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Board -2018 -Mtg -2-Doc 13

Section A: Summary
? This report presents a detailed briefing on pandemic influenza in response
to the June 2018 Board request as part of the Vaccine Investment Strategy
(VIS) 2018. It includes a review of the landscape, gap analysis and
preliminary assessment of potential opt ions for Gavi engagement.
? The Board is asked to approve a learning agenda (with financial implications
of approximately US $ 4 million from 2019 -2022 ), to be developed with
WHO, on the use of routine immunisation of healthcare workers with
seasonal influenz a vaccines to strengthen countries? pandemic
preparedness.

Section B: Detailed Briefing on Pandemic Influenza
Introduction
1.1 The Gavi Board approved a n approach and set of evaluation criteria for
considering vaccine investments for epidemic preparedness and response
in June 2018, within the overarching Vaccine Investment Strategy (VIS)
2018 .1 This approach comprises three steps : firstly, identification, with
WHO, of vaccines for consideration; secondly, development of a ?living
assessment ? as vaccine development progresses ; and finally, a full
investment case for Board consideration . Progression through each stage
is determined by pre -defined triggers . 2
1.2 Given that p andemic influenza meets the ?trigger? for an investment case 3,
the Board requested the Secretariat, in consultation with WHO and experts,
to prepare a n extensive briefing on pandemic influenza preparedness and
bring a related investment case if appropriate .4 As pandemic influenza is an
outlier in terms of both the exceptional global threat that it poses and the

1 https://www.gavi.org/about/governance/gavi -board/minutes/2018/6 -june/minutes/07 --- vaccine -
investment -strategy --- short -list/ 2 A ?living assessment? would be developed once preliminary safety and immunogenicity data is
available for the vaccine (Phase 2a/b ). An investment case would be developed once there is a
defined pathway to vaccine licensure in the short -term (e.g., 1 year), major public health need or
update of a WHO use recommendation. 3 Based on the availability of licensed product(s) and WHO recom mendation 4 The focus of this briefing is on pandemic influenza, however seasonal influenza is important for
pandemic preparedness as demand for seasonal influenza supports global manufacturing capacity.
SUBJECT : PANDEMIC INFLUENZA PREPAREDNESS
Agenda item: 13
Category: For Decision
Report to the Board
28 -29 November 2018

1


Re port to the Board
Doc 13 ? Annex A: Implications/Anticipated impact

Annex A : Implications/Anticipated impact

Risk implication and mitigation
? Should the PPC/ Board choose not to support any activities contributing to
global pandemic influenza preparedness , despite partner activities and
investments , there is a risk that in a pandemic there would be global inequity
in access to and use of pandemic vaccines and consequently Gavi -
supported countries would be disproportionately impacted in t erms of
morbidity, mortality and disruption .
? Although Gavi could invest in interventions to increase pandemic influenza
vaccine supply , the se would be incremental to PIP and , given the limitations
of current technology , would represent high cost s and uncertain impact s.
For this reason, Gavi investment to increase pandemic vaccine supply
capacity and availability is not recommended at this time. Further
information on the risks/ anticipated impacts of this intervention is outlined
in Annex B of the October 2018 PPC Paper (Doc 06c ).
? Rega rding new technology, there is a risk that the impact of Gavi investment
at this time would be diffuse given uncertain timelines and technical/
scientific barriers. For this reason, Gavi investment is not recommended.
However, were Gavi to be absent from d iscussions on new technology there
is a risk that future products would not reflect the needs and use context of
Gavi supported countries, thus the Gavi Secretariat intends to continue to
engage with partners to monitor developments in new technology.
? The recommendation of a learning agenda to assess the feasibility and
impact of routine immunization of healthcare workers with seasonal
influenza vaccines as an approach to strengthen countries? pandemic
preparedness has risks associated with feasibility, methodology (including
identifying study designs which enable the key questions to be answered),
and securing buy -in from countries in the context of competing priorit ies .
Although the potential risk of duplication with initiatives such as PIVI is
recognis ed , this is mitigated by close collaboration with key partners such
as WHO, PIVI, B ARDA and others who have clearly articulate d the gaps
and incremental value of Gavi?s engagement in this area.

