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Board -2019 -Mtg -3-Doc 11

Section A: Executive Summary
Context
The Gavi Board has ultimate responsibility for risk oversight in the Alliance and is
responsible for agreeing on overall risk appetite and understanding and agreeing
the most significant risks and related mitigation. It therefore receives an annual
comprehensive Risk & Assurance Report .
Questions this paper addresses
The Risk & Assuranc e Report 2019 has been reviewed and recommended for
approval by the Audit & Finance Committee (AFC) and guidance has been
incorporated in the final version annexed to this paper. The Gavi Alliance Board is
requested to approve the report attached as Annex A and to provide guidance on
the questions outlined below.
This year?s report includes an additional section sharing some preliminary thoughts
on how Gavi?s risk profile may shift under Gavi 5.0. Board members are invited to
discuss these and share prelimi nary views.
Conclusions
This year?s report shows that Gavi?s overall risk profile has remained relatively
stable with 16 top risks from last year still included and one having decreased to
become a medium risk.
Section B: Risk and Assurance Report
Portfolio discussion on top risks to the Alliance
1.1 This is the fourth annual Risk & Assurance Report which discusses the most
critical risks that could potentially have an impact on the ability of the
Alliance to achieve its mission and strategic goals. The report provides an
update on risk management across the Alliance, an analysis of macro -
trends affecting Gavi?s risk profile, an overview of key changes in top risks
compared to last year, and an overview of how current levels of risk
compare to Gavi?s risk appetite (i.e. the willingness to accept being
exposed). Detailed information including analysis of each top risk and
corresponding mitigation is included in the annexes of the report . Where
SUBJECT : RISK MANAGEMENT UPDATE
Agenda item: 11
Category: For Decision
Report to the Board
4-5 December 2019

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Board -2019 -Mtg -3-Doc 12
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4-5 December 201 9

















SUBJECT: COMMITTEE CHAIR AND I FFIM BOARD REPORT S
Agenda item: 12
To follow

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Board -2019 -Mtg -3-Doc 13
Report to the Board
4-5 December 201 9

















SUBJECT: REVIEW OF DECISIONS
Agenda item: 13
No paper

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Board -2019 -Mtg -3-Doc 14
Report to the Board
4-5 December 201 9

















SUBJECT: CLOSING REMARKS AND REVIEW OF BOARD
WORKPLAN
Agenda item: 14
No paper

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Board -2019 -Mtg -3-Doc 06a


Section A: Executive Summary
Context
This report asks the Board to approve the updated projections of resources and
expenditure for 2016 -2020 and indicative financial projections for 2021 -2025.
The Audit and Finance Committee (AFC) has reviewed the 2016 -2020 and
2021 - 2025 forecast , includi ng the financial implications of the decisions that the
Board will consider at this meeting. The AFC concluded that these decisions could
be approved by the Board , in accordance with the Programme Funding Policy .
? For 2016 -2020 , the overall expenditure forecast has decreased by
US$ 0.1 billion (1%) whereas resources have remained consistent at the level
that was presented in the forecast on the 19 July 2019 Board call.
? For 2021 -2025 , the indicative financial projections for expenditures and
resources remain materially aligned to figures presented in the ?Investment
Opportunity? launched at TICAD, in Yokohama on 30 August 2019.
In addition to the forecast, th is report also provides an update on the evolution of
the estimates of resources and expenditure in 2019, an overview of expenditures
that are subject to Board -approved programme funding limits and of in-country
cash balances of Gavi support , and finally an update on foreign currency exposure .
Conclusion
The updated financial projecti ons show that sufficient resources are available such
that the programmes presented at this Board can be approved in accordance with
the provisions of the Programme Funding Policy.
Section B: Facts and Data
Financial Forecast
1.1 The Gavi financial forecast is updated annually for approval by the Board,
in order to enable the CEO to allot funding to programmes in the following
year , in accordance with the Programme Fundi ng Policy .
1.2 Figure 1 below summarises the forecasted resources and expenditures
(including the proposed decisions to be considered at this meeting ) for the
current period (2016 -2020 ) and subsequent one (2021 -2025 ) and indicates
SUBJECT : FINANCIAL UPDATE, INCLUDING FORECAST
Agenda item: 06a
Category: For Decision
Report to the Board
4-5 December 2019

