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Board -2022 -Mtg -02-Doc 05


Section A: Executive Summary
Context
In less than two years since the creation of COVAX and the Access to COVID -19
Tools Accelerator, COVAX has now delivered over 1.5 billion COVID -19 vaccine
doses to 145 economies, including over 1. 3 billion doses to Advance Market
Commitment (AMC) economies, contributing significantly to coverage rates
achieved in AMC countr ies: 54 % with at least one dose and 46 % fully vaccinated
as of 24 May 2022, though overall coverage between, and within, countries
remains uneven as does coverage of high risk populations. Despite a challenging
supply situation in 2021, successful fundrais ing to the COVAX AMC, advance
purchase agreements (APAs) with multiple manufacturers, and generous dose
donations have ensured that COVAX has adequate supply to meet participants?
vaccine demand going forward. As we look to the future, Gavi will begin plan ning
for integration of COVAX , both operationally into the Gavi Secretariat and
programmatically as part of the Gavi 5.1 strategy (see Doc 03 ). We will need to
ensure adequate capacity as well as talent to ensure we can continue delivery on
the ne w integrated mission of Gavi 5.0 and COVAX as we continue to monitor and
adapt to an evolving environment.
This paper comprises three sections: 1) the current status of COVAX Facility
operations; 2) COVAX Facility role and ambition in vaccine procurement a nd
delivery in 2023, including integration of COVAX Facility operations and activities
into core Gavi Secretariat and programming as part of Gavi 5.1; and 3) COVAX
Facility vaccine policies. This paper builds on previous Board and Committee
discussions and presents decisions for the Board to approve of Gavi?s continued
administration of the COVAX Facility, flexibility to develop new or revised Gavi
COVAX AMC positions aligned with SAGE (Strategic Advisory Group of Experts
on Immunization) guidance, such as on paediatrics and boosters, and support for
the continued limited provision of paediatric doses.
Questions this paper addresses
Part I: Current Status of Operations
? What progress has Gavi made supporting AMC participants achieve their
COVID -19 vaccination goals?
SUBJECT : COVAX: KEY STRATEGIC ISSUES
Agenda item: 05
Category: For Decision
Report to the Board
22 -23 June 2022

Report to the Board
Board -2022 -Mtg -02-Doc 04 -Annex D

Annex D: Financial Forecast Detail COVAX AMC
Figure 1: COVAX AMC Resources

Qualifying Resources Overall cash Qualifying Resources are US$ 12.3 billion . This
reflects the new US$ 1.7 billion pledges from the April 2022 Break C OVID Now
Summit . There was a US$ 253 million decrease to the past resources primarily due to
IFFIm?s Gearing Ratio drawdown l imit and adverse foreign exchange impact . Of the
US$ 12.3 billion pledged, US$ 10.2 billion has been received, US$ 9.4 billion relating
to vaccine procurement and ancillary costs and US $0. 8 billion relating to delivery
support.
IFFIm Proceed s have come down by US$ 69 million to reflect the COVAX portion of
the gearing ratio drawdown li mit (currently 73%) across both Gavi 5.0 and COVAX
resources (US$ 144 million) despite a US$ 75 million increase from two direct pledges
that were converted to IFFIm pledges after December 2021.
The European Investment Bank ( EIB ) Loan has been hedged and will be swapped
on a quarterly basis . The proceeds and repayment now reflect the hedged rate, which
results in a US$ 40 million lower value than the rate used in the previous forecast. This
is a frontloading capacity consideration only, and does not impac t total Qualifying
Resources. The COVAX AMC Financial Forecast only considers the EUR 440 million
AMC portion of the loan, as the balance relates to SFPs.
Dose -sharing and cost -sharing initiatives are key factors in COVAX achieving
vaccine coverage targets . While both initiatives are excluded from the Gavi financial US$ million, cash-flow basis 2020-2023
Prior
Forecast
Dec 2021 Board
Change
upon updating
estimates
Phase III
Investments
New
Forecast
June 2022 Board
Resources Available
New contributions - Phase III - - 1,690 1,690
Direct contributions - Vaccines 8,875 (216) - 8,659
IFFIm Proceeds (projected) 1,153 (69) - 1,084
Subtotal Vaccines (projected) 10,028 (285) - 9,743
Direct contributions - Delivery 799 32 - 831
Subtotal Delivery (projected) 799 32 - 831
EIB Loan Proceeds 537 (40) - 497
BMGF Loan Proceeds 300 - - 300
Investment Income, etc. 1 - - 1
Total Inflows 11,665 (293) 1,690 13,062
EIB Loan Repayment (537) 40 - (497)
BMGF Loan Repayment (300) - - (300)
Qualifying Resources (US$) 10,828 (253) 1,690 12,265
$10.8 bn ($0.3 bn) $1.7 bn $12.3 bn

