COVID-19 – Indonesia approves Comirnaty for booster on children 16-18 yo

A clinical study on children aged 16 years old and above (test subject C4591031 Sub A) showed an efficacy of 95.6 percent in preventing the occurrence of COVID-19 after injection of the Comirnaty booster dose.

 

Jakarta (Indonesia Window) – Indonesia’s National Agency of Drug and Food Control (BPOM) has approved a booster dose posology for youngsters aged 16-18 years old as an extension of the Emergency Use Authorization (EUA) for the Comirnaty vaccine.

The decision is the first approval of a booster dose of COVID-19 vaccine in this age group.

The Comirnaty vaccine is one of 13 COVID-19 vaccines that have received the EUA in Indonesia, BPOM’s head Penny K Lukito said here on Tuesday (Aug. 2).

“The approved booster dose of Comirnaty vaccine is one dose (30 mcg/0.3 mL) for at least six months after the second dose of primary vaccination using the Comirnaty vaccine (homologous booster),” she noted.

Comirnaty vaccine firstly received the EUA in Indonesia on July 14, 2021 with indications for primary vaccination on children aged 12 years old or older.

After that, BPOM again issued an approval for the Comirnaty vaccine EUA extension for the addition of posology booster doses for the adult population aged 18 years old or over on January 2, 2022 as a homologous booster and January 11, 2022 as a heterologous booster.

The agency has evaluated the safety and efficacy of the Comirnaty booster vaccine in adolescents based on data from a third phase clinical study conducted on subjects aged 16 years old or older (C4591031 Sub A).

Real World Evidence data from observational studies were also used to assess the effectiveness of the Comirnaty booster vaccine in the same age group.

Real World Evidence data show the Comirnaty booster is 93 percent effective in reducing the number of hospitalizations due to COVID-19, 92 percent in reducing the risk of severe COVID-19 symptoms, and 81 percent in reducing the potential for death due to COVID-19.

A clinical study on children aged 16 years and over (test subject C4591031 Sub A) also showed a 95.6 percent efficacy in preventing the occurrence of COVID-19 after the Comirnaty booster dose was injected.

Meanwhile, the most frequently reported side effects after administering a booster dose of Comirnaty in children aged 16 years old and over were local reactions at the injection site (21 percent), joint and muscle tissue disorders (6.7 percent), headaches (5 percent), lymphadenopathy (2.7 percent), and gastrointestinal disorders (1.7 percent).

These results are in line with reports of side effects following the administration of two primary doses of Comirnaty.

BPOM also publishes factsheets that can be used as a reference for health workers, and product information for the public.

The factsheet, Penny said, provides complete information regarding the safety and efficacy of the Comirnaty vaccine, including booster doses for children aged 16-18 years old.

Factsheet and information on COVID-19 vaccine products can be accessed via the link http://pionas.pom.go.id/cari/obat-baru

Reporting by Indonesia Window