New Chinese quality standards raise the risk of a hep B vaccine shortage

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.  

- read the Global Times article
- check out the China Daily piece
- here's UPI's post

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