Impact on countries
? Support for the learning agenda has implications for countries . For countries
engaged in a learning agenda, it will require resources to be committed for
activities which may have system benefit but which are unlikely to yield
significant health benefits outside of a pandemic. They will also be expected
to share experiences and knowledge with counterparts.
? Given the systemic links between pandemic influenza preparedness and
preparedness for other emergin g infectious diseases, there are risk s of
potential duplication with global, regional and national efforts (such as,
regulatory strengthening through the African Vaccine Regulatory Forum
[AVAREF ] and similar initiatives and activities relating to the WHO Joint
External Evaluations) . Within the Secretariat, increased knowledge of the
product and policy landscape of vaccines for epidemic preparedness and
response and strong relationships with partners will mitigate these risks .

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Board -2018 -Mtg -2-Doc 12

Section A: Introduction
? This report three decisions by the Board related to Inactivated Poliovirus
Vaccine (IPV), as recommended by the Programme and Policy Committee
(PPC) in October 2018. The first two decisions (Section B) pertain to
potential IPV suppo rt post -2020 , and request the Board to approve support
for IPV in Gavi -70 countries from 2021 that takes into account the principles
retained by the Board in June 2018. The Board is also asked to provide an
in-principle decision to support IPV -containing w hole -cell pertussis
Hexavalent vaccine (Hexavalent ) when it becomes available, as part of
future IPV support. Lastly, the Board is requested to approve a recent
funding reque st from the Government of India to cost -share IPV for three
years (2019 -20 21) due to a significant, unanticipated price increase .
Section B: Support for IPV post -2020
Gavi?s engagement in IPV
1.1 The Board?s first decision related to engagement with IPV was taken in
November 2013 when it approved a funding e nvelope for all Gavi IPV
eligible countries as part of the polio eradication ?Endgame? strategy 1. With
this decision, the Board approved a series of policy exceptions including
waivers to Gavi?s Co -financing policy and Eligibility and Transition policy.
Financing was provided by GPEI (Global Polio Eradication Initiative) donors
as it was considered core to the GPEI programme and Gavi had not
included IPV in its 2016 -2020 strategic period budget.
1.2 A number of subsequent Board decisions have been made related to IPV
(see Appendix 4 ), wi th the latest in June 2018, where the Board approved
to exceptionally fund IPV with core Gavi resources through 2020, with the
caveat that it did not imply Gavi support for IPV post -2020 . At this time, the
Board was supportive of the following principles to guide Gavi?s
engagement with IPV post -2020: p olio eradication is a global public good
and IPV is the global ?insurance policy? to mitigate the risk of poliovirus re -

1 Of 73 countries, 70 are currently supported by Gavi: Ukraine was not supported as IPV was
already introduced in 2006; Georgia opted for a combination vaccine not supported by the Alliance;
and India, although eligible, agreed to fund their own programme but later requested and was
provided one -time catalytic vaccine support from GPEI donors that ended in 2016.
SUBJECT: GAVI ?S SUPPORT FOR INACTIVATED POLIO VACCINE
(IPV) POST -2020 AND FOR INDIA 2019 -2021
Agenda item: 12
Category: For Decision
Report to the Board
28 -29 November 2018

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Board -2018 -Mtg -2-Doc 11
Report to the Board
28-29 November 2018


