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Improving Global Healthcare And
Wellbeing
What are the Path to and Place for “Halal” Vaccines
Pierre A. Morgon, PharmD, LL.M, MBA
Chief Executive Officer
AJ Biologics
History of Vaccines: Roots and DNA of the
Vaccine Industry
Figures showing Vaccination Pustules
From a Chinese work on vaccination
Louis Pasteur used rabbits for the production of the immunogen of rabies vaccine
Pure acetylsalicylic acid manufactured since 1899 (pictures c. 1910)
1930
Jonas Salk in 1955 holds two
bottles of a culture used to grow
polio vaccines
1931, Ernest Goodpasture discovers
the egg as a sterile system to produce
vaccine for fowl pox virus
Top left: Sir Alexander Fleming
(front) in 1945 at a pharmaceutical
production facility
Top right: Sulphamide production
in 1950
Left: Ready-made liquid
preparations manufacturing plant
in 1950
Preparing influenza vaccine at Connaught Laboratories in 1957
Take-home messages from historical evolution?
Not known or understood by lay public
Vaccines are biologics which evolved from complex preparations of
undefinedcontent,towholeorganisms,topurifiedwholeorganismsand
subunitcomponent
Theconceptofwellcharacterizedbiologicisrecentandevolving
Vaccines are the most important contributors to global health
improvement,onlysecondtocleanwaterandsanitation
ModernvaccineR&D,productionandvaccinationprovideasignificantand
sustainablesourceofemploymentacrosspublicandprivateinstitutions
Specific Vaccine Characteristics Driving
Acceptability
 Users are healthy
 Diseases are infectious, transmissible
 Over time, usage reduces the prevalence of
disease and thereby motivation to prevent
 Only adverse effects can be observed:
perception of benefits requires counterfactual
thinking
« Without the flu shot I would have gotten the flu »
Vaccines Are Unique Prescription Medications
Differing From Therapeutic Products
Source: Angelmar R & Morgon P, 2012
 Protect the health of treated AND untreated
individuals: ‘herd-protective’ effect, hence
positive externalities
Vaccines Are Unique Prescription Medications
Differing From Therapeutic Products
Source: Angelmar R & Morgon P, 2012
 Infrequent or once-in-a-lifetime use limits
opportunities to learn from direct experience
 Usage can be mandatory across large
population groups, against societal trends
 Significant governmental involvement through
public health campaigns
Vaccines Are Unique Prescription Medications
Differing From Therapeutic Products
Source: Angelmar R & Morgon P, 2012
Drivers of Vaccine Acceptability
Vaccinesfollowacomplexandfragmented
purchasingprocesswithmanystakeholders,
including:
-publicauthoritiesandrecommendationbodies,
-privateandpublicpurchasers,
-prescribersandendusers.
Which are the Key Determinants of Influencers’
Immunization Recommendation Decisions?
1. Disease epidemiology
2. Burden of disease
3. Public perception of the disease
4. Vaccine clinical effectiveness and safety
5. Vaccine cost-effectiveness
6. Recommendations by other influencers
Sources: Duclos et al., 2011 - Smith, J.C., 2010 - Berndt et al., 2009 - Bryson et al., 2010
Which are the Key Determinants of
Vaccine Purchasers’ Decisions?
1. Acceptability by medical/public health influencers
2. Affordability of the vaccine
3. Accessibility to the vaccine: infrastructure
4. Availability and reliability of supply
5. Public opinion toward disease and vaccine
6. Decisions by other purchasers:
1. Governments: neighboring countries
2. Private insurers: public purchasers
Sources: Levine et al., 2011 - McNeill Jr., 2011 - Hall, 2010 - Gessner et al., 2010 - Lindley et al., 2009
Which are the Key Determinants of
Healthcare Professionals’ Immunization Behavior?
Sources: Chow et al., 2010 - Daley et al., 2010 - Gidengil et al., 2010 - Humiston et al., 2009 - Kempe et al., 2007
1. Medical Concerns
1. Knowledge and Perception of disease
2. Attitudes towards vaccines
3. Norms
2. Consumer-related Concerns
1. Perceived vulnerability to the disease
2. Perceived attitude towards vaccination
3. Self-efficacy in engaging vaccination discussion
3. Financial Concerns: perceived costs of, and
revenues from vaccination
Which are the Key Determinants of
Consumers’ Immunization Behavior?
