War against

COVID-19
Bio Farma’s Strategy on Vaccine

Dicky Mahardhika Taryono

Divisi Riset
 Biotechnology

State-owned Herbal

Pharmas
Chemical

Medical Device
Company in Brief

Established Relocated to Bandung State-owned Enterprise (100 %)

in Aug 6, 1890 in 1923 Sole Vaccine & Antisera
manufacturer in Indonesia

Ca. 1300 Employees

Implement Integrated System
60 % engaged in core Quality activities
(QA, QC, Production, R&D, animal lab, warehouse,GMP, GLP, GCP, ISO9001, ISO14001, OHSAS18001, WHO pre-qualified Vaccines
surveilance/CT, engineering) ISO 17025, ISO 27001
ERM, CSR Based ISO 26000
List of Products
WHO PQ Milestone

2014
Pentabio 5 ds 2015
Pentabio 10 ds
2010 2011
bOPV 20 ds
2006
1999 Measles 20 ds Td 10 ds bOPV 10 ds
2003 2009
TT 10 ds TT Uniject 1 ds
TT 20 ds 2004 mOPV Type 1 - 20ds
DT 10 ds 2001
Hep. B Uniject 1 ds
DTP 10 ds DTP-HB 5 ds
1997 DTP-HB 10 ds

tOPV 10 ds
tOPV 20 ds
Measles 10 ds

CONFIDENTIAL
4
 Bio Farma’s Contribution to the World
No Country No Country No Country No Country No Country No Country
1 Afghanistan 25 Cape Verde 49 Georgia 73 Liberia 97 Nigeria 121 South Korea
2 Albania 26 Cambodia 50 Germany 74 Libya 98 North Korea 122 South Sudan
3 Algeria 27 Cameroon 51 Ghana 75 Macau 99 Oman 123 Srilanka
4 Angola 28 Central Africa 52 Grenada 76 Madagascar 100 Pakistan 124 Sudan
5 Anguilla 29 Chad 53 Guam 77 Malawi 101 Palestine 125 Suriname
6 Antigua & Barbuda 30 China 54 Guatemala 78 Malaysia 102 Panama 126 Swaziland
7 Argentina 31 Colombia 55 Guinea 79 Maldives 103 Papua New Guinea 127 Syria
8 Australia 32 Comoros 56 Guinea Bissau 80 Mali 104 Paraguay 128 Tajikistan
9 Azerbaijan 33 Congo 57 Guyana 81 Mauritania 105 Peru 129 Tanzania
10 Bahamas 34 Cuba 58 Haiti 82 Mauritius 106 Qatar 130 Thailand
11 Bangladesh 35 Curacao 59 Honduras 83 Mexico 107 Philippines 131 Togo
12 Barbados 36 Djibouti 60 Hong kong 84 Micronesia 108 Rwanda 132 Trinidad
13 Belgium 37 Dominican Rep. 61 India 85 Mongolia 109 Saint Kitts & Nevis 133 Tunisia
14 Belize 38 East Timor (Timor Leste) 62 Iran 86 Montserrat 110 Saint Lucia 134 Turkey
15 Benin 39 Ecuador 63 Israel 87 Morocco 111 Saint Vincent and the Grenadines 135 Turkmenistan
16 Bhutan 40 Egypt 64 Ivory Coast 88 Mozambique 112 Sao Tome and Principe 136 Turks & Caicos
17 Bolivia 41 El Salvador 65 Jamaica 89 Myanmar 113 Saudi Arabia 137 Uganda
18 Bosnia and Herzegovina 42 Equatorial guinea 66 Kenya 90 Namibia 114 Senegal 138 Uruguay
19 Botswana 43 Eritrea 67 Kosovo 91 Nepal 115 Seychelles 139 Uzbekistan
20 Brazil 44 Ethiopia 68 Kuwait 92 Netherlands 116 Sierra Leone 140 Vietnam
21 British Virgin Island 45 Fiji 69 Kyrgyztan 93 Netherlands Antilles 117 Singapore 141 Yemen
22 Brunei Darussalam 46 France 70 Laos 94 New Zealand 118 Solomon Island 142 Zambia
23 Burkina Faso 47 Gabon 71 Lebanon 95 Nicaragua 119 Somalia 143 Zimbabwe
24 Burundi 48 Gambia 72 Lesotho 96 Niger 120 South Africa

