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Board -2020 -Mtg -6-Doc 07

Section A: Executive Summary
Context
In June 2019 , the Board agreed to institutionalise Gavi?s support to former Gavi -
eligible countries and requested the Secretariat to explore options for working with
select never -Gavi eligible middle -income countries (MICs). The development of
th is MICs Appro ach was paused in June 2020 as a result of the pandemic but,
given its pertinence to the delivery of Gavi 5.0, the Board requested the Secretariat
bring it back for decision in December 2020. This paper seeks Board approval
on the proposed MICs Approach as recommended by the PPC .
Questions this paper addresses
? Why is a MICs Approach pertinent to the delivery of Gavi 5.0 , and what are the
objectives, scope of country eligibility, and funds required ?
? In view of the impact of COVID -19, h ow should the Alliance engage in MICs ?
Conclusions
Backsliding in vaccine coverage and the absence of key vaccines in both former
Gavi -eligible (hereafter ?former -Gavi?) countries and select never -Gavi eligible
(hereafter ?never -Gavi?) MICs pose a direct threat to the successful delivery of Gavi
5.0. This paper thus proposes for approval a dedicated MICs Approach , endorsed
by the PPC, to prevent backsliding in former -Gavi countries and to drive the
sustainable introduction of key missing vaccines in former -Gavi countries and
select never -Gavi MICs . But t he impact of the pandemic on both countries and the
Alliance means that trade -offs are required . Hence a gradual engagement that ,
through a distinct equity lens , gives priority to preventing and mitigating backsliding
in former -Gavi countries and to strengthening relationships in never -Gavi MICs to
prepare for future more substantive engagement is recommended . Exceptional
support may also be o ffered to ensure successful introductions of key vaccines, or
to lay the groundwork for their future introduction. The Secretariat will return to the
Board in June 2022 with the full suite of MICs support . A pproval is requested of
the already earmarked 3% of Gavi 5.0 planned expenditure (US$ 281 million), with
a proposed spend of up to 25% in the first 18 months . In reviewing th is proposal ,
which it endorsed, the PPC requested the Secretariat to further consider how
fragil e MICs might be supported , to develop a Theory of Change for the MICs
SUBJECT :
GAVI?S APPROACH TO ENGAGEMENT WITH FORMER
AND NEVER -ELIGIBLE MIDDLE -INCOME COUNTRIES
(MICS)
Agenda item: 07
Category: For Decision
Report to the Board
15-17 December 2020

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Board -2020 -Mtg -6-Doc 08-Annex A

Annex A : Implications/Anticipated impact
? Risk implication and mitigation, including information on the risks of
inaction
Risks associated with the Facility are set out in the paper and in Section 3 of the
Risk & Assurance Report (see Doc 06 ).
? Impact on countries
The failure of the Facility to provide up to 2 billion doses of COVID -19 vaccines
by the end of 2021 will impact equitable access to COVID -19 vaccines, in
particular for low er -income economies.
? Impact on Alliance
The full Alliance is invested in the success of the COVAX Facility and the
COVAX AMC, with Gavi also seeking secondments to ensure that is it fully
leveraging the expertise from acro ss the Alliance partners and stakeholders .
? Legal and governance implications
Gavi, as the legal entity of the Facility is entering into the commitments with
participants and manufacturers and ultimately bears any exposure whether
financial, programmatic or reputational.
The key legal risk has been identified as the SFPs not entering into supply
agreements, while Gavi will have to comply with its commitment to pay for the
firm order commitments to manufacturers. I n that context, i t is worth noting that,
once Gavi exercises its option under its advance purchase agreement (APA)
with the relevant manufacturer (on the basis of the exercise of options by the
SFPs un der the optional model ), Gavi?s options in the APA effectively become
firm order commitments before the SFPs have entered into their supply
contracts with th e relevant manufacturer or procurement agent . This window
represents a potential liability for Gavi.
While a number of SFPs under the committed model have procured a
guarantee, in many instances, the guarantee has been issued by the relevant
SFP?s Ministry of Finance or Ministry of Health, which rep resents the same
sovereign risk as that of the original non -payment. By contrast, t he SFPs under
the optional model do not have a guarantee to cover for the failure to enter into
a supply agreement after they have exercised their option to procure the
vacc ines.