1. Perceived risk/threat from a disease
2. Attitude toward vaccination
3. Subjective —or injunctive— norms
and descriptive norms
4. Anticipated regret
5. Perceived behavioral control
6. Past vaccination behavior
The primary driver of immunization?
Trust…
• Vaccine
• Prescriber
• Authorities
• Influencers
Did you say “Trust”?
Lexington - Thundering herd - California’s anti-vaccine brigade and the dark side of individualism
Sep 26th 2015 | The Economist
Anti-vaccine campaigners – Clueless - Celebrities
make us sick
Jun 28th 2014 | LOS ANGELES | The Economist
[…the anti-vaccination cause has been taken up
by Alicia Silverstone, an actress whose name
may now forever be linked to “Clueless” …]
Did you say “Trust”?
What happens when Trust disappears?
Sources: Leask J. (2011) Target the fence-sitters. Nature 473; 443-45. http://www.hpa.org.uk/hpr/news/
What happens when Trust disappears?
Sources: Noble R et al., JAMA 1987
The Way Forward:
Addressing Successfully Major Challenges
Associated With
Vaccines And Immunization Acceptability
Major Challenges Associated With
Vaccines and Immunization
 Consumer motivation and behavior
 Chicken or egg?: Do immunization beliefs cause related
behavior, or does causality flow in the other direction?
 Maintaining high immunization coverage rates in the
absence of targeted diseases
Reducing the percentage of people who refuse or delay
immunization
 Overcoming vaccine fatigue
« What?
Yet another
vaccine?! »
Source: Angelmar R & Morgon P, 2012
 Dealing with anti-vaccine sentiment and
misinformation
 Poor knowledge about vaccine-preventable diseases
 Lack of trust in vaccine efficacy and safety
 Societal aspirations & scientific trend towards
personalized medicine
 Beliefs about immunization as the cause of serious
health issues, up to conspiracy theories
 And… Religious assertions and objections
Major Challenges Associated With
Vaccines and Immunization
 The way forward: drive positive awareness
 Immunization is compliant with the objectives of
Islamic Law, by preserving health, sanity and life
of one and one’s family and progeny, and
contributing to the preservation of wealth
 There is no detectable evidence of animal
components in the finished products
 Providing vaccines that are totally free of animal
components is a desirable target
Major Challenges Associated With
Vaccines and Immunization
 The path to vaccines “free of animal components”
 No common definition for “Halal”, therefore need for
a referential and certification process: Pharmacopeia
 Animal components: replace by chemically defined
ingredients or ensure compliance with Islamic Law
 Define principles and extent of segregation along
each step of the manufacturing and supply chain
 Ensure technical and financial feasibility while
preserving efficacy, safety and quality
Source: StratGurus 2015
Major Challenges Associated With
Vaccines and Immunization
 Immunization & manufacturing strategy questions
 Do not undermine importance of current vaccines
or compromise existing immunization programs
 Reinforce positive awareness through fact-based
education campaigns
 Predictability of demand dynamics (especially for
infrequently used vaccines): impact on industrial
capacity utilization, to align with Authorities’
expectation for reliability of supply
Major Challenges Associated With
Vaccines and Immunization
 Immunization & manufacturing strategy questions
 Addressing pressures for price and cost
transparency, affordability, and value-for-money
concerns
 Balancing constrained health care budgets and
containing vaccine-related costs in the short-term
while preserving long-term economic sustainability
and benefits of vaccination
Major Challenges Associated With
Vaccines and Immunization
Thank You!
Pierre A. Morgon
PharmD LL.M MBA
Chief Executive Officer
c/o AJ Pharma Holding Sdn Bhd
Level 4, Menara Atlan, 161B, Jalan Ampang
50450 Kuala Lumpur, Malaysia.
Tel: +603 2161 1585
Fax: +603 2161 1595
pierre@ajbiologics.com
pierremorgon

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P Morgon_AJBiologics_World Vaccine Congress_2015 11_vFinal

  • 1.
