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Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines [email protected]

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Page 1: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Vaccine success stories: from initial idea to the market

Jerusha Naidoo MBChB (UCT)

Pfizer Vaccines

[email protected]

Page 2: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Outline

How vaccine producers look at vaccines

and vaccination, in general

“The needs and gaps in the vaccine R&D

pipeline and technology transfer”

« EVM - European Vaccine Manufacturers »

Conclusions

2

Page 3: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Vaccines and future vaccine-preventable diseases

BACTERIAL VIRAL

B. anthracis anthrax Cytomegalovirus congenital infections

C. trachomatis chlamydia Dengue virus hemorrhagic fever

C. difficile diarrhea Epstein-Barr virus infectious mononucleosis

Enterotoxigenic E. coli diarrhea Hepatitis B, C, E hepatitis

H. pylori gastic cancer HIV AIDS

M. tuberculosis tuberculosis HSV-2 herpes

N. meningitidis meningitis Human papillomavirus cervical cancer

S. aureus skin and systemic infections Influenza virus influenzae

S. pneumoniae meningitis & pneumonia Japanese encephalitis virus encephalitis

S. typhi typhoid fever Parainfluenza pneumonia

Shigella spp shigellosis Rotavirus diarrhea

Streptococcus, Group A skin and systemic infections RSV pneumonia

Streptococcus, Group B meningitis SARS pneumonia

V. cholera cholera

Y. pestis plague PARASITIC

A. duodenale, N. americanus hookworm

Leishmania spp leishmaniasis

Plasmodium spp malaria

3 http://www.ifpma.org/pdf/2008_05_20_IFPMA_Value_of_Vaccines.pdf

Page 4: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Vaccines and

vaccination

4

Page 5: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Fletcher MA, Saliou P. Vaccines and infectious disease. EXS 2000;89:69-88

10,000 1,000 100 10 1

YEARS AGO

Smallpox HIV/AIDS Hepatitis B Rotavirus DISEASE

GERM

VACCINE

VACCINATION

DISEASE CONTROL

A brief history of vaccines

“ERADICATION”

5

Page 6: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

H. influenzae type b

N. meningitides (4 Serogroups) CONJUGATE

Ps. aeruginosa (8 serotypes)

S. pneumoniae (13 serotypes)

S. typhi

H. influenzae type b S. typhi POLYSACCHARIDE

N. meningitides (Serogroups A, C, W135, Y)

S. pneumoniae (23 serotypes)

Influenza virus Hepatitis B virus SUBUNIT

HPV

B. pertussis

C. diphtheriae B. pertussis TOXOID

C. tetani

Rabies virus B. pertussis B. anthracis Hepatitis A virus INACTIVATED

S. typhi B. pertussis

V. cholera C. burnetti

Y. pestis Influenza virus

Japanese encephalitis virus

Poliovirus

Tick-borne encephalitis virus

Vaccinia M. tuberculosis B. anthracis Influenza virus LIVE-ATTENUATED

Yellow fever virus F. tularensis Rotavirus

Poliovirus S. typhi

Measles / rubella / mumps viruses VZV

1940s to 1970s

6

Based on: Fletcher MA, Saliou P.

Vaccines and infectious disease.

EXS. 2000;89:69-88

Antiquity

1880s to 1890s

1920s to 1930s

1980s to present

Expanded Programme on

Immunization vaccines

Vaccines that have been used or are currently licensed

Page 7: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Thanks to novel technologies, new vaccines are

now possible

Novel technologies Targeted diseases

Conjugation Pneumococcal infections

Meningococcal infections

Subunits, with new

adjuvant formulations

Influenza, pandemic or pre-

pandemic

Recombinant / virus-like

particles (VLP) Cervical cancer (HPV)

Live-attenuated Chicken-pox (VZV)

Herpes zoster (VZV latent)

