COVAX: THE VACCINES PILLAR OF THE ACCESS TO COVID-19 TOOLS (ACT) ACCELERATOR STRUCTURE AND PRINCIPLES - 9 NOVEMBER 2020 - CEPI
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COVAX: STRUCTURE AND PRINCIPLES
COVAX: THE
VACCINES PILLAR
OF THE ACCESS TO
COVID-19 TOOLS
(ACT) ACCELERATOR
STRUCTURE AND
PRINCIPLES
1
9 NOVEMBER 2020COVAX: STRUCTURE AND PRINCIPLES
Disclaimer: The work of the COVAX Facility is
being accomplished across a range of complex
matters and variables that continually evolve
as more information on the pandemic becomes
available, and involves contributions from a
number of individuals and organisations. As a
result, this document, including specific details
on membership of various groups, should be
taken as indicative as of the date of publication.
2CONTENTS
COVAX: STRUCTURE AND PRINCIPLES
Introduction 5
What is COVAX? 5
What is this document? 5
Section 1: Overview of key bodies 6
1. Cross-cutting 6
1.1 COVAX Coordination Meeting (CCM) 6
Overview 6
Areas of focus 6
Decision-making principles 6
Members 6
Format 7
1.2 Areas of Inter-Organisational Coordination 7
2. Workstream – Development and Manufacturing 7
2.1 Research and Development and Manufacturing 7
Investment Committee (RDMIC)
Overview 7
Objectives 7
Areas of focus 7
Decision-making principles 8
Members 8
Format 8
2.2 Technical Review Group (TRG) 8
Overview 8
Objectives 9
Areas of focus 9
Decision-making principles 9
Members 9
Format 10
2.3 SWAT teams and Regulatory Advisory Group (RAG) 10
Overview 10
Objectives for all SWAT teams and RAG 10
Areas of focus 10
Decision-making principles 11
Members 11
3COVAX: STRUCTURE AND PRINCIPLES
Format 12
3. Workstream – Procurement and Delivery at Scale 13
3.1 COVAX Facility 13
Office of the COVAX Facility 13
COVAX Shareholders Council 13
COVAX AMC Engagement Group 13
COVAX Consensus Group 13
Independent Product Group (IPG) 14
Procurement Reference Group (PRG) 14
Gavi Board 15
Market-Sensitive Decisions Committee (MSDC) 15
Audit and Finance Committee (AFC) 15
3.2 Country Readiness and Delivery (CRD) 16
Overview 16
Members 16
3.3 Learning, Monitoring and Evaluation 19
Objectives 19
4. Workstream: Policy and Allocation 20
4.1 WHO Strategic Advisory Group of Experts (SAGE) 20
on Immunization
Overview 20
Members 20
SAGE Working Group on Covid-19 vaccines 20
4.2 Allocation Mechanism 22
Joint Allocation Taskforce (JAT) 22
Independent Allocation Validation Group (IAVG) 22
4.3 Policy and Allocation Working Groups 23
Vaccine Strategy Sub-Working Group 23
Vaccine Policy Sub-Working Group 24
Access and Allocation Sub-Working Group 24
Section 2 – Principles 27
1. Governing principles 27
2. Principles for managing Conflicts of Interest for the COVAX 27
Coordination Meeting (CCM) and its Committees
Background 27
Definitions 28
Principles 28
4INTRODUCTION:
COVAX: STRUCTURE AND PRINCIPLES
WHAT IS COVAX?
WHAT IS COVAX Developing one or more safe and effective
COVID-19 vaccines is one of the most complex
challenges of our time. Unlike with past vaccine
Developing a vaccine against COVID-19 is one development, scaling up manufacturing and
of the most pressing challenges of our time. The completion of human trials for vaccine candidates
global pandemic has already caused the loss of must be done in parallel. Even with accelerated
more than one million lives and disrupted the lives investment in manufacturing, and the completion
of billions more. As well as reducing the tragic of trials to ensure vaccine candidates are safe
loss of life, introducing vaccines will prevent the and effective, there is no scenario in which supply
loss hundreds of billions of dollars to the global over the next 18 months will exceed demand –
economy every month. although at today’s anticipated trajectory, some
vaccine candidates could become available within
Many leaders have called for a global solution this time frame.
to address this global issue. For a collaborative
endeavor, that involves the best shared science to COVAX is a global solution for equitable access:
resolve, in the shortest possible time, a pandemic through portfolio diversification, pooling of
that involves every region and territory on the financial and scientific resources, and economies
planet. In response, the Access to COVID-19 of scale, participating governments and regional
Tools (ACT) Accelerator – a groundbreaking blocs can hedge the risk of backing unsuccessful
collaboration to accelerate development, candidates, just as governments with limited or no
production and equitable access to COVID-19 ability to finance their own bilateral procurement
diagnostics, treatments and vaccines – was can be assured access to life-saving vaccines that
launched in April 2020. would otherwise have been beyond their reach.
COVAX is the vaccines pillar of the ACT
Accelerator, co-led by the Coalition for Epidemic WHAT IS THIS DOCUMENT
Preparedness Innovations (CEPI), Gavi, the Vaccine
Alliance, and the World Health Organization (WHO).
Its goal is to help end the acute phase of the global The following document outlines the current
pandemic by the end of 2021 by providing access working structure and overall guiding principles of
to at least 2 billion doses of safe and effective collaboration between the organisations involved
COVID-19 vaccines to the most vulnerable in all in implementing COVAX. Building on existing bodies
participating economies. If it succeeds in this goal, wherever possible, and adapting to emerging
through the appropriate allocation of safe and needs, this working structure will continue to
effective doses of vaccines in phases determined evolve as needed.
by epidemiology and public health to slow and
ultimately to stop the pandemic, it could save
millions of lives and transform the economic
prospects of governments and individuals.
5SECTION 1:
COVAX: STRUCTURE AND PRINCIPLES
OVERVIEW OF
KEY BODIES
1. CROSS-CUTTING • CCM acts as bridge and steering group and
is therefore responsible for coordination and
driving the work of COVAX.
1.1 COVAX COORDINATION MEETING (CCM) • COVAX builds on existing management bodies
rather than creating new management.
• For decisions beyond the mandate of COVAX
Overview
or that may implicate or affect the broader
work of the organisations, there must be
The CCM is the high-level body that meets to
explicit approval from relevant Boards.
coordinate efforts across the different elements
of COVAX, the vaccines pillar of the Access to • Financial accountability remains fully within
COVID-19 Tools (ACT) Accelerator. The CCM is each organisation. No decision can be
chaired by the Board Chairs of CEPI and Gavi, taken that would contradict a decision
and includes the institutional leads of all three by the respective Boards of CEPI and
organisations, providing a link to the established Gavi; exceptions must be approved by the
governance of each organisation. It meets to help organisation’s Board.
coordinate, guide and resolve issues across COVAX.
