BEIJING: 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 east China's 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 initial vaccination.
As of 3 pm 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.