UAE BPOM Publish, President Jokowi: COVID-19 Vaccination For Children Age 12-17 Coming Soon

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JAKARTA - President Joko Widodo (Jokowi) said children aged 12 to 17 years would soon receive a COVID-19 vaccination. This follows the issuance of an emergency use authorization (UAE) by the Food and Drug Supervisory Agency (BPOM).

The type of COVID-19 vaccine that will be used is Sinovac. This vaccine is the product of a company from China, namely Sinovac Biotech Ltd.

"BPOM has issued an emergency use permit or EUA for the Sinovac vaccine which is declared safe for use for children aged 12-17 years old. So that vaccination for children can start immediately," Jokowi said in a video statement posted on the Presidential Secretariat's YouTube, Monday, 28 June.

However, the former Governor of DKI Jakarta did not elaborate further regarding the plan to administer the Sinovac vaccine for children. Including when to give it.

He only ensured that this step was a vaccination to protect children from the COVID-19 pandemic and reduce the number of virus transmission in the community.

Previously, the Food and Drug Supervisory Agency (BPOM) recommended the use of the COVID-19 vaccine for children aged 12-17 years.

This recommendation is contained in the Submission Letter Number RG.01.02.322.06.21.00169/T regarding the Evaluation Results of the Efficacy and Safety of the National Committee for Drug Evaluation which they sent to Bio Farma on 27 June.

Through the letter, BPOM recommends accepting the proposed use of the COVID-19 vaccine in children aged 12-17 years at a dose of 600SU/0.5 milliliters. There are three considerations in the use of vaccines in this age group.

First, the immunogenicity and safety profile at the medium dose (600 SU/05 mL) were better than the low dose (300 SU/0.5 mL).

Second, from the safety data of Phase I and Phase II clinical trials, the profile of systemic AE in the form of fever in the 12-17 year old population was not reported compared to the age of 3-5 years and 6-11 years.

Finally, the immunogenicity and safety in the adolescent population of 12-17 years was confirmed by data from clinical trials in the adult population because the maturation of the immune system in adolescents corresponds to that of adults.

As for children under the age of 12 years, BPOM has not recommended it. They requested that clinical trials with more subjects be carried out based on the age group of 6-12 years and continued by 3-5 years of age.