Mengenal Vaksin Covid-19: Pengembangan dan Proses Produksi

(1)

Mengenal Vaksin Covid-19:

Pengembangan dan Proses Produksi

Neni Nurainy

1,2,3

1

_{Research and Development Division PT Bio Farma}

2

_{Akademi Ilmuwan Muda Indonesia (ALMI)}

3

_{Formind (IYSF), Formind Institute}

Bibir Covid Serial XX, 28 Januari 2021

Indonesia Healthcare Forum (Indo HCF) dan KREKI dan IKKESINDO

Unjani

(2)

Manfaat Vaksin

Eradikasi

Eliminasi

Global

Kelom

pok

Individual

MENIMBULKAN

KEKEBALAN

(3)

Jenis-jenis vaksin

Live attenuated vaccines

(LAV)

Killed (inactivated) antigen

vaccines

Toxoid vaccines

Vaksin rekombinan

New

Technology

Dilemahkan (attenuated) dari

virus/bakteri

Eg. Measles, mumps, rubella

(MMR) and varicella

(chickenpox), BCG

Dimatikan dengan reaksi kimia atau

pemanasan Eg. Vaksin Whole-cell

pertussis, Inactivated polio virus, flu

Toksin yang berbahaya

diinaktifasi menjadi toxoid

Eg. Vaksin Difteri/Tetanus

Rekayasa genetik,target

protein diproduksi di

E.coli/yeast

Eg. Hep B, HPV

Vaksin

Peptide,

mRNA, DNA,

viral vector

(4)

Kesiapsiagaan Terhadap Wabah Di Masa Datang

The Coalition for Epidemic Preparedness Innovation

List of R n D Blueprint priority diseases

Preparing diseases for epidemic preparedness:

• Crimean-Congo Hemorrhagic Fever

• Ebola Viral Disease &

Marburg Viral Disease

• Lassa Fever

• MERS and SARS

• Nipah and henipaviral

• Rift Valley Fever

• Zika disease

• Disease X

Disease X represents

the potential that unknown pathogen may be

cause serious epidemics in the future

COVID 19

(5)

Tantangan Pengembangan Vaksin

untuk Outbreak dan Pandemik

Kecepatan:

Pendekatan berbeda untuk

mempersingkat waktu:

Teknologi platform yang cepat

Relaksasi Regulasi (skema

khusus:EUA)

Biaya:

Biaya cukup tinggi

Tidak ada garansi dipakai rutin

- Consortium/ Global Fund

Skalabilitas dan Akses

Produksi jumlah yang besar

dalam waktu singkat

kapasitas global tidak cukup

dalam situasi pandemik

Global

partnership/collaboration

Tantangan Pengembangan Vaksin

untuk Outbreak dan Pandemik

(6)

Kecepatan: Teknologi yang cepat (rapid response)

https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines, diakses 16 Desember 2020

56 CT; 11 pada CT III, 166 in Preclinical

10 CANIDATE VACCINES IN PHASE III CLINICAL

EVALUATION,

VACCINE PLATFORM

LOCATION OF PHASE III STUDIES

Sinovac Inactivated

virus Brazil/Indonesia

Wuhan Institute of Biological Products / Sinopharm

Inactivated

virus United Arab Emirates

Beijing Institute of Biological Products / Sinopharm

Inactivated

virus China

University of Oxford /

AstraZeneca Viral vector * US CanSino Biological Inc. /

Beijing Institute of Biotechnology

Viral vector * Pakistan

Gamaleya Research Institute Viral vector Russia

Janssen Pharmaceutical

Companies Viral vector

USA, Brazil, Colombia,

Peru, Mexico, Philippines, South Africa

Novavax Protein subunit The United Kingdom

Moderna / NIAID RNA USA

BioNTech / Fosun Pharma /

Pfizer RNA USA, Argentina, Brazil

30% 16% 13% 13% 13% 5% 4% 4% 2% 2% 0% 5% 10% 15% 20% 25% 30% 35% PS VVNR DNA IV RNA VVR VLP VVR + APC LAV VVNR + APC Platform PS Protein subunit

