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Documents (9878)

Showing 12 of 9878 View All
Showing 132 of 824 pages

10 Review of decisions No paper pdf




Bo ard -2021 -Mtg -2-Do c 10 1
Report to the Board
23-24 June 20 21

















SUBJECT : REVIEW OF DECISIONS
Agenda item: 10
No paper

11 Closing remarks No paper pdf




Bo ard -2021 -Mtg -2-Do c 11 1
Report to the Board
22-24 June 20 21

















SUBJECT : CLOSING REMARKS
Agenda item: 11
No paper

AFC Chair Report to Board June 2021 pdf

1



Bo ard -2021 -Mtg -2-Aud it an d Fin an ce Co mmittee Ch air Rep o rt

Section A: Introduction
? This report provides the Gavi Alliance Board with an overview of the
activities of the Audit and Finance Committee ( AFC ) since the 15 -17
December 202 0 Gavi Alliance Board meeting .
? The start of the year has been particularly intense f or Gavi with the
operationalisation of COVAX , the transition to the new strateg ic period
including the implementation of the Secretariat reorganisation and the
acceleration of the statutory f inancial reporting timetable all against the
backdrop of continued disruptions to routine programmatic activity cau sed
by the pandemic , and within a remote working environment .
? The AFC continue s to meet more f requently to ensure that the
operationalisation of the COVAX Facility is i n accordance with the risk
management f ramework :
o In the f irst half of 202 1, the AFC met f ive times to receive updat es
f rom the Of f ice of the COVAX Facility and the appointed advisers to
consider f inancial and operational risks , and proposed mitigation s.
The complexity of the Facility, the dynamic nature of the pandemic
and the f ast -mo ving pharmaceutical vaccine landscape have
contributed to a complex risk environment and the members of the
Secretariat and the AFC have ?lent in? accordingly . Considerable
progress has been made to identif y, measure and mitigate the risks.
Im portantly, mi tigation of credit risk is expected to be implemented
during July. At this time no matters require the attention of the Gavi
Alliance Board.
o In addition, the AFC met f our times to consider Gavi ?core ? matters in
accordance with the standard wo rkplan . Subjects reviewed are noted
under Section B and matters to be reviewed in u pcoming meetings
are included under Section C. No issues have been identif ied as a
result of this work.
? AFC recommendations to the Gavi Alliance Board are attached as Annex
A.



SUBJECT : AUDIT & FINANCE COMMIT T EE CHAIR REPORT
Category: For Inf ormation
Report to the Board
23 -24 June 20 21

EAC Chair Report to Board June 2021 pdf

1



Board -2021 -Mtg -2-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 Committee Chair last
reported to the Board in December 2020 .
? The EAC met virtually on 14 and 1 5 April to approve the multi -year
evaluati on workplan for Gavi 5.0; provide guidance on the Evaluation
Operational Guidelines (EOGs) ; and discuss approaches adopted in the
evaluation sector to adapt evaluation methods in response to COVID -19
and in fragile and conflict contexts.
o The EAC a cknowl edged that the 5.0 multi -year evaluation workplan
is comprehensive , covering the key strategic areas for centralised
evaluation.
o The EAC noted the interconnec tivities between the 5.0 centralised
evaluations , particularly around the zero -dose approach with fragile
and conflict settings and impact of COVID -19 on Expanded
Programme on Immunization (EPI) programmes (and the lack of data
in these contexts) .
o The EAC provided feedback on the proposed evaluation questions
and emphasised the importance of sharing f indings between
evaluations in a time -efficient manner .

? During a closed session on 14 April, the EAC noted with satisfaction the
reaffirmation by the Gavi leadership of the im portance of the EAC in
supporting the independence of Gavi?s evaluations, and i n guiding
mitigation actions in the event of perceived potential risks to evaluation
independence.
? The EAC also emphasise d the need to further strengthe n the linkages with
the Programme and Policy Committee (PPC) and communication channels
with the Board.
? The EAC did record some concerns regarding key shifts in the Evaluation
Operational Guidelines (EOGs) and agreed to provide written comments by
consensus following the EAC meeting. A consensus statement was
submi tted by the EAC to the Gavi Secretariat on 30 April 2021, as a
constructive roadmap for the way forward , and this will be provided to the
incoming Chair for consideration .
SUBJECT : EVALUATION ADVISORY COMMITTEE CHAIR REPORT
Category: For Information
Report to the Board
23 -24 June 2021

