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Board -2022 -Mtg -03-Doc 12
Report to the Board
7-8 December 2022

Subject Report from Audit and Investigations
Agenda item 12
Category For Information
Section A : Executive Summary
Context
The Managing Director, Audit and Investigations (A&I) is required, under A&I?s Terms
of Reference approved by the Board, to report to the Board at least annually and to
confirm to the Board at least annually the organisational independence of A&I.
Questions this paper addresses
How has A&I fulfilled its Terms of Reference in 2022 , to provide an evaluation, through
a risk -based approach, on the effectiveness of governance, risk management, and
internal control to the organisation?s governing body and senior management ?
How does A&I plan to undertake its 2023 activity?
Does A&I report to a level within the organi sation that allows the activity to fulfil its
responsibilities ? Can A&I confirm the necessary organi sational independence ?
Conclusions
A&I has provided risk -based and objective assurance, advice and insight to the
governing body and senior management and has assessed probity in 2022. A&I has
facilitate d the Audit and Finance Committee in executing its responsibility to oversee,
review and monitor the operation of the A&I function, in support of the Board?s
oversight responsibilities .
A&I has prepared, and the Audit and Finance Committee has approved, a work plan
for 202 3. The plan continues the trend for executing more audits which began i n 2022
in response to elevated and continuing risks and starts to gear up to provide the
accountability and counter -fraud services which would be reasonably expected in the
context of Gavi 5.1 and moving towards Gavi 6.0.
A&I reports to the Board, effectin g this through routine reporting to the Audit and
Finance Committee, and to the CEO, and this reporting arrangement allows the activity
to fulfil its responsibilities. A&I confirms the necessary organisational independence.

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Board -2022 -Mtg -03 -Doc 13

Report to the Board
7-8 December 2022

Subject Committee Chair and IFFIm Board reports
Agenda item 13
To follow

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Board -2022 -Mtg -03 -Doc 14

Report to the Board
7-8 December 2022

Subject Review of decisions
Agenda item 14
No paper

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Board -2022 -Mtg -03 -Doc 15

Report to the Board
7-8 December 2022

Subject Cl osing remarks
Agenda item 15
No paper

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Board -2022 -Mtg -03-Doc 10
Report to the Board
7-8 December 2022
Section A: Executive Summary
Context
COVAX, the Alliance?s emergency vaccine response to COVID -19 is set to sunset
in 2023. This paper considers Gavi?s potential role in providing countries with
access to COVID -19 vaccines starting in 2024. The Gavi COVID -19 Vaccine
Investment Approach, part of Gavi 5.1, considers how a future Gavi -supported
COVID -19 vaccine pr ogramme could be designed and implemented considering
target populations and scope of country support . The investment approach tak es
into account modelling on the estimated impact of future COVID -19 programmes
and potential implications for the broader immunisation landscape while building
on key learnings to date .
The Secretariat is proposing an up -to -investment figure of US$ 1.8 billion for the
first phase of the programme (2 024 -2025) . This would ensure timely ongoing
procurement of vaccines for higher risk groups in AMC countries , with
differentiated support for the Gavi54 - those countries eligible for Gavi support -
and the AMC37 - the never - and former -Gavi eligible countries which received
COVAX support.
The approval requested of the Board at this meeting is ?in principle? reflecting the
inherit uncertainty in underlying assumptions , and yet the need to start planning .
The Secretariat will return to the Board by June 2023 for approval of the financial
envelope , with updated country demand estimates to inform supply volumes , and
an updated delivery approach based on continued learning s from COVID -19
vaccine Delivery Support (CDS) deployment . The Secretariat w ill also return to the
Board and relevant committees should WHO SAGE (Strategic Advisory Group of
Experts on Immunization) guidance and/or the assumptions on which this
investment approach is based deviate significantly from current status . Finally , the
Secretariat will return to the Board in June 2024 as part of the Gavi 6.0 strategy
development process to assess the case for the continuation of the programme
informed by the experience of the first phase, trade -offs with other Gavi 6.0
priorities , and up to date epidemiological considerations for a longer -term
COVID -19 vaccine programme as part of the 2024 Vaccine Investment Strategy
(VIS) .
Key inputs were collected from across the Secretariat and partners (including
WHO, UNICEF, CEPI ( Coalition for Epidemic Preparedness Innovations) ) and
through country consultations. Additionally, the investment approach reflects the
steer provided by Board and Programme and Policy Committee ( PPC ) members
Subject Gavi?s role in a future COVID -19 V accine Programme
Agenda item 10
Category For Decision

