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Malaysian Vaccine
Program: Pathway for Malaysia’s
Nascent Vaccine Industry
Jay Padasian Senior Vice President, BioMedical
BiotechCorp.
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Agenda Introduction
GAP: The Case for Influenza Vaccines
The Global Vaccine Scenario
The Malaysian Vaccine Scenario
Vaccine Manufacturing
The Malaysian Vaccine Programme
Conclusion
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Introduction
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Progression of Outbreaks Outbreak
Disease occurs in greater numbers than expected
Epidemic
A localized, rapid
spread of an
infectious disease to
many
Pandemic A global disease outbreak
Isolated Cases
Pandemics • HIV/AIDS
• Smallpox
• The Plague
Epidemics • Dengue
• Cholera
• Meningitis
• Hepatitis
Influenza
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United Nations (UN) Initiatives to
Combat Outbreaks
UNICEF: MDG* 4 aims to reduce child mortality by increasing paediatric vaccine coverage
WHO: Global Action Plan (GAP) for Influenza
Vaccines
WHO: MDG* 6 aims to combat HIV/AIDS,
Malaria, NTDs
WHO: Global strategy for dengue prevention and
control, 2012–2020
*MDG – Millennium Development Goal
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MDG 4: Routine Immunization
Millennium Development Goal (MDG) 4 (2000 – 2015):
Increased coverage of paediatric vaccines through inclusion
of:-
1) Pneumococcal conjugate vaccine (PCV)
2) Haemophilus influenzae type b (Hib) vaccine
3) Rotavirus vaccine
*WFFC – World Fit for Children (UNICEF)
MDG 4, Routine Immunization (2010)
Goals Gains Pending Work
WFFC* – Fully immunize
90% of children by
2010
Both DPT3 and measles
immunization coverage reached
78% in developing countries.
In 115 countries, DPT3 coverage
reached 95%.
26 million children are still
not immunized, 1.4 million
children still die from
vaccine-preventable
diseases.
Source: United Nation’s Children Fund, UNICEF
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Key Takeaway: In Oct 2012, WHO
included pneumococcal vaccinations in
their Recommendations for Routine
Immunization for all countries.
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Meningococcal
vaccination is
compulsory for those
going for Hajj.
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9 Vaccination is pivotal
against pandemic
and seasonal
Influenza
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Key Takeaway: MOH Immunization
Schedule is currently not updated to
WHO’s MDG. Last update was in 2004.
Source: Clinical Practice Guidelines (Childhood Immunisation),
MOH/P/PAK/81.04 (GU), December 2004
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Healthcare Statistics, Malaysia
Source: Ministry of Health
Key Takeaway: Opportunity for vaccine self sufficiency in Malaysia
due to the high penetration. Potential for building vaccine capacity in
Malaysia versus foreign importation
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United Nations (UN) Initiatives to
Combat Outbreaks
UNICEF: MDG* 4 aims to reduce child mortality by increasing paediatric vaccine coverage
WHO: Global Action Plan (GAP) for Influenza
Vaccines
WHO: MDG* 6 aims to combat HIV/AIDS,
Malaria, NTDs
WHO: Global strategy for dengue prevention and
control, 2012–2020
*MDG – Millennium Development Goal
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GAP*: The Case for
Influenza Vaccines
*GAP – Global Action Plan
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Deadliest Pandemics in History
Source: Centres for Disease Control and Prevention, WHO
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Focus on Influenza Outbreaks
Sources: “H5N1 Avian Influenza: Timeline of Major Events”, WHO, December 13, 2011
Nature Publishing Group
Global Alert and Response, WHO, April 17, 2013
Influenza Timeline
Key Takeaway: Compared to other
pandemics such as the Plague, Influenza
still threatens the world.
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Influenza Facts
Sources: CDC, WHO
• Caused Asian
Flu Pandemic in
1957
• Still Circulates
in birds
• “Common Flu”
virus
• Swine Flu
• Similar strain as
Spanish
Influenza.
• Resurfaced in
‘09-’10
• Most common
Bird Flu
• Mortality rate of
60%
• No human-to-
human
transmission
• Avian Flu
which
resurfaced in
China,
April ‘13
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The H1N1 Pandemic: Race
between the Virus and Vaccine
Source: Excerpts from WHO Workshop on Influenza Business Sustainability
Key Takeaway: During the H1N1
pandemic, the vaccine was administered
in week 40 after the outbreak occurred.
Mortality approx. 18,500
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The Global
Vaccine Scenario
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There is a need…
Only 3.6% or 250 million of the
global population would receive a full pandemic influenza vaccination.
Source: World Health Organization, 2011
WHO is actively seeking solutions to address the global shortage of vaccines.