06b ? Annex A

Re port to the Report to the Board
Board -201 9-Mtg -3-Doc 0 6b ? Annex A

Annex A: Implications/Anticipated impact
Risk implication and mitigation, including information on the risks of inaction
? PEF: the 2020 PEF budget is dependent on countries? demand for technical
assistance as well as partners? capacity to provide the required technical support
to sustainably address coverage and equity challenges and support well
function ing immunisation programmes. As highlighted in the Risk and Assurance
Report (Doc 11 ), partner capacity is recognised as a top risk for th e Alliance and
is being actively monitored.
? Secretariat: the 2020 Secretariat budget includes the cost of the preparation for the
replenishment and the event itself. Current assumptions for these costs are based
on the overall spend during the last mid -term review and replenishment period.
Impact on countries
? Overall, the Ministry of Health in Gavi countries have the primary responsibility for
delivering on Gavi programmes. Gavi?s deliverables and associated activities are
intended to support this implemen tation and delivery on the goals.
? Through the Joint Appraisal process, countries identify their technical assistance
needs, which form the basis of the partner proposals for activities to be funded
through the PEF. This creates more country ownership and v isibility for countries
on the work -streams being implemented, allowing better coordination of activities
and better alignment with Gavi funded programmes .
Impact on Alliance
? WHO and UNICEF will remain core partners of the Alliance, continue to provide
mos t of the assistance funded by Gavi and engage with Gavi as true partners.
However, as the PEF TCA intends to leverage the capacity of a broader set of
partner institutions, the Alliance model which at Gavi?s inception relied solely on
WHO and UNICEF as imp lementing partners is de facto evolving towards a
broader diversity of partners providing assistance to countries.

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Board -2019 -Mtg -3-Doc 06b

Section A: Executive Summary
Context
This paper pr esent s the detailed component s of t he Partners ? Engagement
Framework (PEF) and Secretariat budget for 2020 and seeks the Board ?s approval
of the se budget s.
In compiling its budget request for 2020 (the last year of the current strategic
period ), the Secretariat continued to focus on efficiency gains and a high level of
fiscal responsibility while preparing for Replenishment and Gavi 5.0
operationali sation.
Conclusion
No increase is proposed in relation to the 2020 PEF and Secretariat budget
compared to the 2019 budget , excluding the financial impact of the one -off cost of
the replenishment :
? The proposed 2020 PEF budget of US$ 253 million is at the same level as the
Board -approved 2019 budget, with minor changes between the respective
components. Specifically, t he PEF budget reflects a higher allocation for
targeted country assistance (TCA) in line with the growing emphasis on
subnational level technical support and enhanced focus on fragile countries.
? Secretariat budget needs are estimated at US$ 110 million for 2020, compared
to US$ 108 million for 2019. The increase is primarily due to the inclusion of a
one -off cost of US$ 2 .1 million for replenishment .
The Gavi updated financial forecast for the strategic period 2016 -2020 presented
in Doc 0 6a makes a provision for the proposed budget amounts and indicates that
enough resources are available .
Section B: 2020 Proposed PEF and Secretariat Budget
Overview of expenditure
1.1 The table below provides a summary of programmatic, Secretariat and PEF
expenditures for 2019 along with the projections for 2020 .
SUBJECT : PARTNERS? ENGAGEMENT FRAMEWORK &
SECRETARIAT BUDGET 2020
Agenda item: 06b
Category: For Decision
Report to the Board
4-5 December 2019