06 Annex B COVAX MEL and Reporting Framework pdf

Report to the Board
Board -2021 -Mtg -2-Doc 06-Annex B

Annex B: COVAX Reporting Framework
Section A: Update on Gavi?s COVAX Facility and COVAX AMC Monitoring,
Evaluation and Learning (MEL) strategy
The Gavi Secretariat presented its proposed MEL approach to the Gavi Board in
December 2020. Since then, we have further refined this approach and begun
implementing key aspects of the strategy. The approach is intended to be holistic in
nature, spanning from inputs through to impact across the COVAX Facility and COVAX
AMC , and complementary to work being led by other COVAX partners and the wider
global health community . It is intended to support both accountability and learning
perspective s and will need to evolve and adapt over time to reflect the changing nature
and needs of COVAX. It has close linkages to the Secretariat?s and broader COVAX Risk
Management and Assurance work .
The table below provides some of the key highlights and update s on progress against the
core elements of Gavi?s COVAX Facility and COVAX AMC MEL Strategy since the
December 2020 Gavi Board .
MEL strategy
component
Key activity Highlights / update (May 2021)
Cross -cutting COVAX Theory of Chang e Core COVAX Theory of Change shared with
December 2020 Gavi Board
Updated COVAX Theory of Change (integrating
2022 strategy) under development , incorporating
feedback from core partners
Monitoring COVAX Reporting Framework Draft COVAX Reporting Framework shared with
December 2020 Gavi Board (indicators only)
COVAX Reporting Framework (indicators and
targets) shared with May 2021 PPC
COVAX Reporting Framework (indicators, targets
and actuals) shared with June 2021 Gavi Board
Complementary monitoring to
COVAX Reporting Framework
COVAX Facility and Gavi Secretariat teams are
expanding the set of complementary monitoring
metrics being tracked internally (to be used, for
example, for programme management, course
correction and monitoring the evolution of COVAX)
Core country monitoring and
reporting on COVID -19 / COVAX
WHO -UNICEF Joint Reporting Form COVID -19
module (monthly reporting) launched in March
2021

06 Annex C COVAX Risk Report pdf

Re port to the Board

Board -2021 -Mtg -2-Doc 06-Annex C
Annex C: COVAX Risk Re port

The COVAX Facility ?s mission of securing equitable access to COVID -19 vaccines
continues to require navigating uncharted territory at unprecedented speed and scale ,
which naturally comes with risk . The COVAX Facility acknowledges that many risks
are worth taking , given that inaction would leave many countries behind, and the global
economy and Gavi?s core mission would continue to be disrupted by the pandemic .
Anticipating what might happen and proac tive management of these potential risks
helps the COVAX Facility to manage expectations, reduce vulnerabilities, and secure
success.

Gavi?s last Risk & Assurance Report include d a high -level assessment of the risks
associated with the COVAX Facility 1. Building on this initial assessment , t he Office of
the COVAX Facility has created and maintains a central COVAX Facility -wide risk
register, bringing together all top risks across the COVAX Facility , from deal -making
to allocation and delivery . This serves to clarify risk ownership , stay abreast of new
risks, track mitigation actions, and inform decisions, prioritisation and management
attention . Since the COVAX risk landscape is very dynamic, i t is continuously updated
and aligned with other risk -related information sources, e.g. in the Country Readiness
and Delivery (CRD) work stream of the COVAX Pillar and the COVAX Pillar Strategic
Coordination Office .

Now that the Facility has moved towards shipping actual vaccines to countries, risk
exposures have also shifted towards supply, allocation and delivery risks in -country.
The COVAX Facility continues to operate in a dynamic, competitive and challenging
exte rnal environment, continues to develop new initiatives such as dose -sharing, cost -
sharing and the human ita rian buffer , and awaits a large scale -up of activities and
transactions towards the end of the year after the current smaller first wave of vaccine
allocations and shipments. The emergence of new virus variants and safety signals
for some vaccines has also create d further uncertainty both for supply and
allocation/uptake, with the potential for refusals due to product preferences and
vaccine confidence potentially being affected in country populations due to (perceived)
safety concerns . Finally, the develop ment of the 2022 strategy and future country
participa tion model for the COVAX Facility have the potential to reduce some inherent
risks, but may also bring new risks.

