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30 November - 2 December 20 21

















SUBJECT: RE VIEW OF DECISIONS
Agenda item: 13
No paper

Board -2021 -Mtg -4-Doc 14 1
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30 November - 2 December 20 21

















SUBJECT: CLOSING REMARKS
Agenda item: 14
No paper

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Board -2021 -Mtg -4-EAC Committee Chair Report


Section A: Introduction
? This report provides the Board with an overview of the activities of the
Evaluation Advisory Committee ( EAC ) since the interim Committee Chair
last reported to the Board in June 2021 . Since then, Professor James
Hargreaves has joined the committee as the new EAC Chair.
? The EAC met virtually on 29 and 30 September to provide guidance on
progress on on -going evaluations and approve updates to the multi -year
evaluation workplan for Gavi 5.0; provide guidance on the Evaluation
Operational Guidelines (EOGs) an d on progress of the COVAX Facility and
Advance Market Commitment (AMC) evaluability and evaluation design
study and on the challenges identified at this early stage of the evaluation .
o The EAC approved a revised multi -year evaluation workplan, which
includ ed a modified timeline for the development of the request for
proposal (RFP) for the zero -dose evaluation . This has been
postponed until Q1 2022 given the limited bandwidth and shifting
priorities at the country level, largely due to the COVID -19 pandemic .
o In relation to Gavi?s EOGs, EAC members considered it important to
remove the portion of Clause 7.5.1 in Gavi?s Evaluation Policy that
restricts EAC members from sitting on evaluation Steering
Committees (SCs) on the basis that this prevents the EAC from
ensuring the independence and quality of evaluations ; and that
participating throughout t he evaluation process, including on SCs,
would enable the EAC to maintain the oversight required to fulfil its
Terms of Reference. The EAC Chair sought guidance on the
proposed modification to the Evaluation Policy from the Governance
Committee on 23 Novem ber 2021. The EAC will reconvene on 26
November 2021 to consider formally recommend ing an amendment
to the policy . The EAC Chair will provide an update during the Board
meeting on the outcome of the se discussions.
o The EAC provided guidance on how to stren gthen reporting channels
with the Board and increasing the visibility and utility of centralised
evaluations. EAC members also noted that it would be worth
engaging more with the PPC and to consider using technical
briefings to share findings from evaluations.
o On the COVAX Facility and AMC evaluability and evaluation design
study, the EAC provided guidance to address challenges that include
SUBJECT : EVALUATION ADVISORY COMMITTEE CHAIR REPORT
Category: For Information
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30 November - 2 December 2021

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Report to the Board
Board -2021 -Mtg -4-Doc 11-Annex B

Annex B: Implications and Anticipated Impact
Impact on countries
Approval of the PSE strategy enables the Secretariat to mobilise additional finances
and resources in support of Gavi ?s strategic objectives and identified country needs.
The private sector has a range of assets that can be harnesses and directed to achieve
programmatic impact by increasing the quality of immunisation services in
implementing countries, ensuring sustainability, and contributing to the efficiency of
Gavi?s mission.
Risk implication s and mitigation
As Gavi moves into the 5.0 period, private sector engagement represents a critical
opportunity. However, it is prudent to recognise that, in a fast -moving environment,
opportunities can take multiple forms and that private sector engagement can be
complex, with a series of interconnected sets of actors and agendas. Inherent to this
is the managing and mitigation of risk to Gavi, countries, and the immunisation
programme.

In 2020, the Secretariat?s Risk and Assurance Report assessed its PSE as a low -risk
activity. However, the Secreta riat?s r isk appetite should be balanced against its level
of ambition . An analysis of the Secretariat?s PSE work falls into two risk categories:
1. Risk of inaction related to developing private sector partnerships
2. Risk of action related to developing private sector partnerships
1. Risk of inaction related to developing private sector partnerships
Regarding the a bove, inaction can affect Gavi?s and countries ambition s for impact, as
well as affect Gavi?s brand reputatio n as a leading Public Private Partnership ,
innovative development model, and appeal to donors who are attracted to its unique
PPP model.
2. Risk of action to developing private sector partnerships
To ensure a thorough review of the risks associated with this segment, the Secretariat
commissioned PwC to conduct a risk assessment. This segment can be reviewed in
further sub risk categories:
a) Shift in donor priorities
b) Costs of partnerships management
c) Limited clarit y on operational structure
d) Reputational risk
e) Limited private sector involvement
f) Risk of dispersion
g) Resourcing risk

