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)