Section A: Introduction
? Gavi, the Vaccine Alliance, was founded in 2000 to accelerate access
to new and underused life -saving vaccines in the world?s poorest
countries suffering high rates of child mortality and morbidity. Building on
the Alliance?s impressive success in bridging the gap b etween rich and poor
countries in terms of access to vaccines, the scope of Gavi?s work has
steadily expanded. It has been called upon to play a key role in introducing
and scaling -up inactivated polio vaccine (IPV) as well as in outbreak
response by fundi ng stockpiles of vaccines for diseases with epidemic
potential. The Alliance?s current strategy is committed to further accelerate
vaccine introductions as well as support equitable coverage of routine
immunisation services, recognising that about 20% of c hildren in Gavi -
eligible countries 1 do not receive a full course of even basic vaccines and
that immunisation coverage rates among these countries are quite uneven.
As the world moves from the Millennium Development Goals (MDGs) into
the Sustainable Develo pment Goals (SDGs), the Alliance?s 2021 -20 25
strategy (?Gavi 5.0?) is an opportunity to contribute to the SDG vision of
?healthy lives? and ?leaving no one behind ?. In this context, Gavi?s current
mission will be more relevant than ever in the years ahead .
? The PPC provided feedback on the questions and context related to
the development of Gavi strategy 2021 -2025. It emphasi sed that the core
focus for the Alliance will remain on its current mission of accelerating
access to vaccine s and increasing equitable coverage in the world?s poorest
countries . PPC members noted that the key question will be ?how? to do so
in a rapidly changing environment and with a diverse and fragile portfolio of
countries. The PPC also noted that the Alliance may need to broaden its
engagement in certain areas and articulate how it will contribute to global
priorities such as Universal Health Coverage and Global Health Security.
This might also entail engaging additional countries which are lagging
behind on immunisation and help the m make better use of their domestic
resources for immunisation so that vulnerable children everywhere are
reached with life -saving vaccines .

1 Throughout this document the term ?Gavi -eligible? refers to Gavi -72 countries unless mentioned
differently
SUBJECT : GAVI 5.0 : T HE ALLIANCE?S 2021 -20 25 STRATEGY
Agenda item: 11
Category: For Guidance

Re port to the Board

Doc 1 1 ? Annex B: Supplementary contextual analyses

Annex B: Supplementary contextual analyses
This document provides a number of more detailed, contextual analyses as additional
background to the two key questions that will inform Gavi post -2020 Strategy:
1. How will the Alliance ensure continued progress on equitable coverage
in the countries that are yet to transition?
2. How can the global community engage non -Gavi countries to address
growing inequities and maximise the impact of their domestic
investments in immunisation?
3. How will the Alliance ensure continued progress on equitable coverage
in the countries that are yet to transition?




Re port to the Board

Doc 1 1 ? Annex B: Supplementary contextual analyses

Report to the Board
Doc 11 ? Annex A: Methodology for income level classification

Annex A: Methodology for income level classification
The m ethodology is based on the fact -based framework put forward by Hans Rosling
in his book Factfulness 1 (data available on www. gapminder .org ). Hans Rosling
characterised people as belonging to four ?levels? rather than living in developed or
developing countries.
These levels are based on the average daily income of the population in any country/
geography. A count ry will have people living across the four income levels (people
earning different amounts) , however, their shares will differ substantially.
Hans Rosling defines the income levels as following:
? Level 1: Earning US $ 2 per day
? Level 2: Earning between US $ 2 - US $ 8 p er day
? Level 3 : Earning between US $ 8 - US $ 32 per day
? Level 4: Earning more than US $ 32 per day
People living on less than US $ 8 per day (Level 1 and 2 population) are at an increased
risk of suffering irreversible health and catastrophic financial conseq uences from
illness . This represents the ?vulnerable population?.
1 Factfulness: Ten Reasons We're Wrong About the W orld --and Why Things Are Better Than You Think;
by Hans Rosling , Anna Rosling R?nnlund, Ola Rosling; 2018
Further details on Hans Rosling?s four levels of income :
?Level 1?: These one billion people live off less than US $ 2 per day. They get
around on their own two barefoot feet, cook over an open flame like a cookfire,
fetch water in a bucket, and sleep on the ground. They cannot afford to buy
food, or access to health services.
?Level 2?: This is the income group where th e majority of the world's people
lives today (3 billion people), getting by on US $ 2-8 a day. Members of this
group may have minimal possessions like a bicycle, a mattress, or a gas
canister for cooking at home. If faced with illness the out -of-pocket spen ding
will eat up their minimal savings and throw them back to the extreme poverty
of level 1.
?Level 3?: People in level 3 live on anywhere from US $ 8 a day to US $ 32.
They have running water, might own a motorbike, and their meals are a rich
and colourful mix of foods from day to day. Like level 1, roughly one billion of
the world's people live on level 4.
?Level 4?: These 1 billion people live off US $ 32 a day or more and have
running water (both hot and cold) at home, a vehicle in the driveway, and plen ty
of nutrients on their plate. They have also likely had the chance to finish twelve
years of school, or more.

