-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: info@sinovac.com.
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: info@sinovac.com
Investors:
Amy Glynn/Sara Pellegrino
The Ruth Group
Tel: +1-646-536-7023/7002
Email: aglynn@theruthgroup.com
spellegrino@theruthgroup.com
Media
Janine McCargo
The Ruth Group
Tel: +1-656-536-7033
Email: jmccargo@theruthgroup.com
SOURCE Sinovac Biotech Ltd.