Board -2022 -Mtg -03-Doc 11a -Annex A 1
Annex A: Framework for Gavi Funding to Countries


Gavi Alliance
Framework for Gavi
Funding to Countries
Version 1.0

DOCUMENT ADMINISTRATION
VERSION NUMBER OWNER DATE
1.0 Policy Team 8 December 2022

1. Purpose and Scope of Document
1.1 This document serves as an overarching framework for Gavi?s three
programmatic funding policies for Gavi -eligible countries: a) The Eligibility &
Transition Policy; b) The Co -financing Policy; and c) The Health Systems and
Immunisation Strengthening (HSIS) Policy. The purpose of this document is to
set out the objectives, principles and approach for Gavi funding to eligible
countries.
1.2 Gavi supports lower -income countries, to increase the equitable and
sustainable use of vaccines in routine immunisation programmes. This
document describes the policies that outline the scope of Gavi funding available
to Gavi -eligible countries. This funding is intended to support countries as they
increase the equitable and sustainable use of vaccines in routine programmes
and facilitate their successful transition out of Gavi support. It includes the
procurement of vaccines and support to strengthen health systems to extend
routine immunisation services to reach zero dose and missed communi ties, as
well as introduce new vaccines, conduct planned campaigns and other
supplemental delivery strategies, and implement outbreak response
vaccination.
1.3 This document does not cover other Gavi funding through the Partners?
Engagement Framework, the Middle -Income Country?s Approach (the ?MICs
Approach?) for former and select never Gavi -eligible countries, nor other special
initiatives which Gavi might fund from time to time.
2. Principles of Gavi Funding to Eligible Countries
2.1 Country -driven, predi ctable and sustainable: Gavi support is country -driven,
meaning that it bolsters country leadership to sustainably deliver and finance
immunisation. Support is planned and predictable over time. It is directly linked

Board -2022 -Mtg -03-Doc 11a -Annex B 1
Report to the Board
7-8 December 2022
Gavi Alliance
Health Systems and Immunisation
Strengthening Policy
Version 1.0
Annex B: Health System and Immunisation Strengthening Policy






DOCUMENT ADMINISTRATION





VERSION
NUMBER APPROVAL PROCESS DATE
1.0
Prepared by: Marta Tufet, Head,
Policy
Reviewed by: PPC 1 November 2022
Approved by: Board [Full date]
Effective from: 1 January 2023
Next review: At the request of the Board


