Classified as Internal
gavi.org
GAVI?S ROLE IN A FUTURE
COVID -19 VACCINE PROGRAMME
BOARD MEETING
Derrick Sim, Richard Mihigo
7 -8 December 2022, Geneva, Switzerland
Classified as Internal
Why should Gavi support a future COVID - 19 programme ?
2
Shift from an
emergency
response focused
on global health
security to
protection of the
most vulnerable ,
while retaining ability
to quickly mobilise in
a worst -case
scenario
Strategic
Objective
Board Meeting, 7 ?8 December 2022
Impact to date...
Recent modelling estimates that COVAX -supported COVID -19 doses have
averted over 1.7 million deaths across AMC participants
AMCs look to COVAX to supply a large proportion of their COVID -19 doses
? with LICs relying on COVAX for ~75% of their supply ? providing
continued access critical for global fight against COVID -19
Current epidemiology...
Initial impact projections show deaths averted per fully vaccinated person ,
especially for higher -risk populations, are in the same range as those of other
Gavi -supported vaccine programmes
Looking ahead...
A COVID -19 programme can support and strengthen platforms for life -course
vaccination and contribute to learnings on integration of immunisation into
primary health care in view of Gavi 6.0
Many regions are experiencing a surge as several variants continue to co -
circulate . Some countries are experiencing their highest ever incidence,
although vaccination has helped reduce severe disease and death .

gavi.org
Finance
BOARD MEETING
David Marlow, Assietou Diouf
7 -8 December 2022, Geneva, Switzerland
Key Forecast and Budget Highlights
US$ 183 m
Gavi 5.0: available for future
investments (after new investments)
? Decrease in resources due to market condition offset by lower forecast expenditure.
Flexibility remains to respond to uncertain context .
? Funding for HPV relaunch & updated Co -Financing, Eligibility & Transition policies reflected
No increase
Gavi 5.0: Secretariat budget
US$ 1.9 bn
COVAX: resources released
through negotiations
Secretariat capacity
Increasing risk for the Alliance
? Total budget remains within Board approved envelope ; with underspend rephased
? Average operating expense ratio for Gavi 5.0 remains 7.5%; increases for 2023 -2024
? Renegotiations to return ~ US$ 1.9 bn to the AMC
? C ombined exit costs and expiration forecast to date reduced to ~US$ 1.8 bn, with additional
risk of expiries based on 2023 demand (figures exclude in -country wastage)
? Efficiency and simplification with launch of Operational Excellence framework
? Holistic workforce plan to meet Secretariat resource capability needs and drive end to end
process effectiveness across all functions
2 Board Meeting, 7 -8 December 2022

1



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

1





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

Board - 2022 - Mtg - 03 - Doc 09 - Annex A Report to the Board
7 - 8 December 2022
Annex A : COVAX Reporting Framework
Section A: Update on Gavi?s COVAX Facility and COVAX AMC Monitoring,
Evaluation and Learning (MEL) strategy
The table below provides some of the key highlights and updates on progress against
the core elements of Gavi?s COVAX Facility and COVAX AMC MEL Strategy since the
June 2022 Gavi Board.
MEL
strategy
component Key activity Highlights / update ( October 2022 )
Cross -
cutting COVAX Theory
of Change Modest updates to vision and objectives for
2022 made mid - year, in alignment to broader
COVAX Pillar updates. Discussions on updates
for 2023 ongoing.
Monitoring COVAX
Reporting
Framework Reporting against COVAX Reporting
Framework made available for PPC and Board.
Some modest refinements made to 2022
COVAX Reporting Framework (see below)
since June 2022 Board meeting .
Complementar
y monitoring to
COVAX
Reporting
Framework COVAX Facility, Gavi Secretariat teams and
core COVAX partners continue to monitor
aspects of the Facility and AMC to a much
greater extent beyond the metrics currently
captured in the topline Reporting Framework.
Examples include:
? COVID19 Vaccine Deliver y Partnership
outputs focusing on absorption rates , delivery
financing and other key delivery metrics;
? Monitoring of progress across subgrants
funded through COVID19 Delivery Support;
? Other operational metrics and analyses
across supply, allocation, deliveries and in -
country implementation gathered internally.
Core country
monitoring and
reporting on
COVID - 19 /
COVAX COVAX continues to utilise the WHO - UNICEF
electronic Joint Reporting Form COVID - 19
module (monthly reporting) launched in March
2021 to gather core reporting from COVAX
participants. Despite improvements over time,
reporting completeness continues to be an
issue. Concerted efforts are underway with
Pillar partners to improve reporting on priority
population groups in particular.
Recipients of COVID - 19 Delivery Support
grants are expected to report back on a six -
monthly basis to Gavi.

