The vaccine is manufactured through the production facility of the state-owned pharmaceutical company PT Bio Farma in Bandung, West Java.
“The IndoVac vaccine becomes the first COVID-19 vaccine that is produced locally in the country from the upstream to the downstream process,” Lukito noted at a press conference on the provision of Emergency Use Authorization (EUA) for Local COVID-19 Vaccine at the BPOM building, here on Friday.
The agency head remarked that IndoVac is a recombinant protein subunit COVID-19 vaccine developed by PT Bio Farma in collaboration with Baylor College of Medicine, USA.
The BPOM issued the EUA for IndoVac vaccine on September 24, 2022.
In accordance with the EUA requirements, the BPOM had earlier evaluated the aspects of 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 Practice (GMP).
According to the BPOM head, the agency had approved the issuance of the EUA for the IndoVac vaccine with the indication for COVID-19 prevention for individuals aged 18 years and above.
IndoVac vaccine is targeted to be used for primary series, with the doses administered 28 days apart.
Regarding the IndoVac vaccine's efficacy, based on the results of the immuno-bridging study in the phase three clinical trials, the vaccine's neutralizing antibodies are not inferior as compared to the protein subunit vaccine that is used for comparison (92.5 percent vs 87.09 percent).
The reported side effects or adverse events in the clinical trials of the IndoVac vaccine are mild. The vaccine has also received a halal certificate from the relevant authority in Indonesia.
“The most frequently reported side effects were local pain and muscle pain (myalgia) whose occurrence was comparable to the side effects of using the comparison subunit protein recombinant vaccine, which had already received EUA," she remarked.
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Translator: Andi Firdaus, Raka Adji
Editor: Sri Haryati
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