Members
Objectives
• o-chairs: Jane Halton (Board Chair, CEPI);
C
• Ensure alignment between partners and the Ngozi Okonjo-Iweala (Board Chair, Gavi)
wider ACT Accelerator
• Institutional Leads: Seth Berkley (Gavi);
• Inform major workstream decisions Richard Hatchett (CEPI); Soumya
Swaminathan (WHO)
• Discuss major strategic questions
• orkstream leads: Aurélia Nguyen (Gavi);
W
• Address bottlenecks as needed, including Kate O’Brien (WHO); Melanie Saville (CEPI)
through high-level stakeholder management
• I ndustry partner representatives: Roger
• Take responsibility for progress towards goals Connor (GSK), selected through International
Federation of Pharmaceutical Manufacturers
Areas of focus & Associations (IFPMA); Mahima Datla
(Biological E. Limited), selected through
The CCM provides guidance across the various Developing Countries Vaccine Manufacturers
COVAX workstreams, with a particular focus on the Network (DCVMN)
many areas of interdependency and collaboration.
• ivil society representative: Mesfin Teklu
C
Decision-making principles Tessema (International Rescue Committee)
• Each partner must act with integrity to • UNICEF representative: Omar Abdi
further COVAX aims. Organisational Interest
and Conflicts of Interest must be managed • y invitation: Chair of the Research and
B
transparently with the highest degree Development and Manufacturing Investment
of integrity. Committee (RDMIC), Chair of the Independent
Product Group (IPG)
6COVAX: STRUCTURE AND PRINCIPLES
Format investment recommendations that the CEPI Board
(through its Executive and Investment Committee)
• Forum: Video/teleconference reviews/endorses. Accountability for decision-
making and investor requirements remains clearly
• Frequency: Fortnightly (once every two weeks) with the respective institutional governance bodies.
• Length: Two hours Objectives
The principal objectives of the RDMIC are to:
1.2 AREAS OF INTER-ORGANISATIONAL
COORDINATION • Drive portfolio strategy and investment
decision recommendations aligned with overall
COVAX strategic objectives.
The three lead COVAX organisations – CEPI, Gavi
and WHO – coordinate closely on the following • Define the target composition, diversity,
issues: costing; funding and resource mobilisation; investment allocation and risk profile of the
indemnification and liability; consolidated data; portfolio of COVAX-funded vaccine candidate
Conflict of Interest principles; engagement of civil projects and cross-cutting enabling projects.
society organisations (CSOs); regulatory (including
safety) preparedness and guidance; end-to-end • Recommend project selection and investment
operationalisation; and deals with manufacturers. decisions greater than US$ 5 million – for
example, new project selections, stage gate
2. WORKSTREAM – DEVELOPMENT
reviews, portfolio reviews (+ down selections),
major change requests.
AND MANUFACTURING • Oversee overall progress of COVAX-funded
vaccine candidate projects and cross-cutting
2.1 RESEARCH AND DEVELOPMENT enabling projects.
AND MANUFACTURING INVESTMENT
COMMITTEE (RDMIC) • Identify and address cross-portfolio challenges
and interdependencies.
Areas of focus
Overview
• Definition of COVAX-funded vaccine candidate
The Research and Development and and cross-cutting enabling project portfolio
Manufacturing Investment Committee is a composition, diversity, investment allocation
multidisciplinary group with industry expertise and risk.
that manages the allocations of funds under the
Development and Manufacturing Workstream • Recommendations for decisions on project
of COVAX. It provides investment decision prioritisation, selection and investment.
recommendations for selection and progression of
the portfolio of COVAX-funded vaccine candidate • Final endorsement of recommendations for
projects and cross-cutting enabling projects that new projects.
accelerate vaccine R&D and manufacturing.
• Final endorsement of recommendations for
The RDMIC also reviews non-COVAX-funded project progression (stage gate reviews).
vaccine development and manufacturing
projects to ensure cross-portfolio challenges, • Development/endorsement of
interdependencies and decisions can be surfaced recommendations for project budget overruns
and addressed appropriately. greater than US$ 5 million or timeline delays
greater than three months.
The RDMIC provides portfolio strategy and
investment decision recommendations to rapidly • Monitoring of overall project progress and
identify, develop and manufacture COVID-19 resolution of escalated project issues.
vaccines that can be deployed at scale to address
global health needs. The RDMIC operates as • Identification of cross-portfolio challenges,
an expert advisory group, primarily to make interdependencies and decisions.
7COVAX: STRUCTURE AND PRINCIPLES
Decision-making principles • John Nkengasong (Africa Centres for Disease
Control and Prevention)
Decision-making principles for RDMIC are:
• Peter Paradiso (Independent Consultant)
• All members must act with integrity and
impartiality at all times, in accordance Extended members:
with policies or principles of the COVAX
Development and Manufacturing Workstream. • Melanie Saville, Technical Review Group
Chair (CEPI)
• Decisions are driven by consensus. If
consensus cannot be reached, decision will be • Luc Debruyne, Strategic Advisor (CEPI)
made by the RDMIC Chair.
Format
• Voting requires quorum of at least two thirds
of RDIMC core members and includes the • Forum: Video/teleconference
RDMIC Chair and the CEO (or delegate) of the
institution allocating funds. • Frequency: Weekly
• Technical aspects of proposals to the RDMIC • Length: Two hours
will be actively and objectively reviewed
through the Technical Review Group (TRG)
prior to RDMIC. 2.2 TECHNICAL REVIEW GROUP (TRG)
Members
Overview
The RDMIC is comprised of the CEPI CEO, Gavi
CEO, Bill & Melinda Gates Foundation President The Technical Review Group (TRG) is a cross-
of Global Health, (ex-) industry R&D experts, (ex-) cutting, multidisciplinary advisory group with
industry manufacturing experts, current active expertise in all areas of vaccine research and
industry (non-vaccine) leaders and senior global development, including enabling sciences, clinical
public health leaders (including a CEPI Board development, manufacturing, regulatory affairs,
member, to ensure linkages) and is accountable to public health and industry. The TRG is responsible
the CEPI Board. for the overall technical review, oversight, support
and steering of vaccine development projects
Extended members – including the Chair of under the Development and Manufacturing
the Technical Review Group and external Workstream to meet the challenges of speed,
strategic advisors, as appropriate – also attend access and manufacturing scale.
