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P Morgon_AJBiologics_World Vaccine Congress_2015 11_vFinal

Pierre A. MORGON PharmD MLL MBA
Pierre A. MORGON PharmD MLL MBA

Improving global healthcare and wellbeing requires addressing major challenges with vaccines and immunization acceptance. Key challenges include maintaining high vaccination rates without targeted diseases, overcoming vaccine fatigue, and dealing with misinformation that reduces trust. The path forward is promoting education on how vaccines comply with Islamic law while working to develop vaccines free of animal components through defined manufacturing processes. Addressing pressures around affordability, supply reliability, and demonstrating value are also important for immunization strategies and vaccine development.

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P Morgon_AJBiologics_World Vaccine Congress_2015 11_vFinal
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
P Morgon_AJBiologics_World Vaccine Congress_2015 11_vFinal
P Morgon_AJBiologics_World Vaccine Congress_2015 11_vFinal
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
P Morgon_AJBiologics_World Vaccine Congress_2015 11_vFinal
P Morgon_AJBiologics_World Vaccine Congress_2015 11_vFinal
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 束 Without the flu shot I would have gotten the flu 損 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 - Californias 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 束 What? Yet another vaccine?! 損 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 ones 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

  • 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 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 束 Without the flu shot I would have gotten the flu 損 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 - Californias 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 束 What? Yet another vaccine?! 損 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 ones 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