BEIJING, Sept. 1 (Xinhua) -- The vaccine for the
A/H1N1 influenza produced by Chinese pharmaceutical company Hualan Biological
Engineering Inc. on Tuesday passed an expert evaluation organized by the State
Food and Drug Administration (SFDA).
Hualan's flu vaccine could safely be given to people
aged above three in a single shot, 15 microgram dose, and was approved by the
unanimous vote of 41 experts after they studied the recent adverse drug
reactions of the vaccine.
The experts will submit a report to the SFDA which
will make the final decision in three days. Should the SFDA greenlight Hualan's
vaccine, the company would get its production license for the drug this week.
It made Hualan the second Chinese company to gain
approval from the SFDA expert team over the A/H1N1 influenza vaccine.
On Monday, the experts approved flu vaccines produced
by Sinovac Biotech Ltd., or the Beijing Kexing Bioproducts. However, Sinovac's
vaccines were only approved to be given to three- to 60-year-olds.
Hualan was among the first companies in China to
receive the seed virus of the A/H1N1 flu for vaccine production. The Henan-based
company started a two-month clinical test on its vaccines on July 22, also the
first in the country. More than 2,000 testees took part in the test in Taizhou
in eastern Jiangsu Province.
Tuesday's experts panel suggested Hualan to continue
its clinical tests until mid September, as the company had originally planned.
Follow-up tests should continue for six months after the testees receive their
As of 3 p.m. Monday, China had reported 3,757 cases
of A/H1N1 flu on the mainland, of whom 3,249 had recovered, with no confirmed
deaths, said the Health Ministry.
Earlier this month, Health Minister Chen Zhu said
China would be able to produce enough A/H1N1 flu vaccine for 65 million people
by the end of the year.
World Tackles A/H1N1