An important step for Indonesia’s independence in the pharmaceutical sector
Bandung, W Java, Indonesia, September 9, 2022 – (ACN Newswire) – PT Bio Farma, the holding company of state-owned pharmaceutical companies in Indonesia, has announced a new milestone in the manufacturing of IndoVac, a brand of Covid-19 vaccine s has been in development since November 2021.
|IndoVac Covid-19 vaccine in production at PT Bio Farma facilities near Bandung, Indonesia PT|
Honesti Baasyir, president and CEO of PT Bio Farma, said the company worked with Baylor College of Medicine, a private, independent health science center in Houston, Texas, to develop IndoVac, a vaccine vaccine. -recombinant protein unit produced from yeast.
PT Bio Farma has completed phase 1 and phase 2 clinical trials and is currently in phase 3 to produce the primary series vaccines or 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 can be adapted to new strains of Covid-19. Results from phase 1 and phase 2 clinical trials have shown that IndoVac offers quality safety and efficacy, no less competitive than other Covid-19 vaccines. We are now completing a report to wrap up Phase 3.”
Honesti said that 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 issue the Emergency Use Authorization (EUA) permit for short-term IndoVac primary series vaccines. .
The EUA, issued by a country’s regulatory agency, is a permit for 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 at a hearing with Committee IX in the Indonesian House of Representatives said the regulator plans to release the EUA for IndoVac’s primary series vaccines in mid -September 2022.
Bio Farma has also processed 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.
Ministry of Religious Affairs Halal Certification Agency (BPJPH) certificate is expected to be released soon after BPOM releases EUA for IndoVac.
After obtaining all the necessary permits, Bio Farma is ready to take the next step, which is to mass produce IndoVac’s primary series vaccines. Initially, 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 could further increase the volume to 100 million doses per year, depending on market demands and needs. Honesti said that after the company obtains all necessary permits, IndoVac’s primary series vaccines “can be widely used by people aged 18 and over.”
Booster vaccine and childhood vaccine
At the same time, Bio Farma also launched clinical trials for its booster vaccine on September 1, 2022. “We have obtained clinical trial approval (PPUK) from BPOM for the IndoVac booster vaccine,” said Honest. Next, Bio Farma plans to conduct clinical trials for children after obtaining the PPUK from BPOM.
Bio Farma conducted clinical trials for its booster vaccine at Hasan Sadikin General Hospital (Faculty of Medicine, Padjajaran University, Bandung) and Dr. IGNG Ngoerah General Hospital in Bali (Department of Health Sciences of Children, Udayana University). The trials involved 900 subjects aged 8 and over 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 if the vaccine provides good efficacy to help protect subjects against heavy symptoms and the risks of death from Covid-19 infection.
All Covid-19 vaccines manufactured by Bio Farma, including the 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 Covid-19 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 securing it. If no one opposes it at this level, we will take the next step until we obtain a commercial license and IndoVac patent from the ministry, as a product of Bio Farma,” Honesti said.
For Bio Farma, this is not the first time that it has embarked on clinical trials. The company has conducted more than 30 clinical trials in Indonesia. This includes phase 3 clinical trials for the Covid-19 vaccine. Bio Farma also has experience in conducting overseas clinical trials for Pentabio and the novel type 2 oral polio vaccine (nOPV2).
Vaccines made in Indonesia
Honesti Basyir said IndoVac is special as 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 nation’s children. Bio Farma manages the manufacturing process from upstream to downstream.
The local content of IndoVac’s primary series vaccines, according to Bio Farma, will be around 80%. “This is another step towards independence in the health sector. With such a high proportion of local content, we hope to help reduce the country’s dependence on imported vaccines. This will also have an impact on foreign exchange reserves,” Honesti said.
In the long term, Bio Farma hopes to conquer the export market with IndoVac vaccines. “We will not only produce them (the 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 its Covid-19 vaccines, Bio Farma plans to contribute to the health industry, not only in Indonesia, but also in the world.”
Bio Farma’s success in poliomyelitis vaccine
Honesti said that apart from manufacturing Covid-19 primary series vaccines, which is currently awaiting Phase 3 clinical trial results and EUA, Bio Farma has previously proven it can obtain EUA. of BPOM and the EUL of WHO for its novel Oral Polio Vaccine Type 2 (nOPV2).
The EUL, which is published by the WHO, is a procedure for evaluating and listing vaccines during public health emergencies by non-vaccine producing countries. Since Indonesia has not had 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.
Countries that have used Bio Farma’s nOPV2 vaccine include 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 collaborated with world-class research institutes like the Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has become the main supplier of the poliomyelitis vaccine in the world. The company currently contributes 67% of the global polio vaccine supply. It distributes vaccines by bilateral or multilateral means (via UNICEF).
Besides the production of poliomyelitis vaccines, Bio Farma’s laboratories have obtained international recognition as reference laboratories for verifying poliovirus samples. The world previously waited for two countries, Afghanistan and Pakistan, to fight polio diseases, before a “worldless polio” could be declared. However, during the wait, polio outbreaks occurred in Africa and the Middle East.
The nOPV2 vaccine has become an important product to prevent the spread of poliomyelitis. Bio Farma’s success in producing and exporting the nOPV2 vaccine means that the Indonesian state-owned company has contributed to the global health sector, in addition to supplying the needed polio vaccine for domestic use in Indonesia.
R. Rifa Herdian
PT Bio Farma (Persero)
General Secretariat & Investor Relations
Email: [email protected]
Source: BUMNPT Bio Farma (Persero)
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