Board -2022 -Mtg -03-Doc 11a -Annex B 2
Report to the Board
7-8 December 2022
1. Scope & Objective
1.1 The objective of this policy is to ensure that HSIS funding is allocated and
programmed to enable countries to build strong, equitable, sustainable, and
high - quality immunisation programmes. Funding is available for countries to
strengthen and extend immunisation serv ices to regularly reach zero -dose
children and communities using tailored and differentiated strategies to build a
stronger primary health care platform.
1.2 The policy applies to all Gavi -eligible countries; however, in the
implementation of the policy, s pecific considerations for the use of funds, and
the depth of the Alliance?s engagement will vary depending on the country
need, fragility status and other country and local contexts.
1.3 The scope of this policy is Gavi?s Health System and Immunisation
Strengthening support including Health System Strengthening (HSS), the Cold
Chain Equipment Optimization Platform (CCEOP) and support to vaccine
implementation. While this scope does not cover time -limited funding such as
the Equity Accelerato r Funding (EAF) 1, COVID -19 Delivery Support (CDS), or
support through the Partners? Engagement Framework (PEF) Targeted Country
Assistance (TCA) 2, countries are expected to align planning of support through
EAF, PEF/TCA and HSIS funding. The Framework fo r Gavi Funding to
Countries provides an overview of the support and the objectives, principles
and approach for Gavi funding to eligible countries.
2. Principles
2.1 The following principles should be used to prioritise HSIS investment objectives
and lead grant design:
? Country -driven, predictable and sustainable beyond Gavi support:
grants should be designed to focus on system strengthening. Gavi
strongly encourages countries to increasingly take over operational
costs necessary for recurrent activities as they approach exit from Gavi
support.
? Equity: missed communities, first priority: investments should
prioritise reaching zero -dose and under -immunised children and missed
communities as well as mitigate risk of disruption of ongoing routine
immunisation.
? Tailored to context, adaptable and flexible: Proposed interventions
should be aligned with national plans and priorities and adapted to the
local context. Interventions should be tailored to address the specific
1 The Equity Accelerator Fund (EAF) is not covered by the policy as this support is time -limited to Gavi?s 5.0
Strategy Period (2021 -2025). 2 Gavi provides technical assistance to countries through the Partners? Engagement Framework (PEF) to support
countries in introducing vaccines and strengthening routine immunisation programmes through its core partners
[WHO, UNICEF, Centers for Disease Control and Prevention (CDC), and the World Bank] and expanded partners
(including local institutions) via Targete d Country Assistance (TCA).

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Board -2022 -Mtg -03-Doc 11a

Report to the Board
7-8 December 2022

Subject Funding Policy Review : Context and Health System
Immunisation Strengthening (HSIS) Policy
Agenda item 11a
Category For Decision

Section A: Executive Summary
Context
The aim of the Funding Policy Review is to simplify, streamline and align Gavi?s three
key funding policies: 1) Eligibility and Transition Policy; 2) Co -financing Policy; and 3)
Health System and Immunisation Strengthening (HSIS) Support Framework 1. The
review began in 2019 as part of the op erationalisation of Gavi 5.0. It was paused in
2020 due to the pandemic and restarted in late 2021 with touchpoints at the October
2021 and May and October 2022 meetings of the Programme and Policy Committee
(PPC). An independent evaluation and subsequent consultation and policy analysis
found the policies to have been fundamental to Gavi?s success but recognised that
more nuance and flexibility could improve their implementation.
Questions this paper addresses
Whilst the initial scope of the review sought to comprehensively update the policies,
the scope has since been modified in consultation with Board members and Alliance
partners in recogni tion of the current political and economic environment. As a result ,
the Secretariat has focused on addressing key, urgent issues for the current strategic
period, with a view to address longer -term aspects as part of the operationalisation of
Gavi 6.0. The updat ed focus of the review is on : i) addressing the risk of unsuccessful
transition of countries from Gavi support; ii) ensuring co -financing is not a barrier to
uptake of the malaria vaccine; and iii) ensuring prior Board -approved HSIS Framework
shifts are reflected in a new HSIS Policy.
This paper provides the scope and context of the overarching review and the process
and consultations that have led to the proposed revisions , as well as a reminder of
what shifts have already been approved and implemented to HSIS support. This paper
sho uld be read and discussed in conjunction with Doc 11b, which proposes specific
shifts to the co-financing , and eligibility and transition polices , as well as an approach
to co -financing for malaria vaccine . Additionally, this paper presents the updated
Framework for Gavi Funding to Countries , which outlines the key principles and
interactions between the three policies .


1 The HSIS support framework operates in a similar manner as a Gavi policy, but with a greater level of
detail. The Policy review seeks to resolve this inconsistency with other Board -approved policies.

