A Chinese-made bird flu vaccine has been approved by
the State Food and Drug Administration (SFDA) for a 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.
(Xinhua News Agency May 11, 2007)
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