Update: 25 March 2019 OIC Members (51) >140

 Bio Farma Products during Pandemic

.
.
. VTM : BioVTM
.
.
.
RT PCR Kit : mBioCov-19

Vaccine
.
.
.
• Penyakit dengan gejala pneumonia pertama kali ditemukan di Wuhan dan dilaporkan ke kantor WHO Tiongkok
pada 31 Desember 2019.
• WHO mendeklarasikan penyakit yang disebabkan oleh coronavirus tersebut sebagai Public Health Emergency of
International Concern pada 30 Januari 2020.
• Pada 11 Februari 2020, nama COVID-19 (Corona Virus Infection Disease 2019) dan virus SARS-CoV-2 (Severe
Acute Respiratory Syndrome Corona Virus-2) diumumkan oleh WHO sebagai nama resmi penyakit dan virus yang
menyebabkannya tersebut.
• Pada 11 Maret 2020, WHO menyatakan wabah COVID-19 sebagai pandemi global 7
Meanwhile in Indonesia....
KEPPRES RI No. 12 Tahun 2020
(13 April 2020)

11
 Tahap Pengembangan Vaksin
Identifikasi Penelitian Uji klinis Uji klinis Uji klinis Registrasi
Uji Preklinis Komersial
antigen vaksin Fase 1 Fase 2 Fase 3 ke BPOM

Tahap R & D

Tahap Uji klinis

Tahap Up-scaling

Lk 10 thn Lk. 4 thn Lk. 1 thn

 Strategi Pengembangan Vaksin Pandemi
Identifikasi Penelitian Uji klinis Uji klinis Uji klinis Registrasi
Uji Preklinis Komersial
antigen vaksin Fase 1 Fase 2 Fase 3 ke NRA

Tahap R & D Teknologi bioinformatics

:

Penggunaan darurat ?
Ijin NRA

Uji Klinis dilanjutkan

Lk 6 – 18 bln Lk. 6 – 8 bln
 Pendekatan Vaksin COVID-19

Source: Nature (2020)

Source: Nature (2020)

Source: Nature (2020)
Source: Nature (2020)
Source: Nature (2020)
Source: Nature (2020)
Tipe Kandidat Vaksin
SARS-CoV-2
Estimasi uji klinis fase 1: Juni
2020
Johnson & Johnson; Geovax Labs and BravoVax; University of Oxford and Advent Srl; Tonix
Pharmaceuticals and Southern Research; Altimmune; Greffex; Vaxart; CanSino Biologics; Zydus
Cadila; Institute Pasteur

Estimasi uji klinis fase 1: April 2020

Inovio Pharmaceuticals with Beijing Advaccine Biotechnology; Applied DNA Sciences, Takis Biotech and
Evvivax; Zydus Cadila

Estimasi uji klinis fase 1: April 2020

CureVac; Moderna and US National Institute of Allergy and Infectious Diseases; Stermirna Therapeutics, Tongji
University and Chinese Center for Disease Control and Prevention; Imperial College London

Codagenix with Serum Institute of India Estimasi uji klinis fase 1: Agustus 2020

Novavax; Clover Biopharmaceuticals with GSK; Baylor College of Medicine, University of Texas Medical Branch, Estimasi uji klinis fase 1: Juni
New York Blood Center and Fundan University, China; University of Saskatchewan, Canada; University of 2020 Goal
Queensland, Australia, and Dynavax; Vaxart; Generex; ExpreS2ion; Vaxil Bio; Sanofi Pasteur; iBio/CC-Pharming

Keterangan: à Highlight merah: didanai CEPI Sumber: https://www.pharmaceutical-journal.com/news-and-analysis/infographics/the-race-to-stop-covid-

Strategi Bio Farma dalam Penyiapan Vaksin COVID-19

Jangka • Kolaborasi
Pendek-
Menengah Internasional

Jangka • Konsorsium
Panjang Nasional
 Program Jangka Pendek - Kolaborasi Internasional
Penjajakan dengan Sinovac China

Mitra Internasional

Bulk vaksin lulus tahap uji

preklinis/uji klinis 1 sedang
berjalan

Formulasi/Filling Penggunaan darurat

?
oleh Bio Farma Ijin NRA
Uji Klinis dilanjutkan
 Clinical Trial

• On going
• FK UNPAD
• Open Recruitment
• 1620 subjects
• Start Early August 2020
Program Jangka Menengah - Kolaborasi Internasional

