Indonesian pharmaceutical company PT Bio Farma ready to mass-produce IndoVac Covid-19 vaccines

Bandung, Indonesia – (NewMediaWire) – September 10, 2022 – (ACN Newswire) – PT Bio Farma, the holding company of state-owned pharmaceutical companies in Indonesia, announced a new milestone in manufacturing IndoVac, a brand of Covid-19 vaccine it has been developing since November 2021. Honesti Baasyir, Chief Executive Officer of PT Bio Farma said the company collaborated with Baylor College of Medicine, a private, independent health sciences center in Houston, Texas, to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

Bio Farma has completed phase 1 and phase 2 clinical trials and is currently in phase 3, in the production of primary series vaccines, that is, the two doses of vaccines for anyone aged 18 and over. “IndoVac uses vaccine technology platforms that are compatible with our plant equipment and facilities. Recombinant protein vaccine technology platforms also offer other advantages: they adapt to new strains of Covid-19. Phase 1 and Phase 2 results show that IndoVac offers safety and efficacy, no less than other Covid-19 vaccines.

“We are currently documenting the study for the completion of phase 3.” Honesti said Bio Farma had intense communication with the Indonesian Food and Drug Administration (BPOM) since July to provide the necessary data, so that BPOM could issue the Emergency Use Authorization (EUA) for the vaccines. ‘IndoVac as soon as possible. An EUA, issued by a country’s regulatory agency, is a license to produce medical supplies (including vaccines) and drugs during a public health emergency.

In Indonesia, BPOM plays the key role as the regulatory guardian of medicines and vaccines used in the country. BPOM chief Penny K. Lukito told a hearing in the Indonesian House of Representatives that the regulator plans to issue an EUA for IndoVac’s primary series vaccines by mid-September 2022.

Sharia Compliant

Bio Farma has also handled Halal (or Sharia Compliant) certification for IndoVac’s primary series vaccines, to provide comfort to Indonesian Muslim consumers. The vaccines have passed an audit by the Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which examines the halal aspect of a product. The Ministry of Religious Affairs Halal Certification Agency (BPJPH) certificate is expected shortly after BPOM releases the EUA for IndoVac.

After obtaining all necessary permits, Bio Farma is ready to move into mass production with IndoVac’s primary series vaccines. Bio Farma plans to produce 20 million doses of the primary series vaccine in the first year, before increasing to 40 million doses in 2023 as the company expands its production facilities. In 2024, the volume per year could increase further to reach 100 million doses, depending on demand and market needs.

Booster vaccine and childhood vaccine

Meanwhile, Bio Farma also started clinical trials for its booster vaccine on September 1 at Hasan Sadikin General Hospital in Bandung (Faculty of Medicine, Padjajaran University) and Dr. IGNG General Hospital. Ngoerah from Bali (Child Health Sciences, Udayana Univ.). The trials involved 900 subjects aged 8 and over to test IndoVac’s booster vaccines. Bio Farma plans to conduct clinical trials for children next, after obtaining the PPUK from BPOM.

All Covid-19 vaccines manufactured by Bio Farma, including primary series, booster vaccines and vaccines for children, will be labeled IndoVac. On July 29, Bio Farma began the process of registering IndoVac as a brand name for vaccines with the General Directorate of Intellectual Property (DGIP) of the Ministry of Justice and Human Rights.

President Joko Widodo named the vaccine IndoVac. “We are in the process of getting the name. If no one objects at this level, we will take the next step until we get an IndoVac commercial license and patent from the ministry, as a product from Bio Farma,” Honesti said. .

For Bio Farma, this is not the first time in clinical trials. The company has conducted more than 30 clinical trials across Indonesia, including phase 3 clinical trials for the Covid-19 vaccine. Bio Farma also has experience in conducting clinical trials abroad, for Pentabio and the new type 2 oral polio vaccine (nOPV2).

Vaccines made in Indonesia

Honesti Basyir said IndoVac is special because it is one of the few vaccines made in Indonesia. Vaccines, which include primary series vaccines, booster vaccines and childhood vaccines, are developed and manufactured for the country’s children. Bio Farma manages the complete manufacturing process from upstream to downstream.

Local content in vaccines, according to Bio Farma, will be around 80%. “It’s a step closer to the independence of the health sector. With such a high proportion of local content, we hope to reduce the country’s dependence on imported vaccines,” Honesti said.

Bio Farma hopes to conquer the export market with IndoVac vaccines. “We will not only produce them (in all three types of vaccines) to meet national needs, but we will also target supplying global markets,” he said. “We have registered on the Emergency Use List (EUL) with the World Health Organization (for the primary series), so this vaccine can be used in other countries through the Covax facility. (multilateral purchase) Through our Covid-19 vaccines, Bio Farma expects to contribute to the health industry, not only in Indonesia, but in the world.

Bio Farma’s success with the poliomyelitis vaccine

Honesti said that apart from the Covid-19 primary series vaccines, Bio Farma had previously obtained EUA from BPOM and EUL from WHO for its new oral polio vaccine type 2 (nOPV2). The EUL is a procedure for evaluating and listing vaccines during public health emergencies in non-vaccine producing countries. However, since Indonesia has not experienced a polio outbreak since 2014, it has never used nOPV2. The vaccine manufactured by Bio Farma has been used by countries in Africa, Europe and the Middle East.

Among the countries that have used the polio vaccine are Algeria, Cameroon, Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal and Uganda. In Europe the vaccine has been used in Ukraine and in the Middle East it has been used in Israel, Egypt, Somalia and Yemen. In the manufacture of the nOPV2 vaccine, Bio Farma has collaborated with world-class research institutions such as the Bill and Melinda Gates Foundation (BMGF), PATH and WHO, and has since become the main supplier of the vaccine in the world, currently contributing 67% of global supply. It distributes vaccines through bilateral and multilateral means (via UNICEF).

Bio Farma Laboratories are internationally recognized as reference laboratories for verifying poliovirus samples. The world was previously waiting for two countries, Afghanistan and Pakistan, to fight polio, for a “polio-free world” to be declared. However, polio outbreaks have occurred in Africa and the Middle East, so the nOPV2 vaccine has become important in preventing the spread of the disease. Bio Farma’s success in producing and exporting the nOPV2 vaccine shows that the Indonesian state-owned company is contributing to the global health sector, in addition to supplying the vaccine for domestic use in Indonesia.

Media Contact:
R. Rifa Herdian
PT Bio Farma (Persero)
General Secretariat & Investor Relations
Tel: +62-81-2542-8844
Email: [email protected]

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