Sushant Sahastrabuddhe International Vaccine Institute

1. Leveraging Private Public Partnerships in
COVID-19 Pandemic Response
Dr. Sushant Sahastrabuddhe
On behalf of Dr. Anh Wartel
15th Sep 2022

2. Presentation Content
 Introduction
 Roles of DCVMN
 Impact of COVID-19 on Clinical Development, Clinical Trials, and Manufacturing
 Leveraging PPP in COVID-19 Pandemic Response at IVI
 Conclusion
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3. 2
Introduction

4. Global Vaccine Market and Trends.…Before COVID-19 Pandemic
 Significant breakthroughs in bioprocess and analytical
technologies for supporting vaccine development in 2000s
 Bioprocess industry remains challenging and complex
 Global vaccine market is growing rapidly, attracting interest and
new players
 From 2000 to 2013, the vaccine market grew from 4 billion US
dollars to 24 billion USD
 By 2028, the value of the vaccine market is estimated to be
around 100 billion USD
 And more than 120 new products are in development, 60 of
which are of special importance for developing countries
 Vaccine development is costly and lengthy in terms of processes
D’Amore & Yang (2019). Advances and Challenges in Vaccine Development and Manufacture. Available at: https://bioprocessintl.com/manufacturing/vaccines/advances-
and-challenges-in-vaccine-development-and-manufacture/ (accessed in Sep 2022)
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5. Vaccine Product Profile
 High Product
Sensitivity
• Biological products
• Significant risks of
production failures
• Quality is the OVER-
RIDING criterion
• Highly regulated
production
environment
• Dependency on well
functioning NRA
• Requiring constant
temperature control ⇔
Cold Chain from
Manufacturer to End
user
• Limited shelf life
 Limited Supply
• 1- 5 suppliers per
product
• High entry cost to
manufacturers
• Diverse dynamics in
individual vaccine
markets
• New vaccines often
result in monopoly
supply
 Vaccine
Production and
Market
competition
• Production of a
dose: 6 -24 Months
• Capacity Increase:
2-3 years
• New Plant: 5-7
years
• New regulatory
requirements can
cause interruptions
• New vaccines being
introduced globally,
global competition
• Initial selection has
long term impact
Requiring a specific approach to be developed for vaccine procurement
D’Amore & Yang (2019). Advances and Challenges in Vaccine Development and Manufacture. Available at: https://bioprocessintl.com/manufacturing/vaccines/advances-and-challenges-in-vaccine-development-and-
manufacture/ (accessed in Sep 2022); WHO Website (2020). Accessed in Sep 2022
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6. Market Growth Prediction from 2007 to 2023
Growth Factors:
• Importance of communicable
diseases and new threats
• New vaccines, new
presentations, and indications
• Cost effectiveness of
immunizations
• New funding opportunities
(Gov, PPP, donors, Foundations..)
• New research techniques and
manufacturing technologies
• Increasing demand, new target
population, larger emerging
markets
• Higher prices, improved
profitability for the industry
• "Blockbuster" sales for some
innovative vaccines
WHO Website (2020)
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7. Emerging Manufacturers are playing a Critical Role
 Brazil: Bio-Manguinhos, Butantan Institute
 China: Chengdu, Shanghai (SIBP), Sinovac, Shenzhen
AVP, Shenzhen Kangtai
 Cuba: CIGB, Instituto Finlay
 India: Panacea Biotec, Shantha Biotechnics, Bharat
Biotech, Biological E (BE), Serum Institute of India,
Indian Immuonologicals, Zydus cadila
 Indonesia: Biofarma
 Mexico: Birmex
 Republic of Korea: Berna Green Cross (Berna), LG Life
Sciences (LG), SK Bioscience
 Emerging market suppliers
• Critical to competition, supply security and
affordable prices
• Quality standards and requirements are the
same
• Emerging producers are playing a critical role in
developing countries: EPI and combo vaccines
• Now supplying about 50% procurement through
UNICEF by volume (less than 30% by value)
• Top country by value for UNICEF vaccine
procurement 2012 - India
WHO Website (2020)
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8. 7
Role of DCVMN

9. 8
Developing Countries Vaccine Manufacturers Network (DCVMN)
 DCVMN is a public health-driven alliance of corporate vaccine manufacturers based in developing countries – DCVMN members from India,
Indonesia, Bangladesh, Pakistan, Brazil, Argentina, China, Korea, Taiwan, Thailand, Vietnam, Russia
 Its mandate to protect all people against known and emerging infectious diseases, by improving the availability of high-quality vaccines globally,
recognizing the need for international scientific, technical and economic cooperation
 Since 2000, motivated by the WHO and the Gavi Alliance, aiming to improve vaccine supply to developing countries where populations were
growing rapidly, incidence of disease was high and purchasing power was low
This collaborative model improves manufacturers’ capabilities to supply
affordable vaccines globally
Hayman & Pagliusi (2020). Emerging vaccine manufacturers are innovating for the next decade. Vaccine; DCVMN. Available at:
https://www.dcvmn.org/-Vaccines- (accessed in May 2021)

