Sinovac’s Coronavac™, SARS-CoV-2 Vaccine (Vero Cell), Inactivated, Announces Approval for Phase I/II Clinical Trial in Ad...
September 23 2020 - 8:30AM
Business Wire
Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”),
a leading provider of biopharmaceutical products in China,
announced today that the inactivated COVID-19 vaccine candidate
developed by Sinovac Life Sciences (Sinovac LS), or “CoronaVac”,
was approved by the National Medical Products Administration (NMPA)
for clinical trial in adolescents and children in August 10th,
2020.
This randomized, double-blinded, and placebo-controlled phase
I/II clinical trial among adolescents and children between the ages
of 3-17 years old was approved by the Ethics Committee of the Hebei
Provincial CDC on September 11, 2020, with the trial expected to
commence soon. In this clinical trial, low dosage (300SU/dose) and
medium dosage (600SU/dose) with two-dose immunization scheduled at
28-day intervals will be adapted. Sinovac has accelerated its
vaccine development against the rapid spread of the coronavirus, so
as to maximize the safety and health of citizens in China and other
select countries around the world.
In recent months, the Company’s Phase I/II clinical trials of
CoronaVac in adults (18 to 59 years old) and elderly volunteers (60
years old and above) were conducted in Jiangsu and Hebei Provinces
on April 16th and May 22nd, respectively. The vaccine candidate
appeared to be well tolerated for different dosage and no serious
vaccine-related adverse events were reported. Both seroconversion
rates in adults and elderly volunteers were above 90%, indicating
favorable safety and immunogenicity of CoronaVac.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company
that focuses on the research, development, manufacturing and
commercialization of vaccines that protect against human infectious
diseases. Sinovac’s product portfolio includes vaccines against
enterovirus71 (EV71), hepatitis A and B, seasonal influenza,
Quadrivalent Influenza vaccine (“QIV”), H5N1 pandemic influenza
(avian flu), H1N1 influenza (swine flu), varicella vaccine and
mumps. Healive, the hepatitis A vaccine manufactured by the
Company, has passed the assessment under WHO prequalification
procedures in 2017. The EV71 vaccine, an innovative vaccine
developed by Sinovac against hand foot and mouth disease caused by
EV71, was commercialized in China in 2016. In 2009, Sinovac was the
first company worldwide to receive approval for its H1N1 influenza
vaccine, which it has supplied to the Chinese Government’s
vaccination campaign and stockpiling program. The Company is also
the only supplier of the H5N1 pandemic influenza vaccine to the
government stockpiling program. The Company is developing a number
of new products including a Sabin-strain inactivated polio vaccine,
pneumococcal polysaccharides vaccine, and a SARS-CoV-2 (commonly
referred to as COVID-19) vaccine. Sinovac primarily sells its
vaccines in China, while also exploring growth opportunities in
international markets. The Company is registering its products in
over 30 countries outside of China. For more information please see
the Company’s website at www.sinovac.com.
Safe Harbor Statement
This announcement may include certain statements that are not
descriptions of historical facts, but are 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
terminology such as “will,” “expects,” “anticipates,” “future,”
“intends,” “plans,” “believes,” “estimates” and similar statements.
Forward-looking statements involve risks, uncertainties and other
factors that could cause actual results to differ materially from
those contained in any such statements. In particular, the outcome
of any litigation is uncertain, and the Company cannot predict the
potential results of the litigation it filed or that could be filed
against it by others. Additionally, the triggering of a shareholder
rights plan is nearly unprecedented, and the Company cannot predict
the impact on the Company or its stock price should its rights plan
have been triggered.
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version on businesswire.com: https://www.businesswire.com/news/home/20200923005504/en/
Sinovac Biotech Ltd. Helen Yang Tel: +86-10-8279-9871
Fax: +86-10-6296-6910 Email: ir@sinovac.com
ICR Inc. Bill Zima U.S.: 1-646-308-1707 Email:
william.zima@icrinc.com
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