Gavi is working with Citi group to address this risk through such mitigants as
requiring SFPs to put money in escrow (which would require an amendment to
the ir existing commitment agreement with Gavi ) or to obtain a standby letter of
credit (which the relevant SFP would have to pay for), or requiring Gavi to
procure a breach of contract guarantee f rom the Multilateral Investment
Guarantee Agency ( MIGA ) for certain countries within MIGA?s scope of
coverage, as well as a liquidity facility on top (given that claiming under MIGA?s
guarantee requires taking the defaulting country through an arbitration process
and obtaining a favourable arbitral award ).

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?
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Board -2020 -Mtg -6-Doc 08 -Annex B

Annex B: COVAX Budget 2021 and three -year forecast
Section A: Summary
1.1 This objective of this paper is to present the Office of the COVAX Facility
budget for 2021 and Forecast 2022 and 2023 to the Board for approval .

1.2 The July Board meeting approved US$ 8.4 million seed funding to enable the
setting up of the Office of the Covax Facility. It was agreed that t hese costs
would ultimately be funded by the SFP contributions and AMC funds.

1.3 A three year budget has been prepared for the expected life of the Facility ( a
three year facility was outlined in the terms and conditions for the SFPs). This
budget will be funded by the upfront payments of SFPs and Gavi COVAX
AMC funds.

1.4 Total Facility operating c osts are forecast to be US $ 135 million over the three
years.

1.5 The budget Facility costs for 2021 are US $ 55 m illion of which US $ 23 m illion
are staff/ consultants/ professional fees.

1.6 An estimate has been made to identify (where possible) and allocate costs of
the Facility to SFP and AMC participants. New processes are being
introduced and new risk mitigation measures established some specifically to
support the new SFPs. It is therefor e expected that more of the Facility costs
will be funded by SFPs than the AMC. An initial estimated split of costs of
70% SFP and 30% AMC has been made and a more accurate assessment
will be made as the Facility design is finalised and operationalised.

1.7 The 2021 budget has been recommended for approval by the AFC .
Section B: Office of the COVAX Facility Budget
2.1 The table below provides a summary of the COVAX operational ex penditure
budget for 202 1 along with projections for 202 2 and 202 3.

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Board -2020 -Mtg -6-Doc 06


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 & 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 . This year?s report presents a reframed set of 16 top risks in the conte xt of
Gavi 5.0, the COVID -19 pandemic and the COVAX Facility. The report has been
reviewed and recommended for approval by the Audit & Finance Committee
(AFC). The Gavi Alliance Board is requested to approve the report attached as
Annex A and to provide gu idance on the questions outlined below.
Conclusions
This year?s report shows that Gavi?s overall risk profile has increased across the
board, with nine top risks from last year having increased , one new risk and one
having decreased. While inherently risks are heightened, mitigating these risks and
obtaining assurance over the effectiveness of mitigation is now more complicated
due to COVID -19 related restrictions and affected capacities. As a result, the Gav i
Alliance Board needs to acknowledge that Gavi will be operating with a riskier
strategy in a riskier world, and it will be critical to reflect this in a recalibrated risk
appetite (i.e. consciously accepting for some risks that they may materialise as pa rt
of pursuing our mission) and to continue to actively monitor and re -assess risks as
they change or our understanding of them evolves. Section 2.3 of the report
therefore includes suggestions on how to recalibrate risk appetite, which can serve
(together with the Gavi Alliance Board?s guidance on this) as the basis for a
subsequent update of Gavi?s Risk Appetite Statement to further specify and codify
Gavi?s risk appetite for the Gavi 5.0 strategic period .


SUBJECT : RISK MANAGEMENT UPDATE
Agenda item: 06
Category: For Decision
Report to the Board
15 -17 Dec ember 2020

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Board -2020 -Mtg -6-Doc 07 -Annex A
Annex A: Implications/Anticipated impact

Risk implication and mitigation: There are two key risks of the proposed MICs
Approach. The first is that the Secretariat does not have the capacity to deliver
successfully, given limited bandwidth across existing core Gavi and COVAX
activities. This is mitigated through a gradual, targe ted approach in the next 18
months, the request for two full time equivalents (FTEs), and the identification of
synergies with the COVAX Facility, as all never -Gavi MICs proposed for near -term
engagement are in the 92 economies engaged in the Advance Marke t
Commitment. Without additional resources, the Secretariat will not be able to roll
out the MICs Approach and it would need to be deprioritised .

