Perspectives for Vaccines Outside High-income Countries:

From Experience at Gavi, The Vaccine AllianceMugen UJIIE M.D. M.T.M

Chief of Travel Clinic / Director of Vaccination Support Center

Disease Control and Prevention Center

National Center for Global Health and Medicine

15:30-16:10 Dec 13th, 2019

Email: mgujiie@hosp.ncgm.go.jp

Twitter: @carpe_diem0820

https://www.sciencemag.org/news/2017/04/here-s-visual-proof-why-vaccines-do-more-good-harm

Characteristics of Vaccine

Vaccinee can not recognize the diseases prevented with vaccines, so the effectivenss of vaccination must be scientifically evaluated and understood as knowledge.

On the other hand, an adverse event that occurred after vaccination may be evaluated as a side effect as only healthy people receive immunization for prevention.

• Vaccines are one of the greatest achievements of biomedical science and public health.

Achievements in Public Health, 1900-1999 Impact of Vaccines Universally Recommended for Children -- United States, 1990-1998

Impact of immunization on the Number of Annual Cases of Disease in The USA

Vaccine Fact Book 2012, PhRMA

Immunization currently prevents 2-3 million deaths every year• Immunization prevents deaths every year in all age groups

from diseases like diphtheria, tetanus, pertussis (whooping cough), influenza and measles. It is one of the most successful and cost-effective public health interventions. An additional 1.5 million deaths could be avoided, however, if global vaccination coverage improves.

WHO Facts,Detail, Immunizationshttps://www.who.int/news-room/facts-in-pictures/detail/immunization

Gavi, The Vaccine Alliance（Gavi）

• A global partnership organization established in 2000 at the annual meeting of the World Economic Forum (Davos Conference)

• To aim at increasing the fairness of children's right to vaccination and improving the vaccine gap in the world by linking the stakeholders such as low-income countries with many children who die of preventable infectious diseases, funding countries for immunization , WHO, UNICEF, World Bank, Bill & Melinda Gates Foundation, the vaccine industry, research and technical institutions, civil society organizations, etc.

• Since 2000, Gavi's support activities have estimated that more than 760 million children have received vaccinations, and it has saved more than 13 million lives between 2000 and 2018 (Progress Report 2018).

• Japan plans to invest a total of US $ 148.5 million from 2011 to 2020

Gavi in May 2016 - April 2017:

• Senior Programme Manager, Vaccine Implementation at Gavi, the Vaccine Alliance (on Secondment), Geneva, Switzerland

• PCV Programme

The world before vaccines

Flu pandemic

1918-1920

> 50-100 million deaths worldwide

Smallpox

epidemic

INDIA

1974

15,000 deaths

Yellow fever

PHILADELPHIA

1793

>5,000 deaths

Cholera

pandemic

EUROPE

1829-1851

>200,000 deaths

Polio

NEW YORK

1916

6,000 deaths

Examples of major disease outbreaks

Smallpox1798 Rabies

1885

Typhoid1886

Cholera1896

Plague1897

Tuberculosis(Bacille Calmette-Guérin)

1927 Typhus1938

Tetanus toxoid

Pertussis1926

Diphtheriatoxoid

1923

Influenza1936

YellowFever1935

Polio (injected inactivated)(1955) Mumps, live

(1967)

Anthrax, secreted proteins (1970)

Pneumococcus polysaccharides (1977)

Hepatitis B (plasma derived) (1981)Tick-borne encephalitis (1981)

Hepatitis B surface antigen recombinant (1986)

Typhoid (salmonella Ty21a), Live (1989)

13 valent pneumococcal conjugates (2010)

Zoster, live (2006)Rotavirus (attenuated and new reassortants (2006)Human papillomavirus recombinant quadrivalent (2006)

Cold-Adapted Influenza (2003)

Rotavirus reassortants (1999)Meningococcal conjugate* (group C) (1999)

Acellar pertussis, various (1996)Hepatitis A, inactivated (1996)

Cholera, live attenuated (1994)Typhoid (Vi) polysaccharide (1994)

Japanese encephalitis, inactivated (1992)

Polio (oral live) (1963)Measles, live (1963)

Rubella, live (1969)

Meningococcal polysaccharides (1974)

Adenovirus (1980)Rabies, cell culture (1980)

H. influenza type B polysaccharide (1985)

H. influenzae conjugate* (1987)

Varicella (1995)

