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Board -2020 -Mtg -4-Doc 05
Report to the Board
30 Ju ly 20 20

















SUBJECT: REVIEW OF DECISIONS
Agenda item: 05
No paper

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Board -2020 -Mtg -4-Doc 04b
Classified as Internal

Section A: Summary
Context
Following the launch of the ACT Accelerator with the goal of achieving equitable
access to new COVID -19 therapeutics, diagnostics and vaccines , Gavi has led on
the preliminary technical design of the COVAX Facility (the ?Facility ?), a global
mechanism to pool resources and demand for a COVID -19 vaccine with the goal
of accelerat ing the availability of and access to safe and efficacious vaccine s, and
on the design of the COVAX A dvance Market Commitment (the ? COVAX AMC ?),
a financing mechanism to ensure access to COVID -19 vaccines .
To realise the objectives of the Facility, a legal entity is required to enter into
agreements with high income economies and upper middle -income economies
wishing to participate in the Facility and potential manufacturers of a COVID -19
vaccine . A number of legal options for the Facility were explored ; however, g iven
the urg en cy for the Facility to be ope rational quickly in order to enter into advance
purchase contracts with manufacturers and considering Gavi?s unique experience
in accelerating access to vaccines in low income economies and credibility with
high income economies as well as manufacturers, it is proposed that Gavi
administer the Facility . Administrative costs, including resourcing needs, would be
covered by incremental funding . If the Board approves Gavi as administrator of the
Facility, a governance mechanism is p roposed that builds on Gavi?s existing
structures as much as possible , while recogni sing the need for certain new bodies
and advisory functions .
Questions this paper addresses
1) Given the urgency to operationalise the Facility, should Gavi serve as the
administrator of the Facility?
2) What are the risks and challenges of Gavi serving as administrator for the
Facility and how can the se risks and challenges be managed ?
3) What governan ce arrangements sh ould be in place to ensure that
responsibilities to oversee the Facility and decision -making sit with the
appropriate governing bodies , for example, should the MSDC be expanded to
included representatives of self -financing countries for the purpose of reviewing
the business terms of COVAX agreements with manufacturers ?
SUBJECT : COVAX FACILITY STRUCTURE AND GOVERNANCE
Agenda item: 04b
Category: For Decision
Report to the Board
30 July 2020

Report to the Board
Board -2020 -Mtg -4-Doc 04b -Annex D
Annex D : Facility resourcing needs over time

4 This document reflects ongoing work and discussions within the Gavi Secretariat to propose aglobal COVID-19 vaccine coordination mechanism. The design of the mechanism and Gavi's rolemay evolve based on consultations outcome and Gavi Board review.Its contents are confidential and should not bedisclosed to any unauthorised persons.
R e s o u rc in g n e e d s a re e x p e c te d to v a ry s h o rt- v s . lo n g -te rm
Resourcing
im plications
?S urge period? (next 3-6 m onths)
Extra / ?surge? resource need to absorb the bolus of work for the
Facility design, deal making, engagem ent with countries and fund
raising
Com plete design (incl. coordination with CEPI and W HO)
Identify candidates, structure and finalize deals with m anufacturers
(partly in collaboration with CEPI)
Conduct pipeline analytics / forecasting
Engage countries to finalize EOI/sign term sheets
Set up IT systems, monitoring & evaluation tools, fram eworks
Drive legal agreem ents with manufacturers and countries
Support recruitment of Facility staff
Identify and ?attract donors?
Define financing mechanism s for new countries for GAVI
S teady state (im plem entation m ode)
Refine design as situation evolves (country participation, evolution of
pandemic & pipeline) & continue coordination
Core team of fully dedicated professionals to drive the
im plem entation of the Facility
Manage deals with m anufacturers and continue to ?enrich? portfolio
(as function of the pandemic) -coordinate procurement activities
Continue analytics / forecasting
Drive continued country and other stakeholder engagement (incl.
advocacy)
Drive monitoring & evaluation
Continue resource mobilization & advocacy work
Design &
coordination
Deal making &
Vaccines
portfolio
management
Country
engagement
Resource
Mobilisation
Selected
enabling
functions
DETAILS IN BACKUP

 

 

 

SEPTEMBER 2017 JULY 2020
MARKET -SENSITIVE DECISIONS COMMITTEE CHARTER V9
TRACKED
1. P U RP O S E
The Market -Sensitive Decisions Committee (?Committee? or ?the MSDC ?) is
established by the Board (?Board?) of the Gavi Alliance (?Gavi ?) to support the Board
in fulfilling its oversight responsibilities .
The Committee will make decisions which are market and/or commercially sensitive,
subject to powers reserved specifically to the Board in Article 13 of the Statutes.
Words and expressions used in this Charter shall, unless the context requires
otherwise, have the meaning attributed to them in the Gavi By -laws Board and
Committee Operating Procedures (?Operating Procedures?) .
2. C O V A X
Additionally, with Gavi having assumed the administration of the COVAX Facility 1, and
es tablished the COVAX AMC 2, the Committee will undertake any decisions associated
with transactions effected through the COVAX Facility (hereinafter shall be take n to
include both the COVAX Facility and the COVAX AMC unless express ly stated
otherwise , as described ).
2. 3. M E M B E RS H I P
The membership , resources, responsibilities and authorities of the Committee to
perform its role effectively is are stipulated in this Charter, which may be amended by
the Board as and when required or deemed necessary and is are specifically governed
by Article 18 of the Statutes and Section 18 of the Operating Procedures Gavi ?s By -laws ,
Article 4 which govern s Committee member appointment , including relevant


