Indonesian Pharmaceutical PT Bio Farma Ready to Mass Produce IndoVac Covid-19 Vaccines
(NewMediaWire) – September 10, 2022 – (ACN Newswire) – 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, President Director of PT BioFarma, 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.
Bio Farma has completed Phase 1 and Phase 2 clinical
trials and is currently in the Phase 3 stage, in producing primary series
vaccines, or the two vaccine doses for everyone aged 18 years and older.
“IndoVac uses vaccine technology platforms which are compatible with the
equipment and facilities in our factories. The technology platforms for protein
recombinant vaccines also offer other benefits: they adapt to new strains of
Covid-19. The results from Phase 1 and Phase 2 show that IndoVac offers safety
and efficacy, no less so than other Covid-19 vaccines.
“We are now documenting the study for
completion of Phase 3.” Honesti said Bio Farma has had intense
communication with the Indonesian Food and Drug Administration (BPOM) since
July to provide the necessary data, so BPOM can release the Emergency Use
Authorization (EUA) for the IndoVac’s vaccines in the shortest term. An EUA,
released by a country’s regulatory agency, is a permit to produce medical
supplies (including vaccines) and medications during a public health emergency.
In Indonesia, BPOM plays the key role as the
regulatory gatekeeper of medicines and vaccines used in the country. BPOM’s
head, Penny K. Lukito, said during a hearing at the Indonesian House of
Representatives that the regulator expects to release an EUA for IndoVac’s
primary series vaccines by mid-September 2022.
Shariah Compliant
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 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) of the Religious Affairs Ministry is expected soon
after BPOM releases the EUA for IndoVac.
After securing all the necessary permits, Bio Farma is
ready to move on to the mass production stage with IndoVac’s primary series
vaccines. Bio Farma plans to produce 20 million doses of the primary series
vaccine in year one, before this is increased to 40 million doses in 2023, as
the company expands its production facilities. In 2024, volume per year may
further increase to 100 million doses, depending on the demand and market need.
Booster Vaccine and Vaccine for
Children
At the same time, Bio Farma also started clinical
trials for its booster vaccine on Sept 1, at Hasan Sadikin General Hospital, Bandung (Faculty of Medicine
of Padjajaran Univ.) and Dr. I.G.N.G Ngoerah General Hospital in Bali
(Children’s Health Sciences, Udayana Univ .). Trials involved 900 subjects aged
8 and above to test IndoVac’s booster vaccines. Bio Farma plans to conduct
clinical trials for children next, after it secures the PPUK from BPOM.
All Covid-19 vaccines made by Bio Farma, including
primary series, booster vaccines and vaccines for children, will be labelled
IndoVac. Bio Farma began the process of registering IndoVac as the brand name
for the vaccines with 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 the name. 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’s not the first time in clinical
trials. The company has conducted more than 30 clinical trials across
Indonesia, including the Phase 3 clinical trials for the Covid-19 vaccine. Bio
Farma also has experience conducting clinical trials overseas, for Pentabio and
Novel Oral Polio Vaccine type 2 (nOPV2).
Made-in-Indonesia Vaccines
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 the nation’s children. Bio Farma handles the complete
manufacturing process from upstream to downstream.
The locally sourced content in the 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 hope to reduce the nation’s dependency on imported vaccines,”
Honesti said.
Bio Farma hopes to capture the export market with
IndoVac vaccines. “We will not only produce them (in 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 our Covid-19 vaccines, Bio Farma expects to contribute to the health
industry, not just in Indonesia, but in the world.
Bio Farma’s Success with Polio
Vaccine
Honesti said apart from the Covid-19 primary series
vaccines, Bio Farma previously secured the EUA from BPOM and the EUL from the
WHO for its novel Oral Polio Vaccine type 2 (nOPV2). The EUL is a procedure for
assessing and listing vaccines during public health emergencies in
non-vaccine-producing countries. However, 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 the polio 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 research institutions like Bill and Melinda Gates
Foundation (BMGF), PATH and the WHO, and has since become the main supplier of the vaccine in the world, currently contributing 67 per cent to
the global supply. It distributes the vaccines via bilateral
and multilateral means (through UNICEF).
Bio Farma’s
Laboratories have been internationally acknowledged as reference labs to check
samples of polioviruses. The world was
previously waiting for two countries, Afghanistan and Pakistan, to combat polio
diseases, for a ‘polio-free world’ to be declared. However, polio outbreaks occurred in Africa and the Middle East, so the nOPV2
vaccine became important in preventing spread of the disease. Bio Farma’s success in producing and exporting nOPV2
vaccine shows the Indonesian state-owned company contributing to the
world’s health sector, apart from providing the vaccine for
domestic use at home in Indonesia.
Media Contact:
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
Tel: +62-81-2542-8844
Email: rifaherdian@biofarma.co.id
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