PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in manufacturing IndoVac, its Covid-19 vaccine brand, including primary series vaccines, booster vaccines and vaccines for children, in development since November 2021.
Honesti Baasyir, President Director of 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.
According to Honesti, “IndoVac uses vaccine technology platforms which are compatible with our equipment and facilities. The technology platforms for protein recombinant vaccines also offer other benefits; they can be adapted to new strains of Covid-19.
“Results from primary series Phase 1 and Phase 2 clinical trials show that IndoVac vaccines offer quality safety and efficacy, no less competitive than other Covid-19 vaccines. Now we are completing documentation to wrap up Phase 3.”
Honesti said Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July to provide necessary Phase 3 primary series data, so the BPOM can release an Emergency Use Authorization (EUA) permit for the vaccine. The EUA is the permit for medical supplies, including vaccines and medications, used 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 at the Indonesian House of Representatives, said that the regulator expects to release the EUA for IndoVac’s primary series vaccines in mid-September.
Bio Farma has also processed the Halal (or Shariah compliant) certification for IndoVac’s primary series vaccine. The vaccine has passed an audit by 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) of the Religious Affairs Ministry is expected to be released soon after the BPOM EUA for IndoVac.
After securing all the necessary permits, Bio Farma will be ready to move on to the next stage, mass production of the vaccine. Bio Farma plans to produce an initial 20 million doses of primary series vaccine this year, which will be further increased to 40 million doses in 2023, as the company expands its production facilities. In 2024, production may further increase to 100 million doses per year, depending on demand and the market.
Booster Vaccine and Vaccine for Children
Bio Farma also started clinical trials for its booster vaccine on September 1. Bio Farma conducted the trials for its booster vaccine at Hasan Sadikin General Hospital in Bandung (Faculty of Medicine, Padjajaran University) and Dr I.G.N.G Ngoerah General Hospital in Bali (Children’s Health Sciences Dept, Udayana University). Trials involved 900 subjects aged 8 and above to test the booster vaccines. Next, the company plans to conduct clinical trials for children, following registration with the BPOM.
All Covid-19 vaccines made by Bio Farma, including the primary series vaccines, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.
President Joko Widodo gave the IndoVac name to the vaccine. “We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma,” Honesti said.
Honesti said IndoVac is special, as one of the few made-in-Indonesia vaccine products, developed and manufactured for the nation’s children. Bio Farma handles the manufacturing process from upstream to downstream. The locally sourced content in the IndoVac vaccines, according to Bio Farma, will be around 80%.
“This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation’s dependency on imported vaccines,” Honesti said.
Bio Farma hopes to capture the export market with its IndoVac vaccines. “We will not only produce them to meet domestic needs, but for the supply of global markets,” said Honesti. “We registered for EUL with the World Health Organization (WHO), so the vaccine can be used in other countries through Covax Facility multilateral procurement. (The EUL assesses and lists vaccines during emergencies in non-vaccine-producing countries.)
“With our Covid-19 vaccines, we hope to contribute to the health industry, not just in Indonesia, but in the world,” said Honesti.
For Bio Farma, it is not the first experience with clinical trials, having conducted more than 30 clinical trials (including Covid-19) in Indonesia. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).
Bio Farma’s Success in Polio Vaccine
Honesti said apart from the Covid-19 primary series vaccines, Bio Farma previously secured EUA from BPOM and EUL from WHO for its novel Oral Polio Vaccine type 2 (nOPV2). As Indonesia hasn’t had any polio outbreaks since 2014, it never used nOPV2. However, the Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.
Among the countries in Africa that have used Bio Farma’s nOPV2’s vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen.
In manufacturing the nOPV2 vaccine, Bio Farma collaborated with world-class institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has since become the main supplier of polio vaccines in the world, and currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).
Bio Farma’s Laboratories have been internationally acknowledged as reference labs to check samples of polio viruses, while Bio Farma’s success in producing and exporting nOPV2 vaccines shows the Indonesian state-owned company contributing to the world’s health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.