COVAX Facility -wide top risks

The heatmap below depicts the most critical risks that could potentially have an impact
on the ability of the COVAX Facility to achieve its mission and goals.

The 6 top risks rated very high are:

1) Constrained global supply (access ) ? The risk of significantly reduced supply
following signature of Advance Purchase Agreements (APAs) has already
materialised and remains a very high risk going forward. While the current supply
constraints are mainly caused by manufacturer production issues and export controls,
1 See Section 3 of the report : https://www.gavi.org/news/document -library/gavi -risk -and -assurance -
report -2020

06 Annex D Risk Considerations for the COVAX Participation Model pdf

Report to the Board
Board -2021 -Mtg -2-Doc 06-Annex D
Annex D: COVAX Country Participation Model: Risk Considerations
Section A: Summary
? In May 2021, the PPC requested the Secretariat perform a high -level analysis on
the risk considerations for the three country participation model options . This paper
considers the financial, reputational, pandemic response , governance, and
operational risks of the three models along with the impact on AMC -92 in terms of
pricing structure, supply, and the ability to make deals. The high -level risk analysis
and considerations indicate that the AMC+ model tends to mitigate the most risks
to Gavi and the COVAX Facility with the greatest advantage seen in the area s of
reputational and pandemic response risk.
Section B: Risk Considerations
Financial
? The main financial risk with the Status Quo model is created when Gavi enters into
legally binding commitments with manufacturers on behalf of Self -Financing
Participants (SFPs ) without full payment from them. Currently, the sovereign credit
risks are to be mitigated using bespoke insurance products . The Status Quo model
maintains the current financial risk to the COVAX Facility and the Secretariat ,
which the Facility is working to mitigate, while the AMC+ and AMC -92 only models
carry less, or no inherent financial risk related to SFPs and therefore would not
require the same level of mitigation through insurance solutions .
? The AMC+ model would redefine key principles for future engagement with SFPs .
The revised key principles currently envision that SFPs would be required to
provide a complete financial backstop (e.g., f ull payment in escrow, standby letter
of credit , guarantee from a multilateral development bank ) in advance of Gavi
making a firm order commitment to a manufacturer thereby mitigating Gavi?s
financial exposure . The AMC -92 only model also eliminates the financial risk to
Gavi as there would not be any SFPs participating in the Facility.
Reputational
? Both the Status Quo and the AMC+ model options present some risk to Gavi
associated with deviating from Gavi?s core mission of focusing on the poorest
countries . However, t he AMC -92 -only model carries the highest reputational risk
to Gavi as it moves away from an equity -based approach and would exclud e SFPs
rel iant on the COVAX Facility for procurement of C OVID -19 vaccines in 2022.
Without other secure avenues to procure vaccines, s ome SFPs may object to
being excluded before the end of the acute phase of the pandemic. The AMC+
model p uts the onus on SFPs themselves to choose whether they would like to
participate in the COVAX Facility in 2022 . Therefore , the reputational risk will be
lower as the Facility will be open to all participants who need COVAX .

Pandemic Response
? The Status Quo and AMC+ model s have the lowest risk to the COVAX Facility vis -
a-vis the pandemic response . This is because the models ensure there is at least

