BEIJING, May 11 (Xinhua) -- A Chinese-made bird flu vaccine has been approved by the State Food and Drug Administration (SFDA) fora second phase of clinical trials.
The second phase of clinical trials will further test the vaccine's
tolerance, safety, and immunogenicity to the H5N1 virus strain, according to Yin
Weidong, President of Sinovac Biotech, the Beijing-based pharmaceutical company
behind the trials.
The first phase of trials ended last June with none of the 120 people
injected with the vaccine experiencing any serious side-effects.
The SFDA has also approved trials for a H5N1 split virus vaccine,
with less reported side effects than the full-strain vaccine.
A researcher with Sinovac announced that some 880 volunteers are
expected to participate in the trials for the two vaccines.
Zhang Jiansan, vice President of Sinovac said that the company is
planning to expand its production facilities to produce massive quantities of
the bird flu vaccine after the drug has completed the SFDA-led trials.
In China, vaccines must undergo three phases of clinical trials
before being allowed on the market.
It is still hard for people to catch the H5N1-strain of the bird flu
virus, but experts fear it may mutate into a form that spreads easily among
people, potentially sparking a pandemic.
China has reported a total of 24 human cases of bird flu since 2003.
On March 28, the Ministry of Health confirmed that a 16 year-old boy had died
from bird flu in eastern Anhui Province, bringing the total number of people in
China who have been killed by the virus to 15.