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WHO Extended the Use of SINOVAC COVID-19 Vaccine under EUL to Individuals Aged 3 Years and Above
November 22, 2022, Beijing -- Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that its COVID-19 vaccine, CoronaVac®, recently has been validated by the World Health Organization ("WHO") for extended use in children as young as three years old under Emergency Use Listing ("EUL") Procedure. This is the youngest age that the WHO has validated for EUL of COVID-19 vaccines in the world so far.
Prior to this, CoronaVac® has been validated for emergency use under the WHO EUL procedure and recommended by the Strategic Advisory Group of Experts on Immunization ("SAGE") for use in all individuals aged 18 and above, in June 2021.
In an effort to provide protection for a larger number of populations, SINOVAC initiated global clinical studies of CoronaVac® among children since 2021. Preliminary study results show that CoronaVac® reduced COVID-19 infection, COIVD-related hospitalization and ICU admission in children aged three to five years during the Omicron outbreaks; the vaccine provided over 90% effectiveness against hospitalization and ICU admission in children and adolescents six to 16 years-old, when Delta variant was prevalent; and the vaccine provided over 95% effectiveness against moderate to severe cases in children and adolescents three to 18 years-old, when Omicron BA.2 was predominant.
Up to now, with more than 2.9 billion doses shipped globally, CoronaVac® has been approved for use in more than 60 countries and regions worldwide, among which, more than a dozen of authorities in Asian, Latin American, and African regions have approved the vaccines’ use in minors, before the WHO's extension to children.
CoronaVac® has been approved for emergency use in children six months and older in Chile and for off-label use in children 6 to 35 months old in Hong Kong, marking the only inactivated COVID-19 vaccine approved for children as young as six months old in the world.
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.
For more information, please see the Company’s website at www.sinovac.com.
Contact:
Sinovac Biotech Ltd.
PR Team
pr@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.