RDMIC meetings to contribute expert R&D and
manufacturing perspectives. Extended members Each vaccine project is supported by a Vaccine
are non-voting members. Team composed of: a Project Leader; Project
Manager; Contract Manager; and functional
Core (voting) members: experts in preclinical studies, clinical development,
manufacturing and regulatory issues.
• Chris Viehbacher, Chair (Gurnet Point Capital)
In an “open session” (objectives below), TRG
• Seth Berkley (Gavi) members provide recommendations for
cross-cutting enabling projects; identify
• Richard Hatchett (CEPI) interdependencies; and approve formation of
SWAT teams to address challenges in order to
• Subhash Kapre (Inventprise) accelerate vaccine R&D and manufacturing across
all vaccine candidates.
• Michael King (Independent Consultant,
retired Merck/MSD) In a “closed session” (objectives below), TRG
members with no Conflicts of Interest provide
• Kiran Mazumdar-Shaw (Biocon) extensive technical review of specific vaccine
development projects, and recommend selection
• Trevor Mundel (Bill & Melinda Gates Foundation) and progression of the portfolio of COVAX-funded
vaccine candidates to the RDMIC.
8COVAX: STRUCTURE AND PRINCIPLES
Objectives escalation of budget overruns greater than
US$ 5 million or timeline delays greater than
The principal objectives of TRG closed sessions three months to RDMIC.
are to:
TRG open sessions
• Provide end-to-end oversight of project
execution, to include review and monitoring • Technical review and recommendations for
of Vaccine Teams’ progress, milestones working group creation, deliverables and
and budgets; timelines; and
• Review significant deviations in projects • Review of SWAT teams’ deliverables and
(scope, time or budget) and approve or recommendations for addressing bottlenecks
escalate to RDMIC; and common challenges across vaccine
development projects.
• Recommend project selection based on
technical review and investment decisions less Decision-making principles
than US$ 5 million (e.g. new project selections,
stage gate reviews, change requests); Decision-making principles for the TRG are:
• Support and provide guidance to Vaccine • All members must act with integrity and
Teams through scientific, technical and impartiality at all times, in accordance
operational review of projects and risks; with policies or principles of the COVAX
Development and Manufacturing Workstream.
• Raise challenges or issues from Vaccine Teams
to be addressed by SWAT teams; and • Technical review of development plans to be
conducted by non-conflicted TRG members.
• Make stage gate recommendations to
the RDMIC. • Technical review of SWAT teams’ inputs (cross-
cutting, non-proprietary), to include additional
The principal objectives of TRG open sessions experts (extended members) with express
are to: permission of the Chair.
• Provide end-to-end oversight of SWAT team • Extended members are observers and do
execution, to include review and monitoring not hold decision rights (to avoid Conflicts
of SWAT teams’ progress, milestones and of Interest).
challenges;
• Voting requires quorum of at least two thirds
• Approve working group creation, deliverables of TRG core members and includes the TRG
and timelines; and Chair. Decisions are driven by consensus. If
consensus cannot be reached, decision will be
• Provide technical support and guidance to made by the TRG Chair.
SWAT teams and the Regulatory Advisory
Group (RAG) on project-agnostic challenges Members
and issues.
Core members
Areas of focus
• Melanie Saville, Chair (CEPI)
TRG closed sessions
• Vasee Moorthy (WHO)
• Stage gate recommendations for projects
based on review of milestones; • Derrick Sim (Gavi)
• Recommendations based on review of • Rebecca Grais (Médecins Sans Frontières –
scientific, technical, financial, operational and MSF)
risk reports from Vaccine Teams; and
• Emilio Emini (Bill & Melinda Gates Foundation)
• Review of budget overruns or project timeline
delays, and recommendations for approval or • Paul Kristiansen (CEPI)
9COVAX: STRUCTURE AND PRINCIPLES
• Jakob Cramer (CEPI) technical issues and challenges common
across all COVID-19 vaccine development
• Debra Yeskey (CEPI) projects to promote and accelerate vaccine
development. SWAT core members represent
• Svein Rune Andersen (CEPI) diverse stakeholders in the vaccine development
ecosystem, providing expertise in enabling
• Ingrid Kromann (CEPI) sciences; clinical development and operations;
and manufacturing to scale. The Regulatory
• Nick Jackson (CEPI) Advisory Group (RAG), composed of regulators
representing all global regions, works to resolve
• Gabrielle Breugelmans (CEPI) and provide guidance for harmonised pathways to
address regulatory science challenges, in order to
Additional members included in TRG open sessions accelerate vaccine development.
• Steve Lockhart (IFPMA) SWAT teams include: (1) Clinical Development
and Operations; (2) Enabling Sciences; and (3)
• Norio Tamura (IFPMA) Manufacturing. The RAG provides guidance
for regulatory science challenges and
• Ricardo Palacios (DCVMN) interdependencies escalated by all three
SWAT disciplines.
• Weining Meng (DCVMN)
Objectives for all SWAT teams and RAG
• Adriansjah Azhari (DCVMN)
• Focus on resolving common technical cross-
• Michael King (Independent Consultant, project questions and challenges at speed;
retired MSF/Merck)
• Act as an open source of information for
• Jean Lang (IFPMA) COVAX Vaccine Teams (see definition in
TRG section, above) and COVID-19 vaccine
• Jim Robinson (CEPI) developers more broadly;
• Nicolas Havelange (CEPI) • Promote harmonisation and comparability
across projects; and
• David Robinson (Bill & Melinda Gates Foundation)
• Bring together different stakeholders
• Peter Dull (Bill & Melinda Gates Foundation) and coordinate with other players in the
ecosystem to maximise efforts.
• Emer Cooke (WHO)
Areas of focus
• Ivana Knezevic (WHO)
Clinical Development and Operations SWAT
Format
• Clinical and operational readiness by
• Forum: Video/teleconference supporting: clinical trial sites in low- and
middle-income economies; landscape analyses;
• Frequency: Weekly and creation of databases or networks.
• Length: One hour • Addressing vaccine safety considerations
during development, including case definitions,
planning towards clinical trials and vaccine
2.3 SWAT TEAMS AND REGULATORY ADVISORY safety surveillance.
GROUP (RAG)
• Clinical science elements for clinical trials,
such as endpoint case definitions, adaptive
Overview trial designs, correlates of protection and
optimisation options.
SWAT (Support Work to Advance Teams)
are groups of experts focused on resolving
10COVAX: STRUCTURE AND PRINCIPLES
Enabling Sciences SWAT Members
• Assay standardisation through development Core members for each SWAT team and the
of an international antibody standard; RAG define and revise key questions, deliverables
centralised laboratory capacity for clinical and timelines as needed and drive activities
trials; defining type and performance of according to defined deliverables. Core members
diagnostic assays; and addressing regulatory are involved with decision-making, with additional
challenges in standardisation. experts joining working groups, workshops or core
team meetings on an ad hoc basis.
