Sinovac Provides Update on Clinical Trial for H1N1 Vaccine Trials
03 Agosto 2009 - 9:30AM
PR Newswire (US)
-H1N1 Vaccine Shows Good Safety Profile- BEIJING, Aug. 3
/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 have received their first shot of the vaccine
and, during the three-day observation of safety, the preliminary
tests on the A/H1N1 influenza vaccine have indicated that the
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
safety observation period, none of the volunteers participating in
Sinovac's clinical tests exhibited any signs of severe adverse
reactions. Total adverse event rate is 11.8%, which is similar to
seasonal influenza vaccine. The adverse events were all mild and
transient. The most common symptom is 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 great 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 site to inspect the clinical study. In June
2009, Sinovac announced that the Ministry of Health had made an
initial order of 4 million doses of Panflu, which is expected to be
delivered by the end of September. As usual, Sinovac's seasonal
influenza vaccine has been released by China SFDA and officially
launched to the market at the end of July 2009. 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 & 7002 or & ; Or Media:
Janine McCargo, The Ruth Group at +1-656-536-7033 or Web site:
http://www.sinovac.com/
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