VVnr Viral Vector (non-replicating)

DNA DNA

IV Inactivated Virus

RNA RNA

VVr Viral Vector (replicating)

VLP Virus Like Particle

VVr + APC VVr + Antigen Presenting Cell

LAV Live Attenutaed Virus

(7)

(8)

Platform Technology pengembangan vaksin Covid19

(9)

Platform vaksin Kelebihan Kekurangan

Attenuated/kuman yang dilemahkan (i.e BCG, OPV, campak)

• Sangat imunogenik

• antigen lengkap karena kuman utuh, tidak perlu adjuvant • Non-infeksius

• Pengembangan seed lama:

• Risiko infeksi/kembali virulen dan efek samping lain • Tidak cocok saat pandemi terjadi

Inactivated/kuman yang dimatikan (i.e IPV, wP)

• Imunogenik

• Antigen lengkap karena kuman utuh, tidak perlu adjuvant • Pengembangan seed vaksin cepat

• Kuman infeksius

• Untuk produksi memerlukan fasilitas dengan biosafety level tinggi seperti BSL3/ BSL4 untuk pandemik

Subunit/protein

rekombinan (ie Hepatitis B)

• Non-infeksius, sel yang digunakan E.coli/ragi

• Risiko efek samping lebih rendah karena seleksi antigen • Waktu pengembangan seed vaksin relative cepat

• Seed dibuat berdasarkan informasi genetik

• Antigen sendiri kurang imunogenik sehingga memerlukan penambahan adjuvant

• Jika lebih dari satu antigen digunakan, diperlukan formulasi multivalent yang lebih komplek

DNA • Non-infeksius

• Pengembangan seed sangat cepat

• Multivalen antigen dapat dilakukan lebih simpel

• Imunogenicity rendah

• Ada risiko integrasi ke genetik penerima

• Belum ada vaksin komersial, belum terbukti khasiat dan keamanannya di manusia

RNA • Non-infeksius

• Degradabel dan tidak ada risiko integrasi genetik • Pengembangan seed sangat cepat

• Multivalen antigen dapat dilakukan lebih simpel

• Aktivitas RNAse dapat menimbulkan kestabilan vaksin • Belum ada vaksin komersial, belum terbukti khasiat dan

keamanannya di manusia Viral vector • Non-infeksius

• Respon yang ditimbulkan humoral dan seluler • Waktu pengembangan seed cepat

• Seed dibuat berdasarkan informasi genetik

• Potensi efek samping dari vektor

• Respon imun sebelumnya terhadap vector dari paparan alami dapat melemahkan khasiat vaksin sendiri

• Belum ada vaksin komersial, belum terbukti khasiat dan keamanannya di manusia

Perbandingan Platform Teknologi Vaksin

(10)

(11)

(12)

Pengembangan Pipeline Vaksin

Tahap riset Desain kandidat vaksin

Karakterisasi

vaksin Uji Preklinis Produksi skala _pilot Pengembangan _klinis Persetujuan _Regulator _KomersialProduksi

▪ Understand the disease ▪ Epid. Data ▪ Identify antigen ▪ Seed history ▪ Presentation ▪ Route of administr, ▪ Bulk manuf. ▪ Formulation ▪ Identity ▪ Purity ▪ Standards ▪ Stability ▪ Safety ▪ Toxicology ▪ Teratology ▪ Etc. ▪ Clinical lots ▪ cGMP ▪ QC ▪ QS ▪ GCP ▪ Phase I ▪ Phase II ▪ Phase III ▪ Documents/ Data (CTD) ▪ Regulatory compliance ▪ cGMP ▪ QC ▪ QMS Pharmacovigillance Industrial Investment 6-15 tahun

IND

(13)

Melanie Savile, WHO Briefing Session for Developers on R n D for Covid-19 vaccine, 26 Mei 2020