10. 9
Developing Countries Vaccine Manufacturers Network (DCVMN) –
Cont’d
 Major Achievements
• As of October 2019, DCVMN members produced over 70 WHO PQ vaccines types, in a variety of presentations, accounting for half of the total pre-qualified vaccines
• Contributing to the Polio-free world
• Ending cholera
• Tackling re-emerging diseases (e.g., measles)
• Track record of vaccine innovations
• Accelerating the R&D Pipeline (i.e., improve existing vaccines; prevent known and emerging infectious diseases; development of next-generation vaccines for TB, dengue, malaria
• As of Oct 2019, 24/181 (~15%) of vaccines development are novel vaccines never licensed, such as chikungunya, Zika, RSV, HIV, or second-generation vaccines against dengue and malaria
Hayman & Pagliusi. Emerging vaccine manufacturers are innovating for the next decade. Vaccine (2020); Jadhav, Gautam, Gairola. Role of vaccine manufacturers in
developing countries towards global healthcare by providing quality vaccines at affordable prices. CMI (2014)
India, China, Brazil, Russian,
Republic of Korea, and
Turkey recorded great growth
rates in 2012 vaccine sales
and are anticipated to
become larger than the
developed markets by 2020

11. 10
Impact of COVID-19
on Clinical
Development,
Clinical Trials, and
Manufacturing

12. And then COVID-19 hit the whole world !...
As of Sep 2022,
• > 600M Total COVID-19 Cases
• > 6M Total Deaths
• >190 countries/regions affected
Johns Hoskins University. Coronavirus resource center. Available at: https://coronavirus.jhu.edu/map.html
(accessed in Sep 2022)
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13. 12
COVID-19 Vaccines Development and Platforms - Source of Various
Collaborations
 Various vaccine platforms: mRNA, DNA, viral vector, inactivated, protein-subunit, LAV being developed by Pharmaceutical & Biotech companies,
including in emerging countries
 As of Aug 2022:
• 356 vaccine candidates and 138 in a clinical setting and 34 vaccines in use (EUA/EUL vaccines)
 PPPs are essential to vaccine development,
• especially in the early 1990s with the effort to create a vaccine for HIV/AIDS, Malaria, and Tuberculosis
• Gavi used a pre-licensure procurement commitment to fund the development of the Ebola vaccine
• Such forms of public sector support were dramatically expanded to fight Covid-19, including the U.S. government’s Operation Warp Speed
 Its efforts were quantifiably successful leading to viable vaccines in a dramatically short timespan: 12–18 months compared to the average of 8–
15 years for previous vaccines
 These past efforts offer valuable lessons for utilizing PPPs to address pandemics and contribute to existing infrastructure that can be deployed in
furtherance of global Covid-19 vaccine supply chains
COVID-19 Vaccine Tracker – LSHTM. Available at: https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/ (Accessed in Sep 2022); Krammer F et al. SARS-COV-2 Vaccines in Development.
Nature (2020); Savoy & Mendez-Leal (2021). Beyond COVAX. The importance of PPPs for COVID-19 Vaccine Delivery to Developing Countries

