EN
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 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 (Paneflu®), 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.