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September 2, 2009

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Experts vet 2nd H1N1 vaccine

A SECOND domestically produced swine flu vaccine has been approved by a state panel of experts and is close to receiving a production license.

An H1N1 flu vaccine developed by the Chinese pharmaceutical company Hualan Biological Engineering Inc was endorsed yesterday in an evaluation organized by the State Food and Drug Administration.

Hualan's formulation can safely be given to people above three years old in a single shot, the 41-member panel of experts said in a unanimous opinion.

The experts said they will submit a report to the FDA, which will make a final decision in three days. Should the SFDA authorize Hualan's vaccine, the company would receive a production license for the drug this week.

On Monday, the experts approved swine flu vaccine produced by Sinovac Biotech Ltd for use on people between age 3 and 60.

Hualan was among the first companies in China to receive the seed virus of the H1N1 flu for vaccine production. The Henan Province-based company started a two-month clinical test on its vaccine on July 22, also the first in the country. More than 2,000 subjects took part in the tests, in Taizhou in east China's Jiangsu Province.

The expert panel suggested that Hualan continue its clinical tests until mid-September, as the company had originally planned. Follow-up tests should continue for six months after the subjects receive their initial vaccination.

Zhao Kai, the leader of the experts team and a member of the Chinese Academy of Engineering, said earlier this week that if a domestically made vaccine is approved for mass production, the government will decide whether and how to distribute it based on the flu's development.


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