29-06-2022, 08:08 AM
CoronaVac was well tolerated and safe and induced humoral responses in children and adolescents aged 3–17 years.
To our knowledge, this is the first report of immunogenicity and safety of COVID-19 candidate vaccine among children as low as 3 years old. We found that two doses of the CoronaVac were safe and well tolerated at doses of 1·5 μg and 3·0 μg among children and adolescents aged 3–17 years old. The prevalence of adverse reactions in different dose groups was similar, indicating that there was no dose-related concern on safety.
We have done two phase 1/2 clinical trials of CoronaVac in participants aged 18–59 years and aged 60 years and older.
The preliminary immunogenicity and safety results supported the expansion of the trial to children and adolescents. We subsequently did a single-centre, randomised, double-blind, controlled, phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of CoronaVac in children and adolescents aged 3–17 years.
On the basis of the results of previous trials and considering the low weight of this population, two different doses—1·5 μg and 3·0 μg—were adopted in this study.
https://www.thelancet.com/journals/lanin...4/fulltext
To our knowledge, this is the first report of immunogenicity and safety of COVID-19 candidate vaccine among children as low as 3 years old. We found that two doses of the CoronaVac were safe and well tolerated at doses of 1·5 μg and 3·0 μg among children and adolescents aged 3–17 years old. The prevalence of adverse reactions in different dose groups was similar, indicating that there was no dose-related concern on safety.
We have done two phase 1/2 clinical trials of CoronaVac in participants aged 18–59 years and aged 60 years and older.
The preliminary immunogenicity and safety results supported the expansion of the trial to children and adolescents. We subsequently did a single-centre, randomised, double-blind, controlled, phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of CoronaVac in children and adolescents aged 3–17 years.
On the basis of the results of previous trials and considering the low weight of this population, two different doses—1·5 μg and 3·0 μg—were adopted in this study.
https://www.thelancet.com/journals/lanin...4/fulltext