Board -2022 -Mtg -03-Doc 11b -Annex A 1
Report to the Board
7-8 December 2022
Annex A : Eligibility and Transition Policy


Gavi Alliance
Eligibility and Transition
Policy
Version 4.0



DOCUMENT ADMINISTRATION
VERSION
NUMBER APPROVAL PROCESS DATE
4.0
Prepared by: Marta Tufet, Head,
Policy
Reviewed by: PPC 1 November 2022
Approved by: Board [Full date]
Effective from: 1 January 2023
Next review: At the request of the Board
3.0
Reviewed by: Gavi Programme
and Policy Committee 3 May 2018
Approved by: Gavi Alliance Board 7 June 2018
Effective from: 7 June 2018
2.0
Prepared by: Robert Newman,
Policy and Performance
Reviewed by: Gavi Programme
and Policy Committee 4 and 21 May 2015
Approved by: Gavi Alliance Board June 2015
Effective from: 1 July 2015






Board -2022 -Mtg -03-Doc 11b -Annex A 2
Report to the Board
7-8 December 2022
1. Purpose & Objective
1.1 The purpose of this policy is to set out the criteria and procedures that
determine which countries are eligible for Gavi support and to define the
transition pathway through which this support is phased out, ensuring that Gavi
funding is aligned with its mission to focus support on lower -income countries.
1.2 Further information about the levels of Gavi funding for Gavi -eligible countries
is found in the co -financing policy and Health Systems and Immunisation
Strengthening (HSIS) policy. A dditionally, the Framework for Gavi Funding
to Countries outlines the overall structure of Gavi?s support to countries.
2. Definitions
2.1 Gross National Income per capita (GNI p.c.): GNI is the sum of value added
by all resident producers plus any product taxes (less subsidies) not included
in the valuation of output plus net receipts of primary income (compensation of
employees and property income) from abroad. GNI p.c. is GNI divided by mid -
year population. GNI p.c. in US dollars is converted using the W orld Bank Atlas
Method which smooths exchange rate fluctuations using a three -year rolling
average, price -adjusted conversion factor, calculated by the World Bank.
2.2 Gavi -eligible country: a country which is in one of the three phases of Gavi
support defined by GNI p.c. thresholds. These phases and thresholds are
detailed in section 4 of this policy.
2.3 Penta3 coverage: percentage of infants in a given country that received three
doses of pentavalent (or equivalent) vaccine based on WHO/UNICEF WUENIC
source.
3. Principles
3.1 The following principles guide the application of the Gavi -eligibility and
transition policy:
Country -led, predictable and sustainable: Gavi support is country -driven,
meaning that it bolsters country leadership to sustainably deliver and
finance immunisation. It is predictable over time and directly linked to a
country?s ability to pay and is intended to be catalytic and time -limited and
to incentivise domestic investm ents in health.
Tailored to context, adaptable and flexible: The use of Gavi support is
differentiated to meet the needs of countries as they change over time.
4. Procedures and Thresholds
4.1 Gavi uses GNI p.c. to determine eligibility for Gavi support. T he threshold for
eligibility for Gavi support is US$ 1730 GNI p.c. in 2023. The threshold for
eligibility is updated annually using the inflation adjustments the World Bank
makes annually to its income categories.