The second risk is that a focus on COVID -19 vaccine introduction detracts from
the routine immunisation agend a, which is critical in these countries. Gavi will
prioritise the backsliding agenda in former Gavi -eligible countries, and, where
relevant, use COVID -19 as an entry point for a broader immunisation agenda in
both former and never Gavi -eligible countries.

Risk of inaction: If the Secretariat does not begin targeted engagement with MICs
now, there is a risk of further backsliding on routine immunisation in former Gavi -
eligible countries that would undermine the critical work done to date. There is also
risk that former and n ever Gavi -eligible countries are not prepared to introduce
lifesaving pneumococcal conjugate, rotavirus, and human papillomavirus vaccines
once the acute phase of the pandemic has subsided.

Impact on countries: The proposed Approach is critical to helpin g MICs mitigate
reductions in routine immunisation coverage and start to build the ecosystems
necessary to introduce new vaccines, especially for zero -dose children and missed
communities.

Impact on Alliance: The Alliance is significantly stretched by CO VID -19 and may
have limited capacity to implement the proposed MICs Approach. This is mitigated
by the provision of resources, accessible to partners, to enable delivery of the MICs
Approach.

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Board -2020 -Mtg -6-Doc 07 -Annex B
Annex B : Paragraphs referenced in decision points for the MICs Approach

Paragraphs 4.1 -4.5 of Document 04 to October 2020 PPC
4.1 In light of COVID -19, it is proposed that the MICs Approach be implemented
gradually , recognising that in the next 18 months, most countries , the
Secretariat and the Alliance will not have capacity to engage beyond
responding to the COVID -19 pandemic and introducing new COVID -19
vaccines . The primary focus over the next 18 months will be on
preventing and mitigating backsliding in former -Gavi countries , whil st
prioritising countries with large numbers of zero -dose children 1.
4.2 Support for former -Gavi countries
(a) Primary focus: Preventing and mitigating backsliding. Two Pillars of
support originally presented to the Board in June 2020 are proposed for
initial engagement with former -Gavi countries , namely political will
building and enhanc ing the immunisation ecosystem . The
Secretariat also proposes to deploy some targeted interventions to
meet the increased need s in former -Gavi countries . Engagements would
only focus on countries where there are meaningful opportunities to
deliver impact and would thus not take place in all countries. Activities
could include 2:
? Advocating to keep routine vaccinatio n on the political agenda
in a way that prioritises equity , including by bringing the voices of
the marginalised to the table.
? Providing technical assistance to help countries re -establish
routine immunisation services by developing plans to
communicate and engage communities towards the resumption of
safe vaccination services, rebuilding confidence in the system, and
designing strategies for identifying and catching up missed
communities.
? Targeted interventions to restore coverage and catch up missed
children, while fostering integrated service delivery and promoting
supportive innovations (e.g. digital tools).
? Fostering peer -to -peer learning through, for example, the Learning
Network for Countries in Transition (LNCT) , th e Vaccine
Procurement Practitioner?s Network (VPPN), and regional networks
such as the Pan American Health Organization (PAHO) Revolving
Fund (RF) , disseminating examples of best practice s on returning to
fully functioning routine immunisation services.
(b) Secondary focus: L ay ing the groundwork for future successful
introductions of PCV, rotavirus , and HPV vaccines by l everaging
1 Four former -Gavi countries have notable numbers of zero -dose children: Angola, India, Indonesia, and
Ukraine. Data from WUENIC, 2018. 2 This draws on Gavi?s ?Maintain, Restore and Strengthen? guidance (October 2020).

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Board -2020 -Mtg -6-Doc 07 -Annex C 1
Annex C: Summary of support proposed under the MICs Approach
Figure 1: Summary of initial engagement (January 2021 ? June 2022)

Country grouping 1
Former
Gavi -eligible
countries
Never Gavi -
eligible LMICs
Additional
never Gavi -
eligible & IDA -
eligible
economies
Indicative funding
allocation during
initial engagement
# countries in scope 2
17 3 11
(10 with
potential
engagement) 4
11
(9 with
potential
engagement) 5

Proposed
Activities
Preventing &
mitigating
backsliding
? ? ? ~US $ 60 million
Laying the
groundwork
for new
vaccine
intro duction s,
& responding
to country
intros of PCV,
rotavirus &
HPV 6
? ? ? ~US $ 10 million
Indicative funding
allocation during initial
engagement
~90% ~10%

