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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 global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.
SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis vaccine (sIPV), and the live attenuated varicella vaccine.
SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.
With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.
For more information, please see the Company's website at www.sinovac.com.