07 - Annex C
Board-2019-Mtg-3-Doc 07-Annex C

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Board -2019 -Mtg -3-Doc 07

Section A : Executive Summary
Context
Despite progress since 2000, the global burden of malaria is increasing. The first
licensed malaria vaccine, RTS,S /AS01 , is a potential tool to complement existing
interventions. In 2016, Gavi, in partnership with others , committed to fund the
Malaria Vaccine Implementation Programme (MVIP) for 2017 -2020 .1 The MVIP is
a pilot of routine programm atic use of RTS,S which will generate evidence to inform
future WHO policy recommendations and investment decisions on broader roll -out
of RTS,S. Funding for 2021 -2023 is now required to complete the MVIP , which
was anticipated at the time of the original MVIP funding decision .
W hile RTS,S policy and investment decision s are on the horizon , a critical decision
regarding continuation or otherwise of vaccine production by the manufacturer
needs to be made soon (preferably before end 2019) and in advance of th e broader
policy and investment decisions . There are v arious options regarding production ,
each of which has different programmatic and financial trade -offs . Th is paper
seeks Board decisions on both topics (MVIP and vaccine production) based on the
recommendations of the Programme and Policy Committee (PPC) .
Questions this paper addresses
1) What does the latest evidence , including data emerging following the
recommendation for pilots, tell us about the safety and impact of RTS,S ?
2) What is the value of the MVIP and what resources are required to complete
it?
3) What options are available for Gavi engagement in vaccine production
pending policy/investment decisions and what are the implications , trade -
offs and risks ?
Conclusions
The MVIP will provide critical evidence to inform broader policy and inves tment
decisions. The PPC recommended that the Board approve funding of

1 https://www.gavi.org/about/governance/gavi -board/minutes/2016/22 -june/minutes/09 --- malaria -
vaccine -pilots --- appendices/
SUBJECT : MALARIA VACCINE PILOTS AND LONG -TERM SUPPLY
Agenda item: 07
Category: For Decision
Report to the Board
4-5 December 2019

07 ? Annex A

Report to the Board
Board -2019 -Mtg -3-Doc 07-Annex A
Annex A: Implications / Anticipated Impact

Risk implications and mitigation for both funding of the malaria vaccine implementation
programme and longer -term supply are included in the paper. The impact on countries
and the Alliance and gender implications are described below .

1. Impact on countries and on the Alliance

a) The decision to continue funding the pilots will directly affect the MVIP
countries, given their investment in the routine use of vaccine. However even
countries that are n ot currently included in the pilots are likely to have an interest
in understanding how RTS,S could add to current malaria interventions , and a
lack of funding to complete the pilots would jeopardise the ability to make policy
and investment decisions .

b) A number of countries have communicated their strong interest in considering
introduction of RTS,S . The decision regar ding whether to risk -share continued
manufacturing will impact countries in terms of the supply available for their
introduction and scale -up of RTS,S in the case of positive policy and investment
decisions .

c) This decision is relevant to the Alliance in several ways :

i. Given the global burden of malaria and the public health impact, the
availability of a new intervention could have significant impact in terms of
contributing to the prevention of malaria -related morbidity and mortality in
the longer term .

ii. At this stage, there is an opportunity to signal the need to understand the
role of RTS,S as part of a broader disease control strategy and the
implications of using a partially efficacious vaccine.

iii. The experience with RTS,S provides a learning opportuni ty which could
enable us to plan for pilot s introductions and for the future supply of
vaccines without dual markets.

2. Gender implications of this decision

Full analysis of the gender implications of a malaria vaccine programme would be
included in a fu ll investment case for broader roll -out .

Looking forward to a potential malaria vaccine programme there is greater gender
equity with childhood vaccines in Africa than for care -seeking behaviour, which is
poorer for girls than boys. Moreover, girls are m ore likely to be tasked with caring for
their younger sick siblings, with knock -on effects for girls? school attendance and
achievement.

20, AVENUE A PPIA ? CH - 1211 G ENEVA 27 ? S WITZERLAND ? T EL CENTRAL +41 22 791 2111 ? F AX CENTRAL +41 22 791 3111 ? WWW . WHO . INT