1 COVID -19 Vaccines Global Access (COVAX) Facility ? a time -limited mechanism designed to
pool global COVID -19 vaccine demand and country resources toward incentivising
manufacturers to expand production capacity so that a large number of vaccine doses are
available rapidly to deploy globally in a n equitable manner. 2 The COVAX AMC is a finance mechanism supported by ODA funding to ensure that
implementing countries have equitable access to vaccines made available through the COVAX
Facility .

 

 

 

Report to the Board
Board -2020 -Mtg -4-Doc 04a -Annex A
Annex A : Terms of the COVAX AMC

This document sets out the main terms of the Gavi COVAX Advance Market
Commitment (? COVAX AMC ? or ? AMC ?).
Objectives and Eligibility
The objective of the COVAX AMC is to reduce the impact of COVID -19 in eligible
economies by accelerating the introduction and scale up of vaccines that protect
against COVID -19 (? Objective ?). Economies eligible to benefit from the COVAX AMC
will be [insert Gavi board decision] (? Eligible Economies ?). Eligible Economies which
are approved by the Gavi board shall be able to benefit from the COVAX AMC as
?Funded Economies ?.
Governments and other organisations (? AMC Donors ?) commit funds to the COVAX
AMC which will be made available to Gavi to support the Objective.
Role of Gavi under the COVAX AMC
Gavi policies shall apply to the COVAX AMC except where otherwise specified by the
Gavi Board.
The Gavi Secretariat shall administer the COVAX AMC. The Secretariat will enter into
Grant Agreements with AMC Dono rs, engage with Funded Economies, and enter into
agreements with vaccine manufacturers.
Engaging with Funded Economies
The engagement with Funded Economies will include:
? Discussions about economies? interest in applying for support for COVID -19
vaccines, and readiness to introduce these vaccines
? Development of and applications for COVID -19 vaccine programmes as
approved by the Gavi Board
Engaging with manufacturers
The Secretariat will negotiate and enter into agreements (such as advance purchas e
commitments) with manufacturers which commit to procurement of vaccines that meet
the WHO TPP on behalf of Funded Economies.
The Pharmaceutical Manufacturers will be expected to:
1. Use any payment advances towards the production of its COVID -19 vaccine
pro gramme;
2. Inform Gavi periodically of its progress in its COVID -19 vaccine programme(s);
3. Deliver its production of its COVID -19 vaccine programme to Eligible
Economies in the terms and conditions defined in the Vaccine Purchase
Commitment Agreement; and
4. In t he event of not being able to comply with the Vaccine Purchase Commitment
Agreement, inform the Gavi opportunely to negotiate its termination and settle
the applicable penalties and/or compensations to the Facility as determined by
the contract.

Gavi

Gavi

Gavi

Report to the Board
Board -2020 -Mtg -4-Doc 04a -Annex B
Annex B : The COVAX AMC Group: proposed eligible economies
List based on World Bank 2018 GNI data, released in July 2019
World Bank
classification
Economy
Low income Afghanistan
Benin
Burkina Faso
Burundi
Central African Republic
Chad
Congo, Dem. Rep.
Eritrea
Ethiopia
Gambia, The
Guinea
Guinea -Bissau
Haiti
Korea, Dem. People's Rep.
Liberia
Madagascar
Malawi
Mali
Mozambique
Nepal
Niger
Rwanda
Sierra Leone
Somalia
South Sudan
Syrian Arab Republic
Tajikistan
Tanzania
Togo
Uganda
Yemen, Rep.
Lower middle income Angola
Bangladesh
Bhutan
Bolivia
Cabo Verde
Cambodia
Cameroon
Comoros
Congo, Rep.
C?te d'Ivoire
Djibouti
Egypt, Arab Rep.
Report to the Board
Board -2020 -Mtg -4-Doc 04a -Annex B
El Salvador
Eswatini
Ghana
Honduras
India
Indonesia
Kenya
Kiribati
Kyrgyz Republic
Lao PDR
Lesotho
Mauritania
Micronesia, Fed. Sts.
Moldova
Mongolia
Morocco
Myanmar
Nicaragua
Nigeria
Pakistan
Papua New Guinea
Philippines
S?o Tom? and Principe
Senegal
Solomon Islands
Sudan
Timor -Leste
Tunisia
Ukraine
Uzbekistan
Vanuatu
Vietnam
West Bank and Gaza
Zambia
Zimbabwe
Additional IDA eligible Dominica
Fiji
Grenada
Guyana
Kosovo
Maldives
Marshall Islands
Samoa
St. Lucia
St. Vincent and the Grenadines
Tonga
Tuvalu

