China-based SINOVAC Biotech has announced that results from blind data analysis of a multi-centre, case-driven, randomised, double-blind, placebo-controlled Phase III clinical trial show that CoronaVac^® is safe in healthy children and adolescents aged 3 to 17 years old.

The study is being conducted in Chile, Malaysia, the Philippines and South Africa and involves 2,140 participants aged 3 to 17 years, including 684 participants in a safety subgroup. Further studies will extend the age group to 6 months.

Data from the safety subgroup revealed that the incidence of adverse reactions after the second dose was much lower than after the first dose. Common side effects include pain at the injection site, headache, and fever. Most adverse events were mild/moderate (Grade 1 and 2) with no severe adverse reactions. 

CoronaVac^® was found to be safe in children and adolescents between the ages of 3 to 17 years old. Further results of this study will provide clinical evidence for countries to approve the use of CoronaVac^® in children and adolescents between 6 months to 17 years of age.

Since September 2021, countries that have approved the use of CoronaVac^® in children and adolescents include Chile, Ecuador, El Salvador, Colombia, Cambodia, and Indonesia. By the end of October, China had administered more than 110 million doses of CoronaVac® to children under the age of 18.