SINOVAC Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that CoronaVac®, an innovative, inactivated coronavirus vaccine developed by SINOVAC Life Sciences Co., Ltd. (“SINOVAC”), a subsidiary of the Company, received approval from the Public Health Institute of Chile (“ISP”) for emergency use for children and adolescents aged between 6 and 17.
ISP Director Heriberto Garcia made the announcement at a press conference held following a meeting where experts discussed the use of CoronaVac®. “Data shows the number of infected children has been rising because they are not vaccinated. To continue protecting the population, we have approved CoronaVac® for children aged six and up," Garcia said. The ISP experts also highlighted the good safety profile and tested immunogenic response of CoronaVac®.
CoronaVac® had been approved for emergency use in the population aged from 3 to 17 years old on May 28, 2021, in China. It was also approved for use in the population aged from 12 to 17 years old by Indonesian authorities in June 2021.
The Lancet Infectious Diseases has published results from the Phase I/II clinical trials of CoronaVac® in healthy children aged 3 to 17 years of age in China.
At this time, SINOVAC has provided CoronaVac® to nearly 50 countries and regions, including mainland China. The total supply has already exceeded 1.8 billion doses. Moreover, it’s estimated that over 1.4 billion doses have been administrated worldwide. SINOVAC has become the largest domestic supplier and exporter of China’s COVID-19 vaccine. The safety and effectiveness of CoronaVac® has been verified around the world.
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, mumps and Poliomyelitis. SINOVAC’s COVID-19 vaccine, CoronaVac®, has been granted emergency use approval or conditional marketing authorization by over 50 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. In 2021, SINOVAC’s Sabin-strain inactivated polio vaccine has approved for registration. The Company is developing several new products including 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.
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This press release may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price as a result of the trigger of the rights plan.