Chinese human bird flu vaccine tests safe, effective
(Xinhua)
Updated: 2006-08-28 11:28
Preliminary clinical tests show that a bird flu vaccine
for human use developed by Chinese researchers is safe and effective,
researchers said in Beijing on Monday.
The vaccine was jointly developed
by China's Ministry of Science and Technology, Center for Disease Control and
Prevention and Beijing Sinovac Biotech Co., a Beijing-based pharmaceutical
company.
They said on Monday that the first phase of clinical trials has
proved the vaccine is safe and effective for humans.
Six volunteers took
part in the clinical tests last November at the Beijing China-Japan Friendship
Hospital, after the State Food and Drug Administration granted the vaccine
developers the green light for clinical trials.
Results from the first
phase, which ended in June, showed that the four antigens worked at different
levels in stimulating the production of antibodies, according to the company.
It said the 10 microgram dosage of the vaccine proved most effective,
stimulating 78.3 percent protective antibodies, exceeding the European Union
standard of 70 percent for a flu vaccine.
The 120 participants who were
vaccinated have shown no serious adverse reactions, researchers said. Blood
tests and urine tests all indicate that the vaccine is safe for human use.
The vaccine was developed from the virus's NIBRG-14 strain which was
provided by the World Health Organization (WHO) and protects against the deadly
H5N1 strain of avian influenza.
The vaccine can be mass produced,
according to researchers.
Bird flu remains essentially an animal
disease, but experts fear that the H5N1 virus could mutate into a form that
could pass easily among humans.
The virus has killed 14 people in China
since 2003.
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