- ANTARA FOTO/Fikri Yusuf
VIVA English Site – Head of the Food and Drug Supervisory Agency (BPOM), Penny K Lukito said Merah Putih Vaccine with the trademark IndoVac is the first COVID-19 vaccine that producing in Indonesia through PT Bio Farma's production facility in Bandung, West Java.
During a press conference for the issuance of an Emergency Use Permit (EUA) for Domestic COVID-19 Vaccines at the BPOM RI Building, Jakarta, on Friday, September 30, 2022, Penny K Lukito said the IndoVac Vaccine was the first COVID-19 vaccine to be produced locally in the country.
BPOM issued an Emergency Use Authorization (EUA) for the IndoVac Vaccine on September 24, 2022.
The emergency use permit is the initial door of access to obtain the COVID-19 vaccine that the community needs as a strategic effort in dealing with the pandemic and protecting against COVID-19.
Penny K Lukito conveyed that IndoVac is a COVID-19 vaccine containing the active substance recombinant Receptor-Binding Domain (RBD) protein S of the SARS-Cov-2 virus with a recombinant protein subunit platform developed by PT Bio Farma in collaboration with Baylor College of Medicine, USA.
Ilustrasi vaksin booster
- VIVA/ David Rorimpandey
By EUA requirements, BPOM has previously evaluated the aspects of the efficacy, safety, and quality of the IndoVac Vaccine by referring to the internationally applicable COVID-19 vaccine evaluation standards, as well as evaluating the fulfillment of Good Manufacturing Practices (GMP).
According to Penny, BPOM has approved the issuance of the IndoVac Vaccine EUA with indications as active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals aged 18 years and over.
The IndoVac vaccine will be used in primary vaccination which is given in 2 injection doses (25 g/dose) with an interval of 28 days.
IndoVac Vaccine Efficacy refers to the results of the immune bridging test in phase 3 clinical trials, showing non-inferior Vaccine neutralization antibodies with the comparison protein subunit vaccine (92.5 percent vs. 87.09 percent).
The side effects or adverse events (AEs) in the Indovac Vaccine clinical trials were reported to be generally mild and have been certified halal by the competent authorities in Indonesia.
"The most frequently reported side effects are local pain and muscle pain (myalgia) that appear comparable to the side effects of using the comparison subunit protein recombinant vaccine, which has already received EUA," Penny K Lukito explained.