14. COVID-19 Clinical Trials in LMICs
 Majority of COVID-19 clinical trials were conducted in upper- or high-income
countries
• How relevant are the study results for low-resource settings?
 Few COVID-19 studies were first conducted in South Africa (AZ/Oxford, Janssen, J&J)
• More still needs to be done in Africa (e.g., Kenya, Uganda,…)
• Ready-now trial sites available in multiple countries across the continent
• IVI awarded by BMGF on Phase III site readiness to assess, support, and train study sites in 4
countries (i.e., Ghana, Mozambique, Nepal, Philippines)
Makoni. COVID-19 vaccine trials in Africa. Lancet (2020); Le TT et al. Evolution of the COVID-19 vaccine development landscape. nature reviews. Available at:
https://www.nature.com/articles/d41573-020-00151-8 (accessed in Sep 2021)
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15. 14
 Solidarity Trial Vaccines (STV):
• an international, multi-center, multi vaccine,
adaptive, shared placebo, event-driven, individually
randomized controlled clinical trial
• to evaluate the efficacy and safety of promising new
COVID-19 vaccines
 The primary objective is to evaluate the effect of each
vaccine on reducing the rate of virologically confirmed
COVID-19 disease, regardless of the severity
 The Solidarity Trial Vaccines has started recruitment in
selected sites in the Philippines, Mali, and Colombia
 Key features of the trial include:
•mobile trial sites to enable reaching people in remote
areas and achieve more equitable recruitment
•interim analyses to identify better performing candidates
and to eliminate those that are performing poorly against
pre-specified statistical thresholds
•long-term follow-up to increase the rigor of results and
enable formal evaluation of efficacy vs. severe disease and
duration of efficacy
 The selection of candidate vaccines for the STV involves
evaluation of pre-defined criteria, including:
•their safety and proven potential for effectiveness
•stability of the vaccine
•demonstration that they can be stored and transported easily
under normal conditions
•availability - whether they can be produced quickly for global
distribution
•the ease with which they can be given to individuals (how the
vaccines are given, the number of doses, etc)
 Its Governance:
• International Steering Committee to govern the conduct of the
trial in accordance with the international trial protocol -
composed of representatives from participating country
governments who nominate two members – a representative of
the Ministry of Health (or national Medical Research Council, or
equivalent) and the national Principal Investigator.
• Executive Group of the Steering Committee composed of
independent international experts to ensure the study is being
conducted appropriately
• Global Data and Safety Monitoring Committee (DSMC) to
analyse confidential trial data to determine the safety and
efficacy of the vaccines being investigated
Solidarity Trial Vaccines
WHO (2022). Solidarity Trial Vaccines. Available at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-trial-of-
covid-19-vaccines# (Accessed in Sep 2022)

16. 15
Challenges in Global Access to COVID-19 Vaccines: Production, Affordability,
Allocation, and Deployment
 Several COVID-19 vaccines are authorized or approved for use, with many more in
the late stages of clinical development
 Yet having licensed vaccines is not enough to achieve global control of COVID-19:
they also need to be produced at scale, priced affordably, and allocated globally
 The four dimensions of the global vaccination challenge are closely related, and the
development and production steps have important implications for pricing,
allocation, and public confidence
Wouters et al. (2021). Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment. Lancet

17. COVID-19 Vaccine Manufacturing
 CEPI believed that 4 billion of the 10 billion
doses of vaccine manufacturing capacity could
be used for COVID vaccines
 Models predicted that we would not have
enough doses until 2024
 Operation Warp Speed (US) manufactured
hundreds of millions of doses “at risk”, making
vaccines before proven to be safe and effective
 Licensing/Contracting: Vaccine manufacturers
are licensing vaccines to other manufacturers:
Serum Institute (ChAdOx), Butantan (Sinovac),
SK bioscience (ChAdOx), Lonza (Moderna)
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18. 17
Manufacturing Locations from EUL Vaccines
Moderna
AZ/Oxford
Pfizer/
BioNtech
 Global vaccines needs are huge
 Vaccine makers projection: 12B doses
in 2021
 Production capacity for 2021 varies widely
among vaccines makers and platforms
 Global manufacturing partnerships (i.e., bulk
manufacturing, fill & finish)
Sinopharm
(Beijing)
Janssen
(J&J)
Duke – Global Health Innovation Center. Available at: https://launchandscalefaster.org/covid-19/vaccinemanufacturing (accessed in Sep 2021)

19. 18
Manufacturing Partners Overview
Launch & Scale – Speedometer. Vaccine Manufacturing. Available at: Vaccine Manufacturing | Launch and Scale Speedometer (launchandscalefaster.org) (accessed in Sep 2022)

20. 19
Leveraging PPP in
COVID-19 Pandemic
Response at IVI

21. 20
IVI is an UN-chartered
international organization
dedicated to accelerating vaccine
R&D for global health
20
… we can achieve our VISION of developing countries free
of suffering from infectious disease
… is to expand our global presence and expand our collaborative
partnerships and innovative capabilities
… is to discover, develop and deliver safe, effective
and affordable vaccines to enable the world's most
vulnerable people to have full, productive lives
Together
Next step
Our mission
1

22. 21
Global Vaccine Research Institute
IVI is a truly
international
organization that
has work across
multiple regions
OECD–recognized International Organization
(not for profit)
HQ and labs at Seoul
National University
Field programs in
28+countries:
Asia, Africa, Latin
America
25nationalities in
workforce of 214
UNDP initiative First international
organization in Korea (1997) 39countries and WHO as
state parties (Colombia
Madagascar and Argentina
pending final submission to UN)
1
21

