The Food and Drug Supervisory Agency (BPOM) has issued emergency use authorization (EUA) for the IndoVac COVID-19 vaccine produced by state-owned pharmaceutical company PT Bio Farma for use as a booster vaccine.
“I approved the EUA for the IndoVac booster vaccine on Thursday. It can be issued immediately,” BPOM Head Penny K. Lukito said at a press conference on the issuance of the EUA for the InaVac primary vaccine in Jakarta on Friday.
With the EUA for IndoVac, all booster dose vaccine products using the protein subunit platform can be used by the public.
Earlier, PT Bio Farma President Director Honesti Basyir informed that the company is ready to produce 20 million doses of the IndoVac vaccine in the initial stage.
The number can be increased to 40 million doses per year by 2023 with the addition of production facilities.
The production capacity can be further increased to 100 million doses per year by 2024, depending on the need and demand, he added.
Bio Farma had started producing the IndoVac vaccine for meeting domestic and foreign needs following its launch by President Joko Widodo (Jokowi) on October 13, 2022.
For domestic needs, Bio Farma will submit all mechanisms to the Ministry of Health and will accommodate the ministry’s needs.
In terms of marketing authorization, after obtaining the EUA for primary vaccination, Bio Farma has completed the clinical trial for adult boosters and has submitted the report to BPOM.
For export needs, Bio Farma is in the process of submitting an Emergency Use Listing (EUL) to the World Health Organization (WHO). After obtaining the EUL, Bio Farma will be able to meet international demand for COVID-19 vaccines.
Earlier, IndoVac’s clinical trials showed that the vaccine is safe in terms of adverse events following immunization (KIPI) and has mild side effects, such as pain at the injection site.
IndoVac was also shown to have good efficacy in increasing the titer, or the concentration of antibodies.
During immuno-bridging trials with comparison vaccines with an efficacy of above 80 percent, the IndoVac vaccine was found to be non-inferior, meaning it had better effectiveness compared to comparison vaccines, with an efficacy of above 80 percent.
Source: Antara News