BANDUNG, INDONESIA, Sept 12, 2022 – (ACN Newswire) – PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a fresh milestone in manufacturing IndoVac, its Covid-19 vaccines brand, including primary series vaccines, booster vaccines and vaccines for children, in development since November 2021.
|IndoVac Covid-19 vaccine in production at PT Bio Farma’s facilities near Bandung, Indonesia (Image: PT Bio Farma)|
Honesti Baasyir, President Director of Bio Farma, said the business collaborated with Baylor College of Medicine, an exclusive, independent health sciences centre in Houston, Texas to build up IndoVac, a recombinant protein subunit vaccine created from yeast.
In accordance with Honesti, “IndoVac uses vaccine technology platforms which are appropriate for our equipment and facilities. The technology platforms for protein recombinant vaccines also offer other benefits; they may 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, believe it or not competitive than other Covid-19 vaccines. Now we have been completing documentation to summary Phase 3.”
Honesti said Bio Farma has already established intense communication with the Indonesian Food and Drug Administration (BPOM) since July to supply necessary Phase 3 primary series data, therefore the BPOM can release a crisis Use Authorization (EUA) permit for the vaccine. The EUA may be the permit for medical supplies, including vaccines and medications, used throughout a public health emergency.
In Indonesia, BPOM plays the main element role as a regulatory gatekeeper of medicines and vaccines found in the united states. BPOM’s head Penny K. Lukito, throughout a hearing at the Indonesian House of Representatives, said that the regulator expects release a the EUA for IndoVac’s primary series vaccines in mid-September.
Bio Farma in addition has 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 facet of something. The certificate from the Halal Certification Agency (BPJPH) of the Religious Affairs Ministry is likely to be released immediately after the BPOM EUA for IndoVac.
After securing all of the necessary permits, Bio Farma decide to move on to another stage, mass production of the vaccine. Bio Farma plans to create a short 20 million doses of primary series vaccine this season, which is further risen to 40 million doses in 2023, because the company expands its production facilities. In 2024, production may further increase to 100 million doses each year, based on demand and the marketplace.
Booster Vaccine and Vaccine for Children
Bio Farma also started clinical trials because of its booster vaccine on September 1. Bio Farma conducted the trials because of 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 check the booster vaccines. Next, the business plans to conduct clinical trials for children, following registration with the BPOM.
All Covid-19 vaccines created by Bio Farma, like the primary series vaccines, booster vaccines and vaccines for children, will undoubtedly be labelled IndoVac. Bio Farma started the procedure of registering IndoVac as a brandname 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 have been along the way of securing it. Should no-one object as of this level, we shall proceed to another stage until we secure an IndoVac trade licence and patent from the ministry, as something of Bio Farma,” Honesti said.
Honesti said IndoVac is special, among the few made-in-Indonesia vaccine products, developed and manufactured for the country’s children. Bio Farma handles the manufacturing process from upstream to downstream. The locally sourced content in the IndoVac vaccines, in accordance with Bio Farma, will undoubtedly be around 80%.
“It is a step nearer to achieving independence in medical sector. With this type of high proportion of local content, we be prepared to help reduce the country’s dependency on imported vaccines,” Honesti said.
Bio Farma hopes to fully capture the export market using its IndoVac vaccines. “We shall not merely produce them to meet up domestic needs, but also for the way to obtain global markets,” said Honesti. “We registered for EUL with the planet Health Organization (WHO), therefore the vaccine may be used far away through Covax Facility multilateral procurement. (The EUL assesses and lists vaccines during emergencies in non-vaccine-producing countries.)
“With this Covid-19 vaccines, hopefully to donate to medical industry, not only in Indonesia, however in the planet,” said Honesti.
For Bio Farma, it isn’t the initial experience with clinical trials, having conducted a lot more than 30 clinical trials (including Covid-19) in Indonesia. Bio Farma also offers 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 in addition to the Covid-19 primary series vaccines, Bio Farma previously secured EUA from BPOM and EUL from WHO because of 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 utilized by countries in Africa, Europe and the center East.
On the list of countries in Africa which 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 found in Ukraine and in the centre East, it had been found 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 end up being the main supplier of polio vaccines on earth, and currently contributes 67 percent to the global way to obtain polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).
Bio Farma’s Laboratories have already been internationally known as reference labs to check on examples of polio viruses, while Bio Farma’s success in producing and exporting nOPV2 vaccines shows the Indonesian state-owned company adding to the world’s health sector, aside from providing the required polio vaccine for domestic use in the home in Indonesia.
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
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