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September 1, 2009

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Experts endorse H1N1 vaccine

A SWINE flu vaccine produced by Chinese pharmaceutical company Sinovac passed evaluation yesterday by a panel of experts organized by the State Food and Drug Administration and may be given a production license this week.

Sinovac's H1N1 flu vaccine can be given safely to people aged three to 60 in a single shot and was approved by the unanimous vote of 43 experts.

The clinical trials on the vaccine show its immunity factors reached international standards, and its adverse reactions were similar to those of vaccines for seasonal flu, a medical conference was told yesterday.

The report will be the primary mover for the FDA to issue a production license. It will be submitted today, after which a final decision will be made within three days, said Li Guoqing, the director of the FDA's Center for Drug Evaluation. Five other drug makers have also submitted applications for registration of swine flu vaccines. Evaluation of a vaccine developed by the Hualan Biological Engineering Inc will be released today, Li said.

"It is the first time that we have invited so many experts from 11 different medical specialties to evaluate a drug. It was an urgent and crucial task," Li said.

Zhao Kai, the leader of the experts team and a member of the Chinese Academy of Engineering, said that, if approved for mass production, the vaccine would be reserved by the state instead of going on general sale.

"The government will decide whether and how to distribute the vaccine based on the flu's development," Zhao said.

Shu Yuelong, another member of the experts team and an official from the Chinese Center for Disease Control and Prevention, said a flu pandemic in the northern hemisphere was almost "inevitable" during the coming autumn and winter.

"Many countries are racing to develop a vaccine, and the World Health Organization hopes that every country is willing to share results of its clinical trials," Shu said.

Yin Weidong, president of Sinovac, said he was expecting a production license so the vaccine could help prevent and control the spread of swine flu "not only in China but worldwide." Li said the FDA was ready to make drug evaluations open to the public, especially evaluations of innovative medicines and those in which the public has a major interest.

As of yesterday afternoon, 3,757 cases of swine flu had been reported on the Chinese mainland. Of those, 3,249 patients have recovered and no one has died, the Health Ministry said.


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