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

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

14. Take-home messages from historical evolution?
Not known or understood by lay public
Vaccines are biologics which evolved from complex preparations of
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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

20. Vaccinesfollowacomplexandfragmented
purchasingprocesswithmanystakeholders,
including:
-publicauthoritiesandrecommendationbodies,
-privateandpublicpurchasers,
-prescribersandendusers.

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