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Documents (9879)

Showing 12 of 9879 View All
Showing 222 of 824 pages

08 Gavi s Engagement in Ebola vaccine pdf

1



Board -2019 -Mtg -3-Doc 08

Section A: Executive Summary
Context
The current time -limited Ebola funding envelope approved in 2014 will come to an
end in 202 0; furthermore, since the Programme and Policy Committee ( PPC )
discussion in October 2019 the first Ebola vaccine was licensed and pre -qualified
and licensed doses are expected to become available in mid -2020 , with other
vaccine s to follow . Following discussion by the PPC, t his paper proposes the
opening of a new funding window for a long -term licensed Ebola vaccine
programme. This would comprise support for reactive vaccination for outbreak
response through an emergency stockpile ? including vaccination in neighbouring
count ries ? and preventive vaccination of high -risk groups outside of an outbreak
(such as certain healthcare workers in countries classified as being at high risk) .

Questions this paper addresses
To consider the value of an Ebola vaccine programme this pape r adapts the
Vaccine Investment Strategy (VIS) evaluation approach for vaccines for epidemic
preparedness and response approved in June 2018. This framework presents the
four main questions :
1) Is the epidemic potential of Ebola Virus Disease sufficient to prioritise a
stockpile? (Section 2)
2) Would use of the vaccine be feasible/impactful (and in what contexts )?
(Sections 3,4 )
3) What is Gavi?s comparative advantage? (Section 5)
4) What are the financial implications? (Section 6)
Conclusions
The Board is asked to approve the opening of a funding window for an Ebola
vaccine programme with estimated financial implications of US$ 9 million for 2020
and US$ 169 million for 2021 -2025 . This funding window would replace the time -
limited Ebola envelop e approved in 2014. The Board is asked to approve retaining
the health systems strengthening ( HSS )/operational cost support window from the
2014 Ebola envelope in order to provide any required operational support for the
use of investigational vaccine reco mmended by WHO , for the interim period before
licensed vaccine doses are available in sufficient volume and the stockpile is
operational including in the ongoing outbreak and other outbreaks that may occur .
SUBJECT : GAVI ?S ENGAGEMENT IN EBOLA VACCINE
Agenda item: 08
Category: For Decision
Report to the Board
4-5 December 2019

09 Annex A Implications Anticipated Impact pdf

09 ? Annex A

Report to the Board
Board -2019 -Mtg -3-Doc 09-Annex A
Annex A: Implications/Anticipated impact
Risk implication
? Risk of inaction: A decision to not move forward with the proposed changes in
an updated policy could potentially result in the policies being out of alignment
with the new strategy. It would continue to foster overly complex and
burdensome approaches and misaligned incentives. There could be a risk that
Gavi would not achieve its goals if its funding policies cannot adequately
support the new strategy.
? The proposed policy shifts respond to changes identified through examination
of performance in Gavi 4.0 or to changes required to deliver on Gavi 5.0. While
the proposed changes are intended to simplify and streamline the policies and
the processes that follow, changing the policies could result in confusion for
stakeholders. This could be mitigated through clear communication to
countries, partners and governance bodies, which would begin as early as the
start of 2020. Finally, certain changes, such as increased differentiation or
potentially higher funding in certain contexts (e.g. fragile countries), great er
flexibility to waive requirements and integration of grants could reduce current
ability to scrutinise use of funding. In finalising approaches and developing an
updated set of policies in phase II, the Secretariat will examine this potential
risk and i dentify mitigation measures at policy or operational levels.
Impact on countries
? The intention in making these policy changes is to at least maintain cost
neutrality for countries. For example, the shift in calculation for co -financing will
be carefully ex amined in the next phase to minimise distortions. However, in
some cases there might be a deliberate choice to adjust the level of funding for
a country. For example, in line with the Gavi 5.0 principle of equity, some
countries might see increased or redu ced funding for HSS depending on their
number of zero -dose or underimmunised populations. The Secretariat will
communicate early and transparently on these proposed implications to
minimise disruption .
? To better manage more integrated grants, countries wil l need to have increased
programme and financial management capacity. The degree of integration
could be further differentiated, with higher capacity countries rolling out
integrated grants, and increased investment in capacity building to prepare
countrie s with lower capacity.
? A stronger focus on differentiation and tailoring to country context will ideally
result in a more streamlined and responsive approach to addressing country
needs. For example, principles for differentiation in HSS grants, integrati ng
CCEOP, and removal of the universal PBF scheme will allow countries to better
design their proposals and use more suitable mechanisms to achieve their
goals. Finally, correcting policy rigidity (for example, co -financing waivers in
exceptional circumst ances) will allow the Secretariat to better respond to rapidly
changing contexts, enabling countries to access the appropriate support in a
timely manner.

