On Tuesday, the State Food and Drug Administration (SFDA) gave Beijing-based Sinovac Biotech the go ahead for clinical trials of a possible human vaccine for avian influenza.
Yin Weidong, Sinovac's general manager, said the company is already prepared for mass production.
SFDA experts were quoted by Xinhua News Agency today as saying that the vaccine had passed basic safety and effectiveness testing in pre-clinical trials, and that production methods had proved reliable.
The clinical trials will comprise two phases, the first of which will involve testing on 100 people. The developer has yet to make an agreement with a particular hospital at which to carry them out, but once it does it will be able to confirm when they will take place.
Sinovac, the first in the world to develop a SARS vaccine, had its pre-clinical trials endorsed by a Ministry of Science and Technology expert group on October 14 and proceeded to apply to the SFDA for human testing on October 21.
The company began to develop a human bird flu vaccine in early 2004, and the SFDA said it had fast-tracked examination procedures for the vaccine.
According to Xinhua yesterday, the Ministry of Agriculture said on Monday that 21 outbreaks of bird flu amongst bird populations in nine provinces, autonomous regions and municipalities had been confirmed so far this year.
Two human cases had also been confirmed by the Ministry of Health and WHO. One victim in the eastern province of Anhui died, while another in central China's Hunan Province recovered. The latter's sister also died, but the cause could not be confirmed because her remains were cremated before adequate tests could be completed.
Seven other drug firms in the US, EU and Japan are currently developing human vaccines for bird flu.
(Xinhua News Agency November 23, 2005)
