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Chinese Watchdog Approves Clinical Tests of Human Bird Flu Vaccine

Posted on: Tuesday, 22 November 2005, 12:00 CST

Text of report in English by official Chinese news agency Xinhua (New China News Agency)

Beijing, 22 November: China's drug watchdog Tuesday [22 November] approved its home-made human bird flu vaccine for clinical test, a major progress in China's prevention efforts of possible pandemic flu.

The vaccine was developed from NIBRG-14 virus strain recommended and provided by the World Health Organization (WHO), according to the State Food and Drug Administration (SFDA).

Pre-clinical trials show the vaccine is fairly safe and effective and the virus strain and the producing procedures of the vaccine are reliable, said SFDA experts.

China began developing epidemic flu vaccine last year. SFDA has been monitoring the progress since its early stage. Fast-track examination procedures was granted to the vaccine after SFDA received application from the producer, according to SFDA.

Beijing-based vaccine producer Sinovac Biotech, the first in the world to develop a SARS vaccine, applied to SFDA for clinical tests of the human bird flu vaccine in October. At present, the mass production for the vaccine is ready, said Yin Weidong, general manager of the company.

China has so far reported 21 bird flu outbreaks in nine provinces, autonomous regions and municipalities, and has confirmed two human cases of bird flu. One victim in east China's Anhui Province has died and the other in central China's Hunan Province has recovered.

Currently, seven other drug firms in the world, like those in the United States, the European Union and Japan, are also developing vaccines of this kind.

Source: BBC Monitoring Asia Pacific

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