  • 2. Improving Global Healthcare And Wellbeing What are the Path to and Place for “Halal” Vaccines Pierre A. Morgon, PharmD, LL.M, MBA Chief Executive Officer AJ Biologics
  • 3. History of Vaccines: Roots and DNA of the Vaccine Industry
  • 4. Figures showing Vaccination Pustules From a Chinese work on vaccination
  • 5.
  • 6.
  • 7. Louis Pasteur used rabbits for the production of the immunogen of rabies vaccine
  • 8. Pure acetylsalicylic acid manufactured since 1899 (pictures c. 1910)
  • 9. 1930 Jonas Salk in 1955 holds two bottles of a culture used to grow polio vaccines 1931, Ernest Goodpasture discovers the egg as a sterile system to produce vaccine for fowl pox virus
  • 10. Top left: Sir Alexander Fleming (front) in 1945 at a pharmaceutical production facility Top right: Sulphamide production in 1950 Left: Ready-made liquid preparations manufacturing plant in 1950
  • 11. Preparing influenza vaccine at Connaught Laboratories in 1957
  • 12.
  • 13.
  • 14. Take-home messages from historical evolution? Not known or understood by lay public Vaccines are biologics which evolved from complex preparations of undefinedcontent,towholeorganisms,topurifiedwholeorganismsand subunitcomponent Theconceptofwellcharacterizedbiologicisrecentandevolving Vaccines are the most important contributors to global health improvement,onlysecondtocleanwaterandsanitation ModernvaccineR&D,productionandvaccinationprovideasignificantand sustainablesourceofemploymentacrosspublicandprivateinstitutions
  • 15. Specific Vaccine Characteristics Driving Acceptability
  • 16.  Users are healthy  Diseases are infectious, transmissible  Over time, usage reduces the prevalence of disease and thereby motivation to prevent  Only adverse effects can be observed: perception of benefits requires counterfactual thinking « Without the flu shot I would have gotten the flu » Vaccines Are Unique Prescription Medications Differing From Therapeutic Products Source: Angelmar R & Morgon P, 2012
  • 17.  Protect the health of treated AND untreated individuals: ‘herd-protective’ effect, hence positive externalities Vaccines Are Unique Prescription Medications Differing From Therapeutic Products Source: Angelmar R & Morgon P, 2012
  • 18.  Infrequent or once-in-a-lifetime use limits opportunities to learn from direct experience  Usage can be mandatory across large population groups, against societal trends  Significant governmental involvement through public health campaigns Vaccines Are Unique Prescription Medications Differing From Therapeutic Products Source: Angelmar R & Morgon P, 2012
  • 19. Drivers of Vaccine Acceptability
  • 21. Which are the Key Determinants of Influencers’ Immunization Recommendation Decisions? 1. Disease epidemiology 2. Burden of disease 3. Public perception of the disease 4. Vaccine clinical effectiveness and safety 5. Vaccine cost-effectiveness 6. Recommendations by other influencers Sources: Duclos et al., 2011 - Smith, J.C., 2010 - Berndt et al., 2009 - Bryson et al., 2010
  • 22. Which are the Key Determinants of Vaccine Purchasers’ Decisions? 1. Acceptability by medical/public health influencers 2. Affordability of the vaccine 3. Accessibility to the vaccine: infrastructure 4. Availability and reliability of supply 5. Public opinion toward disease and vaccine 6. Decisions by other purchasers: 1. Governments: neighboring countries 2. Private insurers: public purchasers Sources: Levine et al., 2011 - McNeill Jr., 2011 - Hall, 2010 - Gessner et al., 2010 - Lindley et al., 2009
  • 23. Which are the Key Determinants of Healthcare Professionals’ Immunization Behavior? Sources: Chow et al., 2010 - Daley et al., 2010 - Gidengil et al., 2010 - Humiston et al., 2009 - Kempe et al., 2007 1. Medical Concerns 1. Knowledge and Perception of disease 2. Attitudes towards vaccines 3. Norms 2. Consumer-related Concerns 1. Perceived vulnerability to the disease 2. Perceived attitude towards vaccination 3. Self-efficacy in engaging vaccination discussion 3. Financial Concerns: perceived costs of, and revenues from vaccination
  • 24. Which are the Key Determinants of Consumers’ Immunization Behavior? 1. Perceived risk/threat from a disease 2. Attitude toward vaccination 3. Subjective —or injunctive— norms and descriptive norms 4. Anticipated regret 5. Perceived behavioral control 6. Past vaccination behavior
  • 25. The primary driver of immunization? Trust… • Vaccine • Prescriber • Authorities • Influencers
  • 26. Did you say “Trust”? Lexington - Thundering herd - California’s anti-vaccine brigade and the dark side of individualism Sep 26th 2015 | The Economist
  • 27. Anti-vaccine campaigners – Clueless - Celebrities make us sick Jun 28th 2014 | LOS ANGELES | The Economist […the anti-vaccination cause has been taken up by Alicia Silverstone, an actress whose name may now forever be linked to “Clueless” …] Did you say “Trust”?
