EN
South Africa Phase III Clinical Study Shows SINOVAC CoronaVac® Safe for Children as Young as 6 Months
Beijing, China, December 24, 2021 – SINOVAC Biotech Ltd. (NASDAQ: SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, today announced results of a Phase III clinical study of its COVID-19 inactivated vaccine CoronaVac® in South Africa indicating safety for children from 6 months to 17 years. The results are part of an international, multi-center, case-driven, randomized, double blind, placebo-controlled Phase III clinical trial currently being held in South Africa, Chile, Malaysia, the Philippines and Kenya, investigating the immunogenicity, safety and efficacy of the SINOVAC COVID-19 vaccine in children and adolescents.
On October 28, subjects aged 6 to 35 months were recruited in South Africa and 200 volunteers were successfully enrolled in the Phase III clinical trial on December 20. No Grade-3 or above adverse events were reported. As of December 22, nearly 4,000 children in South Africa have participated in the trial with zero reported severe adverse events.
This follows several countries – including Chile, Ecuador, El Salvador, Colombia, Cambodia and Indonesia – approving the use of the SINOVAC COVID-19 vaccine for children of varying ages since September.
According to the latest data disclosed at a press conference held by the Joint Prevention and Control Mechanism of the State Council on December 20, more than 140 million children aged 3 to 11 years have received the COVID-19 vaccine in mainland China. Currently, only inactivated vaccines are approved for emergency use in this age group and a high level of antibody positive conversion was observed with the antibody level equal to, or higher than that of adults.
About SINOVAC's Phase I/II Trials in Children
On June 28, the Lancet Infectious Diseases online published the results of Phase I/II clinical studies of CoronaVac® in healthy children and adolescents aged 3 to 17 years in China with results showing good safety and tolerability, and a strong humoral immune response. On July 19, SINOVAC released the results of its world-first immunity persistence study of 180 individuals 3 to 17 years of age. It showed a 100% neutral antibody-positive conversion rate. The geometric mean titer (GMT) remained at a high level 28 days after the second dose, as well as another 3 months afterwards, which indicated that CoronaVac® induces stable and good immunogenicity.
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 and mumps. SINOVAC's COVID-19 vaccine, CoronaVac®, has been granted emergency use approval or conditional marketing authorization by over 40 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. The Company is developing several new products including a Sabin-strain inactivated polio vaccine and 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.
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of "supply vaccines to eliminate human diseases", the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.
The company's diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.
SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world's first inactivated SARS vaccine (Phase I completed), China's first H5N1 influenza vaccine (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.
Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines,recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.
With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.
For more information, please see the Company’s website at www.sinovac.com.