06 Annex E Participation model options pdf

1
Report to the Board
Board -2021 -Mtg -2-Doc 06 -Annex E
Clas sified as Internal
Annex E: Participation model options
Annex E to Doc 08 to May 2021 PPC
3.5 Options for future engagem ent with SFPs : Three options for a country
participation model going forward have been identified: 1) Status Quo of AMC -
92 and 99 1 SFPs; 2) AMC -92 and those SFPs deemed to need the Facility
the most; 3) AMC -92 only. The table in Annex D provides a comparison of
the three options.
3.6 Option 1: maintain the status quo of AMC -92 and all SFPs. Retaining the
current model would retain the global, collective nature of the Facility and
provide continuity to participants. All SFPs could continue to participate, which
would mean the Facility may engage with countries that do not need it and have
no intention of procuring vaccines through it, ad ding unnecessary transaction
costs and complexity. Furthermore, this would also not address concerns about
complexity and financial risk to Gavi.
3.7 Option 2: retain AMC -92 and those SFPs in greatest need of COVAX. In
designing the new model, the focus would be on the twin objectives of
simplifying operations and minimising the financial risk to Gavi while
maintaining access for those most in need. The key question for this model is
whether the eligibility criteria to focus participation on those countries in
greatest need should be defined by criteria set by the Facility, or whether it
would be for countries to decide on continued participation based on a revised
singular model of participation that reduces risk to Gavi.
3.8 For Option 2, eligibility criteria opt ions were analysed including Gross National
Income ( GNI ) per capita, GNI plus small populations and lack of bilateral deals.
However, conversations with multilateral banks confirm it is not possible to
define criteria based on income that determine need as they do not consider
purchasing power and technical capacity. Information on bilateral deals and
the epidemiological situation is unreliable and constantly changing and there is
a high reputational risk to Gavi if it is perceived to be disregarding count ries?
needs due to outdated or partial information.
3.9 When first designing the COVAX Facility model, the participation model was
aimed to encourage all countries to join. For the COVAX Facility beyond 2021,
the model would be redesigned with less flexible terms and conditions, aimed
at simplification, and lowering financial risk to retain countries that need the
Facility whilst disincentivising other countries from continued participation
beyond the end of 2021. This model would be time -limited with a view to
ultimately transitioning to a third phase of supporting AMC participants only
once the market supports access to those with financial resources. Elements
to be considered when designing the new terms and conditions include a single
model mandatory proc urement through UNICEF/PAHO, a commitment to
purchase a minimum amount of doses and a revised payment structure with a
smaller down payment and full payment at the point of ordering with the
1 Including E uropean Commission as a participant

06 Annex F Design of the CDSS envelope and cross cutting delivery elements pdf

1
Report to the Board
Board -2021 -Mtg -2-Doc 06 -Annex F
Annex F: Design of COVID -10 Delivery and System Strengthening (CDSS) envelope
and cross -cutting delivery elements
Annex F to Doc 08 to May 2021 PPC
5.1 As discussed by the Board in December 2020 , Gavi?s support to C OVID -19
vaccine delivery has so far been focused on providing a US$ 150 million
envelope for Technical Assistance (TA) and Cold Chain Equipment (CCE)
support to countries .1 An additional US$ 150 million ?exceptional funding?
envelope was also approved by the Board in December 2020 (subject to
fundraising) to cover critical funding gaps that cannot be funded from other
sources. In recognition of the significant resources available from World Bank
and other multilateral development banks and donors for vaccine delivery,
Gavi/COVAX had not previously planned to provide additional support for
delivery. However, since then, there has been growing concern from countries,
donors, and partners on the lack of delivery support in the near and medium
term, and Gavi has mobilised US$ 775 million to support delivery from United
States Agency for International Development (USAID ) (US$ 500 million),
Canada (CA$ 70 million), and Germany (EUR 180 million 2). As a re sult, Gavi is
able to take a more proactive role in C OVID -19 vaccine delivery funding
while ensuring strong collaboration with multilateral banks and other funders to
ensure a complementary funding landscape.
5.2 In this context, the Alliance, in collaborati on with other key funders, has
designed an approach to supporting C OVID -19 vaccine delivery with two key
components:
a) An integrated C OVID -19 Delivery & System Strengthening (CDSS)
funding envelope (~US $ 650 million)
b) An envelope for cross -cutting delivery elements (~US $ 125 million)
5.3 COVID -19 Delivery & System strengthening (CDSS) funding envelope:
The proposed main objectives would be to ensure successful rapid roll -out and
scale up of COVAX -funded doses over the next two years, while also
strengthening health systems and immunisation programmes for both longer
term delivery of C OVID -19 vaccines and RI . As such, in addition to supporting
the end of the pandemic, the CDSS would contribute to delivering on Gavi 5.0
goals and objectives including supporting countries to build back better on
routine immunisation from the pandemic, to deliver on the equity agenda, and
to establish a stronger platform for PHC. It would also contribute to Gavi?s 5.0
innovation approach (see sec tion 4 above and Doc 10). Based on the
December 2020 Board decision, the Alliance has already started to make
exceptional ?bridge? funding available for near term delivery funding gaps for
COVAX doses already delivered in countries 3. Constituting ~3 -5% of the overall
CDSS, the bridge funding will be deducted from the CDSS allocation of each
country once the CDSS is approved by the Board .
1 Approved by Board in September 2020 (redirection of Gavi core funds to COVAX) 2 Earmarked as funding for UNICEF for ?vaccines logistics? 3 Based on the Board Decision from December 2020 on exceptional support