Reassortments Diarrhea (rotavirus)

http://www.ifpma.org/pdf/2008_05_20_IFPMA_Value_of_Vaccines.pdf 7

Page 8: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

H. influenzae type b

N. meningitides (4 Serogroups) CONJUGATE

Ps. aeruginosa (8 serotypes)

S. pneumoniae (13 serotypes)

S. typhi

H. influenzae type b S. typhi POLYSACCHARIDE

N. meningitides (Serogroups A, C, W135, Y)

S. pneumoniae (23 serotypes)

Influenza virus Hepatitis B virus SUBUNIT

HPV

B. pertussis

C. diphtheriae B. pertussis TOXOID

C. tetani

Rabies virus B. pertussis B. anthracis Hepatitis A virus INACTIVATED

S. typhi B. pertussis

V. cholera C. burnetti

Y. pestis Influenza virus

Japanese encephalitis virus

Poliovirus

Tick-borne encephalitis virus

Vaccinia M. tuberculosis B. anthracis Influenza virus LIVE-ATTENUATED

Yellow fever virus F. tularensis Rotavirus

Poliovirus S. typhi

Measles / rubella / mumps viruses VZV

1940s to 1970s

8

Based on: Fletcher MA, Saliou P.

Vaccines and infectious disease.

EXS. 2000;89:69-88

Antiquity

1880s to 1890s

1920s to 1930s

1980s to present

Expanded Programme on

Immunization vaccines

Vaccines that have been used or are currently licensed

Page 9: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

H. influenzae type b

N. meningitides (4 Serogroups) CONJUGATE

Ps. aeruginosa (8 serotypes)

S. pneumoniae (13 serotypes)

S. typhi

H. influenzae type b S. typhi POLYSACCHARIDE

N. meningitides (Serogroups A, C, W135, Y)

S. pneumoniae (23 serotypes)

Influenza virus Hepatitis B virus SUBUNIT

HPV

B. pertussis

C. diphtheriae B. pertussis TOXOID

C. tetani

Rabies virus B. pertussis B. anthracis Hepatitis A virus INACTIVATED

S. typhi B. pertussis

V. cholera C. burnetti

Y. pestis Influenza virus

Japanese encephalitis virus

Poliovirus

Tick-borne encephalitis virus

Vaccinia M. tuberculosis B. anthracis Influenza virus LIVE-ATTENUATED

Yellow fever virus F. tularensis Rotavirus

Poliovirus S. typhi

Measles / rubella / mumps viruses VZV

1940s to 1970s

9

Based on: Fletcher MA, Saliou P.

Vaccines and infectious disease.

EXS. 2000;89:69-88

Antiquity

1880s to 1890s

1920s to 1930s

1980s to present

Expanded Programme on

Immunization vaccines

Vaccines that have been used or are currently licensed

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Les vaccins combinés

10

« Fortunately,

medical

researchers have

been able to

combine tetanus,

smallpox and

rubella

vaccinations into

one shot »

Page 11: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Pediatric combination vaccines can protect children

against tetanus (T), diphtheria (D), whooping cough (P),

poliomyelitis (IPV), bacterial meningitis (Hib), and

hepatitis B (HBV)

Each new pediatric vaccine must be compatible with the

various infant immunisation schedules in place

Number of primary series doses (“two-dose” or “three-dose”)

Age at first dose and spacing between each primary dose

Association with other new vaccines

• Pneumococcal conjugate, meningococcal conjugate, rotavirus, influenza,

varicella, etc.