• Animal model testing network to ensure
development of appropriate animal models Clinical Development and Operations SWAT:
and high-quality testing of vaccine candidates. Core members
• Guidance on animal model evaluation for • Jakob Cramer, co-lead (CEPI)
vaccine-mediated enhanced disease (VMED)
and correlates of protection. • Peter Dull, co-lead (Bill & Melinda Gates
Foundation)
Manufacturing SWAT
• Hilary Marston (National Institutes of Health,
• Drug product and drug substance strategy USA)
and capacity identification for scale-up and
scale-out of products. • François Roman (IFPMA)
• Supply chain strategy to include securing • Stephen Lockhart (IFPMA)
raw materials, mutually agreed labelling and
alignment with COVAX partners. • Ricardo Palacios (DCVMN)
• Support for batch release assays (including • Robert Chen (Brighton Collaboration)
potency assay requirements); mutual
recognition of the process for timely national • Farah Kumar (Aga Khan Foundation)
batch release; and support for additional
analytical capacity. • Gabrielle Breugelmans (CEPI)
Regulatory Advisory Group (RAG) • Debra Yeskey (CEPI)
• Guidance for regulatory science challenges • Svein Rune Andersen (CEPI)
related to SWAT team activities, towards
harmonisation and streamlined processes • Ana Maria Henao Restrepo (WHO)
where feasible. Membership is focused on
representatives of regulatory authorities from • Peter Smith (London School of Hygiene
around the world. & Tropical Medicine)
Decision-making principles • David Kaslow (PATH)
• Core team experts are involved with decision- • Sophie Mathewson (Gavi)
making in their area of expertise.
• Charlie Weller (Wellcome Trust)
• SWAT team co-leads develop and assess work
packages, as per deliverables description. Enabling Sciences SWAT: Core members
• If consensus cannot be reached on a topic • Paul Kristiansen, co-lead (CEPI)
and further expertise is required, the SWAT
team co-leads can escalate the decision to the • Ivana Knezevic, co-lead (WHO)
Technical Review Group (TRG).
• Jenny Hendriks (IFPMA)
• Karen Markar (Bill & Melinda Gates Foundation)
11COVAX: STRUCTURE AND PRINCIPLES
• Janet Lathey (National Institutes of Health, • Dean Smith (Health Canada)
USA)
• Kristy Tomas (Therapeutic Goods
• Carolyn Clark (CEPI) Administration – TGA, Australia)
• William Dowling (CEPI) • Laurent Mallet (European Directorate for the
Quality of Medicines – EDQM)
• Valentina Bernasconi (CEPI)
• May Ling Choong (Health Sciences Authority –
• Debra Yeskey (CEPI) HSA, Singapore)
• Svein Rune Andersen (CEPI) • Mimi Darko (Food and Drugs Authority –
FDA, Ghana)
• Sheetal Sharma (Safari Doctors)
• Patricia Aprea (National Administration of
Manufacturing SWAT: Core members Drugs, Foods and Medical Devices – ANMAT,
Argentina)
• Ingrid Kromann, co-lead (CEPI)
• Flavia Regina Souza Sobral (National Health
• Nicolas Havelange, co-lead (CEPI) Surveillance Agency – ANVISA, Brazil)
• David Robinson, co-lead (Bill & Melinda Gates • Michael Weissman (TGA, Australia)
Foundation)
• Araki Yasuhiro (Pharmaceuticals and Medical
• Alain Alsalhani (Médecins Sans Frontières – Devices Agency – PMDA, Japan)
MSF)
• Tiziana Scarna, Observer (Gavi)
• Mike Thein (IFPMA)
Format
• Adriansjah Azhari (DCVMN)
SWAT core teams
• Carmen Rodriguez Hernandez (WHO)
• Forum: Video/teleconference
• Diane Wilkinson (Vaccines Europe)
• Frequency: Biweekly
• Jim Robinson (CEPI)
• Length: One to one-and-a-half hours
• Debra Yeskey (CEPI)
RAG
• Svein Rune Andersen (CEPI)
• Forum: Video/teleconference
• Dominique Maugeais (Gavi)
• Frequency: Monthly
Regulatory Advisory Group (RAG): Core members
• Length: Two hours
• Debra Yeskey, co-lead (CEPI)
Working groups
• Svein Rune Andersen, co-lead (CEPI)
• Forum: Video/teleconference
• Emer Cooke, co-lead (WHO)
• Frequency: Weekly, plus monthly topic-
• Marco Cavaleri (European Medicines Agency – specific workshops with extended members
EMA) and developers
• Marion Gruber (Food and Drug Administration • Length: Weekly – One hour; workshops –
– FDA, USA) two to four hours
12COVAX: STRUCTURE AND PRINCIPLES
COVAX AMC Engagement Group
3. WORKSTREAM – PROCUREMENT
AND DELIVERY AT SCALE Overview
The COVAX Advance Market Commitment (AMC)
3.1 COVAX FACILITY Engagement Group* will represent the AMC in
the governance of the Facility. Membership of
the AMC Engagement Group will be open to
Office of the COVAX Facility representatives from implementing economies,
donors and other parties engaged in the financing
Overview and operation of the AMC portion of the Facility.
The group will convene with the aim of supporting
As the legal administrator of the COVAX Facility, real-time information exchange and providing
Gavi has established the Office of the COVAX strategic guidance and advice to the Office of
Facility within the Gavi Secretariat to ensure a the COVAX Facility on the operational aspects of
dedicated team is available to support Facility the COVAX Facility, particularly as it relates to
operations, and to mitigate disruption to Gavi’s implementation in AMC-eligible countries. Within
core work. this body, an AMC Stakeholders Group will convene
representatives from AMC donors; procurement
Managing Director organisations such as UNICEF and PAHO; and
representatives of multilateral development
• Aurélia Nguyen, Gavi banks or regional banks involved in the financing
of the AMC. It will discuss its investments in the
Format AMC; options for additional financing; and receive
specific reporting on progress achieved against
• Housed within the Gavi Secretariat the objectives of the AMC.