Report to the Board
Board -2020 -Mtg -4-Doc 04a -Annex C
Annex C : Lessons from Gavi?s Advance Market Commitment for Pneumococcal
Conjugate Vaccines
Original objectives
The Advance Market Commitments (AMC) for Pneumococcal Conjugate Vaccines
(PCVs) was launched in 2009 with the aim of reducing morbidity and mortality from
pneumococcal disease, preventing an estimated seven million childhood deaths by
2030. The objectives of the pilot AMC were:
? To accelerate the development of vaccines that meet LIC and LMIC needs.
? To bring forward the a vailability of these vaccines for LICs and LMICs.
? To accelerate the uptake of vaccines by ensuring predictable vaccine pricing
for countries and manufacturers.
? To test the effectiveness of the AMC mechanism as an incentive for needed
vaccines.
Results to d ate
Backed with funding from six donors including the Bill and Melinda Gates Foundation,
Canada, Italy, Norway, Russia and the United Kingdom, the AMC has been successful
in:
? Driving down the tail price of PCV from $3.50 in 2010 to $2.00 in 2020
? Accelerati ng vaccine supply, with PCV introduced in implementing countries a
year after introduction in HICs, compared to a typical delay of 10 years, and
uptake to meet growing demand, with the vaccine now introduced in 60
countries
? Improving market health for PCV; three manufacturers are now supplying Gavi
countries
Lessons
The experience of the AMC for PCVs is being used to inform decisions made around
the new COVAX AMC. Specific lessons include:
? Flexible governance structures which are simple to monitor and adjust
according to supply and demand uncertainty in the market ar e critical.
? Clear prioritisation of outcomes drives focus of objectives and leads to greater
achievement of those outcomes.
? Successful engagement with the biopharmaceutical industry improves
sustainability of initiatives; enabling manufacturers to adopt a commercially
viable strategy is critical
? Complementary forces to an AMC are critical for creating the enabling
environment necessary for its success.
For further details, please see the 2019 Annual Report conducted by the AMC
Secretariat, or the 2018 Impact Evaluation conducted by the Boston Consulting Group.
A new impact evaluation will be conducted in 2021 after the AMC has closed.

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Board -2020 -Mtg -4-Doc 04a
Classified as Internal

Section A: Context and summary
The COVID -19 pandemic is spreading rapidly in low income economies 1 (LI Es)
and lower m iddle income economies (LMI Es), with South Asia so far most affected .
The pandemic has put an immediate brake on progress towards the Sustainable
Development Goals . For vaccine programmes in particular, the pandemic has
meant that campaigns against highly infectious disease s like polio and measles
have been paused ? though are now slowly resuming ? routine immunisation
systems are running at far lower levels of capacity, and healthcare workers
normally engaged in immunisation services have been diverted tow ards COVID -
19 response. 45 out of 68 planned vaccine introductions have been impacted in
Gavi -eligible countries. As a result, there is an increasing risk of other disease
outbreaks particularly among children , further encumbering stretched health
services.
Following a call by the G20 under the Saudi Presidency , at an event in April 2020
co -hosted by the President of France, the President of the European Commission,
the Director General of the World Health Organization, and the Bill and Melinda
Gate s Foundation, the Access to COVID -19 Tools (ACT) Accelerator was
launched. This initiative brings together a range of partners to a chieve equitable
access to COVID -19 therapeutics, diagnostics and vaccines.
Gavi and the Coalition for Epidemic Preparedness Innovations (CEPI) were
charged to co -lead the Vaccines Pillar of the ACT -Accelerator. Within th is Pillar,
CEPI , as lead for the Development and Manufacturing Workstream , is making
direct financial investments to support R&D and manufacturing expansion of
promising COVID -19 candidates. WHO , as lead for the Policy and Allocation
Workstream , is developing global policy recommendations and an Allocation
Framework on use of v accines , including via the Strategic Advisory Group of
Experts (SAGE) on Immuni zation. Gavi , as lead for the Vaccine Procurement and
Delivery at Scale Workstream , is with partners developing the COVAX Facility (the
?Facility ?), a global mechanism to pool r esources and demand for COVID -19
vaccine s with the goal of accelerating the availability of and access to safe and
efficacious vaccines , and the COVAX AMC (the ? AMC ?), a financing mechanism
to ensure that low income and lower middle -income economies , as well as other
1 Terminology a s per World Bank income groups:
https://datahelpdesk.worldbank.org/knowledgebase/articles/906519 -world -bank -country -and -lending -groups .
Accessed 23 July 2 020.
SUBJECT : GAVI COVAX AMC
Agenda item: 04a
Category: For Decision
Report to the Board
30 Ju ly 2020