Only a fundamental paradigm shift provides potential of rapid vaccine

development with appropriate safety standards

Major

shifts

Speed: Accel er at e an d advan ce

devel opm en t st ages i n par al l el w i t h con t i n uous r i sk - ben ef i t

m on i t or i n g; qui ck l y r ai se an d depl oy f un ds

Access: Geogr aph i c spr ead of

m an uf act ur i n g an d devel opm en t si t es an d pur sui t of em er gen cy aut h or i zat i on bef or e l i cen sur e

Scale: Adapt i ve ver sus r i gi d

devel opm en t pr ocess an d ear l i er l aun ch of scal e- up

Traditional

paradigm

6 - 11.5 year s Licensure 12- 36 m on t h s

T arget I D, developm ent partner selection, and preclinical

6 - 24 m on t h s Phase I 12 m on t h s Phase I I a 12 m on t h s Phase I I b 12- 18 m on t h s Phase I I I 18- 36 m on t h s

T arget I D, developm ent partner selection, and preclinical

4 - 8 m on t h s

Scale from n=10s to n=100s

Em ergency authori zati on Go/ no- go deci si on to

i nvest in candi dates

Outbreak

paradigm

12 - 18 months

Clinical developm ent Early stage 3 - 4 months Late stage 6 - 8 months Fi rst i n human

SPEED:

Mengapa cepat:

1. Sudah ada pengalaman vaksin Corona

sebelumnya ( Sars-1, Mers)

2. Teknologi platform vaccine

3. Paralel proses (terutama dalam Uji

klinis) dan global effort

(14)

(15)

Vaccine Characteristic

Preferred

Critical/Minimal

Indication of use

Risk Person in outbreak area

Outbreak: risk persons used in conjuction with

other control measure,

Contraindication

None

some contraindication (e.g. Immunocompromised)

Target population

All age, suitable for pregnant and lactating

women

Maybe Adult, elderly

Safety/

reactogenicity

Sufficient to provide benefit, with only mild,

transient adverse events, no serious AES

Outbreak: Safety and reactogenicity whereby

vaccine benefits outweigh safety risks .

Measure Efficacy

At least 70% efficacy

Endpoint assessed: disease, severity,

shedding/transmission

Efficacy with ~50% point estimate.

Endpoint assessed: disease, severity, shedding/

transmission

Dose regiment

Rapid onset < 2 weeks

Outbreak:Single-dose primary series .

Outbreak: no more than 2 regiments

Booster: does permitted

Durability protection

At least one year

At least 6 months

Route of administration

Outbreak: non parenteral

Any route as long as safe

Product stability

High storage Temperatur/higher

termostability

Outbreak: Shelf life of at least 12 months as low as

-60—70°C8. 2 weeks at 2-8 C

Co-administration

Outbreak Stand alone

Stand alone

Presentation

Multi dose

Multi/mono dose

Registration and PQ

Outbreak: WHO PQ

Outbreak: Meets criteria for WHO prequalification

and/or EUAL

Accessibility

Rapid scale up

Target

Product

Profile

WHO,

2020

(16)

ACCESS

Terms of Service Privacy Policy

Careers Contact Us

!

Are We Any Closer To A COV ID-19

Vaccine?

Athira Nortajuddin 1 June 2020

A l ab oratory tech n i c i an hol d s a t ray w i t h d oses of a C OV I D-19 vacci n e can d i d ateA l ab orat ory techn i ci an h ol d s a t ray w i t h d oses of a C OV I D-19 vacci n e can d i d ate ready for t r i al on m on keys at t h e Nat i on al Pri m ate Research C en ter of T hai l an d atready for t r i al on m on keys at t he Nat i on al Pr i m ate Research C en ter of T h ai l an d at C hul al on g korn U n i versi t y. (A FP Photo)C hul al on g k orn U n i versi t y. ( A FP Photo)

The novel coronavirus crisis has introduced us a to a different world – one with a new normal. Temperature checks, social distancing, masks, work-from-home and distance learning are some of the new norms that all of us need to embrace and adapt to. Governments have imposed strict measures in order to break the chain of infections, this includes travel restrictions and citywide lockdowns. The COVID-19 virus is not only a health threat, but has also decimated livelihoods, local

businesses and the economy in general.

