BEIJING, Aug. 4 /PRNewswire-Asia/ -- 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 received their first shot of the vaccine and, during the three day observation period, the preliminary tests indicated that the A/H1N1 influenza 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 observation period, none of the volunteers participating in Sinovac's clinical tests exhibited any sign of severe adverse reactions. Total adverse event rate is 11.8%, which is similar to that of seasonal influenza vaccine. The adverse events were all mild and transient. The most severe symptom was 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 close attention to this clinical trial. Deputy Director General of MOH Disease Control Department, Mr./Ms. Donglou Xiao, Director of SFDA Registration Section, Mr./Ms. Wei Zhang, and other relevant experts visited the clinical trial site to observe the clinical trial. In June 2009, the Beijing municipal government(1) made its first purchase of Panflu from Sinovac, with an initial order of four million doses that are expected to be delivered by the end of September 2009.
Consistent with prior years' practices, Sinovac's seasonal influenza vaccine was released by China SFDA and commercially launched at the end of July 2009.
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® (hepatitis A), Bilive® (combined hepatitis A and B), Anflu® (influenza) and Panflu(TM) (H5N1). Sinovac is currently developing Universal Pandemic Influenza vaccine and Japanese encephalitis vaccine. Additional information about Sinovac is available on its website, http://www.sinovac.com
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Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward- looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
For more information, please contact:
Helen G. Yang
Sinovac Biotech Ltd.
Tel: +86-10-8289-0088 x9871
Amy Glynn/Sara Pellegrino
The Ruth Group
The Ruth Group
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products that protect against human diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.
For more information, please visit the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.