COVAX Shareholders Council Members
Overview • To be determined – potentially implementing
countries, donors and other parties engaged in
The COVAX Shareholders Council will* represent the financing and operation of the Gavi COVAX
self-financing participants (SFPs) in the governance AMC, and participants they choose to invite
of the COVAX Facility. Membership of the COVAX
Shareholders Council will be open to all SFPs in Format
the COVAX Facility. The Council will convene SFPs
with the aim of supporting real-time information • To be determined
exchange and providing strategic guidance and *Provisionally approved by the Gavi Board
advice to the Office of the COVAX Facility on
the operational aspects of the COVAX Facility. COVAX Consensus Group
It is expected that the Council will establish a
smaller Executive Committee to prepare and Overview
guide its discussions. The Executive Committee will
provide a clear link between the Council and other The COVAX Consensus Group* will be established
governance structures to ensure the consolidated to support effective operation of the COVAX
advice and views of the Council is considered in Facility through consensus-based decision-making
relevant deliberations. between various governing bodies, particularly in
areas where disagreement may arise.
Members
Members
• To be determined – potentially all SFPs and
participants they choose to invite • To be determined – potentially, Chair and
Vice Chair of the Gavi Board; co-Chairs of
Format the COVAX Shareholders Council; co-Chairs
of the AMC Engagement Group; and – in an
• To be determined ex-officio, non-voting, capacity – the three
*Provisionally approved by the Gavi Board institutional leads of the vaccines pillar of the
ACT Accelerator (i.e. COVAX).
13COVAX: STRUCTURE AND PRINCIPLES
Format Members
• To be determined • Marie-Paule Kieny, Chair (Inserm)
*Provisionally approved by the Gavi Board
• Rafi Ahmed (Emory University)
Independent Product Group (IPG)
• Delese Mimi Darko (FDA, Ghana)
Overview
• Michel de Wilde (independent consultant)
The Independent Product Group (IPG) is
established to make recommendations to the • Jill Gilmour (independent consultant)
Office of the COVAX Facility on the inclusion of
vaccines in the COVAX Facility; regularly review • Jaap Goudsmit (Harvard University)
the COVAX Facility portfolio for balance; review
updates on timing and availability of doses; • Jorge (George) Kalil (University of Sao Paulo)
and consider any implications for the COVAX
Facility portfolio. • César Muñoz-Fontela (Bernhard Nocht
Institute for Tropical Medicine)
The IPG is primarily advisory, and it does not
have decision-making powers. The aim of the IPG • Connie Schmaljohn (NIAID Integrated Research
review process is to make a recommendation Facility)
to the Office of the COVAX Facility on vaccine
candidate prioritisation and portfolio balance. • Kanta Subbarao (Doherty Institute)
Once the Office of the COVAX Facility has
negotiated the ensuing deal terms, taking into Format
consideration independent technical advice from
the Procurement Reference Group (PRG), the deal • Forum: Video/teleconference
would then be considered by the Market-Sensitive
Decisions Committee (MSDC). • Frequency: Weekly
The IPG will: • Length: Two hours
• Regularly review data and information relating Procurement Reference Group (PRG)
to vaccine candidates (for example, such as
that received from manufacturers, WHO, CEPI Overview
and the RDMIC Secretariat);
Once vaccine candidates have been selected
• Provide guidance and independent technical to be funded by the Facility, informed by
advice to the Office of the COVAX Facility recommendations of the IPG, the Procurement
to inform the selection of candidates to be Reference Group (PRG) will then be responsible
prioritised for deal-making by the COVAX for providing independent advice to the Facility
Facility, and eventually considered by the to ensure an appropriately risk managed COVAX
MSDC; portfolio from a commercial perspective
considering vaccine candidates’ probability
• Regularly review the SARS-CoV-2 vaccine of success and timeline for supply delivery.
pipeline and the COVAX Facility portfolio, Guidance will pertain to the implementation of the
taking into consideration updates related COVID-19 vaccine procurement strategy, and key
to clinical development, manufacturing and business terms of proposed advance purchase
supply, and provide advice on both the pipeline commitments with the manufacturers of these
and COVAX Facility portfolio to the Office of vaccine candidates. Key terms include: volumes;
the COVAX Facility and the Gavi Board; pricing; proportion of firm order commitment
vis-à-vis options; performance metrics; trigger for
• Engage with other bodies including, but not call; and recourse remedies for managing individual
limited to, the RDMIC, PRG, SAGE Working supplier risk, as well as the overall COVAX portfolio.
Group on COVID-19 Vaccines, etc.
The PRG is primarily advisory, and it will not
have decision-making powers. Based on
recommendations from the PRG, the Office
14COVAX: STRUCTURE AND PRINCIPLES
of the COVAX Facility will advance negotiations for transactions related to the COVAX Facility,
with manufacturers and bring recommendations including for the Gavi COVAX AMC.
on final deal terms to the MSDC for approval.
Members*
Members
• Ngozi Okonjo-Iweala, Board Chair (independent
• To be determined member)
Format • Sarah Goulding, Board Vice-Chair (independent
member)
• To be determined
• Etleva Kadilli, Board alternate (UNICEF)
Gavi Board
• Muhammad Pate, Board member (World Bank)
Overview
• Violaine Mitchell, Board alternate (Bill & Melinda
The Board of Gavi, the Vaccine Alliance is Gates Foundation)
responsible for overseeing the role of the Gavi
Secretariat and the Alliance in the Facility, and • Lia Tadesse, Board member (Ethiopia)
will have ultimate responsibility for decisions and
effective implementation of the COVAX Facility. • Arsen Torosyan, Board member (Armenia)
In this role, it will: • Daniel Graymore, Board member (United
Kingdom)
• take responsibility to ensure that the Gavi
Secretariat operates within the mandate • Jan Paehler, Board member (European
granted to it; Commission)
• provide strategic direction and policy-making; • Carmen Coles Tull, Board alternate (United
States of America)
• receive regular reports from the Office of the
COVAX Facility on operational progress and • Maty Dia, Board member (Civil society
performance; organisations)
• receive updates from relevant Board • David Sidwell, Board member; Audit and
Committees (e.g. Audit and Finance Finance Committee Chair (independent
Committee) on COVAX Facility matters; and member)
• provide strategic oversight of the COVID-19 • Helen Rees, Board member; Programme and
programme and effective implementation, Policy Committee Chair (independent member)
including country engagement.
• Seth Berkley, non-voting member (CEO, Gavi)
Members
• Three representatives from the COVAX
• The list of current Gavi Board members is Shareholders Council
available on the Gavi website here.
*Membership of MSDC with respect to COVAX-
Market-Sensitive Decisions Committee related transactions; with the exception of
(MSDC) representatives of the COVAX Shareholders
Council, all MSDC members must be Gavi Board
Overview members or alternate Board members.