Cholera (recombinant Toxin B) # (1993)

Cholera (WC-rBC) (1991)

Lyme OspA, protein (1998)

Pneumococcal conjugate, heptavalent* (2000)

Japanese encephalitis (Vera-cell) (2009)Cholera (WC only) (2009)Human papillomavirus recombinant bivalent (2009)

Meningococcal quadrivalent conjugates* (2005)

Quadrivalent influenza vaccines (2012)Meningococcal C and Y and Haemophilus influenza type b (2012)

Meningococcal B (2013)Influenza vaccine (baculovirus) (2013)

Human papillomavirus, 9-valent (2014)

Enterovirus (2015)Dengue (2015)

Cu

mu

lative

nu

mb

er

of va

ccin

es

Acceleration in vaccine development

Sources: timeline as of the end of 2010: Plotkin SA, Plotkin SL. The development of vaccines: how the

past led to the future. Nature Reviews Microbiology, AOP, 2011, 1–5. 2011-2015: US Food and Drug

Administration (FDA)

50+ licensed vaccines1798–2015

Fully protecting children with vaccines

1. Bacillus Calmette Guerin (BCG) (1 dose)

2. Diphtheria (3 doses)

3. Tetanus (3 doses)

4. Pertussis (3 doses)

5. Hepatitis B (3–4 doses)

6. Hib (3 doses)

7. Pneumococcal (3 doses)

8. Polio* (OPV and/or IPV, 3–4 doses)

9. Rotavirus (2–3 doses)

10. Measles (2 doses)

11. Rubella (1 dose)

12. HPV (2 doses) (adolescent girls)

Recommended for children in all countries

About vaccines

1980

2017

Vaccines have changed our lives

Note: shows reduction in the number of reported cases. Source: WHO: Global and regional immunization profile, July 2017.

Available at: http://www.who.int/immunization/monitoring_surveillance/data/gs_gloprofile.pdf

Tetanus Diphtheria Pertussis Measles Polio

~ 90% reduction in common

vaccine-preventable

diseases

in lower-income

countries

by increasing

equitable use of

vaccines

and protecting

people’s health

Saving

children’s

lives

Gavi’s mission

Vaccine Alliance partners

IMPLEMENTING

COUNTRY

GOVERNMENTS

DONOR COUNTRY

GOVERNMENTS

CIVIL SOCIETY

ORGANISATIONS

VACCINE

MANUFACTURERS

PRIVATE

SECTOR PARTNERS

RESEARCH

AGENCIES

Why Gavi was launched: creating equal access to vaccines

• In 2000

Note: Only countries with universal national programmes are included. World Bank 2017 country classification has been applied to the whole time series.

Source: The International Vaccine Access Center (IVAC) VIMS database. Data as of 31 December 2017.

High-income countries

Low-income countries

% countries with national Hib vaccine programmes

72%

3%

100% 100%

In 2017

How Gavi supports countriesAbout Gavi

Health system strengthening

support

Tailored technical

support

Vaccine

support

About vaccines Healthy communities Closing the immunisation gap

There are currently 64 Gavi-supported countries (2017)9 countries have started fully self-financing their vaccine programmes introduced with Gavi support

DONOR CONTRIBUTIONS AND PLEDGES

• 2016–2020 donor contributions and pledges to Gavi*

• (US$ billion)

16#vaccineswork

• *Comprised of total contributions received and outstanding pledges to GAVI as of 30 June 2016. Total figures above do not include in-kind contributions.

• Source: Gavi, the Vaccine Alliance data as of 30 June 2016.

Continued

support

The Gavi business model: reinventing aid

Country

Country

Country

Country

Country

Country

Pooling demand of

poorest countries

Strengthening vaccine

delivery platforms

Long-term

funding

Donor base

Co-financing

Market shaping

Shaping

markets

Supply Demand

Accelerating

access to vaccines

Sustaining

immunisation

Transition

out of

support

Gavi’s resource mobilisation model: a three-pronged approach

US$ 330m

US$

696m

US$

1,676m

$

US$ 32m

US$ 133m

2000 2010 2016

growing

donor

contributions

1

increasing

country

co-financing

3

MORE SECURE VACCINE SUPPLY

• 2001: 5 suppliers from 5 countries of production

2001

Belgium 1

France 1

Switzerland 1

Senegal 1

Republic of Korea 1

Source: UNICEF Supply Division, 2016.

