Preliminary Results Show SINOVAC’s COVID-19 Vaccine Demonstrates Good Safety Profile Among the Pediatric and Adolescent Population
09 November 2021 - 11:00PM
Business Wire
SINOVAC Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”),
a leading provider of biopharmaceutical products in China,
announced new preliminary data on its inactivated COVID-19 vaccine
CoronaVac®. The results from statistics analysis under blind status
indicated that CoronaVac® is safe for healthy people of different
races in the pediatric and adolescent population ranging from 3 to
17 years of age.
The multi-center, case-driven, randomized, double-blind, and
placebo-controlled phase III study is currently being conducted in
South Africa, Chile, Malaysia, and the Philippines. As of October
2021, a total of 2,140 participants ranging from 6 months to 17
years of age have been enrolled in the study, including 684
participants in the safety subgroup. The blind safety data analysis
for this subgroup shows a good safety profile among healthy
participants aged from 3 to 17 years. The research will continue to
be carried out in 6 months infants and young children. The research
results will provide a stronger scientific basis for countries to
safely carry out the new crown vaccination work for minors over 6
months of age.
Results from the safety data for the 684 participants in the
safety subgroup found that the incidence of adverse effects after
the second dose of vaccination was much lower than that of the
first dose. Local and systemic adverse effects were mainly pain at
the injection site and headache and fever, respectively. Severity
was milder at grades 1 and 2, and no suspicious and unexpected
serious adverse effects occurred.
The preliminary results of this international multi-center phase
III clinical study have shown that the overall incidence of adverse
effects among subjects is similar to that among domestic
adolescents and children phase I/II clinical trials. The findings
suggest that CoronaVac® has a good safety profile among the healthy
pediatric and adolescent population ranging from 3 to 17 years old.
Further research results are expected to provide a scientific basis
for safe vaccination with CoronaVac® for infants as young as 6
months of age.
Since September of this year, several countries, including
Chile, Ecuador, El Salvador, Colombia, Cambodia, and Indonesia,
have approved the use of CoronaVac® for healthy people in the 3-17
age range. In China, as of the end of October, more than 110
million doses of CoronaVac® have been administered to groups of
minors under 18 years of age.
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
COVID-19, enterovirus71 (EV71), hepatitis A and B, seasonal
influenza, 23-Valent pneumococcal polysaccharide (“PPV”), H5N1
pandemic influenza (avian flu), H1N1 influenza (swine flu),
varicella, mumps and Poliomyelitis. SINOVAC’s COVID-19 vaccine,
CoronaVac®, has been granted emergency use approval or conditional
marketing authorization by over 50 countries or regions worldwide.
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. In 2021, SINOVAC’s Sabin-strain
inactivated polio vaccine has approved for registration. The
Company is developing several new products including combined
vaccines. SINOVAC primarily sells its vaccines in China, while also
exploring growth opportunities in international markets. The
Company is seeking market authorization of 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 press release 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 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 as a result of the trigger of the
rights plan.
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version on businesswire.com: https://www.businesswire.com/news/home/20211109005780/en/
Sinovac Biotech Ltd. Helen Yang Tel: +86-10-8279-9871 or
+86-10-5693-1897 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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