A clinical trial of the inactivated Sinovac COVID-19 vaccine on more than 500 healthy children and adolescents has shown encouraging results, according to a study published in The Lancet Infectious Diseases journal on June 28.


"Children and adolescents with COVID-19 usually have mild or asymptomatic infections compared to adults. Despite this, a small number may still be at risk of severe illness, and this population can still transmit the virus to others. Thus, it is vital to test the safety and effectiveness of COVID-19 vaccine candidates in younger age groups," said Gao Qiang, general manager of Sinovac Life Sciences Co., Ltd. 


"We are encouraged by our findings that show CoronaVac is well tolerated and can induce a strong immune response. These results provide new information and suggest that further studies in other regions, involving larger, multi-ethnic populations, may provide additional data to help develop immunization strategies for children and adolescents," he added. 


The randomized, double-blind, controlled phase 1/2 clinical trial evaluated the safety, tolerability and immunogenicity of the CoronaVac vaccine in pediatric populations. The findings indicate that the vaccine is safe, well tolerated and induces a strong antibody response in children and adolescents aged three to 17 years. This was the world's first published study on the use of a COVID-19 vaccine for children as young as three years old. 


The study enrolled 552 participants, comprised of healthy children and adolescents. From Oct. 31 to Dec. 2, 2020, 72 were enrolled in the first phase of the clinical study. Between Dec. 12 and Dec. 30, 2020, 480 more were enrolled in the second phase of the study. 



The combined safety results from phases 1 and 2 showed that most adverse reactions were mild to moderate in severity, recorded within seven days after each dose.


The results of immunogenic evaluation showed that more than 96% of children and adolescents who received two doses of the vaccine in the trial developed antibodies against the novel coronavirus, the study said.


In addition, the study found that children and adolescents had stronger immune responses compared to adults aged 18 to 59 and elderly people aged 60 and above, following two doses of the medium-dose vaccine. The study results indicate a decrease in vaccine response with increase in age.


The results support the use of the medium-dose vaccine with a two-dose schedule in further studies on children and adolescents and suggest the application of this vaccine for emergency use in children and adolescents aged three to17.


In June 2020, Sinovac's CoronaVac became the first vaccine to be approved for emergency use in China. On Feb. 5, 2021, the National Medical Products Administration approved CoronaVac for conditional marketing use. On June 1, CoronaVac was approved for emergency use by the World Health Organization (WHO). Later, China approved the emergency use of CoronaVac for cildern and adolescents on June 3.

On May 5, 2021, Canada became the first country in the world to approve a COVID-19 vaccine for emergency use in children aged 12 to 15 years. 


Later the same month, the U.S. 


Food and Drug Administration and European Medicines Agency also gave the green light to the Pfizer-BioNTech COVID-19 vaccine to be used on adolescents. "Children younger than 12 years are the next population who need a safe and efficient COVID-19 vaccine," said Cao Bin, a doctor from China-Japan Friendship Hospital in Beijing.





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Is Sinovac COVID-19 vaccine safe for children?




A clinical trial of the inactivated Sinovac COVID-19 vaccine on more than 500 healthy children and adolescents has shown encouraging results, according to a study published in The Lancet Infectious Diseases journal on June 28.


"Children and adolescents with COVID-19 usually have mild or asymptomatic infections compared to adults. Despite this, a small number may still be at risk of severe illness, and this population can still transmit the virus to others. Thus, it is vital to test the safety and effectiveness of COVID-19 vaccine candidates in younger age groups," said Gao Qiang, general manager of Sinovac Life Sciences Co., Ltd. 


"We are encouraged by our findings that show CoronaVac is well tolerated and can induce a strong immune response. These results provide new information and suggest that further studies in other regions, involving larger, multi-ethnic populations, may provide additional data to help develop immunization strategies for children and adolescents," he added. 


The randomized, double-blind, controlled phase 1/2 clinical trial evaluated the safety, tolerability and immunogenicity of the CoronaVac vaccine in pediatric populations. The findings indicate that the vaccine is safe, well tolerated and induces a strong antibody response in children and adolescents aged three to 17 years. This was the world's first published study on the use of a COVID-19 vaccine for children as young as three years old. 


The study enrolled 552 participants, comprised of healthy children and adolescents. From Oct. 31 to Dec. 2, 2020, 72 were enrolled in the first phase of the clinical study. Between Dec. 12 and Dec. 30, 2020, 480 more were enrolled in the second phase of the study. 



The combined safety results from phases 1 and 2 showed that most adverse reactions were mild to moderate in severity, recorded within seven days after each dose.


The results of immunogenic evaluation showed that more than 96% of children and adolescents who received two doses of the vaccine in the trial developed antibodies against the novel coronavirus, the study said.


In addition, the study found that children and adolescents had stronger immune responses compared to adults aged 18 to 59 and elderly people aged 60 and above, following two doses of the medium-dose vaccine. The study results indicate a decrease in vaccine response with increase in age.


The results support the use of the medium-dose vaccine with a two-dose schedule in further studies on children and adolescents and suggest the application of this vaccine for emergency use in children and adolescents aged three to17.


In June 2020, Sinovac's CoronaVac became the first vaccine to be approved for emergency use in China. On Feb. 5, 2021, the National Medical Products Administration approved CoronaVac for conditional marketing use. On June 1, CoronaVac was approved for emergency use by the World Health Organization (WHO). Later, China approved the emergency use of CoronaVac for cildern and adolescents on June 3.

On May 5, 2021, Canada became the first country in the world to approve a COVID-19 vaccine for emergency use in children aged 12 to 15 years. 


Later the same month, the U.S. 


Food and Drug Administration and European Medicines Agency also gave the green light to the Pfizer-BioNTech COVID-19 vaccine to be used on adolescents. "Children younger than 12 years are the next population who need a safe and efficient COVID-19 vaccine," said Cao Bin, a doctor from China-Japan Friendship Hospital in Beijing.





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