitis B vaccines because the inoculation is required and paid for by the government in China. The three companies' stock will be quickly used up, and China may need to import hepatitis B vaccines in the future," Yu Mingde, president of the Chinese Pharmaceutical Enterprises Association, told the Global Times.

GlaxoSmithKline ($GSK) and Merck ($MRK) have U.S. FDA approved hepatitis B vaccines. Importation of hepatitis B vaccines will be unnecessary if smaller local producers can increase production. North China Pharmaceutical received GMP certification ahead of the deadline, positioning it to grow its share of the market beyond its current 12% stake. The bigger competitors are likely to return, but Dalian Hissen is not expected to receive certification until the second half of 2014 and Tiantan is yet to apply for its new site.

BioKangtai faces other problems. Last month the Chinese regulator suspended use of its hepatitis B vaccine amid concerns about its role in the deaths of babies. There are now 12 reports of babies dying after receiving the BioKangtai vaccine. An investigation is underway and the World Health Organization has discussed the incidents with local authorities, China Daily reports.

 

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