China approves one-dose homegrown H1N1 flu vaccine

BEIJING. September 4. KAZINFORM China on Thursday granted approval to its first home-grown H1N1 flu vaccine, which producer Sinovac says is effective after only one dose, as the country braces for a feared winter outbreak; Kazinform refers to China Daily.
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The decision could boost the global fight against A(H1N1) influenza, as most experts had assumed that two doses of vaccine per person would be needed to provide adequate protection.

"The Sinovac (A)H1N1 vaccine is officially approved," the head of the State Food and Drug Administration's drug registration department, Zhang Wei, told reporters.

"The completion of trials for Beijing Sinovac's vaccine has shown this vaccine to be very safe," the regulatory agency said in a written statement announcing the decision.

In Geneva, the World Health Organisation (WHO) hailed the announcement of the vaccine's official approval and congratulated Sinovac for its "rapid" work.

"The Chinese were very rapid on this, and we can congratulate them for having shared their trial results with us," said Marie-Paule Kieny, who heads the UN health agency's vaccine research.

Zhang said the SFDA was looking at applications from nine other Chinese companies which are developing vaccines against the A(H1N1) virus, with decisions expected by mid-September.

The approval of the Sinovac vaccine came just days after China's health ministry warned of the growing risk of a mass outbreak as hundreds of millions of students went back to school this week with the winter flu season looming.

"With fall and winter approaching, the risk of a large-scale outbreak is increasing... and the possibility of the first death is gradually rising," the ministry said Monday.

The ministry said the Chinese mainaland had confirmed 3,981 cases of A(H1N1) flu as of Wednesday, but no deaths had been reported.

The WHO says at least 2,185 people have died worldwide after contracting A(H1N1) flu, now the most prevalent strain of influenza. It has been detected in nearly every country in the world; Kazinform cites China Daily.

See www.chinadaily.com.cn for full version

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