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.
Sinovac Biotech Ltd. (SINOVAC) 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, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A and B, seasonal influenza, pneumococcal disease, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps, and poliomyelitis.
SINOVAC's COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The Healive®, a hepatitis A vaccine manufactured by the Company, passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine, that was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) was prequalified by WHO.
SINOVAC was the first company that granted approval for its H1N1 influenza vaccine Panflu.1®, which 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, Panflu®, to the Chinese government stockpiling program.
SINOVAC has been continually dedicating itself to new vaccine research and development, with more combination vaccine products in the pipeline, and constantly exploring opportunities in the international market. SINOVAC looks forward to conducting more extensive and in-depth trade and cooperation with more countries, enterprises, and professional institutions.
For more information, please see the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.