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Vaccine Security
Current procurement of
influenza vaccines
in most South East Asian countries
does not meet the needs
of the region’s population.
Source: Gupta, V., et al, (2012) Influenza Vaccination Guidelines and Vaccine Sales in SEA: 2008-2011
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Influenza Vaccine Sales
per 100,000 population
2008 trivalent
seasonal vaccine
2009 trivalent
seasonal vaccine
2010 trivalent
seasonal
vaccine
2009-2010
monovalent A
(H1N1) pdm09
vaccine
2011 trivalent
seasonal vaccine
Source: Gupta V, Dawood FS, Muangchana C, Lan PT, et al. (2012)
Influenza Vaccination Guidelines and Vaccine Sales in Southeast Asia
1.4% of
population
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Global Vaccine Manufacturing
Malaysia is being LEFT BEHIND.
• Indonesia
• Thailand
• Vietnam
ASEAN
(DCVMN*)
• India
• China
• South Africa
• Brazil
• South Korea
GLOBAL (DCVMN)
• Global manufacturing facilities
• Manufacturing via collaborations
MNC’s
*DCVMN - Developing Countries Vaccine Manufacturers’ Network
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The Malaysian
Vaccine Scenario
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Gaps
• Reliance on external sources, mainly MNC’s
• Shortage of vaccine supply during emergencies (epidemic/pandemic)
Vaccine Security
• Lack of self sufficiency for adult and pediatric immunizations
• Lack of regional cooperation to utilize capacity
Vaccine Capacity
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Impact of Vaccine Security & Vaccine
Capacity Issues
Limited Global Capacity for Influenza
Vaccines + Unpredictable Influenza
Pandemics = TROUBLE.
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Vaccine
Manufacturing Comparisons and analysis
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Current & Potential Influenza
Vaccine Technologies
Source: Centre for Infectious Disease Research and Policy: Game – changing Influenza Vaccines, 2012
Key Takeaway: Various Influenza Vaccine technologies under
clinical development, newer tech appearing in the market
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The Influenza Vaccine
Technology Pathway
Source: Centre for Infectious Disease Research and Policy: Game – changing Influenza Vaccines, 2012
Key Takeaways:
* Significant time and funds required to develop an Influenza
vaccine from concept to commercialization
* Potential solutions: In-license and do fill-finish activities. Also
tie-ups to lock up vaccine supplies during the interim period
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The Malaysian
Vaccine
Programme (MVP)
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The Malaysian Vaccine
Program
Main Reasons for
Implementation
Objective
Self Sufficiency
Lessen dependency on external
sources
Vaccine Security
Pandemics Assurance of availability
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The Malaysian Vaccine
Program
Mode of Implementation
Modes for PPP*
R & D
Support for Developmental
Activities
Commercial
Off-take for
Procurement
Support for meeting
Regulatory Requirements
*PPP – Public Private Partnership
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Potential choice of vaccines V
ac
cin
es Existing
procurement
Pentavalent
HPV
Potential Procurement Policy
Pneumococcal
Meningococcal
Seasonal Influenza
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National Stakeholder Mapping
ENGAGEMENT UNITS
MINISTRY SECRETARIAT
NKEA Healthcare Steering
Committee
ASEAN Economic Cooperation
Division
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Regulatory - Facilities
• Certification of facilities
• Monitoring to ensure strict adherence to
cGMP
cGMP
• Certification and
Monitoring • Facilitate upgrades
of existing laboratories
Laboratories
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Regulatory –WHO Pre-Qualification
(PQ) & Batch Testing
• Required for vaccines to be purchased by UN
agencies
• Need to meet PQ status requirements?
WHO PQ
• Set up of Batch Testing
facilities
Batch Testing
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Regulatory – Clinical Trials
• Long clinical trial process 3 – 6 years
• Facilitation in meeting regulatory requirements
New Vaccines
• Abbreviated clinical development for products
to be manufactured in Malaysia in line with
international standards
Existing Vaccines
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Financials
Possible Business Models
PPP
Technology Partners
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MALAYSIAN - ASEAN
VACCINE INITIATIVE (MAVI)
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MAVI
“ POTENTIAL FOR A COLLABORATIVE
APPROACH TOWARDS BUILDING VACCINE
CAPACITY AND
CAPABILITIES TO ADDRESS VACCINE
SECURITY IN ASEAN”
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CONCLUSION
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* Immunization Schedule not updated.
* Gaps: Regulatory, Manufacturing Capacity, Human Capital, Funding, Market Access
* Vaccine Security
* Self Sufficiency
* Pandemic Preparedness
* New or amended policies to justify new vaccine procurement/ production.
* Building of Regulatory Infrastructure for Vaccines
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Current Status Objectives Action Plans