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)