Pediatric combination vaccines, European Union (1)

11

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http://www.euvac.net/graphics/euvac/vaccination/pertussis.html

Primary Booster Revaccination(s)

Pertussis vaccination overview in the EU

12

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Young infants in some EU countries receive the whole-

cell pertussis vaccine

Three-vaccine combinations

• DTPw

Four-vaccine combinations

• DTPw | Hib

Five-vaccine combinations

• DTPw | IPV | Hib

Acellular pertussis vaccines have been introduced over

the last decade in many other EU countries

Four- to six-vaccine combinations

• DTPa | Hib | IPV | HBV

Pediatric combination vaccines, European Union (2)

13

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14

The challenge of new vaccines

« Good stability, lots of

antibodies, well

tolerated, safe, but

lacking a bit of a

protective immune

response… »

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WHO Pre-ICDRA Conference, Sept. 14, 2008, Bern

Vaccine Development Presents

Unique Challenges

Preventive vaccines are given to healthy people

Many vaccines are used widely and routinely in infants

Vaccines must be safe

Essential to maintain public confidence

Vaccines must be effective

Higher level of efficacy expected than for therapeutics

15

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Fletcher MA, Saliou P. Vaccines and infectious disease. EXS 2000;89:69-88

DISEASE

Doctor & Patient

Transmission

Reservoir

(Koch's postulate)

Incidence & prevalence

Vaccine efficacy

Disease classification

Possibility of diagnosis

Geographic distribution

Hospitalisation rates

Public perception of the vaccine PATHOGEN

Infectious disease experts VACCINE

Healthcare system

Keys to vaccine development

Age groups affected

Risk group affected

Public perception of the disease

Seriousness of the disease

Likelihood of treatment

16

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PERCEPTION OF VACCINATORS AND VACCINE RECIPIENTS

THE INFECTION IS SERIOUS BECAUSE IT Yes No Uncertain

inspires fear and dread

may kill the patient ("acute mortality")

makes the patient seriously ill ("acute morbidity")

predisposes to a secondary infection

leads to a chronic illness

may permanently disable the patient

INFECTION BY THIS PATHOGEN Yes No Uncertain

is incurable

resists palliative / symptomatic treatments

Gravity of the infection

Gravity of the infection

Possibility of treatment

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PERCEPTION OF PUBLIC HEALTH AUTHORITIES Gravity of the infection

Modes of transmission

Reservoir / carrier state

THE MICRO- ORGANISM IS TRANSMITTED TO MAN VIA Yes No Uncertain

air

animal hosts

food

health care facilities

sexual activity

vectors

water

Yes No Uncertain

HE ONLY RESERVOIR IS MAN

with a prolonged period of infectiveness

with isolation precautions or quarantine recommended

INFECTION LEADS TO A CHRONIC CARRIER STATE

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PERCEPTION OF PUBLIC HEALTH AUTHORITIES Gravity of the infection

Incidence & prevalence of the disease

Geographic distribution

THIS INFECTION IS CONSEQUENTIAL BECAUSE Yes No Uncertain

it has a high attack rate

incidence (seasonal) has been increasing recently

incidence (secular) has been increasing recently

recent outbreaks suggest an impending epidemic

recent epidemics were severe

it's an "emerging or re-emerging" infectious disease

it is prevalent in the population

THE DISEASE IS FOUND IN Yes No Uncertain

China

Established Market Economies

Former Socialist Economies

India

Latin America and the Caribbean

Middle East Crescent

Other Asia and Islands

Sub-Saharan Africa

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PERCEPTION OF PUBLIC HEALTH AUTHORITIES Gravity of the infection

Populations most affected by the disease

INFECTION PRIMARILY AFFECTS Yes No Uncertain

neonates

infants

toddlers

children

adolescents

young adults

adults

the elderly

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PERCEPTION OF PUBLIC HEALTH AUTHORITIES Gravity of the infection

