China's food and drug regulators on Wednesday authorized a domestic pharmaceutical firm to begin commercial production of a human bird flu vaccine, following more than two years of clinical trials.
The firm, Beijing-based Sinovac Biotech Co., Ltd. will produce vaccines to defend humans against the H5N1 virus and its epidemic variety, making China the world's second country with the technology and industrial capacity to produce human bird flu vaccine.
According to Yin Weidong, general manager of the firm, Sinovac has the ability to produce new vaccines even if the virus mutates in humans.
China started clinical research and experiments as part of the process of making a vaccine in November 2005, after a domestic epidemic that caused huge losses for poultry breeders.
Trials by Sinovac proved that the vaccine is safe for humans and effective against the virus. According to Yin, more than 500 volunteers have received injections of the vaccine, which shows that it is reliable.
Yan Jiangying, spokeswoman for the State Food and Drug Administration (SFDA), said on Wednesday that the agency had authorized the production of the vaccine to prevent human-to-human transmission of the virus.
According to the SFDA, the vaccine will also be on hand as part of the preparations for dealing with any possible epidemic during the Beijing Olympics this summer.
The SFDA used a special procedure for the human bird flu vaccine, which allows it to approve commercial production simultaneously with the approval of the drug license.
"This is the first time the administration is using the special procedure since it was created in 2005," said Yin Hongzhang, an official with the SFDA.
Since 2005, China has reported 29 human bird flu cases, according to the Chinese Center for Disease Control and Prevention (CCDCP).
According to Wang Yu, director with the CCDCP, the authorization embodies that China holds complete technological chain from epidemic monitoring, patient identification to virus decomposing and industrial production of the vaccine.
"China has completed the technological and substantial reserves of the human bird flu vaccine," Wang said, adding that researches to improve the effectiveness and reduce possible side effects of the vaccine will be carried out soon.
For the moment, the vaccine will not be sold in retailing drug stores but be reserved for emergency distribution in case of major outbreak.
(Xinhua News Agency April 3, 2008)