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Board -2021 -Mtg -4-Doc 08-Annex A


Annex A: WHO background note on operationalisation: supply allocation
framework, technical guidance and integration between malaria control and
immunisation
1. Development of allocation framework for limited supply
Supply is likely be insufficient in the medium term, with a constrain t expected in the
first 4 -6 years following anticipated first introductions in 2023. This could potentially
extend to 9 years should there be demand for additional seasonal doses or if no action
is taken to accelerate supply availability. While efforts to address the supply limitations
and achieve healthy mark et goals are expected to intensify if and when a Gavi malaria
vaccine programme is approved, a prioriti sation process will be required at the onset
to allocate limited vaccine supply in the initial years.
Process to develop the allocation framework for lim ited supply
Given the extent and potential duration of the supply -demand imbalance, difficult
choices will have to be made by countries and their global partners on how to best use
limited resources. The process, i.e. how choices and decisions are made, will be as
important as the underlying scientific rationale. Legitimacy is proposed as the
overarching guiding principle for the development of the allocation Framework: global
decisions about vaccine allocation should be made throu gh transparent processes
that are based on shared values, best available scientific evidence, and
appropriate representation and input by key parties , drawing heavily on the
expertise and views of public health leaders from malaria endemic area.
WHO is co ordinating the development of the framework, ensuring appropriate
representation and consultation of stakeholders. Ministries of Health in affected
countries will be informed of and engaged in the development of the framework.
Convenings to establish the p rinciples and objectives of the framework will include
leadership from Africa and other affected countries, international funding bodies (e.g.
Gavi and Global Fund), key malaria partners (e.g. P MI, RBM regional institutions),
civil -society organi sations, e thics and human rights specialists, PATH, and others.
The Framework is expected to be in place by Q1 2022, and will guide decision making
on vaccine allocation, including where and in which countries limited vaccine doses
might best be allocated initially. Once developed, the framework will be used by
malaria and EPI stakeholders, as they make decisions on malaria control interventions
for a given country or provide support to countries. It will be important for all relevant
stakeholders to adhere to the framework , e.g. , Gavi in its application guidance and
process; partners in their financial, technical and regulatory support to countries; etc.
Inputs to inform decision -making
The graphic below summari ses the proposed process. Different work area s provide
the scientific / public health, implementation and social value considerations as inputs
to decision -making. Stakeholders will be convened to consider the objectives and
principles of the Framework and the pros and cons and trade -offs of differen t options.

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Board -2021 -Mtg -4-Doc 08


Section A: Executive Summary
Context
Malaria remains one of the deadliest diseases for children under five years old,
particularly those living in communities facing deprivation and exclusion. Over 90%
of cases and deaths occur in Africa; six Gavi -eligible countries 1 account for 50%
of global mortality. In 2015, the first vacci ne for malaria, RTS,S/ AS01 E, was
authorised; that year, Gavi, the Global Fund and Unitaid agreed to support pilot
vaccine implementation at WHO?s request to generate evidence for wider use of
the vaccine. The Gavi Board also considered and approved a cost -share
mechanism to enable continued production of the antigen to assure access in the
event of positive policy and funding decisions . In October 2021, WH O issued a
recommendation for wider use based on the evidence from the pilot
implementation, and the Gavi Programme and Policy Committee (PP C)
considered the case for investment in a malaria vaccine programme.
Question this paper addresses
What is the projected value, impact and strategic considerations of a Gavi
investment in a malaria vaccine programme?
Conclusions
As part of a ?toolbox? of malaria control interventions, a malaria vaccin e will further
reduce child mortality on the African continen t but is likely to incur a high cost to
Gavi and countries under current assumptions . A successful malaria vaccine
programme sh ould support deliberate and intensive coordination between malaria
control and immunisation programmes at global and country levels to ensure most
impactful deployment of the vaccine alongside other interventions . Finally, there is
a need and opportunity for market -shaping efforts to support the development of a
healthy m alaria vaccine mar ket .
Section B: Background
1.1 Malaria (particularly the Plasmodium falciparum parasite species) is one of
the leading causes of death globally. In 2019, there were 229 million cases
1 Nigeria (23%), the Democratic Republic of the Congo (11%), United Republic of Tanzania (5%), Burkina
Faso (4%), Mozambique (4%) and Niger (4%); World Malaria Report 2020
SUBJECT : MALARIA VACCINE PROGRAMME INVESTMENT CASE
Agenda item: 08
Category: For Decision
Report to the Board
30 Nov ember - 2 Dec ember 2021