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Board -2022 -Mtg -02-Doc 04


Section A: Executive Summary
At its December 2021 meeting, the Gavi Alliance Board reviewed and approved
the Financial Forecasts for (i) Gavi (excluding COVAX) for the Strategic Period
2021 -2025 ( Gavi 5.0 ) and (ii) COVAX Advance Market Commitment ( COVAX
AMC ).
This paper presents the updated Financial Forecasts for Gavi 5.0 and COVAX
AMC (2020 -2023) including the impact of the additional Gavi 5.0 investment priorit y
presented for decision at this Board meeting and the outcome of the April 2022
Break COVID Now Summit . Further, solely for compl iance with the Programme
Funding Policy and to enable the Secretariat to allot funding , an initial financial
forecast for the 2026 -2030 Strategic Period (Gavi 6.0) is presented for the first time
based on existing programmes .
While many risks remain elevated and this uncertain environment continues to
require close monitoring of assumptions and frequent updates to the forecast as
risks may evolve and materiali se, at this point there are no material changes to
the approved expenditure s in the Gavi 5.0 financial forecast although certain
activities have been rephased to reflect 2021 performance . The consequences of
implementing key strategic initiatives during a global pandemic may continue to
impact 2022 disbursement levels and the pha sing of this financial forecast, which
the Secretariat considers ambitious but achievable, has been carefully considered
as part of the reforecast. The key assumptions underpinning the financial forecast
reflect the Secretariat?s continued assessment that while routine immunisation
programmes are at risk of disruption from the pandemic and implementation of
COVID -19 immunisation programmes, implementing countries continue to
demonstrate resilience and strong commitment to these programmes .
The future direct ion of the C OVID -19 pandemic is uncertain. While COVAX? s
challenge is to ensure it is ready should any of the WHO pandemic scenarios come
to pass, we are at a new juncture in that vaccine supply is readily available. COVAX
is adapting and providing differentiated support in line with the national plans,
priorities and coverage targets of each AMC country. The COVAX AMC forecast
has been updated to reflect the new commitments made at the April 2022 Break
COVID Now Summi t that will enable COVAX to provide urgent delivery support for
lower -income countries , ensure dose donations can be shipped and administered ,
and enable Gavi to launch the Pandemic Vaccine Pool. COVAX is currently
?resizing and rephasing? its portfolio to meet the latest demand context from
countries (working closely with the Market -Sensitive Decision s Committee (MSDC)
SUBJECT : FINANCIAL UPDATE, INCLUDING FORECAST
Agenda item: 04
Category: For Decision
Report to the Board
22 -23 June 2022

Report to the Board

Board -2022 -Mtg -02-Doc 05 -Annex C

Annex C : 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
December 2021 Gavi Board.

MEL
strategy
component
Key activity Highlights / update ( June 2022)
Cross -
cutting
COVAX Theory of
Change
Refined and updated core theory of
change reflecting 2022 strategy developed.
Nested theories of change will also be
utilized by the independent evaluators as
part of their theory -based evaluation.
Monitoring COVAX Reporting
Framework
Reporting against COVAX Reporting
Framework made available for PPC and
Board.
Refined COVAX Reporting Framework to
reflect strategic shifts for 2022. The
framework may be further refined over the
course of 2022 to reflect further evolutions
in programming / strategy.
Complementary
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. E xamples include:
? Vaccine Delivery Partnership outputs
focusing on absorption rates and other key
delivery metrics;
? Monitoring of operational 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
re porting 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.

Report to the Board
Board -2022 -Mtg -02-Doc 05 -Annex A

Annex A: Interim Approach to Paediatric Support

This section provides an update on the interim, time -bound, policy approach on
paediatric vaccination support for children aged 5 -11 valid until June 2022.

The Office of the COVAX Facility, in close consultation with other COVAX partners,
established an interim, time -bound, approach to allocate paediatric vaccines for
children aged 5 -11 fro m April to June 2022 in response to several time -sensitive
demand and supply considerations. Several AMC participants that had achieved high
coverage or demonstrated high absorptive capacity requested paediatric doses from
COVAX and signaled that if COVAX was not able to meet this demand they would
consider buying paediatric doses through bilateral deals at their own expense
(potentially incurring health expenditures in the order of ~US$ 1-1.5 billion 1). In
aggregate, the initial expressed demand was equiv alent to approximately 150 million
doses. In view of the potential availability of Pfizer donated doses that may otherwise
have gone to waste, a decision was taken for COVAX to facilitate access of paediatric
doses for the sub -set of AMC participants expre ssing demand by requesting donors
convert commitments for adult doses to paediatric formulation to meet this demand on
a short -term basis, pending formal governance review and approval of a longer -term
approach. Given the urgent need to respond to particip ants? requests, this approach
was discussed and endorsed by the Chairs of the PPC, Board, and AFC as well as
the Vice Chair of the Board in late March 2022. Separate from this interim approach,
if there is demand from SFPs for paediatric doses and supply f rom donations that are
eligible to go to SFPs, COVAX intends to serve as a channel to allocate these
donations.

