www.gavi.org

TODAY’S VACCINATION ECOSYSTEM STATUS – MARKET-SHAPING PRINCIPLES, PRACTICE, IMPACT AND LESSONS LEARNT

GAVI PERSPECTIVE

Aurélia Nguyen Tuesday 20 January 2015, Veyrier-du-Lac, France

AGENDA

• Market shaping in the Gavi context

• Objectives

• Practice

• Results so far

• Challenges

GAVI, THE VACCINE ALLIANCE

Gavi, the Vaccine Alliance, is a public-private partnership focused

on saving children's lives and protecting people's health by

increasing access to immunisation in poor countries

• Pentavalent

• Pneumococcal

• Rotavirus

• Human

papillomavirus

• Yellow fever

• Measles second

dose

• Inactivated polio

vaccine

• Yellow fever

• Meningococcal A

• Measles-rubella

• Japanese

encephalitis

For Board

review Routine Campaign Stockpile

(for outbreak response)

(fro

m le

ft to r

ight)

: G

avi/2013/A

dri

an B

rooks, G

avi/2012/S

ala

Lew

is,

GA

VI/O

livie

r

Asselin

, G

avi/2012/A

dri

an B

rooks

• Yellow fever

• Meningitis

• Cholera

• (Ebola)

• Malaria

CURRENTLY SUPPORTED GAVI VACCINATION PROGRAMMES

GAVI ADOPTED AN EXPLICIT STRATEGIC GOAL TO SHAPE VACCINE MARKETS…

4 Strategic goals guide Gavi’s mission, 2011-2015

Vaccine goal

Health systems

goal

Financing goal

Market shaping

goal

Accelerate the

uptake and use

of underused and

new vaccines

Contribute to

strengthening

the capacity of

integrated health

systems to deliver

immunisation

Increase the

predictability of

global financing

and improve the

sustainability of

national financing

for immunisation

Shape vaccine

markets to ensure

adequate supply of

appropriate, quality

vaccines at low and

sustainable prices

AGENDA

• Market shaping in the Gavi context

• Objectives

• Practice

• Results so far

• Challenges

…WHICH IS UNDERPINNED BY SUPPLY & PROCUREMENT OBJECTIVES

These objectives aim to meet Gavi’s market shaping goal by

balancing supply and demand, ensuring security of supply,

minimising the cost of vaccines, and fostering development of

appropriate and quality vaccines

AGENDA

• Market shaping in the Gavi context

• Objectives

• Practice

• Results so far

• Challenges

DEMAND FORECASTING IS A CORE ACTIVITY

Provides early recognition and estimates future needs

Allows Gavi Alliance and manufacturers to effectively plan for the long term

Gain better understanding of Gavi’s vaccine markets

GAVI Alliance Strategic Goal 4

Demand forecasting

0 2 5 11

18 23 25 27 28 28 29 30 26 25 23 23 22 23 23 24 22

- - -

-

-

- 1

1 3 4 4 5 9 11 14 14 15 15 15 15 17

- - -

-

-

- -

1 3 4 5 5 5 5 5 5 6 6 6 6 6

1 1 2

1

3

3

4 4

5 7

8 10 12 12 12 12 12 12 12 12 12

103 130 141

155

167

170

172 178

182

194 234

260 269 274 276 277 278 280 281 283 284

-

10

20

30

40

50

60

70

80

90

100

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034

Do

ses

(Mill

ion

s)

Base Unconstrained*: Total Required Supply for 94 Countries by Financing

Other

Nigeria

Graduated

Eligible

2014 SDFv9 Base Uncon (3 dose)

2014 SDFv9 Base Uncon (2 dose)

EXAMPLE SDF: HPV DEMAND 2014-2034

* Scenario: National base unconstrained. Gavi eligible demand is forecasted to peak at 30 million doses in 2026

Categories:

- Eligible: Includes doses that Gavi directly finances and doses that are co-financed by the country.

- Graduated: Doses related to countries that have introduced HPV with Gavi support and have graduated during the forecasting time period.

- Other: Doses from Gavi73 countries that introduce HPV without Gavi and non-Gavi eligible LMICs.

GAVI Strategy

Objectives prioritized Target outcomes

Objective 1 Target outcome TO 1

Target outcome TO 2

Objective 2 Target outcome TO 8

Action plan Interventions

Accountable, Responsible, Supporting

Measured Output

Due Date / Status For TO 1

For TO 2

Etc.