Gavi

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Board -2021 -Mtg -4-Doc 09


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 (see Annex A ).
Questions this paper addresses
The Risk & Assurance Report 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 has been reviewed and recommended for a pproval by the Audit
& Finance Committee (AFC). The Gavi Alliance Board is requested to approve the
report and to provide guidance on the questions outlined below.
Conclusions
This year?s report shows that Gavi?s overall risk profile ha s remained stable with
most top risks continuing to be elevated due to the current environment, Gavi?s
ambitious strategy and the mission of the COVAX Facility. Two top risks have
decreased, two increased, and last year?s single aggregate COVAX -related ris k
has now been disaggregated into four risks as the Facility has moved from design
to operationalisation and delivery. Three risk exposures are deemed to be outside
of Gavi?s updated risk appetite as long as intensive mitigation is still ongoing.
Section B : Risk and Assurance Report 2021
Portfolio discussion on top risks to the Alliance
1.1 This is the 6th 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. its willingness to accept being exposed
SUBJECT : RISK MANAGEMENT UPDATE
Agenda item: 09
Category: For Decision
Report to the Board
30 Nov ember - 2 Dec ember 2021

Report to the Board
Board -2021 -Mtg -4-Doc 10-Annex A

Annex A: Proposed strategic approach
1. Proposed investment priorities
1.1 Continued support to India will be focused on targeted, catalytic support
guided by seven overarching principles, which were endorsed by the PPC
and Board in May and June 2021: equity; time -bound support; sustainability;
learning; innovation; alignment with national plans and donors; and
accountabili ty and transparency 1.
1.2 The Alliance has an opportunity to support India in reaching 1.4 million
zero dose children and save ~118,000 lives through the introduction of
equity -focused vaccines with modest catalytic investments of
US$ 250 million over t he next five years 2. Based on PPC and Board
guidance and further consultations with the Government of India and partners,
the investment amounts proposed earlier this year were recalibrated , resulting
in a modest shift of ~US$ 20 million from vaccine introductions (primarily f rom
TCV) to the zero -dose agenda. Therefore, the proposal is that ~US$ 129 million
in funding would be invested in reaching zero dose children, and
~US$ 122 million would be earmarked for vaccine introductions 3. Figure 1
summarises the updated investment proposal.
Figure 1
Zero -dose children & missed communities
1.3 Building on its impressive progress in expanding the reach of immunisation
services before the pandemic, Gavi?s strategic partnership with India will
aim to further decrease the number of zero -dose and under -immunised
children and expand full immunisation coverage (FIC) in the next five
years. The proposed target of a 30% reduction in zero -dose children by 2026
against the 2019 pre -pandemic baseline aligns with the Alliance?s ambitious
1 For more details, see the May 2021 PPC Paper on the Strategic Partnership with India 2 Approximately US $ 200 million of this total amount are expected to be disbursed in Gavi 5.0 (2021 to 2025). An
additional US$ 10 million in vaccine funding for HPV are being rolled over from the last strategic period. 3 Rounded numbers explain that US$122 million and US$ 129 million equal US$ 250 million. Modest investments can save thousands of lives and
catalyse long -term impact
Zero -dose & missed communities
? Reduce # of zero -dose children in line with Immunisation Agenda 2030 (IA2030) goals ( -30% by 2026) through targeted sub -national strategies
? Human papillomavirus (HPV): avert ~66?000 future deaths 2
? Typhoid conjugate vaccine (TCV):avert ~52?000 future deaths 2
Select investments in national and subnational institutions Continued engagement on vaccine and cold chain equipment market shaping Alignment with separate COVID -19 vaccine support through COVAX +
Strategic focus and objectives Gavi support 1
US$ 116 million 3 New & underused vaccine support (NVS) US$ 6 millionTCV surveillance
Equity -focused vaccine introductions
US$ 119 million Health systems strengthening (HSS) US$ 10 million Targeted Country Assistance (TCA)
1 Flexibility will be retained for reallocation within each funding envelope; figures don?t add up to US$250m due to rounding errors 2 Excludes impact from self -financed doses 3 Excludes $10m for HPV rolled over from the last strategic period