23. 22
IVI has built a strong network across Africa, Asia, and Latin America
that continues to grow across development and epidemiology work
in
20+
projects
28+
sites
Typhoid Cholera
Other (AMR, COVID-19,
Chikungunya, etc…)
~1000
jobs
creating
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24. 23
IVI Vaccines Bring Affordable Innovation to Global Health
VACCINE #1
ORAL
CHOLERA
VACCINE SHANCHOL PQ 2011 EUVICHOL, EUVICHOL
PLUS PQ 2016, 2018
VACCINE #2
Vi-DT TCV
(Typhoid)
Approved by
KMFDS, WHO
submitted
BLA submitted to
BPOM
VACCINE #3
•Non-typhoidal
Salmonella
•Shigella
COST
VACCINE MANUFACTURER
Cost thru
PQ: $28M
Estimated
Cost thru
PQ: $33M
IVI internal
investment
preclinical POC;
Wellcome Trust
$3.2M

25. 24
has enhanced Korean vaccine manufacturing capacity
2016 2021
“Vaccine 3.0”
Infrastructure building
project for vaccine self
sufficiency
2016-2020
• Funded by ROK government,
BMGF, Korean
manufacturers
• Focuses on global health
R&D
• E.g. Cholera Conjugate
Vaccine (CCV)
• Partner with Vaccine
Innovative Technology Alliance
(VITAL) Korea to promote R&D
for global health
• Promote vaccine sovereignty
of Korea and preparedness
against EID
“K-Vaccine Hub”
Center of Excellence, providing essential support
required in establishing K-Bio Hub
• Vaccine research: platform technology
(mRNA, viral vector), adjuvant
• Innovation center: vaccine evaluation system
through standard assays and reagents
• Translational hub: clinical development,
regulatory affairs, and quality assurance
• Globalization: provide networking to industry
to move to the next level
OCV, TCV, HEP B,
HEP A, MERS
Vaccine
• Euvichol® &
Euvichol-Plus® OCV
• Vi-DT TCV
• iNTS
• Hep B microneedle
patch
• Hep A • MERS
COVID-19
Vaccine1
Vaccine product
development
partnerships
with Korean
manufacturers
& agencies
2018 2020
1. Additional partners include Hanmi Pharmaceuticals, NeoImmuneTech, Bioapp, GI Cell, GI Innovation, POSVAX, GeneMatrix and Korea Mouse Phenotyping Center (KMPC)

26. 25
IVI works throughout the value chain to enable our global partners in COVID-19 vaccine
development
Pre-clinical and International Standard
Serum & Assay Development
Capacity Building
• Support for Epi. and Phase
III site development
Clinical Development
• Laboratory: EIA, PRNT, PsVNa
• Phase I-III / effectiveness
IVI is testing COVID-19 vaccines from companies that have committed
~1 billion doses of COVID-19 vaccines to COVAX (~20% of the total)

27. 26
Major Partners
IVI has 160 partners worldwide ranging from government, industry,
academia and civil society to intergovernmental organizations
New:
Denmark

28. 27
Where we'd like to be| Impact and Effectiveness
IVI has led the fight against
cholera in LMICs for 20 years with
90% of the global OCV stockpile
and developed a new-generation
typhoid conjugate vaccine
IVI is a leading PDP with a multi-country presence, bolstering existing core
capabilities such as tech transfer and disease surveillance, the launch of new
capabilities, and reformed governance to bring in 39+ country perspectives to fight
against emerging and pandemic infectious diseases by harnessing cross-cutting R&D
preparedness and capabilities through global partnerships
Path
Forward
Typhoid:
Approved by
KMFDS, WHO
submitted
Typhoid: BLA
submitted to BPOM
70 million doses
delivered and
400,000+ people
vaccinated through
IVI campaigns
Vi-DT typhoid
conjugate vaccine
pending WHO PQ
Target to
vaccinate
540,000 people
in Nepal and
Mozambique
2020-2024

29. 28
Conclusion

30. Conclusion
 Progress on vaccine development and manufacturing has been set in developing countries before the COVD-
19 pandemic, with emerging market suppliers playing a key role in developing countries (i.e., EPI and Combo
vaccines)
 DCVMN is established for over 20 years with key players in vaccine development and manufacturing from
India, Indonesia, and China…
 COVID-19 pandemic paradigm – Overlapping phases, shortening development time, opening-up opportunities
in vaccine development and manufacturing for developing countries, and leveraging the PPPs model would
help increase vaccine production and global supply, particularly for LMICs
 The case for a coordinated multilateral response to the crisis is now well established, and further attention to
expanding access to vaccines for developing countries remains a challenge
 One of the barriers to local production - biomanufacturing knowledge, intellectual property (IP) rights, and
limited technology transfer remain barriers to building additional local production capacity
 Beyond PPP, IVI is committed to education and training programs and has launched the first Global Training
Hub for Biomanufacturing in July 2022, supported by the Korean Government and WHO Academy

31. Thank YOU!