The State Drug Administration (SDA) authorized Beijing-based Sinovac Biotech Co Ltd to select volunteers for its vaccine research, Cao Wenzhuang, director of the Department of Drug Regulation, told China Daily yesterday.

The SDA sets only the standard number of volunteers needed for the first clinical test of the vaccine, Cao said.

However, Cao's department does not select the actual volunteers.

The SARS (severe acute respiratory syndrome) vaccine created by the Sinovac Biotech Co Ltd and two other research institutes - including Chinese Center for Disease Control and Prevention - got the go-ahead for further clinical tests late last year. Cao said his department has approved only one institute: Sinovac.

Sinovac spokespeople did not confirm yesterday how many volunteers are needed or if the process has started.

The research team has drawn up an implementation plan for the clinical research of a SARS vaccine.

The first phase of the testing will last for three months in either Beijing, South China's Guangdong Province or neighboring Guangxi Zhuang Autonomous Region.

The volunteers will comprise 15 men and 15 women between the ages of 18 and 40. They will go through medical examinations and clinical observations.

The volunteers will be vaccinated only after signing an agreement, said the team leader.

Their body temperatures should not be higher than 37 Celsius before vaccination.

The vaccine was found to be safe and effective in experiments on animals, including the rhesus monkey.

The first phase of the test is to determine if it is safe and effective on humans. There were still risks, said the team leader. The vaccination might cause minor adverse effects such as low fever and pain. But these symptoms disappear naturally without medical treatment.

A committee will be set up to protect the rights of the volunteers, who can participate or withdraw from the test at will. Researchers will provide medical treatment if volunteers suffer any ill effects.

And volunteers should follow the researchers' instructions and the requirements of the program.

(China Daily February 5, 2004)