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China's Sinovac gets world's first production license for A/H1N1 flu vaccine


http://en.youth.cn   2009-09-04 09:05:00

by Xinhua writers Miao Xiaojuan, Wang Cong

China approved Thursday the A/H1N1 flu vaccine produced by domestic pharmaceutical company Sinovac, making it the first to get a production license in the global race.

The State Food and Drug Administration (SFDA) issued the license for Sinovac's vaccine called Panflu.1 on Thursday, after it passed SFDA's experts evaluation on Aug. 31.

 

Two A/H1N1 flu vaccines are showed by personnel of Sinovac in Beijing, capital of China, Sep. 3, 2009.

 "Clinical trials show that Panflu.1 is very safe and its immunogenicity factors reach international standards," said Zhang Wei, director of SFDA's registration department.

Panflu.1 could safely be given to people aged from three to 60 years old in a single shot, 15 microgram dose, according to the evaluation report.

Sinovac had the capacity to produce five million doses of vaccine before Oct.1, and 20 to 30 million doses per year, according to its president Yin Weidong.

"Currently Sinovac will focus on meeting the need of the Chinese government. And if we still have extra capacity, Sinovac is quite open to discuss the possible opportunity on A/H1N1 vaccine export," said Yin.

 
source : Xinhua     editor:: Fu Qinghua
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