BPOM Recommends Giving COVID-19 Vaccine For Children 12-17 Years Old

JAKARTA - The Food and Drug Supervisory Agency (BPOM) recommends 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) was 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 were 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.

VOI confirmed the letter circulating on social media to the COVID-19 Vaccine Spokesperson from the Ministry of Health, Siti Nadia Tarmizi, only that she submitted this to the Food and Drug Supervisory Agency (BPOM).

"Ask BPOM, okay," he said.

Meanwhile, the spokesperson for the COVID-19 Vaccine from BPOM, Lucia Rizka Andalusia, has not commented on the vaccine recommendation or the submission letter.

Previously, Minister of Health Budi Gunadi Sadikin said that his party had started planning COVID-19 vaccinations for children under 18 years old. Because, at this time exposure to the coronavirus in children is starting to increase.

Currently, said Budi, the Ministry of Health is starting to look at two vaccine brands that have received emergency use authorization (EUA) from a number of countries.

"We are currently reviewing which vaccines already have EUA for young people. What we have observed now that there are two on our list, one is Sinovac which can be aged from 3 to 17 years, the other is Pfizer which can be aged 12 until 17," Budi said in a virtual press conference, Friday, June 25.

On the other hand, the government is coordinating with the Indonesian Technical Advisory Group on Immunization (ITAGI) on the plan to provide vaccinations for children. The government is also observing the ongoing provision of COVID-19 vaccinations for children in a number of countries.