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Board -2018 -Mtg -2-Doc 10h

Section A: Introduction
? The purpose of this paper is to respond to the request of the Gavi Alliance
Board to address transition challenges in high risk countries by requesting
the approval of post -transition support for Angola and Timor -Leste, based
on detailed country plans, as well as exceptionally approving that Congo?s
eligibility be determined on the latest GNI data .
? The implementation of the proposed country plans for Angola and Timor -
Leste would require an addition al US$ 10 million , in addition to the
US$ 20 million approved by the Board in June 2018 . The main cost driver
of the additional funding is the extension of some existing activities beyond
2020 in the next financing period (e.g. capacity building) and new ly identified
activities (e.g. polio transition in Angola or pneumococcal conjugate vaccine
(PCV ) and human papillomavirus vaccine ( HPV ) introductions in Timor -
Leste ). The PPC was supportive of this request.
? For Congo Repu blic, a costed country plan in line with the Board request
has also been developed. However, since then, critical information has
come to light regarding Congo Republic?s gross national income (GNI) per
capita. Data released in July 2018 shows that the cou ntry?s economy
continues to deteriorate and its 2017 GNI per capita decreased further to
US$ 1,360, the same as it was more than 10 years ago. While Congo?s
three -year GNI per capita average 1 remains just above Gavi?s eligibility
threshold, the latest GNI is significantly lower and represents the largest
decrease among Gavi countries. Furthermore, while the IMF projects
economic growth in Congo for 2018 , this growth would not be enough to
prevent the country from regaining Gavi eligibility in 2020. Therefor e, r ather
than approving post -transition support for 2019 and then Congo Republic
becoming Gavi -eligible in 2020, the PPC recommend s the Gavi Board to
exceptionally determine Congo Republic ?s eligib ility for 2019 on the latest
GNI data. As a result , the PPC recommended that Congo Republic become
eligible for Gavi support as of 1 January 2019 and that its health system
strengthening ( HSS ) grant ceiling be increased from US$ 4.5 million to
US$ 10 million (which is the amount the country needed as part of its post -
transition efforts ).

1 Gavi?s Eligibility and Transition Policy states countries are Gavi -eligible if their average GNI p.c.
over the past three years is equal to or below the threshold amount.
SUBJECT :
CONSENT AGENDA: POST -TRANSITION PLANS FOR
ANGOLA AND TIMOR -LESTE AND CONGO REPUBLIC ?S
ELIGIBILITY FOR GAVI SUPPORT
Agenda item: 10h
Category: For Decision
Report to the Board
28 -29 November 201 8

Report to the Board
Doc 10h ? Annex A: Table with Board Decisions on Post -Transition Support
Annex A : Table with Board Decisions on Post -Transition Support

1 The 14 countries include: Armenia, Azerbaijan, Bhutan, Bolivia, Cuba, Georgia, Guyana, Honduras, Indonesia, Kiribati, Moldova, Mongolia, Sri Lanka and
Vietnam.
Board Meeting Decision Amount Duration of Support Countries Focus of Support
Nov 2017
Post -transition engagement
and envelope
US$ 30 million 2018 ? 2020 14 countries that
transitioned by 2019 1
? Access to pricing ? Support advocacy activities ? Targeted technical to mitigate risks ? Incentives to leverage domestic resources
PNG Tailored Transition Plan US$ 6 million for HSS
and additional support
for an MR campaign

2018 ? 2020

PNG
? Increase HSS allocation ? Support for MR campaign (vaccine and operational) ? Adjust co -financing for vaccines introduced w/Gavi ? Increase TCA ? Revision in 2020 for potential continuation of support
June 2018
Post -transition support for
high -risk countries
US$ 20 million
(indicative amount of
up to US$ 30 million
approved)

2018 ? 2020

Angola, Congo Republic
and Timor -Leste
? Access to pricing ? Support advocacy activities ? Targeted investments on supply chain, capacity building and data ? Catalytic vaccine introduction support ? Strategic investments to increase coverage in targeted areas with low coverage
Nigeria Tailored Transition
Plan
US$ 1 billion (US$ 575
million additional
funding)
2018 -2028 Nigeria
? Increase HSS allocation ? Support the introduction of new vaccines (co -financing) ? Adjust co -financing for vaccines introduced w/Gavi support ? Increase TCA
Nov 2018
(proposed)
Post -transition support for
high -risk countries
Additional US$10
million (to be added to
the approved US$ 20
million)