06 COVAX Update pdf

1



Board -2021 -Mtg -2-Doc 06


Section A: Summary
Context
Since the Board approved the Gavi Secretariat ?s role in administering the COVAX
Facility, it has, in collaboration with partners in the COVAX Pillar, successfully
deliver ed more than 80 million doses of COVID -19 vaccine to 12 9 participants 1
and efforts are underway to prepare for substantial increase in vaccine supply
towards the latter part of this year . Further to the Secretariat?s commitment to the
Board one year ago , this update is intended to seek input on the programme?s
future direction , in cluding on the core question of Gavi?s role in the administration
the COVAX Facility . Whilst acknowledging ongoing challenges such as continued
supply constraints and global inequity in access to COVID -19 vaccines , it is timely
to look towards the longer term evolution of COVA X, taking into consideration the
parallel development of the WHO Global Vaccination Strategy, and discuss several
urgent questions relevant to Gavi?s continued engagement in the COVID -19
pandemic response.
Questions this paper addresses
This paper examines how the context and global goals ha ve evolved since the
COVAX Pillar and Facility were established and puts forward an updated value
proposition for 2022 , as well as addressing the following questions :
? Should Gavi continue to administer the COVAX Facility beyond 2021 ? Based
on experience to date and the future outlook, w hat considerations should inform
the renewed objective of the COVAX Facility?
? Looking at the question of participation beyond 2021, which of the options
outlined would ensure access to COVID -19 vaccine for participants without
alternative sources of secure supply whilst reducing operational complexity and
financial risk for Gavi?
? How could Gavi?s engagement in COVID -19 vaccines mitigate risks and
contribute to achieving Gavi 5.0 goals and objectives going forward?
? How should delivery support be designed to ensure rapid, near term support
for COVID -19 vaccine delivery while in the medium term also strengthening
immunisation programmes for both delivery of COVID -19 vaccines and routine
immunisation in line with Gavi 5.0?

1 As of 7 June 2021
SUBJECT : COVAX UPDATE
Agenda item: 06
Category: For Decision
Report to the Board
23 -24 June 2021

02 CEO's Report pdf

1



Board -2021 -Mtg -2-Doc 02

Report to the Board
23-24 J une 202 1


16 June 202 1

Dear Board members ,

We are now 16 months into the pandemic, and the world continues to be marked
by uncertainty and risk. In most countries, health systems are struggling under the
dual burden of maintaining and restoring routine programmes and responding to
COVID -19. At the same time, some high -income countries are beginning to
celebrate a return to normality, owing to high vaccination rates. As our Board Chair
Jos? Manuel said in his remarks at the launch of our Gavi COVAX Advance Market
Commitment (AMC) Investment Opportunity, ? In a globalised world, all economies
are interdependent. We can?t just say to each other , ?Your side of the boat is
sinking?.? The global economy cannot be restored without everyone protected and
back to work, and if populations remain unprotected, the threat o f new variants
remains.

When we look back on history, there are already many things that we, as a global
community, will applaud ? and many we will say we should have done di fferently.
The pace of vaccine research and development has been remarkable. The re are
16 vaccines in use globally; we were able to move vaccines to lower -income
countries two and a half times faster, to four times the number of countries and
seven times t he number of doses than over the same time span during the swine
flu pandemic. T he level of collaboration across partners is unprecedented: as an
Alliance, we mobilised swiftly to provide countries with the flexibility in funding they
needed , and we worked successfully with countries to maintain and restore routine
immunisation in the face of lockdowns and overburdened health systems.
Importantly, the strong supplier base that the Alliance has developed over the past
21 years has meant that we have not expe rienced shorta ges in our supply of Gavi -
supported routine vaccines, despite heightened competition for raw materials and
for manufacturer capacity.

