SINOVAC Announced Good Safety Results of CoronaVac Studied after Massive Vaccination in City of Dalian, Liaoning Province, China
BEIJING, China, July 27, 2021 -- SINOVAC Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today a research paper, titled Surveillance for adverse events following immunization with COVID-19 vaccines in Dalian, China, is available on SSRN. It can be accessed via https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3890742
The research was jointly conducted by the Dalian Center for Disease Control and Prevention (CDC) and the Fudan University School of Public Health. The study assessed the safety of the COVID-19 vaccination program in Dalian, China. The Chinese National Adverse Events Following Immunization System (CNAEFIS) collected all data from the program.
Results from the analysis showed that a total of 7.12 million doses of vaccine were administered in the city of Dalian from November 27, 2020, through June 8, 2021. This included 6.08 million doses of CoronaVac®, SINOVAC's inactivated COVID-19 vaccine, which accounted for 85.4% of all vaccination doses. The incidence of AEFI after inoculation with CoronaVac® was 81.1 per one million doses, the general incidence of AEFI was 80.3 per one million doses, and the incidence of severe AEFI was 0.8 per one million doses, all indicators are lower than the overall level.
According to the surveillance data of suspected abnormal vaccination reactions in China in 20181, the reported incidence of vaccination AEFI in China was 458.9 per one million doses, and the incidences of severe and non-severe AEFI were each 2.9 and 455.9 per one million doses, respectively. According to a report issued by the Chinese Center for Disease Control and Prevention2, as of April 30, 2021, a total of 265 million doses of vaccine have been administered in mainland China with an overall AEFI rate of 118.6 doses per one million doses, similar to other conventional inactivated vaccines. Common adverse reactions accounted for 82.96% of the total AEFI with an incidence of 98.4 per one million doses. The incidence of rare adverse reactions was 20.2/100 million doses, most of which were allergic rash and angioedema, which did not lead to serious consequences. There were no reports of antibody-dependent enhancement (ADE) cases around the globe, indicating that the new coronary inactivated vaccine is unlikely to cause ADE.
The results of Phase I/II clinical studies of healthy adults, healthy people aged 60 and over, and healthy children and adolescents aged 3-17, as well as the results of the Phase III clinical trial of CoronaVac®, were published in Turkey. Large-scale vaccination campaigns have rolled out in many countries, which has confirmed the safety and effectiveness of CoronaVac®, as well as reliability of large-scale use. In June 2020, CoronaVac® became the first COVID-19 vaccine approved for emergency use in China. On February 5, 2021, the National Medical Products Administration approved CoronaVac® for conditional marketing use in China. In May 28, CoronaVac® was approved use in children aged 3 years and above in China and later the World Health Organization approved CoronaVac® for emergency use in adults on June 1, 2021.
1. Zhang Lina, Li Keli et al. 2018 suspected abnormal response to vaccination in China to monitor Vaccine and Immunization in China, Volume 2, No. 4, August 2020.
2. China Centers for Disease Control and Prevention. COVID-19 Vaccine Safety Monitoring in China. http://www.chinacdc.cn/jkzt/ymyjz/ymyjjz_6758/202105/t20210528_230908.html
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.
Safe Harbor Statements
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.
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871 or
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products that protect against human 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 under "Category 1 Preventative Biological Products" and 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 pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.
For more information, please visit the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.