It is believed that until an effective vaccine is found, the new normal is

likely to stay indeﬁnitely. This can be seen from the recent

announcement made by the President of the Philippines, Rodrigo Duterte who said that he will not allow face to face classes in schools until a COVID-19 vaccine is made available.

To date, over 6.2 million people have been infected with the COVID-19 virus and total deaths recorded have already passed the 370,000 mark.

Scientists and pharmaceutical giants around the world – from ASEAN

member state, Thailand to European countries – are currently working

at breakneck speed to develop a vaccine for the disease since it ﬁrst emerged in Wuhan, China.

According to the Global Alliance for Vaccines and Immunisation (GAVI), as of 11 May, there are more than 102 candidate vaccines that

researchers are working on, of which at least nine are now being tested in clinical trials on humans.

Source: GAVI, the Vaccine Alliance

So, what are some of the latest developments in the race to ﬁnd a COVID-19 vaccine?

“When candidate vaccines make it to human clinical trials, they ﬁrst go

through Phase 1 trials primarily to test the vaccine’s safety, determine

dosages and identify any potential side effects in a small number of people. Phase 2 trials further explore safety and start to investigate efficacy on larger groups. The final stage, Phase 3 trials, which few vaccines ever make it to, are much larger, involving thousands or tens of thousands of people, to confirm and assess the effectiveness of the vaccine and test whether there are any rare side effects that only show

up in large groups,” stated GAVI.

Some candidate vaccines that are in Phase 2 include the Beijing Institute of Biological Products and Wuhan Institute of Biological

Products, which both belong to China’s state-run Sinopharm Group.

Others include BioNtech’s MRNA Vaccine in Germany and the University of Oxford’s Viral Vector Vaccine in the United Kingdom (UK).

There is good news from the Beijing Institute of Biological Products, as it was recently reported that the vaccine jointly developed by the

organisation and China National Biotec Group Co. has completed Phase 2 testing and may be ready for the market at the end of 2020 or early next year, according to a report published in the ofﬁcial WeChat account of the state-owned Assets Supervision and Administration Commission. Nevertheless, Phase 3 would not be endured without challenges. Media reports have stated that the ﬁnal stage of testing needs to be done in a

place where the virus is still spreading rapidly, and China’s cases seem

to have been plummeting every day. Other than that, a viable vaccine needs “massive production capabilities in order to meet global

distribution demands.”

Although many are hoping for a vaccine or a cure to be deployed very soon, "unfortunately, we really do not know which vaccine will work and whether there will be one at all. If we're lucky, we'll receive indications in autumn as to (a potential vaccine's) effectiveness," GAVI head Seth Berkley told a Swiss newspaper.

There are other concerns regarding the search for a vaccine; domestic interests and that a vaccine would ﬁrst go to high-income countries. Based on a statement by GAVI, when a COVID-19 vaccine is ready, scaling-up manufacturing capacity to produce enough for the world will be a difﬁcult task. Even with the current investment into greater

manufacturing capacity, it is not enough to vaccinate everyone straightaway.

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“So, when vaccines do become available, it will most likely be those at greatest risk of the coronavirus – health workers, older people and those with underlying conditions, such as diabetes – that will be prioritised ﬁrst.”

Dr Koh Mia Tuang, a consultant paediatrician with a subspecialty in

paediatric infectious diseases at the University of Malaya’s Medical

Centre in Malaysia recently wrote an article in the local media

discussing the affordability of a COVID-19 vaccine when it is eventually made available.

“There is no guarantee that less developed countries will be able to

afford and have access to the vaccine,” explained Dr Koh.

“Even now, certain more powerful and rich nations have an

understanding with potential vaccine manufacturers to have exclusive rights to the ﬁrst vaccines, which will likely culminate in an artiﬁcial

global vaccine shortage,” he added.

At the moment, drugs such as antivirals lopinavir/ ritonavir (for HIV treatment) and remdesivir (originally developed for Ebola) have been rebranded as temporary treatments for COVID-19 patients with severe conditions.