Market intelligence

Market analysis

Vaccine-specific documents: Short to long term view of how the market

should evolve for particular vaccines and identification of mechanisms to

influence the supply and price environment and achieve set targets

Alliance

coordination

SUPPLY AND PROCUREMENT ROADMAPS SET TARGETS & ENSURE COORDINATION

Roadmap structure

AGENDA

• Market shaping in the Gavi context

• Objectives

• Practice

• Results so far

• Challenges

SINCE 2001, GAVI HAS INCREASED THE VACCINE MARKET SUPPLIER BASE

5 suppliers from 5 countries of production

Source: UNICEF Supply Division

2001

SINCE 2001, GAVI HAS INCREASED THE VACCINE MARKET SUPPLIER BASE

Source: UNICEF Supply Division and WHO list of pre-qualified vaccines, 2014

* Includes 13 Gavi suppliers and manufacturer of select pre-qualified Gavi vaccines

4

China 1

2014

15 manufacturers* from 11 countries of production

HOWEVER, SOME GAVI VACCINE MARKETS ARE MORE MATURE THAN OTHERS

Manufacturers with pre-qualified vaccines (as of Dec 2014) Supply = Demand

Pentavalent Yes (2013 is

first year)

Yellow fever No

Rotavirus No (product

preference imbalance)

PCV Yes (needs careful

management)

Men A Yes

MR Yes

HPV Yes

IPV Yes (needs careful

management)

JE Yes

Cholera

GAVI IS SET TO ACHIEVE ITS 2015 PRICE TARGET, BUT MORE NEEDS TO BE DONE

* Future targets are not publicised to avoid setting a minimum price.

Source: UNICEF Supply Division, 2014.

Cost to fully immunise a child with pentavalent,

pneumococcal and rotavirus vaccines reached a new low

in mid 2014

AGENDA

• Market shaping in the Gavi context

• Objectives

• Practice

• Results so far

• Challenges

PENTA/PCV/ROTA PROJECTED TO ACCOUNT FOR >75% OF 2016-2020 VACCINE COSTS

HOW TO ENSURE FINANCIAL SUSTAINABILITY FOR GRADUATING COUNTRIES?

19

MANUFACTURER PRICE COMMITMENTS FOR GRADUATED COUNTRIES

20

Manufacturer Commitment to graduated countries

Pentavalent*

Crucell • Access to Gavi price through 2020

Sanofi Pasteur / Shantha • 3 years access to Gavi price post-graduation**

Biological E • No commitment

LG Life Sciences • No commitment

Panacea • No commitment

Serum Institute • No commitment

Pneumococcal

GSK

• Access to AMC “tail price” (AMC supply

significantly diminishes from ~2023)

• 5 years price “freeze” post-graduation

Pfizer • Access to AMC “tail price” (AMC supply

significantly diminishes from ~2023)

Rotavirus GSK • 5 years price “freeze” post-graduation

Merck • No commitment

HPV GSK • 5 years price “freeze” post-graduation

Merck • No commitment

Notes: Gavi is currently engaging with manufacturers to try to extend the scope of some of these commitments and to

secure commitments from additional manufacturers. Sanofi Pasteur / Shantha agreement also covers YF and Measles.

* GSK is not expected to supply pentavalent vaccine to Gavi countries after 2014

** For first 16 countries only

Devices

Vaccine preparation/delivery technologies

Thermostability Reduction of vaccine damage from exposure to high or low

temperatures

WHAT INNOVATIONS WILL MAKE A DIFFERENCE?

Presentation & Packaging Size and doses per vial

Vaccine labelling and tracking

Combinations & Schedules

Multiple antigens in one vaccine

Number or timing of doses

Appropriate, effective, safe Improving protection/safety conferred in GAVI countries

VACCINE DELIVERY INNOVATION: UNIJECT

• Product gained prequalification

in December 2014

• Developed to meet needs of low/lower-middle income countries

• New delivery model

• Simplifies vaccine administration

- Reduction of average time per injection

• Could facilitate outreach

- Greater official lay vaccinator integration into immunization activities

- Reduces missed opportunities by ensuring syringe and vial always

available together

- Decreased weight and volume (versus 1 dose vials only)

• Availability to Gavi-supported countries under review

• Initial use (limited to the current capacity)

• Evaluate

>17,000 cases

> 6,000 deaths

EBOLA VACCINE INNOVATION: A MARKET FAILURE & HUMAN SECURITY CHALLENGE

Affects the entire region,

continent…

• WB: Ebola could

cost West Africa

US$ 32 billion

by 2015

• IMF: sub-Saharan

Africa growth forecast

down from 5.5% to 5%

(largely Ebola)

• Morbidity and mortality from

other diseases on the rise

Surrounding

and high-risk

countries

>17,000

cases

> 6,000

deaths

… with risk of further spread

to other parts of the world

4 RECOMMENDED AREAS FOR GAVI ACTION

Recovery of health and

immunisation systems

# cases

(illustrative)

Time Production &

Procurement

funding

Future outbreak

preparedness

1

4

Funding vaccine roll-out

2

Funding vaccine roll-out

2

3

Current

outbreak

Potential

future

outbreak

(magnitude

unknown)

Future

outbreak with

stockpile

present

CHALLENGES WITH MEASURING RESULTS

Change in vaccine price->

Move to measuring a more

holistic view of costs

Security of supply ->

Move to measuring

healthy markets

*Future targets are not publicised

to avoid setting a minimum price

Can Gavi’s existing SG4 indicators be improved? The aim is to have meaningful, transparent and measurable

indicators of progress in shaping vaccine markets

Source: UNICEF Supply Division, 2014

Gavi/2012/Olivier Asselin

Appropriate Products

???

SG4 indicators

www.gavi.org

THANK YOU