Sinovac Commences Vaccination of Volunteers for the Clinical Research of Pandemic Influenza Vaccine (H5N1)
Tuesday August 14, 8:00 am ET
BEIJING, Aug. 14 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. (Amex:
SVA -
News), a China-based biopharmaceutical company focusing on vaccine development, today announced that it has commenced vaccination of volunteers for the clinical research of Pandemic Influenza Vaccine (H5N1), which is the continued research for its Phase I clinical trial of whole viron H5N1 vaccine and the beginning of its Phase I clinical trial of split H5N1 vaccine.
As previously announced, the Phase II clinical trials for the H5N1 vaccine were approved in April 2007 by the China State Food and Drug Administration (SFDA), The SFDA approval covers a Phase Ib and II trials of whole viron vaccine and Phase I and II trial of split vaccine. Subsequent to these approvals, the preparation work was completed by the end of July 2007.
These clinical trials will be open label and will assess the tolerance and safety of the vaccine. The Company anticipates that the Phase II trials will commence shortly and the preliminary results from these clinical trials for both vaccines will be available early next year.
In June 2006, the Phase I clinical trial on a pandemic influenza whole viron inactivated vaccine (H5N1) was successfully completed. The vaccine was co-developed by Sinovac Biotech Co., Ltd. and the China CDC. The results of the Phase I clinical trial were published in "The Lancet" in September of 2006.
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 vaccines include Healive (hepatitis A), Bilive (combined hepatitis A and B) and Anflu (influenza). Sinovac is currently developing human vaccines against the H5N1 strain of pandemic influenza, Japanese encephalitis and SARS. Additional information about Sinovac is available on its website,
http://www.sinovac.com . To be added to our distribution list, please email:
info@sinovac.com.
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.
Phone: +86-10-82890088 Ext. 871
Fax: +86-10-62966910
Investors/Media:
Stephanie Carrington/Janine McCargo
The Ruth Group
Phone: +1-646-536-7017/7033
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious 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, and mumps.
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 was 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 new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.
For more information, please see the Company’s website at www.sinovac.com.
Contact:
Sinovac Biotech Ltd.
PR Team
pr@sinovac.com
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