Honesti Baasyir, the President Director of PT Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

PT Bio Farma has completed Phase 1 and Phase 2 clinical trials and is currently in the Phase 3 stage to produce the primary series vaccines or two vaccine doses for everyone aged 18 years and older.

"IndoVac uses vaccine technology platforms which are compatible with the equipment and facilities within our factories. The technology platforms for protein recombinant vaccines also offer other benefits: they can be adapted to the new strains of Covid-19. Results from Phase 1 and Phase 2 clinical trials showed that IndoVac offers quality safety and efficacy, not less competitive than other Covid-19 vaccines. Now we are completing a report to wrap up Phase 3."

Honesti said, Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July 2022 to provide the necessary data, so that BPOM can release the Emergency Use Authorization (EUA) permit for IndoVac's primary series vaccines in the near term.

The EUA, released by a country's regulatory agency, is a permit for medical supplies (including vaccines) and medications during a public health emergency. In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country.

BPOM's head Penny K. Lukito, during a hearing with Commission IX at the Indonesian House of Representatives, has said that the regulator expects to release the EUA for IndoVac's primary series vaccines in mid-September 2022.

Shariah Compliance

Bio Farma also has processed the Halal (or Shariah compliant) certification for IndoVac's primary series vaccines to provide comfort to Indonesian Muslim consumers. The vaccines have passed an audit from The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product.

The certificate from the Halal Certification Agency (BPJPH) under the Religious Affairs Ministry is expected to be released in the near term after BPOM release the EUA for IndoVac.

After securing all the necessary permits, Bio Farma is ready to move on to the next stage, which is producing IndoVac's primary series vaccines massively. At the first stage, Bio Farma plans to produce a maximum of 20 million doses of primary series vaccines, before this can be further increased to 40 million doses in 2023, as the company expands its production facilities.

In 2024, the company may further increase the volume to 100 million doses per year, depending on the demands and needs in the markets. Honesti said after the company has secured all the necessary permits, then IndoVac's primary series vaccines "can be massively used by people aged 18 and above."

Booster Vaccine and Vaccine for Children

At the same time, Bio Farma also started clinical trials for its booster vaccine on September 1, 2022. "We have secured approval for a clinical trial (PPUK) from BPOM for IndoVac booster vaccine," Honesti said. Next, Bio Farma plans to conduct clinical trials for children after it secures PPUK from BPOM.

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