2018 - 2023

Angola and Timor -Leste
? Access to pricing ? Advocacy support ? Targeted investments on supply chain, capacity building and data ? Catalytic vaccine introduction support ? Strategic investments to increase coverage in targeted areas with low coverage
Gavi eligibility for Congo
Republic
Additional US$ 5.5
million for HSS
support
2018 - to be determined
by eligibility updates Congo Republic
? Increase HSS allocation ? One -off increase in the HSS allocation ? Access to TCA support ? Support the introduction of new vaccines (co -financing) ? No support for vaccines introduced previously w/Gavi support

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Board -2018 -Mtg -2-Doc 10g

Section A: Introduction
? Based on a recommendation from the Programme and Policy Committee
(PPC) this paper asks the Board to approve flexibilities under Gavi's Health
System and Immunisation Strengthening (HSIS) support framework . These
flexibilities aim to support a better balance between Supplementary
Immunisation Activities (SIAs) and routine immunisation (RI) activities in the
implementation of the Gavi Alliance Board approved Measles and Rubella
Strategy.
? In its discussions , the PPC acknowledged that while SIAs remained an
important instrument to ensuring rapid increase in population immunity,
Gavi support structures should be clearly aligned to the goals of
strengthening routine immunisation, achieving high immunity, and avoiding
over -reliance on SIAs .
? The PPC voiced overall support for the decision to provide more flexibilities
to countries in undertaking SIAs . PPC members also noted that it was
important to be consistent in terms of the guidance provided to countries
and propose d that Gavi work closely with some select countries to
operationalise these flexibilities. Gavi, through the A lliance Coordination
Team (A CT ), should carefully monitor the implementation of the flexibilities
in these countries and report back on progress m ade.
? PPC members further acknowledged the need for coherence in guidance
across the Strategic Advisory Group of Experts (SAGE) on Immuni zation ,
the WHO Regional Immuni sation Technical Advisory Group s, and other
technical working groups and agreed that it was important that SAGE
provided clear guidance on the frequency and implementation of
subnational SIAs. Alliance partner regional and country offices would need
to ensure appropriate implementation at the regional and national level.
Section B: Facts a nd Data
1.1 In December 2015, the Gavi Board approved the Measles and Rubella (MR)
Strategy. Under the strategy, Gavi has disbursed from 2017 to date
SUBJECT :
GAVI SUPPORTED MEASLES AND RUBELLA
IMMUNISATION ACTIVITIES : AMENDMENT TO HSIS
SUPPORT FRAMEWORK
Agenda item: 10g
Category: For Decision
Report to the Board
28 -29 November 201 8

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Board -2018 -Mtg -2-Doc 10f

Section A: Introduction
? Based on a recommendation from the Programme and Policy Committee
(PPC) this paper asks the Board to extend remaining 2017/2018 support for
Syria (approved by the Board in December 2016) for use in 2019, while a
new proposal for support is being developed.
? In July 201 8, the World Bank classified Syria as a low income country,
making it eligible for Gavi's portfolio of support as of 1 January 2019.
? In its discussion on this topic, the PPC asked the Secretariat to ensure that
it engages with all humanitarian and development partners and
stakeholders in developing a proposal for support and in the implementation
of support in Syria. The PPC also stressed that Gavi ensures support is
equitably accessible across the whole country. Finally, the PPC requested
regul ar updates on the progress made in Syria.
Section B: Ongoing and planned Alliance support for Syria
1.1 In its eighth year, the Syria crisis remains complex and marked by suffering,
destruction and disregard for human life. At least 5.3 million children out o f
a 13 million population are affected by the conflict, with an estimated 7
million refugees residing outside Syria and 6.2 million internally displaced.
The World Bank estimates the cost of the war for Syria between 2011 -2017
at US$ 226 billion.
1.2 Over the past few years, no recent estimates have been available for Syria?s
gross national income (GNI ) per capita 1. However, in its latest GNI release
in July 2018, the World Bank has classified Syria as a low -income country,
with a GNI per capita below US$ 995. Under Gavi?s Eligibility and
Transition Policy, this makes Syria eligible for Gavi?s portfolio of
support as of 1 January 2019 .2