09 Annex B Paragraphs referenced in decision points pdf

09 ? Annex B

Report to the Board
Board -2019 -Mtg -3-Doc 09-Annex B

Annex B: Paragraphs referenced in decision points for Eligibility & Transition and
Co -financing Policies
Paragraphs 1.8 to 1.1 3 of Doc 04 to the PPC ? Part A ? as amended by
discussions at the PPC
1.8 Support: As indicated by the Board at the Ottawa retreat, the main policy
flexibility envisaged is the tailoring of the accelerated transition phase
through a time -limited extension . This process would be guided by three key
principles: successful transition depen ds, first and foremost, on strong national
ownership and political will, with Gavi playing only a supporting role; any
extension should not create perverse incentives that could lead to repeated
underperformance, and any additional support should be strict ly limited to the
identified needs (e.g. if main bottlenecks are found to be programmatic, and not
financial, only HSS and/or Targeted Country Assistance (TCA) support would
be extended, and not vaccine financing support) ? this question will be
addressed in Phase II.
1.9 Definition: The identification of countries at risk of failing to transition
successfully would use a combination of outcome -level measures (e.g.
coverage and equity), complemented by health system component -level
analytics (e.g. data, supply chain, demand, human resources). This evaluation
would take into account both the absolute levels as well as the directionality of
recent change (i.e. not only if a country?s coverage is high or low, but also
whether it has been increas ing or decreasing). From the experience of other
partners and per Steering Committee (SC) guidance, it is unlikely that precise
metrics and thresholds could be predetermined that would be automatically
valid across all countries. Thus, the evaluation would need to be informed by
dialogue with national stakeholders and partners with relevant technical
expertise, to ensure it appropriately reflects country -specific contextual
considerations.
1.10 Any metrics and analytics used would be aligned with Gavi 5.0 strat egic
indicators and targets and would therefore rely on currently available
information and data sources. Importantly, these are also expected to help
guide Gavi?s engagement with countries early on , ensuring that
investments are adequately tailored and ta rgeted to strengthen programmatic
sustainability well before countries reach the accelerated transition phase. A
major benefit of this approach is that it allows for early dialogue within and early
visibility by the Alliance and the PPC/Board to emerging p rogrammatic
sustainability trends and risks.
1.11 Another key benefit of this approach is that it aligns decision -making and
accountability with the end -goals that Gavi support seeks to achieve ,
including a renewed emphasis on equity in the context of Gavi 5.0. Moreover,
it also explicitly recognises that a detailed analysis of different health system
components is key not only to provide a more nuanced understanding of the
main drivers of programmatic underperformance, but also to inform the design
of investme nts. Additional details can be found in Appendix 3 .

09 Gavi 5 0 Funding Policy Review pdf

1



Board -2019 -Mtg -3-Doc 09


Section A: Executive Summary
As part of operationalising Gavi 5.0, the Secretariat is undertaking a two -phase
review of Gavi?s existing funding policies: Eligibility & Transition Policy, Co -
Financing Policy and the Health System & Immunisation Strengthening
(HSIS) Support Framework 1. The purpose of this paper is to seek Board approval
on select policy changes as identified in th e first phase of the review and
recommended by the Programme and Policy Committee (PPC) . The se changes
reflect key strategic shifts in Gavi 5.0 and lessons learned from Gavi 4.0 .
Implementation experience , evaluations , consultations and analyses have
demonstrated that for the most part these Gavi policies function well . For example,
eligibility based on gross national income ( GNI ) per capita , requirements for
countries to co -finance a portion of vaccine procurement and the objectives for
health systems strengthening (HSS) and other non -vaccine funding continue to
support Gavi?s mission and strategic goals.
However, new directions for Gavi 5.0 and lessons learned from Gavi 4.0 drive a
proposed evolution of Gavi?s funding policies , particularly in view of the following :
? An increased focus on equity
? A stronger emphasis on programmatic sustainability
? Greater differentiation to target and tailor support to countries , particularly
fragile contexts
? Simplification and country ownership .
While the scope of this paper is focused on the proposed policy revisions , how
these policies are implemented will also be a key driver of success in the next
strategic period . The proposed policy changes are part of a much broader effort to
operationalise Gavi 5.0 (see Strategy Progress Update at Doc 04 for other
workstreams) .