Board -2022 -Mtg -03-Doc 08 -Annex A 1
Report to the Board
7-8 December 2022
Annex A: Incumbent supplier and market dynamics analysis
Accommodation of new suppliers into existing (global) markets which are already well
supplied and competitive, and in which demand is no longer growing, will likely have
an impact on the commercial outcome (and hence behaviour) of the incumbent
suppliers. As a general rule, when commercial volumes of a supplier decline, unit
COGS will tend to go up, and required pricing also. In some hitherto ?stable? markets
(e.g., PCV, Rota), we have an indication from incumbent suppliers of the yearly volume
below which they would reconsider their participation in the market. In other markets,
we have an idea of the price increases to be expected as volumes decrease, thanks
to some historical tender bidding behaviour where price -volume ladders were
submitted. As these sou rce data are sensitive, scenarios driven by them will not be
shared, but the Market Shaping team and UNICEF -SD have relative confidence in
predicting how any given market would likely play out given such insights. Another
scenario is where an incumbent man ufacturer simply raises prices after observing that
Gavi is willing to pay more to others, even if their existing price is still profitable.
The markets where undesirable incumbent behaviour can more likely be avoided are
the ones which are currently under supplied or predicted to be heading for undersupply
due to imminent demand expansion or potential supplier exit (e.g. OCV, Malaria,
multivalent Ebola). Markets where new suppliers are sought out for the purpose of
stimulating more competition should have the opposite effect on incumbents (e.g. MR,
or any market where new supplier has a profile advantage).
An example of a market where product profiles are relatively generic, competition is
intense, and prices have no further room for reduction, is Pentaval ent. The healthy
market equilibrium for Gavi supply turns out to be ~4 suppliers globally (optimi sing
across production economics & price of each supplier and overall supply security and
buffer). Given that we have historical price -volume ladder and other bidding data,
some scenarios have been generated, driven by varying levels of volume shift to a
new supplier. In examples such as IPV, not only would exits be inevitable, but we are
already in a situation where new aspiring entrants never managed to secure a Long -
Term Agreement (LTA) with UNICEF in the first place, such is the oversupply already
(even before a notional African IPV comes to the table). HPV is another market that is
predicted to be in overcapacity by the time a viable African HPV source could
materialize.
This is not to say, however, that incumbent suppliers cannot strategi se to maintain
some economic interest in a market in anticipation of their own -branded product facing
reduced demand. In the near term , new African suppliers will not , by and large , ?invent?
vaccines for existing categories but seek to in -license and tech -transfer appropriate
assets from incumbent manufacturers (who will receive royalties in most cases) 1. In
this way, volumes of procured finished goods can shift between ge ographic source but
exiting incumbents could consider partially compensat ing for this if they move fast to


1 In the medium -long term, of course, African R&D will start delivering innovations across improved
product profiles and unaddressed diseases

Board -2022 -Mtg -03-Doc 08 -Annex B 1
Report to the Board
7-8 December 2022
Annex B: Rationale for initial illustrative vaccine product prioriti sation







See also table in Annex A giving qualitative market dynamics analysis of categories B and C .

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Board -2022 -Mtg -03-Doc 08 -Annex C


Report to the Board
7-8 December 202 2
Annex C: A new financial instrument to incentivise African vaccine
manufacturers & investors in Africa

Summary:

The paper outlines the results of the analysis conducted to dat e on a
potential financial instrument , ?Phase I?.
On this basis, approval is sought for Secretari at to develop full proposals
(?Phase II?) for an AMC to accelerate the expansi on of end -to -end African
vaccine Manufacturing ? with the detail ed design return ing to the Board for
consideration and approval in 2023.
Analysis to date indicates the role for a time -limited , Africa -focused Advance
Market Commitment with the following objectives :
? Supporting healthy global markets ? minimise market distortions and help to
sustain low global prices and resilient supply for priority vaccines
? Driving efficient market outcomes ? provide a signal to guide and align new
manufacturers and investors behind resilient , sustainable business propositions
? Reducing barriers to investment ? carefully structuring the level of incentive to
help offset initial costs of market entry whilst aligning support with other providers
of capital for greater overall impact
- guided by the following initial design considerations :
(i) minimising market distortions through a post -tender inventive payment (ii) time -
limited (iii) independent of Gavi?s core funding and (iv) Gavi designed, with an
option for an external partner to host all or part of the instrument.
Background
This Annex summarises work conducted to date in Phase I of the scoping of a
proposed instrument to incentivise African vaccine manufacturers & investors in Africa .
It addresses the strategic objectives of the instrument, its potential scope, and
proposes a process for its further development. The Gavi Board is recommended to
approve embarking on Phase II; the development of a detailed proposal for the design
and oper ationalisation of the AMC .
To reach this stage, t he Secretariat conducted detailed review s of existing work on
African vaccine market dynamics undertaken by the Clinton Health Access Initiative ,
Mc Kinsey and Company, Africa CDC Partnership for African Vaccine Manufacturing
(PAVM) together with reviews carried out into the Pneumococcal AMC . In addition,
detailed consultations were held with the AU, Multilateral and Bilateral Development