Until a viable, safe and effective vaccine is found, it is important to adhere to guidelines and safety measures provided by health authorities. In reference to the popular proverb ‘prevention is better than cure’, and as advised by many medical specialists such as Dr Koh Mia Tuang himself: stay healthy, practice social distancing and diligent

handwashing, wear face masks when possible and avoid crowded areas as preventive measures against the COVID-19 coronavirus.

Rel ated A rti cl es:Rel ated A rti cl es:

Global Virus Vaccine Race Heats Up Thailand Enters Global Race For Vaccine

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COVAX FACILITY→ EQUAL ACCESS minimum 20% national

need, facilitate by GAVI

(17)

Pemilihan Vaksin COVID-19

Prinsip dan Rencana Skenario Supply Vaksin COVID-19

1. Keamanan (tidak ada efek samping berat)

2. Efikasi (ideal : 70% ; minimal 50%)

3. Lama perlindungan panjang (setidaknya

1 tahun, minimal 6 bulan)

4. Stabilitas penyimpanan ( suhu 2 - 8⁰C)

5. Kemasan : Multi dose (optimalisasi

kapasitas rantai dingin vaksin)

6. Platform yang sama untuk memudahkan

evaluasi

7. Ada otorisasi penggunaan oleh BPOM

https://www.who.int/publications/m/item/who-target-product-profiles-for-covid-19-vaccines

Tingkatan

Kelompok Target

Setting Epidemiologi : Transmisi di Masyarakat

Tingkat I

(ketersediaan vaksin

sangat terbatas 1- 10%

populasi nasional

Tenaga Kesehatan di Fasyankes

dan kelompok usia berisiko

Tingkat II

Ketersedian vaksin

terbatas untuk 11 –

20% populasi nasional

Tenaga kesehatan, usia

berisiko kelompok komorbid

(terkontrol), sociodemografi :

tokoh masyarakat/agama, BPJS

PBI, kader kesehatan, dll

Tingkat III

Ketersediaan vaksin

21 – 50% populasi

nasional

Seluruh kelompok pada tingkat

1 dan 2, guru, petugas

transportasi, pekerja esensial

(pedagang pasar, dll) serta

kelompok berisiko lainnya

(18)

Didirikan

6 Agustus 1890 di Jakarta

Pindah ke Bandung

Tahun 1923

Integrated quality system

GMP, GLP, GCP, ISO9001, ISO14001, OHSAS18001, ISO 17025, ISO 27001

ERM, CSR Based ISO 26000

BUMN (100 % milik negara)

Industri Life science (vaksin dan sera)

1300 karyawan

WHO pre-qualified Vacccines ( DTP,

DT, TT, DTP-HB, m/b/tOPV, Measles

and TT, HB in Uniject, Td, Pentabio)

Knowledge-based, R&D-based driven company

Sekilas Bio Farma

Bio Farma’s Products

sudah digunakan

dan diekspor ke

150 negara

(19)

Proses Produksi Vaksin: Aman, Efikasi dan Kualitas

Seleksi Bibit Terbaik

1 Kultivasi 2 Inaktivasi 4 Panen 3 Purifikasi 5 Formulasi 6

Pengisian, pelabelan dan pengepakan

7 BULK – Intermadiate

(20)

Produksi Vaksin

Produksi

antigen

Purifikasi

_Formulasi

Filling/

packaging

Uji

Produk

Final

Seed

(21)

DISTRIBUSI VAKSIN

Rantai Dingin tervalidasi

Monitoring suhu

(22)

Quality System

Product

Develop.

Product

Scale Up

Routine

manuf.