  • 28. What happens when Trust disappears? Sources: Leask J. (2011) Target the fence-sitters. Nature 473; 443-45. http://www.hpa.org.uk/hpr/news/
  • 29. What happens when Trust disappears? Sources: Noble R et al., JAMA 1987
  • 30. The Way Forward: Addressing Successfully Major Challenges Associated With Vaccines And Immunization Acceptability
  • 31. Major Challenges Associated With Vaccines and Immunization  Consumer motivation and behavior  Chicken or egg?: Do immunization beliefs cause related behavior, or does causality flow in the other direction?  Maintaining high immunization coverage rates in the absence of targeted diseases Reducing the percentage of people who refuse or delay immunization  Overcoming vaccine fatigue « What? Yet another vaccine?! » Source: Angelmar R & Morgon P, 2012
  • 32.  Dealing with anti-vaccine sentiment and misinformation  Poor knowledge about vaccine-preventable diseases  Lack of trust in vaccine efficacy and safety  Societal aspirations & scientific trend towards personalized medicine  Beliefs about immunization as the cause of serious health issues, up to conspiracy theories  And… Religious assertions and objections Major Challenges Associated With Vaccines and Immunization
  • 33.  The way forward: drive positive awareness  Immunization is compliant with the objectives of Islamic Law, by preserving health, sanity and life of one and one’s family and progeny, and contributing to the preservation of wealth  There is no detectable evidence of animal components in the finished products  Providing vaccines that are totally free of animal components is a desirable target Major Challenges Associated With Vaccines and Immunization
  • 34.  The path to vaccines “free of animal components”  No common definition for “Halal”, therefore need for a referential and certification process: Pharmacopeia  Animal components: replace by chemically defined ingredients or ensure compliance with Islamic Law  Define principles and extent of segregation along each step of the manufacturing and supply chain  Ensure technical and financial feasibility while preserving efficacy, safety and quality Source: StratGurus 2015 Major Challenges Associated With Vaccines and Immunization
  • 35.  Immunization & manufacturing strategy questions  Do not undermine importance of current vaccines or compromise existing immunization programs  Reinforce positive awareness through fact-based education campaigns  Predictability of demand dynamics (especially for infrequently used vaccines): impact on industrial capacity utilization, to align with Authorities’ expectation for reliability of supply Major Challenges Associated With Vaccines and Immunization
  • 36.  Immunization & manufacturing strategy questions  Addressing pressures for price and cost transparency, affordability, and value-for-money concerns  Balancing constrained health care budgets and containing vaccine-related costs in the short-term while preserving long-term economic sustainability and benefits of vaccination Major Challenges Associated With Vaccines and Immunization
  • 37. Thank You! Pierre A. Morgon PharmD LL.M MBA Chief Executive Officer c/o AJ Pharma Holding Sdn Bhd Level 4, Menara Atlan, 161B, Jalan Ampang 50450 Kuala Lumpur, Malaysia. Tel: +603 2161 1585 Fax: +603 2161 1595 pierre@ajbiologics.com pierremorgon