1


Board -2022 -Mtg -03-Doc 09
Report to the Board
7-8 December 2022

Section A: Executive Summary
Context
Emerging variants and evolution of the COVID -19 pandemic, new vaccine products,
and evolving policy guidance exemplify the continued volatility and uncertainty
surrounding the pandemic. In June 2022, the Board agreed that Gavi continue
admini strating the COVAX Facility in 2023, delegated authority to the CEO to adapt
programmes based on updated World Health Organization (WHO) Strategic Advisory
Group of Experts on Immunization (SAGE) recommendations and approved limited
provision of donated pa ediatrics doses. In line with these decisions and as participants
work toward their own coverage ambitions, COVAX will continue to support AMC
participants? vaccine demand with an increased emphasis on higher -risk groups,
including as new appropriate and r ecommended products enter the market, such as
variant -containing vaccines.
COVAX?s 2023 strategy will bridge to the Gavi 5.1 COVID -19 vaccine investment
approach that would begin in 2024 and is focused on ongoing protection of higher
priority population groups, pending Board approval in December 2022 (D oc 10 ) and
Board approval o f the financial envelope in June 2023. COVAX will also use 2023 to
transition its operating model from one of leading an emergency response to a
programme utilising existing Alliance processes. Some established elements of the
COVAX model will continue in 2023 including retaining the capacity to respond to the
WHO worst -case scenario through the Pandemic Vaccine Pool, while some
components will evolve, such as COVID -19 vaccine delivery support and the
sunsetting of the Humanitarian Buffer, with humanitarian access continuing to be
provided via other means.
Questions this paper addresses
? What progress has COVAX made in 2022 in supporting AMC participants achieve
their COVID -19 vaccination goals?
? What is the state of supply and demand and what are the projections for 2023?
? How does COVAX plan to keep its vaccine portfolio ?fit for purpose ? in 2023,
especially in light of variant -containing vaccines?
? How will COVAX adjust specific initiatives in preparation for the shift from
emergency response to a programme that uses existing Alliance processes?

Subject COVAX : Key Strategic Issues
Agenda item 09
Category For Information

1

Board -2022 -Mtg -03 -Doc 10 -Annex C
Report to the Board
7-8 December 2022
Annex C: Modelling Assumptions
Number of doses per year: The Secretariat is basing calculations for the COVID -19
vaccine programme on one booster dose per year based on the assumption that future
vaccines will give more durable protection , limiting the need for more frequent
vaccination. It is also possible that by 2024 most people globally will have either been
infected with COVID -19 at some point and/ or been vaccinated, and this hybrid
immunity will result in one dose per year being sufficient.
Coverage and demand : The programme should aim to support countries to reach
ambitious targets yet be based on realistic assumptions of coverage. We consid ered
comparable rates of coverage to use as proxies for what we may expect for the
COVID -19 context. Alliance demand planning groups project overall primary coverage
in the AMC 91 to be between 40 and 65 percent by end -2023. A drop off from primary
to boos ter coverage has been assumed using HIC data (~18 percent drop off). The
model, therefore, assumes we can expect countries? additional dose coverage rates
to be somewhere between 35 and 55 percent for the proposed programme.
Procurement cost per dose : Sev eral factors will determine the procurement cost per
dose. For the cost factored into this model, we assume that manufacturing will
continue on an ongoing basis, and therefore there will be predictable supply from a
diverse range of suppliers. Current vacc ine technologies will continue to be used, and
fit-for -purpose vaccines, such as variant containing vaccines, will be well -matched
against circulating variant strains. As we integrate into established Alliance processes ,
we will revert to regular tendering processes through UNICEF. Actual future vaccine
prices may be influenced by volumes contracted/procured, level of competition, new
technologies, product preferences, geographic base of manufacturing networks, and
other factors.
Delivery costing : Delivery costing has been calculated with the support of the Delivery
Costing Working Group (DCWG) in September 2022. The DCWG has members from
CoVDP, UNICEF, BMGF, Harvard School of Public Health, MSH, WHO and Gavi. The
costing encompasses several compo nents, including PPE, hand hygiene, per diem for
service delivery, transportation for outreach, training, planning & coordination, social
mobilization, cold chain maintenance, waste m anagement , vax certificates,
pharmacovigilance. Costing excludes ancilla ries (syringes and safety boxes), TA and
cost of vial.

