Sinovac Biotech Ltd. (Sinovac) has announced that the Chinese State Drug Administration (SFDA) has authorized its operating subsidiary in Beijing, Sinovac Biotech Co., Ltd., to select 30 volunteers for the Phase I clinical test of its potential SARS vaccine.
Sinovac is the only institute that has been approved by the State Drug Administration to conduct human clinical trials of a SARS vaccine. The first phase of testing will last for three months in either of Beijing, Guangdong province or Guangxi region. The volunteers will comprise of 15 men and 15 women aged from 18 to 40.
As previously announced, pre-clinical trials on monkeys showed the vaccine was effective in preventing infection. The monkeys that were inoculated with the vaccine experienced no serious side effects after they were exposed to the potentially deadly virus. The first phase of human testing will determine if it is safe and effective on the human body. Risks do exist but, if any, they are anticipated to be only minor, such as low fever and pain. The clinical protocols for the testing of Sinovac's potential SARS vaccine have been developed in cooperation with the World Health Organization (WHO), and the Chinese State Drug Administration (SFDA). If Phase I testing is successful, then the second phase of clinical testing will have more participants from a wider demographic range.
The drug approval process regulated by the State Drug Administration (SFDA) in China is similar to the one regulated by the FDA in the United States. The process involves pre-clinical in vitro laboratory and in vivo animal testing; IND study (Investigational New Drug); clinical Phases I, II and III; New Drug Application; and finally Marketing Approval for sale. The SFDA has stated that it is fast-tracking the drug approval process for Sinovac's potential SARS vaccine.