19 #vaccineswork

Republic of Korea 1

MORE SECURE VACCINE SUPPLY

2015

Senegal 1

Belgium 1

France 1

* Includes 15 Gavi suppliers and 1 manufacturers of prequalified Gavi vaccines.

** One US manufacturer also produces in the Netherlands.

Note: Country of production represents country of national regulatory agency responsible for vaccine lot release.

Netherlands 1

United States 2**

India 4

Indonesia 1

China 1

Russian Federation 1

Republic of Korea 2

Brazil 1

Sources: UNICEF Supply Division; WHO list of pre-qualified vaccines, 2016

20 #vaccineswork

• 2015: 16 manufacturers* from 11 countries of production

Accelerating access: our vaccine portfolioYear of first

introduction/

use of stockpile

PNEUMO-COCCAL

MULTIVALENT MENINGITIS

INACTIVATED POLIO

JAPANESE ENCEPHALITIS

ORAL CHOLERA

HPV (CERVICAL CANCER)

MEASLES-RUBELLAMENINGITIS A

YELLOW FEVER

HEPATITIS B

PENTAVALENT

HIB

2001 2002 2007 2008 2010 2013 2015 20172009 20142003 2004 2005 2006 2011 2012 2016 2018 2019

Gavi 1.0 Gavi 2.0 Gavi 3.0 Gavi 4.0

>430introductions

and

campaigns

since 2000EBOLA TYPHOID

MEASLES2ND DOSE

ROTAVIRUS

Affordable and sustainable vaccine prices

Cost to immunise a child

with a full course of:

Approx.

USA price:

US$ 950US$ 35(28～)

HEPATITIS B

PENTAVALENT

HIB

ROTAVIRUS

PNEUMOCOCCAL

INACTIVATED POLIO

MEASLES

RUBELLA

HPV (CERVICAL CANCER)

DTP

Available pneumococcal vaccines supported by Gavi, either WHO prequalified, or expected to be prequalified

Price/dose $ 3.50 $2.00 $3.30 $2.90 $3.05

0

20

40

60

80

100Im

mu

nis

atio

n c

ove

rag

e r

ate

(%

)

1980 1985 1990 1995 2000 2005 2010 2018

Immunisation coverage: closing the gap

.

Note: Includes DTP-containing vaccines, such as pentavalent vaccine.

Source: WHO/UNICEF Estimates of National Immunization Coverage, 2016

Expanded Programme

on Immunization takes off

Stagnating immunisation

coverageGavi support to world’s

poorest countries

High-income countries

Globalaverage

96%

86%81%

Launch of Gavi

Post-Gavi

increase

2000-2018

21% points

Lowest-income countries Gavi-supported countries

Elias Zerthouni,2019, Cell

GAVI’S CO-FINANCING POLICY•Country ownership and steps to sustainability

Gav

i/2

012

/Sal

aLe

wis

Initial self

financing

Preparatory

transition

Accelerated

transition

Fully self financing

100% of vaccine cost

variable duration variable duration 5 years 5 years(manufacturer price

commitments)

years

End of Gavi financing

Low-income country threshold

Eligibility threshold

Increasing GNI per capita

HOW THE CO-FINANCING POLICY WORKS

• Purpose: To enhance ownership and put countries on a trajectory towards financial sustainability to prepare for phasing out of Gavi support

Source: Gavi, the Vaccine Alliance, 2016

Improving health systems: key ingredients

Integrated

service

delivery

Health

service

workforce

Health

information

systems

Demand

promotion &

community

engagement

Management

&

coordination

Vaccine

supply chain

Gavi catalyses new partnerships and innovation

Immunisation cold chainVaccine innovation Data and technology

Rwanda launches world's first national drone delivery service powered by Zipline

Rwanda launches world's first national drone delivery service powered by ZiplineIn photos: how vaccines reach the most remote places on earth

Japanese company’s contribution

• Gavi, NEC, and Simprints to deploy world's first scalable child fingerprint identification solution to boost immunisation in developing countries

https://www.gavi.org/gavi-nec-and-simprints-to-deploy-world-s-first-scalable-child-fingerprint-identification-solution-to-boost-immunisation-in-developing-countries

Vaccines: saving lives and boosting economies

Reduced sickness

Improved

learning

Reduced burden

on families

Healthcare savings

Increased

productivity

Increased economic &

political stability

Healthy communities, healthy economies: Gavi’s impact

• Gavi-supported countries, 2000–2018

>760million

children immunised

keep people healthy

>13million

future deaths averted

vaccines save lives

>150 billion US$

costs averted

related to illness

stronger economies

~20countries

set to transition out of

Gavi support by 2020

sustainable future

Economic losses avoided by immunization

Vaccinations in 73 countries between 2001 and 2020 avoid more than 20 million deaths and save an estimated US $ 350 billion in illness costs.The estimated full economic and social value is USD 820 billion.

