(RTTNews) -  Amid growing concerns over mounting swine flue death toll, Sinovac Biotech Ltd. (SVA: News ), a Chinese drug maker, Tuesday announced positive results from the completed clinical trial for its internally-developed H1N1 vaccine, indicating that its vaccine offers good immunogenicity and safety profile.

With global death toll in swine flue passing over the 1000 mark, Swine flu has now made its presence over 168 countries around the globe, with most of the deaths occurring in the American region. Unfortunately, no vaccine has been there to prevent the infection, with companies continuing there effort to provide an effective one. The swine flu virus first emerged in Mexico in April, 2009.

The data revealed by Sinovac in a conference held in Beijing noted that the seropositive rate, seroconvertive rate and GMT increasing multiple of its newly developed vaccine matches with the international criteria for vaccines. Sinovac also indicated it as the first company worldwide to complete clinical trials for the H1N1 vaccine.

A total of 1,614 participants over 3 years old received the H1N1 vaccine, in which none of the volunteers participated exhibited any signs of severe adverse reaction, after receiving one shot of vaccine, the company said. Most common system indicated were pain on the site of injection, with total adverse event rate being similar to seasonal influenza vaccine.
Weidong Yin, President and CEO of Sinovac said, "As demonstrated in the clinical trial of our H1N1 vaccine, we can confirm the immunization schedule and dosage, which can provide the scientific reference to the state government to establish the inoculation strategy of H1N1 vaccine."

This clinical trial were organized by China's Center for Disease Control (CDC), and undertaken by the Beijing CDC. The Ministry of Health (MOH) and the SFDA are continuing to closely monitor this clinical trial. Deputy Director General of MOH Disease Control Department Donglou Xiao, Director of SFDA Registration Section Wei Zhang, and other relevant experts visited the clinical site to inspect the clinical study.

SVA is currently trading at $4.92, up $0.40 or 8.85%, on the Amex.

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by RTT Staff Writer

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