Indicative Secretariat
resourcing during initial
engagement
2 FTEs
No additional resources at this
time; engagement via the
COVAX Facility


1 See Appendix 3 for the list of countries within each category. 2 Numbers of countries based on list of Gavi transitioned countries as of October 2020 and 2019 World Bank
country groups by income. Available online here:
http s://datahelpdesk.worldbank.org/knowledgebase/articles/906519 -world -bank -country -and -lending -groups .
Accessed October 2020. 3 Additional countries to be added pending transition over the next 5 years. 4 One economy, Federated States of Micronesia, is techni cally in scope but has no missing introductions
and so no initial activities are planned. 5 Two economies, Fiji and Marshall Islands, are technically in scope but have with no missing introductions
and so no initial activities are planned. 6 Activities related to new vaccine introductions will only be undertaken in countries that are missing at least
one of PCV, rotavirus or HPV vaccines.

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Board -2020 -Mtg -6-Doc 05b

Section A: Executive Summary
Context
The Alliance has made equity the organising principle of Gavi 5.0 , with an acute
focus on reaching zero -dose and under -immunised 1 children with immunisation.
This is also a key priority for the global community Immunization Agenda 2030,
which was endorsed by the World Health Assembly in May 2020. Despite a 50%
increase in the number of children being reached by routine immunisation since
2000, 10.6 million children still receive no routine vaccines each year in Gavi -
suppo rted countries . Without action, thi s would mean that over 50 million more
children would be missed by 2025. These children are disproportionately clustered
in marginalised communities which are typically among the poorest , with less
access to health and other government services and far wor se health outcomes.
Two thirds of zero -dose children live in households which are below the poverty
line and 50% of deaths from vaccine -preventable diseases in Gavi -supported
countries occur among zero -dose children , although they account for only
13% of c hildren . These communities are also often politically marginalised , face
systemic economic, social and cultural disadvantages and are home to acute
gender disparities. These are precisely the communities which must be prioritised
to achieve the vision of t he Sustainable Development Goals to leave no one
behind .
At its September meeting, t he Board reaffirmed that the Alliance?s focus on
equity is more important than ever in the context of the COVID -19 pandemic,
which has exacerbated existing inequities and increased the number of zero -dose
and under -immunised children. The Board endorsed the need to provide
additional Health Systems Strengthening (HSS) support to countries to
accelerate progress on equity and asked that the Programme & Policy
Committee (PPC) review and recommend the appropriate level of investment. The
Secretariat presented a set of options and trade -offs to the PPC in October . There
was clear agreement among PPC members that additional investments will be
needed to accelerate and sustain progress on reaching zero -dose and under -
immunised children and missed communities in the context of COVID -19. Having
considered potential options, the PPC recommended to increase the level of
HSS support by US$ 500 million to US$ 1.7 billion and funding to partners
1 Zero -dose children are defined for operational purposes as those not receiving a first dose of diphtheria -
tetanus -pertussis (DTP) containing vaccine; under -immunised are those not receiving a full course of three
doses of DTP -containing vaccine .
SUBJECT : ACCELERATING EFFORTS TO REACH ZERO -DOSE
CHILDREN AND MISSED COMMUNITIES IN GAVI 5.0
Agenda item: 05b
Category: For Decision
Report to the Board
15-17 December 2020

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Board -2020 -Mtg -6-Doc 05b -Annex A
An nex A: Theory of change for reaching zero -dose and under -immunised children and missed communities

