COVID-19: BPOM Approves Sinovac Vaccine for Kids Aged 6-11
2 November 2021 10:24 WIB
TEMPO.CO, Jakarta - The National Agency of Drug and Food Control (BPOM) has issued a permit clearing the use of the Sinovac vaccine for children aged 6 to 11 years old based on a safety and immunity assessment.
"The results of the pediatric clinical trial are more about safety and immunogenicity aspects. It shows that (Sinovac) is safe for children aged 6 to 11 years," Head of BPOM Penny Lukito said at an online press conference on Monday.
The issuance of permits for COVID-19 vaccines for children is an urgent matter, considering that schools are starting to implement limited face-to-face learning (PTM), she added.
According to the clinical trial report, similar results were obtained for side-effects of Sinovac in children aged 6-11 as children aged 11-17, which was about 11 percent to 17 percent of the total clinical trial subjects, she informed. A license to use the Sinovac vaccine for children aged 11 to 17 years was previously issued and declared safe for use, she noted.
The clinical trial report also shows that the immunogenicity or ability of the vaccine to trigger the body's immune response is greater in children than adults: it is 96.15 percent in children compared to 89.04 percent in adults, Lukito informed.
The Sinovac vaccine was the first vaccine registered with BPOM for use among children in the 6-11 age group, she noted. She said she hopes that in the future, there will be another COVID-19 vaccine registered for children aged 6-11 years.
"We are waiting in the near future for more vaccines that will soon be registered with BPOM to be used for children aged 6-11 years, hoping that we could have more age coverage for COVID-19 vaccination," Lukito remarked.
Vaccination of children is important, especially with the start of face-to-face learning, and is expected to increase parents' willingness to send their children back to school, she added.