1 However, for the previous three years, WHO had classified Syria as a grade 3 humanitarian
emergency and the W orld Bank classified it as a lower middle -income country. 2 This includes new vaccine support, financial support for health systems strengthening and
operational costs for campaigns/introductions, as well as access to the cold chain equipment
optimisation platform (CCEOP) and technical assistance through the Partners? Engagement
Framework. In addition, Syria is eligible for flexibilities under Gavi ?s Fragility, Emergencies,
SUBJECT : CONSENT AGENDA: ONGOING AND PLANNED SUPPORT
FOR SYRIA
Agenda item: 10f
Category: For Decision
Report to the Board
28 -29 November 201 8

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Board -2018 -Mtg -2-Doc 10e

Section A: Summary
? The IFFIm governing doc uments , namely, its Memorand um (Memorandum)
and Articles of Association (Articles) , have undergone a review with its
lawyers in the United Kingdom (UK) and have been revised and updated in
line with prevailing best practice determined by UK law and governance
standards for charitable organisations registered in the UK.
? The IFFIm Board has received a copy of the revised and updated
Memorandum and Articles for its review and these document s were
approved by the IFFIm Board at its meeting on 16 October 2018.
? The IFFIm Board is now r equired to convene a General M eeting of its sole
member, namely, the Gavi Alliance , to formally approve the revised and
updated Memorandum and Articles and which will then be submitted to th e
UK regulatory authorities in the normal course for registration.
? This requires that the Gavi Alliance appoint a duly authorised representative
to represent it, and to vote, at the General Meeting to be convened by the
IFFIm Board.
? This report invites th e Board to consider the recommendation of the
Governance Committee, at its meeting on 10 October 2018, that the CEO
of the Gavi Alliance be appropriately authorised accordingly.
Section B: IFFIm Memorandum and Articles of Association
1.1 The IFFIm Memorandum and Articles have been revised and updated to
reflect prevailing best practice determined by UK law and governance
standards for charitable organisations registered in the UK regarding certain
aspects of IFFIm?s governance arrangements and provisions.
1.2 The review was undertaken in conjunction with IFFIm?s UK lawyers,
Slaughter and May.
1.3 The changes are largely of a procedural nature.
1.4 The Memorandum was updated to remove a redundant reference to the
Gavi Fund Affiliate and to incorporate s ome minor editorial changes.
SUBJECT : CONSENT AGENDA: CEO AUTHORISATION TO
REPRESENT GAVI A T IFFIm GENERAL MEETING
Agenda item: 10e
Category: For Decision
Report to the Board
28 -29 November 2018

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Board -2018 -Mtg -2-Doc 10d

Section A: Introduction
The Gavi Alliance Governance Committee receives an annual report on the
implementation of the Gavi Alliance Board Travel Policy.
This report outlines a proposed recommendation to the policy as considered by
the Governance Committee at its meeting on 26 November 201 8.
Section B: Review of Board Travel Policy
Proposed amendment
1.1 The Board Travel Policy currently foresees reimbursement of
expenses/payment of per diem either
i) by bank transfer; or
ii) to a cash card provided by Gavi
1.2 Recent trend shows that there is an inc rease in the number of people
choosing bank transfer .
1.3 The recent review of Gavi internal control processes has highlighted that
there is an increased risk of error and delay in payments due to the use of
a variety of different methods for reimbursement of expenses/payment of
per diem under the Board Travel Policy.
1.4 This has been considered by the Governance Committee which has agreed
to recommend an amendment to the policy such that
reimbursements/payments by bank transfer be offered as the primary
proce ss and the provision of a cash card by Gavi only be offered in
exceptional circumstances (but strongly discouraged) .
1.5 The proposed amendement to the policy can be found in tracked changes
in Annex A.


SUBJECT : CONSENT AGENDA: REVIEW OF BOARD TRAVEL POLICY
Agenda item: 10d
Category: For Decision
Report to the Board
28 -29 November 201 8