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The analysis of the clinical trial results showed that the H1N1 vaccinedeveloped by Sinovac induces good immunogenicity after one dose. Theseropositive rate, seroconvertive rate and GMT increasing multiple havereached the international criteria for vaccines, which indicates thatSinovac's H1N1 vaccine has good immunogenicity and offers protection.
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After receiving one shot of the vaccine, none of the volunteersparticipating in Sinovac's clinical trials exhibited any signs of severeadverse reactions. The adverse events were all mild and transient, with painat the site of injection as the most common symptom. The total adverse eventrate is similar to the seasonal influenza vaccine. These results demonstratedthat the H1N1 vaccine has a good safety profile.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Asdemonstrated in the clinical trial of our H1N1 vaccine, we can confirm theimmunization schedule and dosage, which can provide the scientific referenceto the state government to establish the inoculation strategy of H1N1 vaccine.Sinovac plans to complete the summary report as soon as possible and fullyevaluate the safety and immunogenicity of the H1N1 vaccine. Thereafter, weintend to apply for the Production License for H1N1 vaccine in compliance withSFDA's regulations."
The clinical trials were initiated in the Huai Rou district, Beijing Cityon July 22, 2009, with the design of single center, randomization and doubleblindness. The inoculation was completed on August 15, 2009. A total of 1,614participants over 3 years old received the H1N1 vaccine. Blood samples werecollected from the participants on the vaccination date, 14 days postvaccination date and 21 days post vaccination date. The National Institute forthe Control of Pharmaceutical and Biological Products (NICBPB), the centrallaboratory of China State Food and Drug Administration (SFDA), have completedthe HI antibody tests on all blood samples.
This clinical trial was organized by China's Center for Disease Control(CDC), and undertaken by the Beijing CDC. The Ministry of Health (MOH) and theSFDA are continuing to closely monitor this clinical trial. Deputy DirectorGeneral of MOH Disease Control Department Donglou Xiao, Director of SFDARegistration Section Wei Zhang, and other relevant experts visited theclinical site to inspect the clinical study.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company thatfocuses on the research, development, manufacture and commercialization ofvaccines that protect against human infectious diseases. Sinovac'scommercialized vaccines include Healive(R) (hepatitis A), Bilive(R) (combinedhepatitis A and B), Anflu(R) (influenza), Panflu(TM) (H5N1) and H1N1 vaccine.Sinovac is currently developing Universal Pandemic Influenza vaccine andJapanese encephalitis vaccine. Additional information about Sinovac isavailable on its website, http://www.sinovac.com . To be added to ourdistribution list, please email: [email protected].
Safe Harbor Statement
This announcement contains forward-looking statements. These statementsare made under the "safe harbor" provisions of the U.S. Private SecuritiesLitigation Reform Act of 1995. These forward-looking statements can beidentified 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 inthis press release contain forward-looking statements. Statements that are nothistorical facts, including statements about Sinovac's beliefs andexpectations, are forward-looking statements. Forward-looking statementsinvolve inherent risks and uncertainties. A number of important factors couldcause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update anyforward-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 Fax: +86-10-6296-6910 Email: [email protected] Investors: Amy Glynn/Sara Pellegrino The Ruth Group Tel: +1-646-536-7023/7002 Email: [email protected] [email protected] Media Janine McCargo The Ruth Group Tel: +1-656-536-7033
SOURCE Sinovac Biotech Ltd.
