Advancement and Innovation

in the Development of Vaccines

PierreA. Morgon, PharmD, LL.M, MBA

Chief Executive Officer
AJ Biologics

Setting the Stage:

What are Vaccines, and their Differences
from Therapeutic Pharmaceuticals

What are vaccines?

Vaccinesare:
Pharmaceuticalproducts:biologicals
Actingbystimulatingtheimmunesystem,
Mostlyprophylactic,usedto preventthe
adventofacommunicabledisease.

How do Vaccines Work?

Immunity from Disease is the Reference

Vaccine Induced Immunity

Mimics that from the Disease

Vaccine Induced Immunity

Vary According to Vaccine Type and Age of Subject

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)

1931, Ernest Goodpasture discovers

the egg as a sterile system to produce
vaccine for fowl pox virus

1930

Jonas Salk in 1955 holds two

bottles of a culture used to grow
polio vaccines

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
undefined content, to whole organisms, to purified whole organisms and
subunitcomponent

Theconceptofwellcharacterizedbiologicisrecentandevolving
Vaccines are the most important contributors to global health
improvement,onlysecondtocleanwaterandsanitation
ModernvaccineR&D,productionandvaccinationprovideasignificantand
sustainablesourceofemploymentacrosspublicandprivateinstitutions

Fundamentals of VaccineManufacturing

Fundamental Principles of Vaccine Manufacturing

Different Types of Vaccines (1/2)

Different Types of Vaccines (2/2)

Clinical and Industrial Developments

Must be Managed in Parallel

Regulatory Linking both Product Clinical Profile

And Manufacturing Process

Specific Vaccine Characteristics Driving

Acceptability

Vaccines Are Unique Prescription Medications

Differing From TherapeuticProducts
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

Source: Angelmar R & Morgon P, 2012

Vaccines Are Unique Prescription Medications

Differing From TherapeuticProducts
Protect the health of treated AND untreated
individuals: herd-protective effect, hence
positive externalities

Source: Angelmar R & Morgon P, 2012

Vaccines Are Unique Prescription Medications

Differing From TherapeuticProducts
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

Source: Angelmar R & Morgon P, 2012

Drivers of VaccineAcceptability

Vaccines follow acomplex andfragmented

purchasingprocess withmanystakeholders,
including:
-publicauthorities andrecommendationbodies,
-private andpublic purchasers,

-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?

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
Sources: Chow et al., 2010 - Daley et al., 2010 - Gidengil et al., 2010 - Humiston et al., 2009 - Kempe et al., 2007

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

Did you say Trust?

Anti-vaccine campaigners Clueless - Celebrities

makeus 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 ]

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 ImmunizationAcceptability

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
What?
immunization

Overcoming vaccine fatigue

Source: Angelmar R & Morgon P, 2012

Yet another
vaccine?!

Major Challenges Associated With

Vaccines and Immunization
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 synthetic 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

Thank You!
Pierre A. Morgon
PharmD LL.M MBA
Chief ExecutiveOfficer

pierre@ajbiologics.com

pierremorgon

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