1 The HSIS support framework operates in a similar manner as a Gavi policy, but with a greater
level of detail . Th e funding policy review would seek to resolve this inconsistency with other Board -
approved policies .
SUBJECT : GAVI 5.0: FUNDING POLICY REVIEW
Agenda item: 09
Category: For Decision
Report to the Board
4-5 December 2019

10 Annex A The Country Journey pdf

End of Gavi
financingLow - income
country threshold Eligibility
threshold100%
Variable duration 5 years yearsFormer Gavi - eligible
Fully self - financing
% of Gavi
vaccine
cost Preparatory transitionInitial self - financing
$0.20
per dose LMICS
Fully self - financing
Variable duration
End of price freeze for
former Gavi - eligibleAccess to LMIC tiered
price
UMIC threshold
Gavi MIC support threshold
Fully self - financingAnnex A: Diagram of MICs approach and the country journey
Access to price freeze for x
years TBCAccelerated transition
x years TBCCo - financed vaccine support
Technical Country Assistance
Health systems immunisation strengthening Advocacy and political will building
Innovative financing - backed pooled procurementAreas of Gavi support
Preventing Backsliding
Vaccine Introduction Support
Vaccine Introduction Support Vaccine Introduction SupportDRAFT ? For discussion only. Not for distribution
Vaccine catalytic financing
10 - Annex A

10 Update on MICs pdf

1



Board -2019 -Mtg -3-Doc 10


Section A: Executive Summary
Context
In June 2019, the Board requested the Secretariat to develop an institu tionalised
approac h for post -transition support to former Gavi -eligible countries and , in
response to inter -country equity concerns, to also explore extending this approach
to select neve r Gavi -eligible middle -income countries (MICs )1. This paper presents
an update to the Board on progress and the current th inking .
Questions this paper addresses
1. From the country perspective, what are the main barriers to immunisatio n
programme sustainability and new vaccine introductions (NVIs)?
2. Based on these findings , what could Gavi?s MICs approach include and how
will it leverage the Alliance and wider partner efforts?
Conclusions
Barriers to NVIs and sustaining immunisation programmes are complex and
interwoven. Countries perceive the sustainable f inancing of vaccines and
operations and vaccine price as key issues alongside a lack of political will,
restrictive procurement poli cies, inadequate data , and regulatory issues . Other
challenges include limitations in decision -making , insufficient supply chain capacity
and maintenance, and growing vaccine hesitancy. Manufacturers consider low
political will and regulatory barriers to be the main bottlenecks to N VIs and
emphasise the importance of addressing these alongside procurement support.
An MICs approach would be designed to prevent backsliding in former Gavi -
eligible countries and to stimulate the sustainable introduction of key missing
vaccines in former a nd never -Gavi eligible countries. Crucially, the approach would
also be designed to both mobilise and maximise the efficiency of countries ?
domestic resourcing for immunisation. It could include three inter -linked and
mutually reinforcing components to address these challenges: advocacy and
political will bui lding, targeted technical assistance, and an innovative financing
facility to support procurement . Each component could be tailored to the different
groups of countrie s. It would levera ge the Alliance and wider partner initiatives
including UNICEF Supply Division (SD ), the WHO MICs Strategy, and existing

1 Specifically , countries with a GNI p.c. under US $ 4,000 and possibly countries up to US $ 6,000
GNI p.c.
SUBJECT : UPDATE ON DEVELOPMENT OF STRATEGY FOR
MIDDLE -INCOME COUNTRIES (MICs)
Agenda item: 10
Category: For Information
Report to the Board
4-5 December 2019

