Press release
Preliminary Results Show SINOVAC’s COVID-19 Vaccine Demonstrates Good Safety Profile Among the Pediatric and Adolescent Population
BEIJING--(BUSINESS WIRE)-- SINOVAC Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China,
About this update from Sinovac Biotech, Ltd.
[{"type":"text","content":" BEIJING--(BUSINESS WIRE)--\nSINOVAC Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, announced new preliminary data on its inactivated COVID-19 vaccine CoronaVac®. The results from statistics analysis under blind status indicated that CoronaVac® is safe for healthy people of different races in the pediatric and adolescent population ranging from 3 to 17 years of age.\n\nThe multi-center, case-driven, randomized, double-blind, and placebo-controlled phase III study is currently being conducted in South Africa, Chile, Malaysia, and the Philippines. As of October 2021, a total of 2,140 participants ranging from 6 months to 17 years of age have been enrolled in the study, including 684 participants in the safety subgroup. The blind safety data analysis for this subgroup shows a good safety profile among healthy participants aged from 3 to 17 years. The research will continue to be carried out in 6 months infants and young children. The research results will provide a stronger scientific basis for countries to safely carry out the new crown vaccination work for minors over 6 months of age.\n\nResults from the safety data for the 684 participants in the safety subgroup found that the incidence of adverse effects after the second dose of vaccination was much lower than that of the first dose. Local and systemic adverse effects were mainly pain at the injection site and headache and fever, respectively. Severity was milder at grades 1 and 2, and no suspicious and unexpected serious adverse effects occurred.\n\nThe preliminary results of this international multi-center phase III clinical study have shown that the overall incidence of adverse effects among subjects is similar to that among domestic adolescents and children phase I/II clinical trials. The findings suggest that CoronaVac® has a good safety profile among the healthy pediatric and adolescent population ranging from 3 to 17 years old. Further research results are expected to provide a scientific basis for safe vaccination with CoronaVac® for infants as young as 6 months of age.\n\nSince September of this year, several countries, including Chile, Ecuador, El Salvador, Colombia, Cambodia, and Indonesia, have approved the use of CoronaVac® for healthy people in the 3-17 age range. In China, as of the end of Octob...