The Market-Sensitive Decisions Committee Audit and Finance Committee (AFC)
(MSDC) is established by the Gavi Board to
provide oversight and make decisions which are Overview
market and/or commercially sensitive. With Gavi
established as the administrator of the COVAX The Audit and Finance Committee (AFC) is
Facility, the MSDC will undertake this function established by the Gavi Board to support the
153.2 COUNTRY READINESS AND DELIVERY (CRD)
COVAX: STRUCTURE AND PRINCIPLES
Board in fulfilling its oversight responsibilities in
a timely manner in respect of the organisation’s
financial management; risk and control framework,
including internal and external audit; and Overview
adherence to appropriate standards of good
practices and ethics. The AFC will undertake The Country Readiness and Delivery (CRD)
this function in relation to Gavi’s role as the legal workstream is led by WHO, UNICEF and Gavi,
administrator of the COVAX Facility. and it includes implementing and donor agencies
and partners working together at the global and
With respect to the COVAX Facility, the AFC will regional levels to: (1) develop and disseminate
be responsible for: adaptable global goods (e.g. guidance, trainings,
tools, advocacy materials); and (2) support
• ensuring funding availability for COVAX Facility all countries and economies to prepare for
operations, including review of the financial COVID-19 vaccine introduction and to achieve high
implications of Facility-related transactions; acceptance and uptake.
• ensuring the COVAX Facility is properly The CRD workstream is composed of a
represented in Gavi’s Annual Financial Report; coordination working group that has oversight
and of seven other sub-working groups: (1)
communications, advocacy and training; (2)
• monitoring risk to Gavi and the COVAX Facility. data and monitoring; (3) vaccine introduction; (4)
vaccination demand; (5) supply and logistics; (6)
Members costing; and (7) innovation to scale. CRD working
groups collaborate closely across the ACT
• David Sidwell, Chair; Board member Accelerator and beyond to promote a cohesive
(independent member) approach to COVID-19 vaccine readiness for
introduction and deployment.
• Teresa Ressel, Board member
(independent member) The CRD workstream will develop technical
resources and support capacity building of
• Beniamin Carcani, Committee delegate countries for COVID-19 vaccine introduction.
(World Bank) Workstream deliverables include: a country
readiness assessment tool and dashboard;
• Etleva Kadilli, Board alternate (UNICEF) guidance for a National Deployment Vaccine Plan;
adaptable technical guidance across a range
• Kwaku Agyeman-Manu, Board alternate of programmatic areas (e.g. supply chain and
(Ghana) logistics, demand generation and community
engagement, data and monitoring); training
• Emmanuel Maina Djoulde, Committee delegate packages; communications/advocacy materials;
(Cameroon) and recommended indicators for monitoring
preparedness and use.
• Andreas Karlberg Pettersen, Committee
delegate (Norway) Members
• Carmen Coles Tull, Board alternate Coordination Working Group
(United States of America)
• Ann Lindstrand, Co-Lead (WHO)
• Gianmarco Cocozza, Committee delegate
(Italy) • Ann Moen, Co-Lead (WHO)
• Tom Morrow, Committee delegate • Benjamin Schreiber, Co-Lead (UNICEF)
(United Kingdom)
• Nedret Emiroglu (WHO)
• Rafael Vilasanjuan, Board alternate
(Civil society organisations) • Shoshanna Goldin (WHO)
• Patrick Sagna (Dalberg)
16COVAX: STRUCTURE AND PRINCIPLES
• Zeenat Patel (Gavi) • Carla Toko (VillageReach)
• Alex de Jonquieres (Gavi) Sub-working group: Data and Monitoring
• Helen Matzger (Bill & Melinda Gates Foundation) • Marta Gacic-Dobo, Lead (WHO)
• Sunil Bahl (WHO) • Hope Johnson (Gavi)
• Daniel Ngemra (UNICEF) • Laura Craw (Gavi)
• Antoinette Ba (UNICEF) • Mamadou S. Diallo (UNICEF)
• Alba Maria Ropero (PAHO) • Tove Ryman (Bill & Melinda Gates Foundation))
• Oleg Benes (WHO) • Roberta Pastore (WHO)
• Adama Sawadogo (UNICEF) • Pernille Jorgensen (WHO)
• Marta Gacic-Dobo (WHO) • Mark Katz (WHO)
• Diane Summers (UNICEF) • Martha Velandia (WHO)
• Diana Chang-Blanc (WHO) • Jan Grevendonk (WHO)
• Ulla Griffin (UNICEF) • Carolina Danovaro (WHO)
• Jim Robinson (CEPI) • Jason Mwenda Mathiu (WHO)
• Kent Ranson (World Bank) • Apophia Namageyo (CDC)
• Sulzhan Bali (WB) • Garrett Livingston Mehl (WHO)
• Kathy Clark (IFRC) • Jotheeswaran Amuthavalli Thiyagarajan (WHO)
Sub-working group: Communications, Sub-working group: Demand
Advocacy and Training
• Diane Summers, Co-Lead (UNICEF)
• Shoshanna Goldin, Lead (WHO)
• Susan Mackay, Co-Lead (GAVI)
• Mindy Frost (WHO)
• Corbin Kappler (UNICEF)
• Vicky Houssiere (WHO)
• Lisa Menning (WHO)
• Lisa Menning (WHO)
• Neetu Abad (CDC)
• Shushan Mebrahtu (UNICEF)
• James Angus Thomson(UNICEF)
• Alba Maria Ropero Alvarez (PAHO)
• Kate Bagshaw (JSI)
• Katja Schemionek (Gavi)
• Lora Shrimp (JSI)
• Jhilmil Bahl (WHO)
• Helena Ballester Bon (UNICEF ESARO)
• Tamer Elmaghraby (WHO)
• Naureen Navqi
• Denise Traicoff (CDC)
• Emily Ramos (UNICEF)
• Diane Scott (BMGF)
17COVAX: STRUCTURE AND PRINCIPLES
• Matthew Steele (BMGF) • Zhang Guomin (CDC China)
• Ohail Agha (BMGF) • Sonia Freitas (UNICEF)
• Kathleen Clark (IFRC) • Isabelle Cantin (UNICEF)
• Gwendolyn Eamer (IFRC) • Olayinka Sanusi (UNICEF)
• Robert Kanwagi (World Vision) • Hailu Kenea (UNICEF)
Sub-working group: Supply and Logistics • Joselito Nuguid (UNICEF)
• Adama Sawadogo, Co-Lead (UNICEF) • Anne-Laure Maiola (UNICEF)
• Karan Sagar, Co-Lead (Gavi) • Jose Medina Valle (UNICEF)
• Kone Souleymane, Co-Lead (WHO) • Pablo Panadero (UNICEF)
• Michelle Seidel (UNICEF) • Olamide Folorunso (UNICEF)
• Patrick Gaparayi (UNICEF) • Jean-Cedric Meeus (UNICEF)
• Claude Mangobo (WHO) • Samuel Kweku Ocran (UNICEF)
• Maricel Castro (WHO) • Sviatlana Kavaliova (UNICEF)