High-risk groups

PARTICULAR "AT RISK GROUPS" HAVE BEEN IDENTIFIED: Yes No Uncertain

certain occupations

children in day-care centers

chronically-ill people

frail elderly

hospital patients

immuno-suppressed

indigent

military recruits

people with a lifestyle risk

refugees

students

the poor

travellers

Page 22: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

PERCEPTION OF PUBLIC HEALTH AUTHORITIES Gravity of the infection

The vaccination option

VACCINE PROPHYLAXIS IS REASONABLE BECAUSE Yes No Uncertain

there are few predominant sero-groups or serotypes

infection pre-disposes to secondary infections

natural infection confers lifelong protective immunity

elimination or eradication of the agent is possible

the pathogen is resistant to a first-line antimicrobial agent

vaccination is simpler than current preventive measures

an effective cure is unavailable

Page 23: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

PERCEPTION OF HEALTHCARE SYSTEM Gravity of the infection

Clinical presentation of the patient THE PATHOGEN CAUSES Yes No Uncertain

an infectious or parasitic disease

AIDS

bacterial meningitis & meningococcemia

childhood-cluster diseases

dengue

diarrheal diseases

hepatitis B / hepatitis C

intestinal nematode infections

japanese encephalitis

leprosy

malaria

STDs (except AIDS)

trachoma

tropical-cluster diseases

tuberculosis

a respiratory infection

lower respiratory infections

otitis media

upper respiratory infections

a maternal condition

a "condition arising during the perinatal period"

a malignant neoplasm

diabetes mellitus

a neuro-psychiatric disorder

a sense organ disease

a cardiovascular disease

a respiratory disease

a digestive disease

a genito-urinary disease

a skin disease

a musculo-skeletal disease

a congenital anomalie

an oral condition

Page 24: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

PERCEPTION OF PUBLIC HEALTH AUTHORITIES Gravity of the infection

Burden of the infectious disease

Yes No Uncertain

INFECTION LEADS TO HOSPITALIZATION

INFECTION LEADS TO LONG-LASTING INCAPACITATION

Burden of the infectious disease

THE INFECTION CAN BE DIAGNOSED BECAUSE Yes No Uncertain

of a readily-identifiable clinical syndrome

standard laboratory methods identify the pathogen

Public perception of vaccination VACCINATION WOULD BE READILY ACCEPTED SINCE Yes No Uncertain

each vaccine will recognize benefit from immunization

the popular press highlights this pathogen / disease

Opinion Leaders recommend development of the vaccine

Page 25: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

www.evm-vaccines.org www.evm-vaccines.org www.evm-vaccines.org www.evm-vaccines.org www.evm-vaccines.org www.evm-v

The needs and gaps in the vaccine R&D pipeline and

technology transfer

Vaccines

October 2010

Michael Watson,

Vice President Global Immunisation Policy

EVM Board

Chair of IFPMA B&V Committee

Sanofi pasteur, France

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Vaccines’ contribution to Europe’s future

26

Filling the Vaccine Funnel

Phase 1

Research & Pre-clinical

Registration

Phase 2

Phase 3

Launch

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PUSH & PULL for Research & Pre-Clinical

Vaccines’ contribution to Europe’s future

27

PULL: Target priorities, Market attractiveness, Financing, Prizes, Recognition, Corporate social responsibility, Intellectual property

Assay development

& validation

High-throughput

screening

Epidemiology

Antigens

Adjuvants

Animal

models

Understanding

disease pathology

Immunology

Disease/targets

Delivery

platforms

In-vitro

models

Vaccinology

VISION

PUSH: Competence, Resources, Funding & useful data in Vaccinology

Research & Pre-clinical

Page 29: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Many important new and emerging

targets

Unmet needs - HIV, TB, malaria, HCV

Socio-politico-financial

feasability - TB, malaria

Emerging disease - SARS, pandemic flu,

Clostridium difficile

Re-emerging diseases - TB

Migrating diseases - JE, Dengue, West Nile virus

Resistant diseases - MRSA, TB

Social acceptability - HSV-2, Chlamydia

Improve existing

vaccines - Rabies, TB (BCG)

Vaccines’ contribution to Europe’s future

29

Page 30: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

The easy targets have been done!

The remaining targets are difficult…

Approximately 70 infectious disease vaccine targets: »~25 vaccines already have been developed

»~45 vaccines remaining

»Antigenic diversity

»HIV, HCV, rhinoviruses

»Biology of the pathogen

»Chlamydia, HSV, TB

»Limits of ‘natural’ immunity

»HIV, HSV-2, Chlamydia, TB

»Immunopathology

»SARS, RSV, Dengue (?)

