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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 global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.
SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis vaccine (sIPV), and the live attenuated varicella vaccine.
SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.
With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.
For more information, please see the Company's website at www.sinovac.com.