2. Coalition for Epidemic Preparedness Innovations

Misi : Menstimulasi, mendanai dan koordinasi pengembangan vaksin pandemi (Ebola, MERS,
SARS, AI, COVID-19, dll.) serta memberi akses vaksin tersebut kepada penduduk di daerah
outbreak

Pendanaan : Telah secure dana sebesar USD 760 juta menuju target pendanaan sebesar USD 1 M
melalui with multi-year funding dari Norway, UK, Germany, Japan, Canada, Australia,
BMGF, dan Wellcome trust
 ously described4,6–8. In total, we generated 56,565,928 sequence reads
that were de novo-assembled and screened for potential aetiological
agents. Of the 384,096 contigs assembled by Megahit9, the longest
(30,474 nucleotides (nt)) had a high abundance and was closely related
to a bat SARS-like coronavirus (CoV) isolate—bat SL-CoVZC45 (GenBank
accession number MG772933)—that had previously been sampled in
China, with a nucleotide identity of 89.1% (Supplementary Tables 1, 2).
viously identified coronaviruses, we estimated phylogenetic trees on
the basis of the nucleotide sequences of the whole-genome sequence,
the non-structural protein genes ORF1a and ORF1b, and the main struc-
tural proteins encoded by the S, E, M and N genes (Fig. 2 and Extended
Data Fig. 5). In all phylogenies, WHCV clustered with members of the
subgenus Sarbecovirus, including the SARS-CoV that was responsible
for the global SARS pandemic1,2 of 2002–2003, as well as a number

Program Jangka Panjang Kolaborasi Dalam Negeri

The genome sequence of this virus, as well as its termini, were deter-
mined and confirmed by reverse-transcription PCR (RT–PCR)10 and
5′/3′ rapid amplification of cDNA ends (RACE), respectively. This virus
strain was designated as WH-Human 1 coronavirus (WHCV) (and has
also been referred to as ‘2019-nCoV’) and its whole genome sequence
(29,903 nt) has been assigned GenBank accession number MN908947.
Remapping the RNA-sequencing data to the complete genome of WHCV
resulted in an assembly of 123,613 reads, providing 99.99% genome
of SARS-like coronaviruses that have been obtained from bats5,11–13.
However, WHCV changed topological position within the subgenus
Sarbecovirus depending on which gene was used, which suggests that
recombination has occurred in this group of viruses in the past (Fig. 2
and Extended Data Fig. 5). Specifically, in the S gene tree (Extended
Data Fig. 5), WHCV was most closely related to the bat coronavirus
Pengembangan vaksin Covid-19 berbasis
SL-CoVZC45 with 82.3% amino acid identity (and around 77.2% amino
acid identity to SARS-CoV; Supplementary Table 3) whereas in the

rekombinan Sub Unit

10
1a S 3b M 8 N
WHCV 29,903 bp
1b 3a
E 6 7b 9b

Konsorsium Vaksin Covid-19 Nasional

7a 9a

10
Bat SL-CoVZC45 1a S 3b M 8 N 29,802 bp
1b 3a
E 6 7b 9b
7a 9a

8a 8b

SARS-CoV Tor2 1a S 3b M N 29,751 bp

1b 3a
E 6 7b 9b
7a 9a

2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000 20,000 22,000 24,000 26,000 28,000
Position

Fig. 1 | Genome organization of SARS and SARS-like CoVs. The organization of genes for WHCV, bat SL-CoVZC45 and SARS-CoV Tor2.
Green … ACE2 human host receptor
266 | Nature | Vol 579 | 12 March 2020 Gray … CoV spike glycoprotein
trimer
Gray balls … Spike glycoprotein
variation occurring once
Blue balls … Spike glycoprotein
variation occurring more than once
Red balls … Spike glycoprotein variation
near host receptor
 Road Map Konsorsium Nasional Vaksin COVID-19
Seed
Identifikasi Pembuatan Penelitian Vaccine/
antigen seed virus Vaksin
Proto tipe

Lead : Lembaga Eijkman

Mitra : Bio Farma, BaLitbangkes, LIPI, Balitvet, Perg Tinggi

Maret
Feb
2020
2021

Serah terima
dengan
Bio Farma

Uji Uji klinis Uji klinis Uji klinis

Upscaling Registrasi Komersial
Preklinis fase 1 fase 2 fase 3

Q1 Q2 Q3-4
2021 2021 2021
Penggunaan
darurat ?
Ijin BPOM
So...
 Terima kasih

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