Of those where market potential exists, there are

technical challenges

Vaccines’ contribution to Europe’s future

30

Page 31: Vaccine success stories: from initial idea to the market · Vaccine success stories: from initial idea to the market Jerusha Naidoo MBChB (UCT) Pfizer Vaccines ... Yellow fever virus

Technic

al

Feasi

bil

ity

Many diseases, but a technical feasibility and market

attractiveness that varies

Market Attractiveness

Hepatitis E

/ Anthrax

/ Chikungunya

E. coli / UTI

E. coli 0157 /

Enterovirus 71 /

H. pylori (therapeutic) /

/ Dental carries

S. paratyphi /

ETEC /

GAS /

/ Leishmaniasis

Norovirus /

/ Otitis media

Parvo B19 /

PIV /

/ Schistosomiasis

Shigella [protein] /

Rhinovirus /

Meningococcus Serogroup B /

S. aureus /

Staphylococcus CoNS /

RSV /

Bocavirus /

C. jejuni /

/ Cholera

Epstein-Barr virus /

HHV-6 /

Legionella /

M. pneumoniae /

M. gonorrhea /

Trypanosiasis /

Hantavirus /

Hepatitis C (therapeutic) /

hMPV /

HSV 2 /

hMPV-PIV combo /

CMV /

P. acnes /

Enterovirus (T1D) /

Enterococcus sp /

/ Latent TB

Acinetobacter baumannii /

Klebsiella /

E. coli / Nosocomial

P. aeruginosa /

HPV (L2)

/ TBE

Flu (M2E)

/ Periodontal

100 %

0 % 100 %

Preferred Quadrant

Pro

gre

ss

th

e s

cie

nce

GBS

Create the incentive

Caveat - Personal not EVM classification 31 EVM 2010 - Vaccines’ contribution to Europe’s future

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Progressing the science

Vaccines’ contribution to Europe’s future

32

PULL: Target priorities, Market attractiveness, Financing, Prizes, Recognition, Corporate social responsibility, Intellectual property, VISION

Assay development

& validation

High-throughput

screening

Epidemiology

Antigens

Adjuvants

Animal

models

Understanding

disease pathology

Immunology

Disease/targets

Delivery

platforms

In-vitro

models

Vaccinology

VISION

PUSH: Competence, Resources, Funding & useful data in Vaccinology

Research & Pre-clinical

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Vaccines’ contribution to Europe’s future

33

Antigen presenting -

platforms

Antigen discovery

Formulation &

adjuvants

Modes of administration

(Needleless devices)

Analysis of immune

responses in humans (immunochips, robots,

flow cytometry…)

Molecular

adjuvants, emulsions,

microparticles

Viral vectors, DNA, peptides,

recombinant proteins, chimeric

viruses, VLPs, …

Patch, microneedle,

nasal route, …

Structure determination,

genome mining

(bioinformatics)

Vaccine-specific goals of progressing the science

New production methods

ANTIGEN PRESENTATION ANTIGEN

FORMULATION

DELIVERY SYSTEM

MEASUREMENT OF

IMMUNOGENICITY

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Vaccines’ contribution to Europe’s future

34

Vaccine R&D & Lifecycle Activities

Many years 1-2 years 4-8 years 1 year 2 years Continued

Exploratory

PRECLINICAL CLINICAL DEVELOPMENT REGISTRATION

• Antigen

production

• Assay

development

• Animal model

validation

• Preclinical

toxicity

Phase I

•Safety

•Initial

•immunogenicity

Phase II a

• Dose finding

• Dose/schedule

finding

• Immunogenicity

Phase II b

• Early POC

Phase III

• Large scale safety

+

• Lot to lot

consistency

+

• Non-inferiority

(combos)

or

• Efficacy

Lifecycle

management

Launches

Industrial investment

Filing

Post-marketing

commitments

• Safety

• Effectiveness

• Identification

of target

antigens

• Understanding

of pathologies

• Natural history

of disease

• Animal model

Preclinical Proof-of-concept

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Vaccines’ contribution to Europe’s future