05 Annex A Implications Anticipated impact pdf

05 ? Annex A

Re port to the Report to the Board
Board -201 9-Mtg -3-Doc 0 5 ? Annex A

Annex A: Implications/Anticipated impact
Risk implications
Due to fiscal pressures in donors markets alongside competing replenishments, there
is a risk of decreased support from existing donors or inability to increase new donor
contributions to Gavi. Hence, a successful Replenishment that engages all
stakeholders and donors will be crucial for ensuring continuity of Gavi programmes at
country level, as well as maintaining industry and manufacturer confidence.
In addition, the rec ent Global Fund replenishment has underlined the need to
anticipate exchange rate fluctuations. As an illustration, if all donors contributions to
Gavi, pledged in their national currencies, remained at a flat -line level compared to the
Berlin replenishmen t, at today?s exchange rates Gavi would not be able to secure the
minimum required in the new Investment Opportunity.
If there are insufficient resources to deploy in 2021 ?2025, the Alliance would be faced
with hard choices, and would undertake a rigorous prioritisation exercise. Gavi would
need to resize its ambitions around supporting particular vaccines, enabling grants in
health systems, protecting the world with vaccine stockpiles, and/or strategic
investments to secure immunisation returns, among oth er priority areas. Gavi would
also likely have to pull back from some of the work of collaborating with other
institutions.
As a result, country demand would not be met, risking backsliding on the tremendous
progress made to date. This has implications n ot only for the poorest people?s ability
to live healthy lives, but also their ability to thrive and lift themselves out of poverty. In
addition, in a world without vaccines, disease outbreaks would cause significant
economic loss, not only to families and communities from unnecessary suffering and
loss of earnings, but this would be multiplied many times over by loss of trade, lost
productivity, and decimated health services. Many of the hard -fought gains made
could be reversed but with far greater global implications in a hyper -connected world.
It can be a major threat to global prosperity and security if we do not take steps to stop
disease at source.
With respect to assuring contributions from new donors, it should be noted that a
number of them are as king for a seat and/or greater voice at the Board in consideration
of their contributions. Another challenge emerging from discussions with some new
and emerging donors is that some of them may not make donations directly to Gavi
because the Alliance?s sta tus does not meet their definition of an International
Organisation. Finally, the use of innovative finance mechanisms may require legal
issues and tax deductibility limitations to be addressed, especially when considering
contributions from the private se ctor.

05 Replenishment 2020 pdf

1


Board -2019 -Mtg -3-Doc 05

Section A: Executive Summary
Context
This report describes Gavi?s campaign in the lead up to its third pledging
conference, to be hosted by the United Kingdom on 3-4 June 2020 in London . It
presents an overview of the Replenishment launch that was held on 30 August
2019 in Japan as part of the 7 th edition of the Tokyo International Conference on
African Development (TICAD 7) , a summary of the key points of Gavi?s Investment
Opportunity and financia l ask and insights on the campaign approach .
Conclusions
Following a successful Replenishment launch in August 2019 and the unveiling of
the 2021 -2025 Investment Opportunity , the Replenishment process was set in
motion to secure at least US $ 7.4 billion in donor contributions by June 2020 . If the
financial ask is met , Gavi will be able to reach another 300 million people with life -
saving vaccines , preventing 7 -8 million future deaths , and deliver more than
US$ 80 -100 billion in economic benefits to countries .
There is significant potential to further accelerate impact if funding were to exceed
the ask. Gavi?s Replenishment strategy will therefore seek to increase pledges
from core donors, bring in new donors closely aligned with Gavi priorities,
incentivis e private sector pledges , and leverag e innovative financial instruments to
generate flexible fund s. The strategy will also need to mitigate the volatilit y in
exchange rates since the Berlin replenishment .
While the ask is global in nature , Gavi?s campaign will be focused on tailored
approaches , aligned with donor countries? aid priorities. The approach will combine
high -level strategic donor engagement by Gavi?s Leadership and Secretariat, UK -
led government -wide efforts , peer donor outreach, and coordinated civil society
actions in key markets . Global moments will also be leveraged , including Gavi?s
upcoming 20th anniversary , to be celebrated at the World Economic Forum (WEF)
in Davos in January .

SUBJECT : REPLENISHMENT 20 20
Agenda item: 05
Category: For Information
Report to the Board
4-5 December 2019

06a Annex A Implications Anticipated Impact pdf

1

06a - Annex A
Report to the Board


Board -2019 -Mtg -3-Doc 06a -Annex A

Annex A : Implications/Anticipated impact

1. Impact on countries
1.1 Approval of the Financial Forecast will enable funding to be allotted to
programmes throughout 20 20 , in accordance wit h the Programme Funding
Policy.

