-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: 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.