35

1-2 years

PRECLINICAL

Vaccine R&D & Lifecycle - Partnerships

Many years 4-8 years 1 year 2 years continue

Exploratory CLINICAL DEVELOPMENT REGISTRATION

Launch Industrial investment

Filing Preclinical

Academio-Governmental-Regulatory-Policy-funding axis

BioTechs

R&D Based Vaccine Industry/Producers

“Me-Too” Vaccine Industry/Producers – Accelerated timelines/reduced costs

Lifecycle

management

Proof-of-concept

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Vaccines’ contribution to Europe’s future

36

The value of partnership

In-house expertise • Boosters, adolescent & adult – SP & GSK

• Combination infant vaccines

- MMRV, Pentavalent and Hexavalent – SP/SPMSD, Merck & GSK

• H1N1 vaccines – SP, Novartis, Baxter, GSK, Crucell

• Menactra® – SP

• Menveo® – Novartis

• Prevnar® – Pfizer

• Synflorix® – GSK

• Zostavax® – Merck

Partnerships • Cervarix® – GSK, MedImmune, Corixa, NCI, University of Rochester

• Flumist® – Wyeth, MedImmune

• Gardasil® – Merck, CSL, NCI, University of Queensland

• Hib conjugate – GSK, Merck, SP, University of Rochester

• Rotarix® – GSK, AVANT Immunotherapeutics, University of Cincinnati Children's Hospital

• Rotateq® – Merck, Wistar Institute and CHOP

Provenance of recently-licensed vaccines

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37

Funding and Financing

Self-funding ↔ Industry, hospitals

Equity / Private ↔ Biotech

Government ↔ Academia, hospitals

Non-governmental ↔ Industry, biotech,

academia, NGOs

Partnerships ↔ Any or all

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38

Generating “Vaccine Vision”

•Clear shared understanding of the future:

•Disease impact and target priorities:

• Epidemiology, morbidity, mortality and socio-economic

impact

•Demand

• Realistic product profile, production & presentation

• Realistic assessment of development costs and timelines

• Realistic assessment of future value (NPV)

• Clear vision of future demand, price and financing

•Political will

• Shared commitment to need, priorities, demand, price and cost

•Partnerships

• Who will play what role?

•Multilaterally prepared to take some risks

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GAVI Update by Nina Schwalbe

Marrakesh 2012 39

39

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GAVI Overview

40

• GAVI is a public-private global health partnership committed to

saving children’s lives and protecting people’s health by

increasing access to immunization in poor countries.

• The Alliance brings together developing country and donor

governments, the WHO, UNICEF, the World Bank, the vaccine

industry, research and technical agencies, civil society, the Bill &

Melinda Gates Foundation and other private philanthropists.

• Efforts directed through the financing mechanisms of the GAVI

Fund optimize product availability and market pricing, and

coordinate the field support necessary to plan and implement

programs in the world’s poorest countries.

GAVI Business Model

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GAVI’s Partnership Model

As a public-private partnership, GAVI represents the sum of its partners' individual strengths, from WHO's scientific expertise and UNICEF's procurement system to the financial know-how of the World Bank and the market knowledge of the vaccine industry. GAVI aims to maximize its partners' expertise, build upon existing networks and facilitate collaboration to find new solutions.

The Bill & Melinda Gates Foundation's initial five-year pledge of US$ 750 million in 1999 provided the seed money to launch GAVI.

As a co-founder of GAVI and the UN's specialist agency on global health issues, WHO is a key implementing partner.

As the world's biggest buyer and supplier of vaccines for developing countries, UNICEF has a pivotal role in the GAVI Alliance.

The World Bank brings the expertise of the world's biggest source of development assistance to the Alliance.

