Revised: Sinovac Provides Update on Clinical Trial for H1N1 Vaccine Trials
August 04 2009 - 5:19AM
PR Newswire (US)
-H1N1 Vaccine Shows Good Safety Profile- 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,
Donglou Xiao, Director of SFDA Registration Section, 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.
(1) Sinovac's press release dated August 3, 2009 incorrectly
referred to the Ministry of Health for the June 2009 order of four
million doses of Panflu. While we may receive orders from the
Ministry of Health in the future, the June 2009 order was placed by
the Beijing municipal government. 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(R) (hepatitis A), Bilive(R)
(combined hepatitis A and B), Anflu(R) (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: . 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 Fax: +86-10-6296-6910 Email: Investors:
Amy Glynn/Sara Pellegrino The Ruth Group Tel: +1-646-536-7023/7002
Email: Media Janine McCargo The Ruth Group Tel: +1-656-536-7033
Email: DATASOURCE: Sinovac Biotech Ltd. CONTACT: Helen G. Yang,
Sinovac Biotech Ltd. at +86-10-8289-0088 x9871, fax:
+86-10-6296-6910 or ; Investors: Amy Glynn & Sara Pellegrino,
The Ruth Group at +1-646-536-7023 or 7002, or or ; Or Media: Janine
McCargo, The Ruth Group at +1-656-536-7033 or , all for Sinovac Web
site: http://www.sinovac.com/
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