Bandung, W Java, Indonesia, PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.
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.
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.
Bio Farma conducted clinical trials for its booster vaccine at Hasan Sadikin General Hospital (Faculty of Medicine of Padjajaran University, Bandung) and Dr. I.G.N.G Ngoerah General Hospital in Bali (Children’s Health Sciences Department, Udayana University). Trials involved 900 subjects aged 8 and above to test IndoVac’s booster vaccines.
BPOM requires vaccine manufacturers to conduct clinical trials to decide if a vaccine is safe and can boost immunity against Covid-19, and to determine whether the vaccine offers good efficacy to help protect the subjects from heavy symptoms and risks of fatalities due to Covid-19 infection.
All Covid-19 vaccines made by Bio Farma, including the primary series, 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.
For Bio Farma, it is not the first time embarking on clinical trials. The company has conducted more than 30 clinical trials in Indonesia. This includes the Phase 3 clinical trials for the Covid-19 vaccine. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).
Honesti Basyir said IndoVac is special as one of the few made-in-Indonesia vaccine products. The vaccines (which include the primary series vaccines, the booster vaccines and vaccines for children) are developed and manufactured for nation’s children. Bio Farma handles the manufacturing process from upstream to downstream.
The local contents of IndoVac’s primary series 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. This will also impact foreign exchange reserves,” Honesti said.
In the long term, Bio Farma hopes to capture the export market with IndoVac vaccines. “We will not only produce them (the three types of vaccines) to meet domestic needs but also target the supply of global markets,” he said.
“We registered for Emergency Use Listing (EUL) with the World Health Organization (for primary series), so this vaccine can be used in other countries through the Covax Facility (multilateral procurement). Through its Covid-19 vaccines, Bio Farma expects to contribute to the health industry, not just in Indonesia, but also to the world.”
Bio Farma’s Success in Polio Vaccine
Honesti said apart from manufacturing Covid-19 primary series vaccines, which is currently waiting for the results of Phase 3 clinical trials and the EUA, Bio Farma has previously proven that it can secure the EUA from BPOM and the EUL from the WHO for its novel Oral Polio Vaccine type 2 (nOPV2).
The EUL, which is released by the WHO, is a procedure for assessing and listing vaccines during public health emergencies by non-vaccine-producing countries. As Indonesia hasn’t had any polio outbreaks since 2014, it never used nOPV2. The Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.
Among the countries 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 the manufacturing of nOPV2 vaccine, Bio Farma collaborated with world-class research institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has become the main supplier for the polio vaccine in the world. The company currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).
Apart from producing polio vaccines, Bio Farma’s Laboratories have secured international acknowledgement as the reference labs to check samples of polioviruses. The world was previously waiting for two countries, Afghanistan and Pakistan, to combat polio diseases, before a ‘world-free polio’ can be declared. However, during the wait, polio outbreaks occurred in Africa and the Middle East.
The nOPV2 vaccine became an important product to prevent further spread of the polio disease. Bio Farma’s success in producing and exporting nOPV2 vaccine means that the Indonesian state-owned company has contributed to the world’s health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.