CardiovascularSinovac Provides Update On Clinical Trial For H1N1 Vaccine Trials
Sinovac Biotech Ltd. (NYSE AMEX: SVA), a leading provider of vaccines in China, announced today that the clinical trial of its A/H1N1 influenza vaccine is proceeding well. All of the volunteers have received their first shot of the vaccine and, during the three-day observation of safety, the preliminary tests on the A/H1N1 influenza vaccine have indicated that the vaccine is safe and reliable in humans.
The clinical trial began on July 22, 2009 and a total of 1,614 volunteers, including 101 elders, 706 adults, 404 juvenile and 403 children, had received the first shot of the vaccine through July 25. During the three-day safety observation period, none of the volunteers participating in Sinovac"s clinical tests exhibited any signs of severe adverse reactions. Total adverse event rate is 11.8%, which is similar to seasonal influenza vaccine. The adverse events were all mild and transient. The most common symptom is pain at the site of injection.
This clinical trial is organized by China"s Center for Disease Control (CDC), and undertaken by Beijing CDC. The Ministry of Health (MOH) and State Food and Drug Administration (SFDA) are paying great attention to 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. In June 2009, Sinovac announced that the Ministry of Health had made an initial order of 4 million doses of Panflu, which is expected to be delivered by the end of September.
As usual, Sinovac"s seasonal influenza vaccine has been released by China SFDA and officially launched to the market at the end of July 2009.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac"s commercialized vaccines include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), Anflu(R) (influenza) and Panflu(TM) (H5N1). Sinovac is currently developing Universal Pandemic Influenza vaccine and Japanese encephalitis vaccine.
Safe Harbor Statement
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Sinovac Biotech Ltd.