Distribu-tion

Consumer

Use

Product Licensure

•Vendor qualification

•Qualification

•Validation

•Calibration

•Production Process

•QC testing

•Documentation

•Lot Release

•Deviation

•Internal audit

•Training

•Change Control

•Trend Analysis

• Quality Enginering

Customer complain

•Shipping

validation

•Records

•Cold chain

monitor

•Recalls

Dossier

(23)

Strategi Penyediaan Vaksin COVID-19

Jangka

Pendek

Jangka

Menengah/

Panjang

16

➢ Tech transfer proses hilir

(formulasi/filling)

menggunakan bahan

aktif vaksin covid-19

calon mitra

➢ “Capacity building”

➢ Pengembangan vaksin

dari proses hulu

#HoldingBUMNFarmasi

✓

Sinovac, China

✓

Coalition for Epidemic

Preparedness Innovations

(CEPI)

KONSORSIUM VAKSIN COVID-19 NASIONAL

(24)

Skema kolaborasi Vaksin Covid-19

Uji Klinis Fase lll

Registrasi BPOM

Produksi Rutin

Vaksin Jadi

dari Sinovac

Pengiriman Bulk

vaksin Sinovac / Tech

Transfer

Vaksin

Jadi BF

Pengiriman

vaksin Sinovac

Pengajuan EUA

ke BPOM

Produksi Rutin

oleh Bio Farma

EUA dari

interim analis

11 Januari

2021

Uji Kinis fase 3 : Aug 20 – Mei 2021 (Monitoring sd Maret 2021)

Tech Transfer : Sep 20 – Jan 21

(25)

- 18- 59 tahun

- RCT

- 1620 relawan: kelompok vaksin dan placebo

- Pemberian dua kali, selang 14 hari

- Efikasi: insiden Covid 19 pada kelompok

vaksin/placebo

- Titer antibodi anti-Spike: 14 hr dan 6 bulan setelah

injeksi ke dua

- Netralisasi virus

- Pemantauan efek samping (reaksi lokal/sistemik)

Uji Klinis Fase 3:

• Dilakukan di tempat dengan kasus

Covid-19 dengan transmisi tinggi

• Dilakukan di berbagai multietnik untuk

mendapat gambaran keamanan,

respon imun dan efikasi dengan

beragam populasi

• Participant ribuan orang untuk cukup

memberikan data terhadap

kemungkinan adanya rare adverse

event

• Multicentre, untuk Sinovac: Indonesia,

Bangladesh, Turki, Chile, dan Brazil

(26)

Uji Preklinis Vaksin Sinovac

First release: 6 May 2020 www.sciencemag.org (Page numbers not final at time of first release) 8

o n J u n e 8 , 2 0 2 0 h ttp :// s c ie n c e .s c ie n c e m a g .o rg / D o w n lo a d e d fr o m

Imunogenisitas dan efikasi protektif baik

Antibodi netralisasi terhadap 11 strain virus baik

First release: 6 May 2020 www.sciencemag.org (Page numbers not final at time of first release) 9 α γ o n J u n e 8 , 2 0 2 0 h ttp :// s c ie n c e .s c ie n c e m a g .o rg / D o w n lo a d e d fr o m

Protfil keamanan dari sisi imunologi(quantitative)

(27)

Uji Kiinis Fase 1 dan 2 Vaksin Sinovac

13

Figure legends

Figure 1. Incidence rates of adverse reactions among different groups in phase 2.

(A) The incidence rates of adverse reactions among different groups with a Day 0,14 schedule. (B) The incidence rates of adverse reactions among different groups with a Day 0,28 schedule.

IMMUNOGENICITY

At baseline, all the 600 subjects were seronegative (with Nab titers of <1:8); but the seroconversion rates increased over 90% during the later stages of the trial. Within

.

CC-BY-NC-ND 4.0 International license

It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

(which was not certified by peer review)

The copyright holder for this preprint this version posted August 10, 2020.

.

https://doi.org/10.1101/2020.07.31.20161216

doi: medRxiv preprint

Zang et.al., Lancet, 2020

Keamanan: Tidak berbeda signifikan (TS)

dengan placebo, AE: Sakit di tempat suntikan

Baik untuk skedul 0,14 and 0,28 hari schedule

15

Figure legends

Figure 2. Antibody Response in the Per-Protocol Cohort.

.

