BPOM Publishes EUA Comirnaty Vaccine for the 16 to 18 Years

Selasa, 2 Agustus 2022 - 18:18 WIB

Oleh :

Arianti Widya

Infografik vaksin booster

Sumber :

Ilustrasi

VIVA – The Food and Drug Supervisory Agency (BPOM) has approved the addition of posology booster doses for adolescents, especially for ages 16 to 18 years. This approval has the purpose of expanding the Emergency Use Authorization (EUA) for the Comirnaty Vaccine.

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"The Comirnaty vaccine is a COVID-19 vaccine with an mRNA platform developed by Pfizer-Biontech. The Comirnaty vaccine is one of 13 COVID-19 vaccines that have received EUA approval in Indonesia," Head of BPOM, Penny K. Lukito said in a statement.

Penny also revealed the approved booster dose of Comirnaty Vaccine is 1 dose (30 mcg/0.3 mL) for at least 6 months after the second dose of primary vaccination using Comirnaty Vaccine (homologous booster).

The Comirnaty vaccine previously received EUA in Indonesia on July 14, 2021 with indications for primary vaccination at the age of 12 years or older.

After that, BPOM again issued approval for the expansion of the Comirnaty Vaccine EUA for the addition of posology booster doses for adults aged 18 years or over on January 2, 2022 (homologous booster) and January 11, 2022 (heterologous booster).

Ilustrasi vaksin booster

Photo :

VIVA/ David Rorimpandey

With the approval of the EUA Vaccine Comirnaty expansion for booster doses for children aged 16 to 18 years, BPOM has also issued factsheets that can be referred to by health workers as well as product information specifically for the public.

"The factsheet provides complete information regarding the safety and efficacy of the Comirnaty Vaccine, including the use of boosters in children aged 16 to 18 years, as well as matters that must be taken into account in the use of vaccines, including monitoring for possible side effects or Post Immunization Adverse Events (AEFI). and reporting,” Penny remarked.

BPOM has evaluated the safety and efficacy of giving Comirnaty Vaccine booster doses in adolescents based on phase 3 clinical study data conducted on subjects aged 16 years or older (C4591031 Sub A) and Real-World Evidence data from observational studies to assess the effectiveness of booster vaccines. Comirnaty in the same age group.

In this clinical study, a booster dose of Comirnaty Vaccine was administered at least 6 months after complete primary vaccination.

The results of clinical studies show the effectiveness of giving a booster in the age group of 16 years and over, as well as a safety profile that's similar to the safety profile of primary dose vaccination.

Clinical study data on children aged 16 years and over (test subject C4591031 Sub A) who were given a booster dose of the Comirnaty Vaccine showed 95.6% efficacy in preventing the occurrence of COVID-19.

Real World Evidence data also shows the effectiveness of the Comirnaty vaccine booster by 93% in reducing the number of hospitalizations due to COVID-19, 92% in reducing the risk of severe COVID-19, and 81% in reducing deaths because of COVID-19.