The first anti-bird flu vaccine made in China is safe for human
use, its maker Sinovac Biotech claimed yesterday.
The immunity vaccine was developed jointly by Sinovac Biotech,
the first to come up with an anti-SARS vaccine, and the Chinese
Center for Disease Control and Prevention. The Ministry of Science
and Technology and the Ministry of Health supported the
program.
Sionovac Boitech division leader Yin Xiaomei said the results of
the second clinical tests "have proved" the vaccine's major index
is up to international standards. It has yielded positive results
in humans.
The vaccine could undergo another clinical trial, though.
In China, a vaccine can enter the market only after three phases
of clinical trials. But, according to Yin, the SFDA may follow an
international convention that requires only two phases of clinical
tests for vaccines needed against a possible epidemic.
"The Beijing-based company is capable of making the vaccine in
bulk for human use," Yin said.
"We'll apply to the State Food and Drug Administration (SFDA)
soon for registration of the vaccine," Yin said. "And once the SFDA
approves it, the vaccine can enter the market."
It takes four to six months to make the vaccine, and the company
is trying to find ways to quicken the process to be prepared in
case a bird-flu pandemic breaks out in the country, Yin said.
During the second clinical tests conducted from September to
November, none of the 402 volunteers, aged between 18 and 60 years,
suffered from any major adverse reaction, Yin said.
Volunteers on varied doses developed varying degree of immunity
to bird flu, she said. "Which means the vaccine could offer
multiple choices in treating people suffering from bird flu."
(China Daily December 25, 2007)