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Chilean Report Confirms CoronaVac Safety for Pediatric and Adolescent Population
On May 20, 2022, the Public Health Institute of Chile (ISP) released the fourth statistical report "AEFIs after the administration of SARS-CoV-2 vaccines in Chile in the pediatric and adolescent population." The findings confirm the CoronaVac® COVID-19 vaccine manufactured by Sinovac Biotech Ltd., (SINOVAC) is safe for children aged 3 and above.
The report evaluated 6,946,593 SARS-CoV-2 vaccine doses that were administered to children and adolescents from March 1, 2021, to February 26, 2022. More than 70% were administered with SINOVAC’s COVID-19 vaccine, which has been approved for minors as young as 3. The rest were administered with mRNA vaccine manufactured by Pfizer-BioNTech, which has been approved for children 5 years and older. SINOVAC manufactures the only COVID-19 vaccine that is available to children in Chile between the ages of 3 to 5.
In total, 868 adverse events following immunization (AEFI) were reported at a rate of 12.50 AEFI notifications per 100,000 doses administered. For CoronaVac®, the rate was 10.67. Among all AEFIs, 107 cases were classified as serious, at a rate of 1.54 serious AEFI notifications per 100,000 doses administered. Similarly, a lower rate of 1.31 was observed for the SINOVAC COVID-19 vaccine.
These results are consistent with prior studies supporting the safety and effectiveness of CoronaVac® for use in minors for both primary vaccination and booster shots. The latest results from pediatric phase II clinical trials in China also suggest that a third dose of CoronaVac® shows good protection against the Omicron variant, particularly in younger children aged 3 to 5 years old.
CoronaVac® has been approved for use in children and adolescents in 14 countries and regions, offering protection to more than 280 million children worldwide.
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, and mumps.
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 was 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