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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 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.