With support from the Expert Team of the National Committee for Assessing COVID-19 Vaccines and the Indonesian Technical Advisory Group of Immunization (ITAGI), the BPOM granted permits for emergency use of the Comirnaty children's vaccine for the age range of five to 11 years on November 29, 2022, and the Comirnaty children's vaccine for the age bracket of six months to four years on December 11, 2022.
"The Comirnaty children's vaccine has a different formulation and strength from the Comirnaty vaccine for youth and adults. The Comirnaty children's vaccine cannot be used in individuals aged 12 and over," BPOM Head Penny K. Lukito noted in a statement received here, Tuesday.
Lukito said the dose of the Comirnaty children's vaccine for the age bracket of six months to four years for primary vaccination is 3 mcg/0.2 mL that is given in three doses, with the first two doses being offered within three weeks, while the third dose is administered at least eight weeks after the second dose.
Meanwhile, the dose of the Comirnaty children's vaccine for those in the age group of five to 11 years for primary vaccination is 10 mcg/0.2 mL and is given in two doses, with a span of three weeks between the first and second doses, Lukito noted.
She stated that the issuance of a permit for the emergency use of the COVID-19 vaccine for children was preceded by an evaluation of the safety, efficacy, and quality aspects of the vaccine product.
Results of the efficacy test for using the Comirnaty children's vaccine in primary vaccination in those aged six months to less than five years and children aged five years to less than 12 years are comparable to the efficacy of using vaccines in the age group 16 to 25 years that already have vaccine data efficacy, Lukito remarked.
Based on the study results, the Comirnaty children's vaccine for children aged six months to four years and the Comirnaty children's vaccine for children aged 5 to 11 years also have a tolerable safety profile.
Related news: BPOM oversees destruction of syrup drugs containing EG, DEG
According to Lukito, side effects from the use of these vaccine products in children aged six months to less than five years were generally reported to be mild to moderate.
Swollen or enlarged lymph nodes were found in 0.2 percent of the subjects aged six months to less than two years and 0.1 percent of subjects aged two years to less than five years.
Lukito said the results of observing side effects in children aged five years to less than 12 years of particular concern were reports of an angioedema reaction or swelling accompanied by redness in 1.2 percent of the vaccine group subjects and 0.8 percent of the placebo group subjects.
In addition, 13 cases of swelling were reported in 0.9 percent of subjects in the vaccine group and one case in the placebo group.
The safety profile is stated to be similar to the adverse events following the immunization (KIPI) report in the age group above 12 years.
Lukito stated that the BPOM has issued Comirnaty vaccine emergency use permit for primary vaccination in children aged 12 years and over on July 14, 2021.
Furthermore, the BPOM issued a permit for emergency use of the Comirnaty vaccine for additional booster dose posology for adults aged 18 years or over on January 2, 2022, for homologous booster and January 11, 2022, for heterologous booster.
Related news: KPAI backs BPOM's regulation of labeling BPA on plastic packaging
On August 2, 2022, the BPOM approved the addition of a booster dose posology for people in the age group of 16-18 years as an expansion of the permit for emergency use of the Comirnaty vaccine, Lukito remarked.
She stated that the issuance of permits for emergency use of the Comirnaty children's vaccine for the age range of six months to four years and five to 11 years is expected to increase the choice of COVID-19 vaccine products for primary vaccination in children aged less than 12 years apart from the Coronavac vaccine made by Sinovac.
"We hope this vaccine helps meet the need for the COVID-19 vaccine as well as the limited types of vaccines that can be used for the child population," she added.
However, the BPOM continues to urge the public to unwaveringly implement health protocols to prevent COVID-19 transmission and to be wise and careful in using the drugs to treat the disease.
Related news: BPOM needs legal framework to regulate online sales
Related news: BPOM seizes 66,113 products not meeting distribution requirements
Translator: Andi Firdaus, Resinta S
Editor: Fardah Assegaf
Copyright © ANTARA 2022