Report to the Board
Board -2020 -Mtg -6-Doc 05b -Annex B 1
Annex B: Areas highlighted by the PPC to be further addressed in the Board
paper and / or during operationalisation
Cross -Alliance approach needed to operationalise the equity agenda: The Secretariat
and partners will create a cross -Alliance working team (and which does not duplicate
the work of existing bodies) to further operationalise the approach to reach zero -dose
children and missed communities
The proposed amo unts of additional investment may not be sufficient: Currently, there
is limited data on the additional costs of reaching zero -dose children which can be
very high in certain contexts. Recognising this, the PPC underlined the importance of
remaining flexib le. The Secretariat would report back to the PPC and Board
periodically on the progress and impact of this funding, and whether any adjustment
is needed to the amount
The Alliance to ensure integration of the core HSS, additional HSS being allocated for
eq uity and TCA to implement the equity agenda: Equity is the organising principle for
all Alliance support to countries and the Board paper will reflect how all these levers
come together at country level to support progress on equity including how redesigned
portfolio management processes would help countries plan all Gavi support in an
integrated way as part of full portfolio planning. As described in PPC Doc 03a, each
country will develop a theory of change to identify the outcomes it seeks to ach ieve,
the activities that will be needed to achieve this and how the full set of Gavi support
will be used for this. Countries will have a single budget and workplan which will
include all Gavi support.
Partners should be capacitated to deliver on Gavi 5.0 while responding to COVID -19:
The PEF MT will engage on how best to allocate the proposed PEF resources in Gavi
5.0, noting the heightened current resource requirements in the context of COVID and
the need to keep the PEF forecast flexible. The PEF MT can recommend to the Board
an adjustment to the overall PEF envelope in future years if this is deemed necessary.
Countries to be provided with more transparency on the support they receive through
PEF: Allocation of TCA funding will be linked to the HSS allo cation formula in Gavi
5.0, providing more transparency to countries on how countries? TCA funding levels
are determined relative to their HSS allocation. The principle of countries setting the
objectives and priorities for TA, and choosing appropriate par tners, will remain intact
in Gavi 5.0. As part of changes to portfolio management processes, multi -year
approvals of TCA will be implemented so both countries and partners have more
predictability of funding levels.
The Alliance to work with other partners within and beyond the health space to jointly
invest in reaching zero -dose children and missed communities as an entry point to
strengthen PHC: The Alliance has expanded the number of partners it works with very
significantly in Gavi 4.0 including partner s within and outside the health space. With
the focus on missed communities, the Alliance will seek to work systematically with
other development financing institutions to ensure they also prioritise these
communities for delivery of other PHC services, an d to expand partnerships with other
actors outside the health space who have a comparative advantage in identifying and
reaching missed communities (e.g. the Secretariat is currently working to develop
framework agreements with multiple humanitarian organ isations to facilitate

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PPC - 2020 - Mtg - 2 - Doc 03b Report to the
Programme and Policy Committee
28 - 29 October 2020

Section A: Executive Summary
Context
E quity is the organising principle of Gavi 5.0, and the Alliance has made reaching
zero - dose ch ildren and missed communities (which are also home to many under -
immunised children) with a full course of vaccines our paramount commo n priority.
This builds on the coverage and equity agenda during Gavi 4.0 : s ince 2015,
c ountries have reduced the number of zero - dose children 1
by 14% , following five
years of stagnation in Gavi 3.0 . However , with 10.6 million children remaining
deprived of even a single dose of the basic diphtheria - tetanus - pertussis ( DTP )
containing vaccine every year in Gavi - supported countries, much remains to be
done . After a successful replenishment, the Alliance has more resources to invest
in its goal to l eave no one behind with immunisation, scale up promising models of
pro - equity programming at sub - national level initiated during Gavi 4.0 and help
countries to accelerate progress .
T he COVID - 19 pandemic has created unprecedented disruption resulting in ma ny
more zero - dose and under - immunised children, with a disproportionate impact on
poor and marginalised populations. It also means countries are facing higher cost s
as they adapt services to follow new safety protocols , intensify community
engagement to rebuild trust and catch up missed children. The Alliance has
stepped up to support countries in mounting an immediate response to COVID - 19,
and is now pivoting to mai ntain, restore and strengthen immunisation services.
Countries are reprogramm ing Gavi support from their health system strengthening
(HSS) and Partners? Engagement Framework (PEF) budgets to meet these needs .
As b oth HSS and PEF budgets are currently set t o decline in Gavi 5.0 , with HSS
declining by ~ US$ 200 million , t his risks undermining efforts to accelerate progress
on equity unless additional resources are made available to countries .
Questions this paper addresses
1. How will the Alliance support countries to reach zero - dose children and
missed communities, building on progress in Gavi 4.0?
2. How has COVID - 19 affected immunisation and equity and h ow is the
Alliance supporting countries to respond ?

1
Zero - dose children are d efined for operational purposes as those not receiving a first dose of
diphtheria - tetanus - pertussis (DTP) containing vaccine ; under - immunised are those not receiving a
full course of three doses of DTP - containing vaccine SUBJECT : ACCELERATING EFFORTS TO REACH ZERO - DOSE
CHILDREN AND MISSED COMMUNITIES IN GAVI 5.0
Agenda item: 0 3 b
Category: For Decision
Doc 05b - Annex C

Gavi