41 Source: http://www.gavialliance.org/about/partners/the-partnership-model/

Developing country governments

Industrialized country

governments

Civil society

Developing country pharmaceutical

industry

Industrialized country

pharmaceutical industry

Research and technical health

institutes

Developing countries are the most important part of the Alliance. They apply for support, manage grants and finance immunization.

Industrialized country governments‘ experience in overseas development and funding ensure health is prioritized in aid programs.

CSOs help deliver vaccines to remote communities, implement vaccine programs and advocate for immunization.

GAVI aims to make vaccines more affordable for low income countries by expanding the range of suppliers to include developing country manufacturers.

GAVI harnesses the technical expertise of the IFPMA to ensure new vaccines are available that address the needs of developing countries.

Partnership with the research community allows GAVI to tap in the latest information and thinking from the scientific, medical and product delivery communities.

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Conclusions

42

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“Vaccination in the 21st Century”

AGE GROUPS VACCINES

Prenatal Group B Streptococcus, RSV

Neonatal RSV, rotavirus, hepatitis B, M. tuberculosis

2 to 6

months

Pediatric combinations (DTacP / Hib / IPV / hepatitis B),

pneumococcus / meningococcus, RSV / PIV, adenovirus,

hepatitis A

Under-

industrialized

Diarrheal (ETEC, Shigella, Campylobacter)

Vector-borne (malaria, JEV, dengue fever)

1 to 2 years MMRV, pediatric combinations boosters

Under-

industrialized Schistosoma, rabies, S. typhi

4 to 6 years Influenza (intranasal), MMRV booster, Streptococcus mutans

(oral)

11 to 12

years STDs (HIV, HPV, HSV-2), pre-pregnancy (CMV, parvovirus)

Young

adults TdacP, Helicobacter pylori, [travel vaccines]

>55 years Influenza (booster), pneumococcus (booster), varicella-zoster

(booster)

Source: Plotkin, S. A. (1996). "A hundred years of vaccination: the legacy of Louis

Pasteur." Pediatric Infectious Disease Journal 15(5): 391-4 43

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Seriousness of disease & incidence of infection

Seriousness of disease This is a deadly disease (high "acute mortality") Infection causes permanent disability

Acute morbidity is considerable

The pathogen is resistant to chemotherapy

Incidence of infection Disease rates have attracted Public Health Authority

attention

Perception of the vaccine-preventable disease Is considered to be easily contracted

Inspires fear and dread

44

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H. influenzae type b

N. meningitides (4 Serogroups) CONJUGATE

Ps. aeruginosa (8 serotypes)

S. pneumoniae (13 serotypes)

S. typhi

H. influenzae type b S. typhi POLYSACCHARIDE

N. meningitides (Serogroups A, C, W135, Y)

S. pneumoniae (23 serotypes)

Influenza virus Hepatitis B virus SUBUNIT

HPV

B. pertussis

C. diphtheriae B. pertussis TOXOID

C. tetani

Rabies virus B. pertussis B. anthracis Hepatitis A virus INACTIVATED

S. typhi B. pertussis

V. cholera C. burnetti

Y. pestis Influenza virus

Japanese encephalitis virus

Poliovirus

Tick-borne encephalitis virus

Vaccinia M. tuberculosis B. anthracis Influenza virus LIVE-ATTENUATED

Yellow fever virus F. tularensis Rotavirus

Poliovirus S. typhi

Measles / rubella / mumps viruses VZV

1940s to 1970s

45

Based on: Fletcher MA, Saliou P.

Vaccines and infectious disease.

EXS. 2000;89:69-88

Antiquity

1880s to 1890s

1920s to 1930s

1980s to present

Expanded Programme on

Immunization vaccines

Vaccines that have been used or are currently licensed

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Vaccine success stories: from initial idea to the market

Mark A. Fletcher, M.D

Pfizer Vaccines, Paris, FRANCE

[email protected]