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SINOVAC COVID-19 Vaccine Is Conditionally Registered In South Africa

2022年06月25日 PM01:30
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BEIJING

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.

About SINOVAC

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220624005511/en/

CONTACT

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

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