Annex B
Background on the RTS,S/AS01 malaria vaccine



P r ep ar ed f o r
G av i B o ar d an d Co m m i ttee Mem b er s

1 9 N o v em b er 2 019




Prepared by the World Health Organization and PATH













FOR LIMITED CIRCULATION ? FOR USE BY GAVI BOARD & COMMITTEE MEMBERS
This document is being provided as background information ; it is not an official WHO publication.
This document draws on a background brief
prepared in advance of a stakeholder meeting
convened by WHO in October 2019 to discuss the
RTS,S/AS01 malaria vaccine.
07 - Annex B
Board-2019-Mtg-3-Doc 07-Annex B
ii
FOR LIMITED CIRCULATION Contents
Annex B: Background on the RTS,S/AS01 malaria vaccine ................................ ................................ ..... 1
Overview ................................ ................................ ................................ ................................ ............. 1
The disease ................................ ................................ ................................ ................................ .......... 2
The impact of imperfec t tools, used imperfectly ................................ ................................ ............ 2
The need for new tools ................................ ................................ ................................ ................... 2
The vaccine ................................ ................................ ................................ ................................ ......... 3
Current status of the RTS,S/AS01 malaria vaccine ................................ ................................ ......... 4
Efficacy and safety ................................ ................................ ................................ .......................... 4
A vaccine designed to reduce malaria illness and death ................................ ................................ 7
Potential public health impact ................................ ................................ ................................ ........ 7
Increased coverage and reach, including to the poorest children ................................ ................. 8
Cost - effectiveness/economic evaluation ................................ ................................ ........................ 9
Potential demand for the vaccine ................................ ................................ ................................ . 10
Pathway to access and related challenges ................................ ................................ ....................... 11
Regulatory status and 2016 WHO recommendation for pilots ................................ .................... 11
Future WHO policy recommendation ................................ ................................ ........................... 12
Country adoption decisions ................................ ................................ ................................ .......... 13
Global financing decisions ................................ ................................ ................................ ............. 13
Vaccin e supply ................................ ................................ ................................ .............................. 13
Key challenges to access ................................ ................................ ................................ ............... 14
The malaria vaccine as a potential, complementary tool for added protection against malaria ..... 15
Appendix 1. The RTS,S/AS01 malaria vaccine and its potential contributions to achievement of the
Sustainable Development Goals and other internationally agreed goals ................................ ............ 16
Appendix 2. Statement by the Malaria Policy Advisory Committee (MPAC) on the RTS,S/AS01 malaria
vaccine ................................ ................................ ................................ ................................ .................. 18
Appendix 3. Additional information on the Malaria Vaccine Implementation Programme ................ 19
Progre ss to date ................................ ................................ ................................ ............................ 20
Endnotes ................................ ................................ ................................ ................................ ............... 22


07 - Annex B
Board-2019-Mtg-3-Doc 07-Annex B

08 ? Annex A

Report to the Board
Board -2019 -Mtg -3-Doc 08-Annex A
Annex A: Implications / Anticipated Impact
Risk implications and mitigation are included in the paper. The impact on countries
and the Alliance and gender implications are described below.

1. Impact on countries and Alliance

a) Gavi -supported countries face the greatest risk of an Ebola outbreak and a re
disproportionately affected by outbreaks when they occur. Access to vaccines
would enable affected countries to plan for the use of vaccines as part of their
preparedness and risk mitigation activities, thereby limiting the broader impact
on health syst ems and services (including routine immunisation).

b) It is important that countries have strong capacities in prevention, detection and
response, as these will be important also for outbreaks beyond Ebola. This will
require countries and partners to commit resources for new/ strengthened
surveillance and detection activities.

c) This report describes the high degree of uncertainty and need for new
knowledge and evidence ? across all aspects (duration of protection,
vaccin ation strategy, products, etc.). Countries will need to share experiences
and knowledge with counterparts , as they have been doing for recent Ebola
outbreaks, for example through the work of the Guinea n vaccination team in
the current outbreak in DRC .

d) Through engagement in Ebola, the Alliance will contribute to improved
understanding of the role of routine immunisation as part of epidemic and
pandemic response.

e) Section 4 highlights the different roles and responsibilities of Alliance
stakeholders in t he emergency stockpile mechanism and the need to ensure
that in the longer -term Ebola vaccines are considered as part of an integrated
approach to disease prevention and control.

2. Gender implications:

a) Risk: Studies report differences in exposure to EVD by gender, noting that while
men may be at risk of exposure to Ebola infection through initial spill over events
(e.g. through hunting), in protracted outbreaks women are at greatest risk of
exposure through t heir role as caregivers. In Gavi -supported countries where
the majority of HCWs are female, women are also at high risk of occupational
exposure.

b) Impact: In previous outbreaks, EVD has caused very high mortality in pregnant
women. Beyond Ebola infection, the impact of EVD on access to obstetric care
has also been documented. Finally, literature highlights the broader social and
economic impacts of the 2014 -2016 West African outbreak on girls and
women?s access to healthcare and participation in education and the labour
force.