China started its first human trials for a new severe acute respiratory syndrome (SARS) vaccine on Saturday with four volunteers, the first group of the 30 selected, being vaccinated in a hospital in Beijing.
The four volunteers reportedly received their vaccinations calmly on the heavily guarded second floor of the China-Japan Friendship Hospital.
Beijing-based Sinovac Biotech, a company authorized by the State Food and Drug Administration (SFDA), produced the vaccine. It was found to be safe and effective in experiments on animals, including the rhesus monkey, whose immune system is closer to that of humans than other animals.
The current test is being conducted to determine whether it is safe and effective for humans. There are still risks, experts said.
A special committee has been set up to protect the rights of the volunteers, who may continue to participate or withdraw from the test at will.
Researchers will provide medical treatment if the volunteers suffer any adverse effects.
The second phase of clinical testing will involve more participants.
In February, the SFDA authorized Sinovac to select volunteers for China’s first clinical testing of the vaccine. The administration sets the standard number of volunteers needed for the first clinical test, but does not select the actual volunteers.
The first phase of the testing will last three months in Beijing, south China’s Guangdong Province or the Guangxi Zhuang Autonomous Region.
(China Daily May 24, 2004)