Bull World Health Organ. 2017

Pre-school

education

Community

health workers

Calculating immunisation’s return on investment

Public

infrastructur

e

Immunisatio

n

3x7x 9x 18x

(cost of illness)

48x(full income

approach)

The Economic Benefits of Public Infrastructure Spending in

Canada.

The Centre for Spatial Economics, September 2015

The rate of return to the HighScope Perry Preschool

Program.

Department of Economics, University of Chicago, April 2009

Strengthening primary health care through community health workers…

Dessalegn H, Chambers R, Clinton C, Phumaphi J, Sirleaf J, Evans T, et al. 2015

Return on investment from childhood

immunizations in low- and middle-income

countries, 2011-20.

Health Affairs. 35(2):199-207. Ozawa S, Clark S,

Portnoy A, Grewal S, Brenzel L, Walker D. 2016

• In Gavi-supported countries, 2011–2020

Estimates for vaccination’s ROI for the next decade 2021-2030: Taking into account the broader benefits of people living longer, healthier lives, the return on investment rises to US$ 54 per US$ 1 spent.

The immunisation gap

• 19.9million

are not fully protected with basicvaccines

~140

millionchildren born

every year

~80%are in Gavi-supported

countries

India

Nigeria

Pakistan

Indonesia

Other Gavi

Rest of

world

Number of children globally not receiving the third dose of DTP-containing vaccine, 2015.

Source: WHO/UNICEF Estimates of National Immunization Coverage, 2016

1 in 5 children

in Gavi-supported

countries do not get

a full course of

basic vaccines

Increase domestic

resources for immunisation

Improve data quality

Optimise supply chains

Strengthen country leadership

Shape markets

Accelerate vaccines

Gavi’s strategy for closing the gap

STRATEGIC GOALS

FOCUS AREAS: EXAMPLES

Strengthen immunisation delivery

Improve sustainability

Focus on

vaccine coverage and

overcoming inequity to

reach every child

2000–2020: ever accelerating impact

Future deaths

prevented

1 million

+4million

+3million

+5-6million

13-14

million

90 million

+280million

+200million

+300million

~900

millionChildren

immunised

2001-

2005

2006-

2010

2011-

2015

2016-

2020

Gavi’s strategic periods

2001-

2005

2006-

2010

2011-

2015

2016-

2020

Sources: Gavi strategic demand forecasts 9 and 10,

Investing together for a healthy future: the 2016–2020 investment opportunity

Kenya introduces cervical cancer vaccine nationally• APPROXIMATELY 800,000 GIRLS TO BE PROTECTED

ANNUALLY THROUGH INTRODUCTION OF HPV VACCINE INTO ROUTINE IMMUNISATION PROGRAMME

Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis

• The estimated number of patients with cervical cancer in the world in 2018 is approximately 570,000, and 311,000 people died. Estimated age-standardized incidence is 13.1 per 100,000 women worldwide, but varies widely by country, ranging from 2 to 75

Marc A, et al. LancetGlob Health 2019

• sa

New Ebola and Malaria vaccine programme

• Gavi will open a new funding window, with estimated investment of US$ 178 million between now and 2025 for the new Ebola vaccine programme.

• The Gavi Board approved US$ 11.6 million in further funding to support the RTS,S malaria vaccine implementation programme for 2021-2023.

Typhoid Conjugate Vaccine

• Pakistan became the first country in the world to introduce the World Health Organization (WHO)-recommended typhoid conjugate vaccine (TCV) into its routine immunization program.

• It is the first typhoid vaccine that can be given to children as young as 6 months of age and confers longer term protection against typhoid.

Transition from Gavi support

STAR, 22 Jan 2019Daily Trust, 17 Dec 2019

www.gavi.org

Thank you