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SINOVAC COVID-19 Vaccine Is Conditionally Registered In South Africa
Sinovac Biotech Ltd. (NASDAQ: SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that the South African Health Products Regulatory Authority (SAHPRA) granted conditional registration to SINOVAC CoronaVac® in aged 18 and above adults, based on acceptable safety, quality, and efficacy data submitted. The vaccine is administered intramuscularly in two doses with a 14 to 28-day interval.
The CoronaVac® was previously authorized for emergency use with conditions by the SAHPRA on July 3, 2021. Subsequent to the approval, SINOVAC has been committing to the conditions, reporting the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan and submitting periodic safety updates. All the evidence suggested that the SINOVAC COVID-19 vaccine was safe and effective.
SINOVAC COVID-19 vaccine has been available in more than 60 countries, with a total supply of almost 2.9 billion doses.
Sinovac Biotech Ltd. (SINOVAC) 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, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A and B, seasonal influenza, pneumococcal disease, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps, and poliomyelitis.
SINOVAC's COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The Healive®, a hepatitis A vaccine manufactured by the Company, passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine, that was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) was prequalified by WHO.
SINOVAC was the first company that granted approval for its H1N1 influenza vaccine Panflu.1®, which 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, Panflu®, to the Chinese government stockpiling program.
SINOVAC has been continually dedicating itself to new vaccine research and development, with more combination vaccine products in the pipeline, and constantly exploring opportunities in the international market. SINOVAC looks forward to conducting more extensive and in-depth trade and cooperation with more countries, enterprises, and professional institutions.
For more information, please see the Company’s website at www.sinovac.com.
Contacts
Sinovac Biotech Ltd.
Helen Yang
+86-10-8279-9871 or
+86-10-5693-1897
Fax: +86-10-6296-6910
ir@sinovac.com
ICR Inc.
Bill Zima
U.S.: 1-646-308-1707
william.zima@icrinc.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.