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2004 MAR 3 - (NewsRx.com & NewsRx.net) -- Sinovac Biotech Ltd. (SNVBF) 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 15 men and 15 women aged from 18 to 40 years.
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, and the SFDA.
If phase I testing is successful, ...