BPOM Allows Use of Sinovac Vaccine for Children Aged 6-11

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation     Date 1 November 2021
Category: News
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BPOM holds a press statement on the permit to use Sinovac COVID-19 vaccine for children aged 6-11 years old, Monday (01/11). (Photo by: BPOM YouTube)

The Indonesian Food and Drug Administration (BPOM) has granted emergency use authorization (EUA) for Sinovac vaccine to be administered to children aged 6 to 11 years old.

“Thank God, we are grateful that today we can issue permit to use Sinovac COVID-19 vaccine for children aged 6 to 11 years old,” Head of BPOM Penny K. Lukito said in a press statement, Monday (01/11).

The Sinovac vaccine includes CoronaVac vaccine produced by Sinovac Life Science Co., Ltd China and the one produced by state-owned pharmaceutical company PT Bio Farma.

The issuance of this permit refers to the results of the security and immunity assessment generated against COVID-19. Meanwhile, in terms of efficacy, it has the same result as the efficacy of previous clinical trials.

“The result of this clinical trial for children is more on the safety and the immunogenicity aspects. The immunogenicity aspect shows us a fairly high percentage at 96 percent. The safety aspect shows that this vaccine is safe for children aged 6-11 years old,” Penny said, adding that the assessment was carried out by BPOM and a team of experts consisting of members from the National Committee on Drug Evaluation, the ITAGI (Indonesian Technical Advisory Group on Immunization), and other relevant clinicians.

“We would like to express our appreciation for the cooperation from the drug assessment team, in this case consisting of various experts involved in vaccination and vaccine use and of course from ITAGI and clinicians who are members of the National Commission on Drug Evaluation team.” Head of BPOM said.

Previously, BPOM has allowed the use of Sinovac vaccine for children aged 12-17 years old and with the issuance of this permit, the Sinovac vaccine can be administered to children aged 6-17 years old as well as adults.

“I think this is encouraging news because we firmly believe that vaccination for children is urgent, especially since in-person learning has begun,” she said.

With more and more children allowed to get the COVID-19 vaccine, Penny added, it is expected that more parents will have more trust in sending their children back to school for in-person learning.

As stated by the Head of BPOM, the Sinovac vaccine is the first COVID-19 vaccine registered with BPOM that can be given to children aged 6-11 years old.

“We hope that in the near future, that there will be more vaccines that will soon be registered with BPOM to be used for children [aged] 6-11 years old,” she said, adding that further assessment is needed for administering vaccines to children under six years old.

“We are still trying to get more complete data for children under six years old because we and the assessment team need to be more cautious in giving permission for children in early childhood,” she remarked. (PR of BPOM/UN) (FI/EP)

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