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)
