Full Press Release Details
Coronavac, SARS-CoV-2 Vaccine (Vero Cell), Inactivated,
for Phase I/II Clinical Trial in Adolescents and Children
China, September 23, 2020 /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 commenced within September. In this clinical trial,
low dosage (300SU/dose) and medium dosage (600SU/dose) with two-dose immunization scheduled at 28-day interval will be adopted.
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 CoronaVacin 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.
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.
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.