We also stood up the first emergency global vaccine procurement mechanism ?
the COVAX Facility ? built on the knowledge that should a vaccine be developed,
vaccine equity would be our only way out of this pandemic. This was made possible
due to the incredible work from across the Alliance. Sincere gratitude also goes to
our donors who have stepped up with gene rous financial commitments, including
our successful COVAX AMC Summit earlier this month , co -hosted by Prime
Minister Suga of Japan, at which we raised US$ 2.4 billion from nearly 40 donor
Report of the Chief Executive Officer

03 Annex A Risk Appetite Statement 2021 CORRECTED pdf



Gavi Risk Appetite Statement
Version 3.0




DOCUMENT ADMINISTRATION

VERSION
NUMBER APPROVAL PROCESS DATE
1.0 Reviewed and recommended by:
Gavi Programme & Policy Committee
10 November 2014
Reviewed and a pprov ed by: Gavi,
the Vaccine Alliance Board 11 December 2014
2.0 Reviewed and recommended by:
Gavi Audit & Finance Committee
27 April 2017
Reviewed and approv ed by: Gavi,
the Vaccine Alliance Board 15 June 2017
3.0 Reviewed and recommended by:
Gavi Audit & Finance Committee 7 June 2021
Reviewed and approv ed by: Gavi,
the Vaccine Alliance Board
Effective from:
Next review: As and when requested





2

Gavi Alliance Risk Appetite Statemen t


Introduction
Every organisation needs to take risk to achieve its objectives and sometimes the greatest
risk is inaction. Clarity on risk appetite ? the amount of risk an organisation is willing to
take, accept, or tolerate to achieve its goals ? is needed to limit excessive and un reward ed
risk -taking as well as undue r isk aversion which can imped e progress and success .
Effective risk management seeks to optimise potential outcomes by balancing risk versus
reward and weighing the cost s and potential benefits of risk mitigation. Gavi?s Risk
Appetite Statement defines on a broad level the criteria and trade -off considerations that
guid e the Alliance ?s appetite for risk at the mission, strategy and organisation al level .
Having a high appetite for a risk represents a willingness to be exposed to the possibility
of a n uncertain event occurring in the future , e.g. because the downside of the risk, if it
were to materialise, is manageable or acceptable in light of the rewards being pursued ;
because exposure to the risk is required to achieve Gavi?s mission ; or because the costs
of mitigation or trade -offs with other risks are deemed too high . A high risk appetite does
not mean that actual occurrence of the risk is desirable or the event shou ld be tolerated
should it occur. It also does not mean that manag ing and monitor ing of a risk is no longer
needed. The Alliance is in general accept ing to face risks that are required to achieve its
goals, and it is able to do so by relying on robust risk management to ensure these risks
stay within the Board -approved risk appetite .
The purpose of this Board -approved statement is to align stakeholders across the Alliance
and guide decision -makers in taking the right amount of the right type of risks to deliver on
Gavi?s mission. It aims to encourage staff and stakeholders to be risk -aware and to feel
comfortable to take agreed and calculated risks where appropriate, to recognise
un certainty and plan for the possibility of failure, and to learn from both positive and
negative results.
Risk appetite at the mission level
The Gavi Alliance embraces the need to take risk to achieve its ambitious mission of
leav ing no -one behind with immunisation in the world?s poorest countries . It acknowledges
the risks inherent in its distributed operating model , being an Alliance with a lean
Secretariat without in -country presence and dependen t on many partners . It also
acknowledges the risks inherent in its business model , which requires working through
still developing country systems and providing highly catalytic support to implementing
countries to ensure country ownership and sustainab ility .

The Alliance also acknowledge s that it needs to operat e in a highly uncertain and volatile
external environment , especially against the backdrop of the ongoing COVID -19
pandemic . This comes with increased levels of risk , while also hampering r isk mitigation
and assurance due to COVID -19 related restrictions and affected capacities. The Alliance
therefore acknowledge s that , during the duration of the crisis , risks may increasingly
materialise despite best efforts to mitigate th em. The Alliance is also willing to take a high
level of risk where i t is needed to respond flexibly and quick ly to evolving needs ,
recognising that Gavi ?s support to maintain, restore and strengthen immunisation services
is needed now more than ever due to the impact of the pandemic on routine immunisation
programmes .

The Alliance equally acknowledges that its mission of securing equitable access to
COVID -19 vaccines through the administration of the COVAX Facility requires navigat ing

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