2. Risk implication and mitigation, including information on the risks of
inaction
2.1 Determination of Gavi?s financial capacity to approve the recommended
decisions relies on the current Financial Forecast. Risks that may impact the
reliability of financia l forecast are described below, as well as the mitigation
strategies in place to address these ris ks.
2.2 One of those risks arises from exposure to foreign currency exchange rate
fluctuations. In the forecast, non -USD pledges are valued at their USD
equivalents using the current Bloomberg forecast exchange rates when
compiling the forecast (consistent with th e approach agreed with donors at
the Berlin Replenishment Meeting) or, where hedged, at the hedge rate.
Pledges are hedged progressively, and pledges representing 6% of
2016 - 2020 Assured Resources are not yet hedged, pending clarification of
timing.
2.3 Gavi?s eight -month Cash and Investments Reserve provides a cushion for
adverse fluctuations in resources and expenditures. Gavi can also decline or
defer funding requests based on resource availability.
3. Risks associated with the financial forecast and mitigations
Factors that may impact the expenditure forecast include:
3.1 Demand volumes can vary significantly based on small changes in country
introduction assumptions. While the introduction assumptio ns made in the
current forecasts leverage the information readily available, there remains an
inherent high degree of uncertainty on these assumptions. In addition, the
assumptions on introduction timing are often dependent on projections of
when a country will no longer be eligible for new Gavi support. This forecast
represents the application of the current Board approved Eligibility and
Transition Policy. Changes or exceptions to this policy could vary demand
significantly.
3.2 Price forecasts reflect expected market dynamics specific to each vaccine.
The point forecast represents a moderate most likely scenario estimate
among a range of possible estimates and reflects information available at the
time of preparation.
3.3 The forecast includes assumpt ions for supply availability for Rotavirus, HPV ,
IPV , Yellow Fever and Typhoid as currently anticipated.

06a Annex B Terminology used in the Financial Forecast pdf

1
06a ? Annex B

Report to the Board


Board -2019 -Mtg -3-Doc 06a -Annex B
Annex B : Terminology and rounding
Terms used in this paper have the meanings described below, and are relevant to
Gavi?s Board Approved Programme Funding Policy:
a) Assured Resources comprise:
? Cash and investments of Gavi, in the amount that exceeds the Cash and
Investments Reserve (see (g) below)
? Expected proceeds from IFFIm, based on existing donor pledges
? Expected AMC and any other contributions that are contingent on
programmatic expenditu re included in the expenditure forecast
? Confirmed direct contributions to GAVI Alliance that are pledged under
already -signed agreements or otherwise confirmed in writing.
? Projected investment income
b) Allowance for Further Direct Contributions (for th e purpose of approving
funding decisions): An allowance for further expected direct contributions
from existing donors who have not confirmed their pledges for each year,
based on current overall contribution levels. The allowance is mandated by
the Progra mme Funding Policy and is important towards enabling
programme funding decisions to be made while pledges have yet to be
completed for particular years. The allowance assumes that in years where
currently confirmed direct contributions total less than the current level,
further contributions will bring the total to that level. This is currently US$ 1.4 9
billion for the year, which equates to the annual average of confirmed pledges
for 201 7-201 9.
c) Qualifying Resources : The sum of Assured Resources and the Allowance for
Further Direct Contributions (i.e. (a) plus (b) above) .
d) Existing Programmes : Country programmes (for vaccine and cash -based
programmes and investment cases) that have already been approved for
support by Gavi, the Partners? Engagement Fr amework and the Secretariat
budget.
e) New Requests : Projected demand from country applications that are
currently being recommended by the Independent Review Committee for
approval.
f) Expected Future Requests: Projected demand from countries expected t o
request Gavi support in the future for the currently approved portfolio of
vaccines and cash -based programmes. It does not include any additional
vaccines that Gavi may consider for support in the future.
g) Cash and Investments Reserve : The reserve required by the Programme
Funding Policy to be maintained at a minimum equalling eight months of
expected annual expenditures.

00b Final Agenda pdf


Boa rd-201 9-Mtg -3-Doc 0 0b





G avi Alliance Board Meeting
4-5 December 2019
Hyatt Regency Hotel, Delhi, India


Monday 2 and Tuesday 3 December : Pre -Board meetings & Field Visits
Wednesday 4 December : 08.30 -18. 30 (Board meeting Day One)
Thursday 5 December : 08.30 -18.00 (Board mee ting Day Two)
Quorum: 14


Agenda REVISED












Next Board Meeting s: 19 March 2020 , 13.30 -15.30 GVA, Teleconference
11 May 2020, 14.30 -16.30 GVA, Teleconference
24 -25 June 2020, Geneva
16 -17 December 2020, TBD

---
Philip Armstrong , Director, Governance and Secretary to the Board, +41 22 9 09 6504, parmstrong@gavi.org
Joanne Goetz , Head , Governance, +41 22 909 6544, jgoetz@gavi.org
Please note that the Board meeting will be recorded. This recording will be used as an aid to minute the meeting .
A transcr iption of the full proceedings will not normall y be made. Should a transcription be made it will be used
only as an aid to minute the meeting .

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