• Serge Ganivet (UNICEF) • Olga Kosyak (UNICEF)
• Dereje Haile (UNICEF) • Tom Ziraguma (UNICEF)
• Oleg Benes (WHO) • Hamadou Modibo Dicko (UNICEF)
• Lennox Oweg (UNICEF) • Amany Ghoniem (WHO)
• Thomas Sorensen (UNICEF) • Daniel Bridgen (WHO)
• Srihari Dutta (UNICEF) • Michael Zanardi (UNICEF)
• Nasrin Musa (WHO) • Teleb Nadia (WHO)
• Chandrasegarar Soloman (UNICEF) • Wendy Prosser (JSI)
• Mike Brison (Gavi) • Jessica Crawford (Village Reach)
• Karuna Luthra (Gavi) • David Muhia (UNICEF)
• Nora Rodriguez (PAHO) • Andisheh Ghazieh (UNICEF)
• Kelly Hamblin (BMGF) • Silvia Uneddu (UNICEF)
• Khin Devi Aung (UNICEF) • Hussein Kamara (UNICEF)
• Morio, Matt (PATH) • Leon Cases Gonzalez (UNICEF)
• Dorcas Noertoft (UNICEF) Sub-working group: Vaccine Introduction
• Sarah Abdulhady (WHO) • Diana Chang Blanc, Lead (WHO)
18COVAX: STRUCTURE AND PRINCIPLES
• Alejandro Ramirez Gonzalez (WHO) • Marcia Attaran (UNICEF)
• Santosh Gurung (WHO) • Anne Cronin (Gavi)
• Ioana Ghiga (WHO) • Simon Allen (Gavi)
• Nathalie Chenavard (WHO) • Laura Boonstoppel (Thinkwell)
• Hermanthi Dassanayake (WHO) Format
• Nadia Teleb (WHO) • Forum: Video/teleconference
• Louise Henaff (WHO) • Frequency: Varied
• Terri Hyde (CDC) • Length: Varied
• Christoph Steffen (WHO)
3.3 LEARNING, MONITORING AND EVALUATION
• Liudmila Mosina (WHO)
• Antoinette Ba (UNICEF) Objectives
• Ado Bwaka (WHO) COVAX has ambitious goals and objectives. It
presents many challenges, new ways of working
• Ahmadu Yakubu (UNICEF) and opportunities for all stakeholders involved. As
such, there is a strong desire to ensure learning,
• Anissa Sidibe (Gavi) monitoring and evaluation from early stages of
design of the COVAX pillar through to its eventual
• Stephen Sosler (Gavi) results while balancing the realities of trying to
move fast to have impact during a pandemic.
• Reena Doshi (CDC)
Although the overall approach is still being finalised
• Yalda Momeni (UNICEF) in consultation with key stakeholders, the following
components are currently in consideration:
• Emily Nickels/Kendall Krause (Bill & Melinda
Gates Foundation) • A holistic theory of change that documents
key intended results, risks and assumptions;
• Eltayeb Elfakki (WHO)
• A set of Key Performance Indicators that will
• Jason Mathiu (WHO) be used to monitor results across the entire
results chain, from inputs through to impact;
Sub-working group: Costing
• A monitoring report that compiles key results
• Ulla Griffin, Lead (UNICEF) and learning;
• Logan Brenzel (BMGF) • A multi-stage evaluation approach, beginning
with an evaluability and baseline assessment,
• Stephen Resch (Harvard University) for example.
• Allison Portnoy (Harvard University) This learning, monitoring and evaluation work will
engage a broad range of COVAX stakeholders
• Karene Yeung (WHO) and employ a mixed-methods approach (gathering
both qualitative and quantitative data and inputs),
• Raymond Hutubessy (WHO) building on and making use of existing documents,
tools and processes where possible. Key inputs
• Nathalie Vande Maele (WHO) from partners will be critical to ensure alignment
throughout these efforts across the COVAX pillar.
• Alex Adjagba (UNICEF)
19COVAX: STRUCTURE AND PRINCIPLES
4. WORKSTREAM: POLICY
• Shabir Madhi (South Africa)
AND ALLOCATION • Peter McIntyre (New Zealand)
• Ezzeddine Mohsni (Jordan)
4.1 WHO STRATEGIC ADVISORY GROUP OF
EXPERTS (SAGE) ON IMMUNIZATION • Kim Mulholland (Australia)
• Kathleen Neuzil (United States of America)
Overview
• Hanna Nohnyek (Finland)
In accordance with WHO’s mandate to provide
guidance to Member States on health policy • Folake Olayinka, (United States of America)
matters, the Strategic Advisory Group of
Experts (SAGE) on Immunization is tasked with • Andrew J. Pollard (United Kingdom)
developing evidence-based immunisation policy
recommendations. It is the principal external • Firdausi Qadri (Bangladesh)
expert group advising the WHO Director General
on issues related to vaccines, immunisation and SAGE Working Group on Covid-19
the health systems to deliver vaccines. The SAGE vaccines
terms of reference (ToRs) lay out that SAGE
advises the WHO Director-General on six areas, Overview
the third of which is “immunization programme
response to current public health priorities.” SAGE Working Groups provide evidence-based
information and options for recommendations
SAGE comprises 15 independent experts, who together with implications of the various options
serve in their personal capacity and represent to be discussed by SAGE in an open public forum.
a broad range of affiliations and a broad range Working Groups, with support of the WHO
of disciplines encompassing many aspects of Secretariat perform or coordinate, systematic
immunization and vaccines. In addition to the mix assessment of the evidence such as analysis of
of expertise, geographic and gender balance is data addressing efficacy, effectiveness, safety,
considered in the selection of members. SAGE feasibility, and economic aspects of immunisation
members, including the Chairperson and the Vice- policy to address questions developed by the
Chairperson, are appointed by the WHO Director- Working Group in order to propose appropriate
General after a public call for nominations and vaccine policy recommendations to SAGE.
rigorous selection process. After determination of
eligibility, nominations are submitted to a selection In June 2020, SAGE established the Working
panel. Members are selected on the basis of their Group on COVID-19 vaccines following an open
qualifications and ability to contribute to the call for nominations issued on 24 April 2020 and
accomplishment of SAGE’s objectives. Declaration closed on 11 May 2020. In total, 102 nominations
of Interests of all SAGE members are assessed by were received.
