Vax industry braces as China nears global manufacturer status

The World Health Organization's thumbs-up to China's drug regulator is one of the few remaining steps before a transformation of the global vaccine industry. Following a years-long process, WHO earlier this year approved China's State Food and Drug Administration as fit to police drug manufacturing.

The approval opened the door for Chinese vaccine makers to apply for WHO pre-qualification status, a certification required for supplying vaccines to Unicef for distribution in developing countries. Chinese entry into the global vaccine market is expected to drive down prices significantly.

But it remains to be seen whether the see-no-evil Chinese authorities--apparently unable to get to the bottom of the 2008 heparin contamination incident or the 2007 Draconian executioner of a drug official on bribery charges (or perhaps something else entirely)--will prevail.

China currently has 36 manufacturers producing 49 vaccines against 27 diseases, including measles, polio, BCG (TB), hepatitis B and H1N1, according to South Africa's Mail & Guardian.

If China can demonstrate effective vaccine mass-production capabilities (one estimate has it at nearly 1 billion doses per year) and if it charges the significantly lower prices expected, it "could lead to a drastic reduction in the price of vaccines worldwide, as there would be more suppliers, more competition and better bargaining power," says Jiankang Zhang, the program leader in China for global health organization Path, in the article. 

But before it comes to that, Chinese vaccine makers still have to earn WHO's approval of the production standards for each of the vaccines they've been prequalified to make. Those discussions are happening now.

- see the story

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