Bandung, W Java, Indonesia, Sept 9, 2022 – (ACN Newswire) – PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a fresh milestone in manufacturing IndoVac, a Covid-19 vaccine brand it is rolling out since November 2021. 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.
|IndoVac Covid-19 vaccine in production at PT Bio Farma’s facilities near Bandung, Indonesia (Image: PT Bio Farma)|
Bio Farma has completed Phase 1 and Phase 2 clinical trials and happens to be in Phase 3, to create primary series vaccines, or two vaccine doses for everybody aged 18 years and older. “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 could be adapted to new strains of Covid-19. Results from Phase 1 and Phase 2 clinical trials show that IndoVac offers quality safety and efficacy, believe it or not competitive than other Covid-19 vaccines.”
“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 2022 to supply the required data, therefore the BPOM can release a crisis Use Authorization (EUA) permit for IndoVac’s vaccines in the near term. An EUA, released by way of a country’s regulatory agency, is really a permit for medical supplies (including vaccines) and medications 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, has said that the regulator expects release a the EUA for IndoVac’s primary series vaccines in mid-September 2022.
Bio Farma also offers processed the Halal (or Shariah compliant) certification for IndoVac’s primary series vaccines to supply 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 facet of something. The certificate from the Halal Certification Agency (BPJPH) beneath the Religious Affairs Ministry is likely to be released in the near term after BPOM releases the EUA for IndoVac.
After securing all of the necessary permits, Bio Farma is preparing to move on to another stage, mass producing IndoVac’s primary series vaccines. Bio Farma plans to create a short 20 million doses of primary series vaccines, before this is often further risen to 40 million doses in 2023, because the company expands its production facilities. In 2024, volume may further increase to 100 million doses each year, based on demand and the marketplace.
Booster Vaccine and Vaccine for Children
Simultaneously, Bio Farma also started clinical trials because of its booster vaccine on September 1, 2022. Next, Bio Farma plans to conduct clinical trials for children after it secures PPUK from BPOM. Bio Farma conducted the trials because of 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 check IndoVac’s booster vaccines.
BPOM requires vaccine manufacturers to conduct clinical trials to choose in case a vaccine is safe and may boost immunity against Covid-19, also to determine if the vaccine offers good efficacy to greatly help protect the subjects from heavy symptoms and risks of fatalities because of Covid-19 infection.
All Covid-19 vaccines created by Bio Farma, like the primary series, 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. For Bio Farma, it isn’t the very first time in clinical trials, having conducted a lot more than 30 clinical trials in Indonesia. Bio Farma also offers experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).
Honesti Basyir said IndoVac is special among the few made-in-Indonesia vaccine products. The vaccines (such as the principal series vaccines, the booster vaccines and vaccines for children) are developed and manufactured for the country’s children. Bio Farma handles the manufacturing process from upstream to downstream. The locally sourced content in the 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 with IndoVac vaccines. “We shall not merely produce them (the three forms of vaccines) to meet up domestic needs but additionally target the way to obtain global markets,” he said. “We registered for Emergency Use Listing (EUL) with the planet Health Organization (for primary series), which means this vaccine may be used far away through the Covax Facility (multilateral procurement). Through its Covid-19 vaccines, Bio Farma expects to donate to medical industry, not only in Indonesia, but additionally to the planet.”
Bio Farma’s Success in Polio Vaccine
Honesti said in addition to the Covid-19 primary series vaccines, Bio Farma previously secured the EUA from BPOM and the EUL from the WHO because of its novel Oral Polio Vaccine type 2 (nOPV2). The EUL is really a process of assessing and listing vaccines during public health emergencies in non-vaccine-producing countries. As Indonesia hasn’t had any polio outbreaks since 2014, it never used nOPV2. The Bio Farma-manufactured vaccine was utilized by countries in Africa, Europe and the center East.
On the list of countries 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 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 is just about the main supplier for the polio vaccine on earth. The business currently contributes 67 percent to the global way to obtain polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).
Aside from producing polio vaccines, Bio Farma’s Laboratories have already been internationally known as reference labs to check on examples of polioviruses. The planet was previously looking forward to two countries, Afghanistan and Pakistan, to combat polio diseases, before a ‘world-free polio’ could be declared. However, through the wait, polio outbreaks occurred in Africa and the center East, therefore the nOPV2 vaccine became a significant product to avoid further spread of the polio disease.
Bio Farma’s success in producing and exporting nOPV2 vaccine implies that the Indonesian state-owned company has contributed 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
Topic:Clinical Trial Results
Source: BUMN / PT Bio Farma (Persero)
Sectors:Daily News, BioTech, Healthcare & Pharm, Local Biz, MedTech, Clinical Trials
From the Asia Corporate News Network
Copyright 2022 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.