Board -2022 -Mtg -03-Doc 07 -Annex C 1
Report to the Board
7-8 December 2022
Annex C: Initial estimated cost of HPV programme relaunch 2023 -2025
HPV Expenditure Forecast Evolution
In addition to providing detail on the initial estimated cost of the HPV programme
relaunch 2023 ?2025, this annex sets out the changes to, and drivers of, the total
expendit ure forecast of the HPV vaccine program me included in the financial forecast
for the strategic period 2021 -2025. Total forecast expenditure (excluding COVAX
AMC) totals US$ 10.2 billion ( reducing from US$ 10.4 billion in the prior forecast) ?
see Doc 04a ? Financial Update, including forecast for details .
Figure 1: HPV expenditure forecast
Health systems strengthening: US $ 40 million forecast remains an estim ate of direct -HPV support - current HSS grants will be utilised to strengthen HPV programmes , but activities are often embedded in broader routine immunisation strengthening efforts
US$ 509 million ex penditure directly related to HPV Vaccine Programmes was
included in the prior financial forecast (v19.1) approved by the Board in June 2022.
The current financial forecast (v20) presented to the December 2022 Board for
approval includ es a US$ 102 m illion net increase in the HPV Vaccine Programmes
envelope resulting from two offsetting variances :
? US$ 65 million reduction in vaccine programme costs, principally driven by the
forecasted impact of permissive dose -schedule change from 2 dose to
permissive 1 dose regimen , in line with WHO SAGE recommendation .
? US $ 167 million vaccine programme costs, related to the HPV re -launch as
detaile d below funded from earmarked Canada funding ~$ US 60 million (CAD
75 million ) and allocation of existing resource s.

1


Board -2022 -Mtg -03-Doc 04a

Report to the Board
7-8 December 2022

Subject Financial update, including forecast
Agenda item 04a
Category For Decision
Section A: Executive Summary
Context
This paper presents the updated Financial Forecasts for Gavi 5.0 (2021 -2025), COVAX
AMC (2020 -2023) and Gavi 6.0 (illustrative) (2026 -2030) to the Board for approval
based on a recommendation from the Audit and Finance Committee (AFC).
The Gavi 5.0 forecast confirms sufficient financial flexibility given the uncertain context
with US$ 183 million available for future investments.
? The updated forecast includes the impact of the HPV relaunch (US$ 167 million) and
proposed revision to the Eligibility & Transition and Co -Financing policies
(US$ 80 million), both of which are being presented for decision at this meeting.
? The underlying forecast reflects a decrease of US$ 301 million in resources due to
the impact of macro -economic factors (noting no chang e to underlying pledges), and
a decrease in programmatic expenditures of US$ 317 million reflecting continued
disruption of routine immunisation due to the pandemic as well as greater visibility
on country needs and absorptive capacity (based on existing r esources in -country) .
? Key elements of Gavi 5.1 are still under development and therefore this updated
forecast does not include programmatic estimates related to regional manufacturing
diversification, a potential ongoing routine COVID -19 immunisation pro gramme, or
Gavi?s future role in pandemic preparedness and response, noting these elements
are pending further Board approval.
The COVAX AMC forecast reflects the status of ne gotiations with COVID -19 vaccine
manufacturers and includes a n estimate of US$ 1 .9 billion reduction in vaccine liability .
Included in the forecast is US$ 2.7 billion under the Pandemic Vaccine Pool, with
US$ 0.8 billion anticipated to be used in 2023, subject to AMC Investors Group
approval. Therefore, US$ 1.8 billion is anticipated to be available to respond to potential
future escalations in the pandemic.
Questions this paper addresses
Is there sufficient funding available to deliver on Board -approved priorities for Gavi 5.0
and COVAX AMC, with adequate financial flexibility remaining to respond to the
uncertain operating context?
What elements of Gavi 5.1 are included in the financial forecast, and which items still
require financial implications to be determined and reflected?

