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Sinovac Announces that Government Investigation Rules Out Healive

2009-01-03

Sinovac Announces that Government Investigation Rules Out Healive's Role in Child's Death
 - Autopsy Results Show the Death was Caused by Myocarditis -

Wednesday December 31, 8:00 am ET

BEIJING, Dec. 31 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Alternext US: SVA), a leading provider of vaccines in China, today provided an update regarding the suspension of the Company's inactivated hepatitis A vaccine Healive®, following a report of the death of a minor in the Fengtai District in the City of Beijing on November 27, 2008. The Company learnt from authorities that according to the autopsy results, the death was caused by myocarditis, an inflammation of the muscular part of the heart generally due to a viral or bacterial infection. It may cause chest pain, rapid signs of heart failure, or sudden death. The administration of Healive was not a factor.

Mr. Xiaofeng Liang, director of National Planed Immunization Center of China CDC, stated, "All vaccines available on the Chinese market are considered safe products as they are produced and inspected through strict processes. It is impossible to cause disease by vaccinating with inactivated vaccines."

Mr. Weidong Yin, Chairman, President and CEO of Sinovac Biotech Ltd., commented, "Although the autopsy results showed that the death of the minor was not related to the administration of our vaccine, we are sorry for the family's loss. We are confident about the safety profile of Healive as supported by the clinical trials and the track record of vaccine administration following launch in 2002. Since vaccination has proven to be the most effective and successful approach to preventing diseases, we continue to supply our high quality vaccines in order to improve public health and maximize shareholder value."

As previously disclosed, the Health Services Bureau of Fengtai District in the City of Beijing suspended the use of 83 doses of inactivated hepatitis A vaccine Healive® following a report of the death of a minor in the Fengtai District on November 27, 2008, which coincided with the administration of the vaccine two days prior.

Classification of Adverse Events Following Immunization (AEFI)

According to WHO, five types of adverse events may occur following the administration of a preventative vaccine including: vaccine reaction, programme error, coincidental event, injection reaction and unknown. A coincidental event is the event that happens after immunization but is not caused by the vaccine.

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 global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.

SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis  vaccine (sIPV), and the live attenuated varicella vaccine.

SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.

With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.

For more information, please see the Company's website at www.sinovac.com.