CC-BY-NC-ND 4.0 International license

It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

(which was not certified by peer review)doi: https://doi.org/10.1101/2020.07.31.20161216.this version posted August 10, 2020. The copyright holder for this preprint

medRxiv preprint

Antibody titer, GMT (4x dari baseline) 90%

• Vaksin ditorelasi

dengan baik (aman)

• Adverse Event TS

placebo vs vaksin

• Jumlah serokonversi

(4x titer GMT)

> 90% (Vaksin)

• TS antara skedul

0,14 dan 0,28 hari

• Tes Netralisasi virus

> 90% (vaksin)

• Imunogenik pada

dewasa sehat (18-59

th)

• 120 orang ~ 3 ug • 120 orang ~ 6 ug • Placebo ~ 60 orang

(28)

Identifikasi antigen Pembuatan seed virus Penelitian Vaksin Seed Vaccine/ Proto tipe

Lead : Lembaga Eijkman

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

Serah terima dengan Bio Farma

Upscaling _PreklinisUji Uji klinis fase 1

Uji klinis fase 2

Uji klinis

fase 3 Registrasi Komersial Maret 2020 Feb 2021 Q1 2021 Q2 2021 Q3-4 2021 Penggunaan darurat ? Ijin BPOM Q1 –Q2 2022 Q3 –Q4 2022

Program Jangka Panjang Kolaborasi Dalam Negeri (Triple Helix)

Pengembangan vaksin Covid-19 merah putih

rekombinan Sub Unit berbasis protein S dan N

(29)

Sistem Jaminan Halal (

Halal Assurance System)

1. Kebijakan Halal

2. Tim Managemen Halal

3. Pelatihan dan edukasi

4. Bahan

5. Produk

6. Fasilitas Produksi

7. Prosedur Tertulis Untuk

aktivitas kritis

8. Mampu Telusur

9. Pengangan Produk yang

tidak memenuhi kriteria

10. Audit Internal

11. Kaji Ulang Management

Produk dalam proses

konsultasi:

1. Flubio

2. DT

3. Td

4. TT

5. Pentabio

6. Typhoid

7. Covid-19 (daftar ke

CEROL LPOM MUI)

BCG dan pelarut

(30)

Vaksin Sinovac: Halal (MUI) dan

mendapat EUA (Badan POM)

(31)

(32)

Perbandingan efikasi dan imunogenisitas

AZ, Moderna, Pfizer, Novavax, Sinovac

Developer

Hasil Efikasi dari

CT 3

Data imunogenisitas - antibodi dari CT1/2

Referensi

AstraZeneca –

Oxford:

AZD1222

70%

>99% subjek memiliki antibodi netralisasi

(menetralisir virus).

CT3: Voysey et al. 2020. The Lancet

CT1/2: Folegatti et al. 2020. The Lancet

Moderna:

mRNA-1273

94,1%

100% antibodi netralisasi.

CT3: Baden et al. 2020. NEJM

CT1: Jackson et al. 2020. NEJM

Pfizer:

BNT162b2

95%

100% antibodi netralisasi.

CT3: Polack et al. 2020. NEJM

CT1: Walsh et al. 2020. NEJM

Novavax:

NVX-CoV2373

Belum ada

100% antibodi netralisasi.

CT1/2: Keech et al. 2020. NEJM

Sinovac

91,2% Turki,

78% Brazil

65,3% Indonesia

97% antibodi netralisasi (dosis 3ug), 100%

(dosis 6ug).

Pada data Indonesia: 99.74% seropositive(14

hari) dan 99.23% (setelah 3 bulan)

CT3:

• https://asia.nikkei.com/Spotlight/Coronavirus/Sinovac-s-COVID-19-vaccine-has-91-efficacy-Turkey-says

• https://www.scmp.com/news/china/science/article/311515 5/covid-19-fifth-chinese-vaccine-reach-final-trials-produces

CT1/2. Zhang et al. 2020. The Lancet

Note: data imunogenisitas belum dilaporkan dari hasil interim report uji klinis fase 3 dari semua developer, data profil antibodi diperoleh dari data CT fase 1/2