www.gavi.org

Gavi Yellow Fever Diagnostic Initiative

Lee Hampton, MD, MSc14 March 2019

Reach every child

Conflict of Interest Disclosure: Nothing to Disclose

2

Gavi Background

3

in lower-income

countries

by increasing

equitable use of

vaccines

and protecting

people’s health

Saving

children’s

lives

Gavi’s mission

About Gavi

Vaccine Alliance partners

IMPLEMENTING

COUNTRY

GOVERNMENTS

DONOR COUNTRY

GOVERNMENTS

CIVIL SOCIETY

ORGANISATIONS

VACCINE

MANUFACTURERS

PRIVATE

SECTOR PARTNERS

RESEARCH

AGENCIES

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

About Gavi

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

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Yellow Fever and Laboratory Capacity

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Eliminate Yellow Fever Epidemics (EYE) –2017-2026

EYE strategy aims to build a global coalition of countries and

partners to tackle the increased risk of yellow fever epidemics

• Targets 40 countries considered most vulnerable to YF outbreaks

• 27 in the African region

• Strategy based around 3 key strategic objectives

1)Protect at-risk populations

2)Prevent international spread

3)Contain outbreaks rapidly

• Scientifically validated by SAGE in Oct 2016; Gavi Board approval in Dec 2016

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Gavi and Yellow Fever (YF)

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Gavi board has approved up to US$ 428 million

for yellow fever vaccine use during 2016-2020

• Routine immunization

• Preventive mass campaigns

• Outbreak reactive campaigns and vaccine stockpile

Yellow fever outbreaks are a major problem

• Outbreaks since 2015 include Angola, Brazil, DRC,

Ethiopia, Nigeria, Republic of Congo and Uganda

• 2016 DRC outbreak cost Gavi alone US$ 13.7 million

• YF vaccine supply improving but finite

Reliable YF diagnostic capacity can improve the

impact and efficiency of YF vaccine investment

• Yellow fever clinically similar to other diseases

• Laboratory testing needed to distinguish it

Timely detection and response prevents death and disease – Case of Angola YF outbreak

Source: Zhao et al,

Modeling the Large-scale

Yellow Fever Outbreak in

Luanda, Angola, and the

Impact of Vaccination,

PLOS Neg Trop Dis,

2018, 12:e0006158.

Time

Required for

Identification

& Laboratory

Confirmation

of Outbreak

Index Case

Aggressive vaccination response

estimated to have prevented over 360

deaths and 5200 cases in Luanda alone

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0

5.000.000

10.000.000

15.000.000

20.000.000

25.000.000

05-dec 05-jan 05-feb 05-mrt 05-apr 05-mei 05-jun 05-jul 05-aug

Cum

ula

tive

YF

Va

ccin

e D

ose

s S

hip

pe

d to

An

go

la

an

d D

RC

th

rou

gh

IC

G P

roce

ss

Cumulative doses shipped Angola + DRCCumulative doses shipped Angola

Spread of Angola YF outbreak

to the Democratic Republic of Congo

Time Required for

Identification and

Laboratory

Confirmation of

Outbreak Index

Case

More rapid yellow fever outbreak detection and response may allow more efficient vaccine use

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Average time needed to confirm yellow fever highlights need to improve laboratory testing

0 20 40 60 80 100

NUMBER OF DAYS

13

Sample arrives to National

Laboratory

National Laboratory completes

testing

National Laboratory

positive sample

received by courier

Sample received by

Regional Reference Laboratory

Regional Reference Laboratory completes

testing

Avg. 10

daysAvg. 2

days

Avg. 77

days

Avg. 11

days

Source: Based on site visits to Angola, Benin, Burkina Faso,,

Cameroon, CAR, Chad, Cote d’Ivoire, DRC, The Gambia, Niger,

Sudan, and Togo

Gavi Alliance assessments and stakeholder outreach have identified laboratory capacity gaps

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Data Source Gaps

- Yellow fever laboratory capacity

assessment

- Eliminating Yellow Fever

Epidemics Laboratory Technical

Working Group

- FIND yellow fever diagnostic

market assessment

- Laboratory capacity assessment

- Donor outreach

- Frequent stockouts of critical reagents

- Limited national Quality Assurance /

Quality Control (QA/QC) testing

- Insufficient YF training

- Sample transportation bottleneck

- Validated, standardized YF test kits not

available

- Lack of funding for YF testing supplies

and equipment

Gavi Support for Yellow Fever Diagnostic Laboratory Capacity

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Stakeholders have identified potential solutions for which Gavi Alliance has comparative advantage

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Problems Solutions

Validated, standardized YF Tests

not available

Limited QA/QC and proficiency

testing, insufficient YF training

Many samples not tested due to

stockouts of critical reagents

Sample transportation bottleneck

Lack of funding for YF testing

supplies and equipment

Market shaping to encourage

availability of validated YF test kits

Regular QA/QC, proficiency testing,

technical assistance, and training

Improved procurement of testing

materials

Facilitate intl. sample transportation

Improve natl. confirmation capacity

Funding provided in such a way to

ensure financial sustainability

Changes in YF marker of infection require that both molecular and serology test kits be available

17Waggoner JJ, Rojas A, Pinsky BA. 2018. Yellow fever virus: diagnostics

for a persistent arboviral threat. J Clin Microbiol 56:e00827-18.

Through pooled procurement, Gavi hopes to create sufficient market pull for validated YF Dx test kits

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Strongest level of

evidence for currently

available molecular (PCR)

YF tests

Level of evidence needed to

warrant laboratory network use

and Gavi support

Strongest level of

evidence for currently

available serology

YF tests

Sustainable financing to improve reliability in YF diagnostics

National governments

Gavi

Other donors

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• Countries will eventually need to provide funding

for YF diagnostic capacity and procurement

• National governments already covering some

core costs (e.g., staff, utilities, buildings)

• Country co-financing will not be required initially:

• Allow countries sufficient time to include co-

financing amount in their budget cycles

• Experience from other Gavi investments will be

leveraged in developing a sustainable system

• Gavi YF diagnostic laboratory capacity support will

complement other laboratory strengthening efforts

Gavi Board approved US$ 13.5 million for 2019-2021

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US$ 8.2 million• Diagnostic equipment and

supplies

US$ 5.3 million

• Technical assistance

• QA/QC testing

• Sample transportation

• Laboratory network coordination

Diagnostic Procurement

Laboratory Network

Capacity

Applies to African countries eligible for Gavi support at high risk for YF

Countries can continue to use other Gavi funds for general laboratory capacity

Yellow fever laboratory capacity included in Gavi country transition process

Gavi yellow fever diagnostic initiative focused but multifaceted

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Goal is to allow better targeting of YF vaccine use, particularly by

improving timeliness and completeness of YF laboratory network testing

Multiple partners are already involved, including:

• WHO

• U.S. CDC

• National public health yellow fever laboratories

• EYE laboratory technical working group members

Number of partners involved will expand over time

Although focused on yellow fever, there is potentially scope for

collaboration to address general challenges, including:

• International and domestic sample transportation

• Laboratory quality assurance

• Institut Pasteur Dakar

• Uganda Viral Research Institute

• Centre Pasteur Cameroon

• FIND

• Erasmus MC

www.gavi.org

Questions?