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Sinovac Releases Statement on Healive Vaccine Suspension
Sinovac Releases Statement on Healive Vaccine Suspension
Tuesday December 2, 7:00 am ET
The suspended vaccine was part of lot 2008052105 that passed the routine government inspection in July 2008. To date, 19,850 doses vaccines from the lot have been distributed. According to data released by the Center for Adverse Drug Reaction Monitoring of Beijing, there is no other reported adverse reaction to the lot to date. Sinovac has not received, and is not aware of, similar notice of suspension from any other district in Beijing where the lot has been distributed or any other part of China where other lots of the Healive® vaccine have been distributed. On November 29, 2008, the Beijing Drug Administration and Drug Administration of Haidian District of City of Beijing conducted a joint administrative investigation that included an inspection of the company's manufacturing site and review of its manufacturing, inspection and sales processes, and concluded in a written report that no abnormality was found.
Sinovac has full confidence in the quality of its products. It will continue to cooperate with government agencies in their investigation of the incident and will provide an update once the investigation is completed.
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® (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 . To be added to our distribution list, please email: info@sinovac.com.
For more information, please contact: Helen G. Yang Sinovac Biotech Ltd. Tel: +86-10-8289-0088 x871 Fax: +86-10-6296-6910 Email: info@sinovac.com Investors/Media: Stephanie Carrington / Janine McCargo The Ruth Group Tel: +1-646-536-7017/7033 Email: scarrington@theruthgroup.com / jmccargo@theruthgroup.com
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