1


Board -2022 -Mtg -03-Doc 04b

Report to the Board
7-8 December 2022

Subject Partners? Engagement Framework and Secretariat Budget
(2023 ?2024)
Agenda item 04b
Category For Decision
Section A : Executive Summary
Context
This paper presents the operating budget s for the Gavi Secretariat , COVAX AMC
(COVAX) and Partners? Engagement Framework (PEF) for the fiscal years 202 3 and
202 4 to the Board for approval based on a recommendation from the Audit and
Finance Committee (AFC) .
The proposed Secretariat budget for 2023 and 2024 is in line with the total Gavi 5.0
envelope included in the Board approved Financial Forecast , including the additional
budgets approved for the special initiatives (Malaria, Diagnostics and Middle -Income
Country strategy (MICs) ), with the US$ 45 million underspend from 2021 and 2022
rephased across the strategic period . This rephasing reflects the anticipated
acceleration of activities delayed due to the pandemic and higher inflation, as well as
provid ing a level of flexibility to enable the Secretariat to respond to uncertainties and
evolving needs given that we are still operating in the context of the pandemic as well
as enhanced global economic uncertainty. This flexibility will also enable certain
ope rating costs associated with Gavi 5.1 to be absorbed , specifically the human
papillomavirus (HPV ) vaccine relaunch and some of the potential costs relating to
regional manufacturing diversification (noting these are still to be determined) .
The Secretariat budget does not yet reflect the efficiency gains and synergies to be
realised through the new Operational Excellence approach . The Operational
Excellence framework is structured around 5I?s: Innovate (e.g. EVOLVE), Integrate
(e.g. COVAX Integration), Improve (e.g. simplify the way we work ), Invigorate (Gavi?s
culture and employee engagement ) and Inform (change management and
communication ). The full financial impact of the Operational Excellence initiatives and
related needed capabilities still need to be qualified and quantified . This will include a
holistic view of implementation costs (funded under the existing budget) , financial
benefits, impact on the organisation design and workforce, and a multi -year timeline
for execution.
The proposed COVAX budget is in line with the 2020 -2023 budget envelope approved
by the Board , with the US$ 10 million underspend from 2022 rephased to 2023 . The
Board has approved the COVAX mandate until the end of 2023 .
A potential COVID -19 vaccine programme from 2024 onwards as well as Gavi?s role
in pandemic preparedness and response (PPR) is being considered as part of Gavi
5.1. An in -principle decision on these Gavi 5.1 priorities is being requested by the

Doc 01d ? Annex B






December 2022
COVAX AMC ENGAGEMENT GROUP
TERMS OF REFERENCE
1. Purpose
The COVAX Facility Advance Market Commitment (?AMC?) Engagement Group (?the AMC
Group ?) is established by the Board (?Board?) of the Gavi Alliance (?Gavi?) to convene
representatives from implementing countries, donors and other parties engaged in the
financing and operation of the AMC portion of the Facility , with the aim of providing st rategic
guidance and advice to the Office of the COVAX Facility (?the Office?) on the operational
aspects of the COVAX Facility .
The AMC Group i s not deemed to be a committee of the Board in that its primary role is
essentially an advisory function as cont emplated under Article 20 of the Statues. It is
empowered by the Board to undertake the responsibilities outlined in these terms of
reference.
2. Membership
A. Composition and size
Membership of the AMC Group will be open to representatives of implementing countries,
donors and other parties engaged in the financing and operation of the AMC portion of the
Facility.
Additionally, a representative each from UNICEF, WHO, PAHO, the World Bank , Civil So ciety ,
and former members of the COVAX Facility Shareholders Council shall have a permanent
observer seat on the Engagement Group .
All members are treated equally in terms of membership, rights and privileges .
B. Competencies and skills
All members are expected to act in a manner consistent with the Facility?s goals.
The criteria for AMC Group membership shall be consistent with Gavi?s guiding principles on
gender for Board and Board Committee nominations and Gavi?s Conflicts of Interest Policy for
Gover nance Bodies.

Classified as Internal #
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