Based on feedback from the Chairs and partner consultations, the interim approach
included defined guardrails in terms of timing (until Jun e 2022), supply (meeting
whatever demand there was through donated Pfizer doses ? the only vaccine currently
with EUL and a SAGE recommendation for this age group), and demand, namely
1) Pfizer -eligible participants with >40% primary series coverage; 2) pa rticipants
proactively expressing demand; 3) participants making progress towards vaccinating
(with primary series and boosters) higher priority groups in the WHO prioritisation
roadmap; and 4) participants with demonstrated capacity to continue delivering EPI
vaccines through routine immunisation. It was also agreed that participants would not
be able to use COVID delivery support (CDS) funding to support the administration of
these paediatric doses. Syringes suitable for the paediatric formulation would b e
substituted for the adult formulation syringes that would otherwise have been
purchased for this volume of doses, and in principle, donors would cover the syringe
and other ancillary costs.??

To formali se demand requests for the interim approach, Expression of Interest forms
were sent to 26 participants in early April 2022 , all of whom had previously proactively
requested paediatric doses from COVAX and had already achieved or were expected
to achieve greater than 40% primary series cover age of their total population by
mid - May 2022 . Of those, 23 responded and 18 requested approximately 120 million
doses to be delivered between May and December 2022, although it should be noted
that demand is skewed heavily toward a few participants. Base d on a review of the
demand in the context of implementation feasibility as well as status of higher priority

Report to the Board
Board -2022 -Mtg -02-Doc 05 -Annex B

Annex B: Supporting Considerations for a Future COVAX -Supported Paediatrics
Program me and Risks and Trade -offs

Supporting considerations related to Option 2 ?

Paediatric vaccine supply : At present, there is one vaccine product (Pfizer) which has
received WHO EUL and SAGE recommendation for administration to children aged 5 -
?11 and which could be readily available through COVAX; currently there are no
vaccines with WHO EUL or SAGE recomm endation for administration in children
under 5. In addition, although the Moderna vaccine has not yet received EUL or SAGE
recommendation for use in under 12s, the EMA has approved a 6 -11 year paediatric
indication that is the same formulation as the boos ter already available through the
COVAX Facility. Subject to national policy, it is possible that countries could decide to
use Moderna booster doses they have received through COVAX for a paediatric
vaccination program me. The products available and expect ed over the next months
come with program matic challenges including UCC requirements (Pfizer), the
management of paediatric vs. adult formulations, and the availability of syringes.
Regarding devices, Pfizer requires a 0.2ml and Moderna a 0.25ml dose ? vol umes
without readily available supply of AD devices - and will require COVAX to provide 1ml
RUPs as an alternative (in line with WHO guidance). Several other products across
different platforms (mRNA, inactivated, ad -based, protein subunit) are undergoing
regulatory review and awaiting SRA, WHO EUL or SAGE recommendation in the short
and medium term (i.e. mid 2022 and 2023), broadening the supply options to meet
existing and future demand.

Paediatric vaccine demand from COVAX AMC participants: The AMC pa rticipants that
sought COVAX support for paediatric vaccination in the first few months of 2022 would
be covered by the interim policy approach. While there are no specific estimates,
additional demand from COVAX participants is expected to materialise in the coming
months as participants follow the policies and practices of high -income -countries
(HICs), countries in their respective region, and highly absorptive countries, to direct
resources to vaccinate children in parallel with their continued efforts t o reach their
higher priority populations. This trend will accelerate as additional vaccines for 5 -11
and as vaccines for younger age groups (under 5 -year -olds) receive WHO EUL and
are recommended by SAGE. Option 2 would seek to meet demand whilst also put ting
in place limited guardrails to ensure focus on higher priority population groups is
reinforced and avoid displacing routine immunisation .

Public health impact of paediatric vaccination: The WHO SAGE roadmap for
prioritising use of COVID -19 vaccines advises the administration of primary series and
boosters to higher priority groups, such as older adults, immunocompromised persons
or health care workers, before reaching medium and lower pr iority groups, such as
children and adolescents. The rationale for this is that globally, there are fewer
symptomatic infections and cases of severe disease and death in children than in older
adult age groups; the burden of long COVID also appears lower a mong children
compared to adults. However, benefits of vaccinating children go beyond direct health
benefits, such as positive psychosocial benefits and minimising school disruptions and
consequently disruptions to parents and society at large. 22 Paediatri c vaccine
effectiveness data in the context of Omicron indicates that immunity against infection
wanes rapidly but, as for adults, protection against severe disease is

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