WHO at the time of appointment and in advance
of each SAGE meeting. This Working Group is requested to advise WHO
and its Member States on the use of initially
Members pre-licensed vaccines, followed by updates as
additional information on product use becomes
• Alejandro Cravioto, SAGE Chair (Mexico) available. The timeliness of setting up this group
has ensured a coordinated approach with
• Kari Johansen, SAGE Vice-Chair (Sweden) the vaccine Research and Development (R&D)
community, in order to accelerate timelines
• Rakesh Aggarwal (India) and maximise global efforts to make evidence-
informed policy decisions for the best use of a
• Ilesh Jani (Mozambique) vaccine against COVID-19. The ultimate goal of a
vaccine against COVID-19 is to rapidly contain the
• Jaleela Jawad (Bahrain) pandemic, save lives, protect health care systems,
and restore global economies.
• Noni MacDonald (Canada)
20COVAX: STRUCTURE AND PRINCIPLES
Specifically, the Working Group has been asked to: • Hyam Bashour, Expert (Al-Sham Private
University, Syria)
• provide continuous review of the available
evidence on the progress of candidate • David Durrheim, Expert (University of
vaccines against COVID-19, and provide Newcastle, Australia)
regular updates to SAGE;
• Ruth Faden, Expert (Johns Hopkins Berman
• provide guidance for the development of Institute of Bioethics, USA)
prediction models to determine the optimal
age groups and target populations for vaccine • Nicholas Grassly, Expert (Imperial College
introduction and guide vaccine introduction London, UK)
for optimal impact, and contribute to updates
of target product profiles of vaccines for • Sonali Kochhar, Expert (University of
outbreak and for endemic use; Washington, USA)
• prepare policy advice to SAGE on the • Eusebio Macete, Expert (Manhiça Health
accelerated use of vaccines (pre-licensure and Research Centre, Mozambique)
post-licensure) to mitigate the public health
impact of COVID-19, to possibly curtail the • Kayvon Modjarrad, Expert (Walter Reed Army
ongoing pandemic, as well as to prevent or Institute of Research, USA)
reduce the risk of spread of disease in the
future. This will include recommendations for • Sarah Pallas, Expert (Centers for Disease
early allocation of vaccines when vaccine Control and Prevention, USA)
supply is still limited;
• Mary Ramsay, Expert (Public Health England,
• provide guidance to ensure equitable access UK)
to vaccination, and guidance on the safety
of vaccines when safety data from wider • Peter Smith, Expert (London School of Hygiene
population use become available, in close & Tropical Medicine, UK)
collaboration with Global Advisory Committee
on Vaccine Safety (GACVS). • H. Keipp Talbot, Expert (Vanderbilt University
Medical Center, USA)
• link to the terms of reference: https://www.who.
int/immunization/sage/sage_wg_covid-19/en/ • Cristiana Toscano, Expert (Federal University
of Goiás, Brazil)
While SAGE Working Groups do not permit
observers, it was agreed that in this exceptional • Yin Zundong, Expert (Chinese Center for
situation ex officio membership would be Disease Control and Prevention, China)
implemented. Ex officio membership was
offered to four chairs of related WHO advisory • Klaus Cichutek, Ex-Officio Member/Chair,
committees, and the chairs of the six WHO WHO Expert Committee on Biological
Regional Immunization Technical Advisory Standardization (Paul-Ehrlich-Institut,
Committees. Germany):
Members • Peter Figueroa, Ex-Officio Member/Chair,
PAHO Regional Immunization Technical Advisory
• Hanna Nohynek, SAGE Member, Chair of the Group (University of the West Indies, Jamaica)
Working Group (Finnish Institute for Health and
Welfare, Finland) • Adam Finn, Ex-Officio Member/Chair, European
Technical Advisory Group of Experts on
• Folake Olayinka, SAGE Member (John Snow, Inc., Immunization (University of Bristol, UK)
USA)
• Gagandeep Kang, Ex-Officio Member/Chair,
• Muhammed Afolabi, Expert (London School of South-East Asian Regional Immunization
Hygiene & Tropical Medicine, UK) Technical Advisory Group (Christian Medical
College, India)
• Celia Alpuche, Expert (Instituto Nacional de
Salud Publica, Mexico)
21COVAX: STRUCTURE AND PRINCIPLES
• David Kaslow, Ex-Officio Member/Chair, Members
Product Development for Vaccines Advisory
Committee (PATH, USA) • To be comprised of Gavi and WHO staff
members, with technical consultations
• Ziad Memish, Ex-Officio Member/Chair, undertaken as needed
Eastern Mediterranean Regional Immunization
Technical Advisory Group/Member, Strategic Format
and Technical Advisory Group for Infectious
Hazards (Ministry of Health, Saudi Arabia) • To be determined
• Christopher Morgan, Ex-Officio Member/ Independent Allocation Validation Group
Chair, Western Pacific Regional Immunization (IAVG)
Technical Advisory Group (Jhpiego, Australia)
Overview
• Saad Omer, Ex-Officio Member/Member,
Global Advisory Committee on Vaccine Safety The Independent Allocation Validation Group
(Yale Institute for Global Health, USA) (IAVG) will be established as an independent body
to validate the VAD proposal put forward by the
• Helen Rees, Ex-Officio Member/Chair, African JAT. Composed of technical experts, the IAVG will
Regional Immunization Technical Advisory validate that the proposed VADs are technically
Group (University of the Witwatersrand, informed, based on latest available data and
South Africa) evidence, and that Conflicts of Interest are
identified, documents and managed appropriately.
They may also request clarifications from the
4.2 ALLOCATION MECHANISM JAT, and for the model to be rerun if needed,
before making their final determination. The VAD is
characterised as a strong recommendation with
The Facility will apply the WHO-developed any adjustments being made on an exceptional
Fair Allocation Framework as the basis for vaccine basis for clearly pre-defined reasons, such as
allocation decisions for Facility participants, specific operational considerations. The VAD, once
operationalised through the Allocation Mechanism. validated by the IAVG, will be passed to the Office
The Allocation Mechanism governance will of the COVAX Facility for implementation with
comprise the Joint Allocation Taskforce (JAT) and support from procuring agencies.
the Independent Allocation Validation Group (IAVG).
It is envisaged that the IAVG will be comprised of
Joint Allocation Taskforce (JAT) independent experts jointly nominated by the core
COVAX partners (WHO, Gavi Secretariat and CEPI),
Overview with observers from CSOs and representatives
of economies participating in the COVAX Facility.
The Joint Allocation Taskforce (JAT), comprised The ToRs for the IAVG are being defined jointly
of staff from the WHO and the Office of the by the lead COVAX organisations, according to
COVAX Facility, will, based on a data-driven established existing processes for constituting
allocation model, prepare a Vaccine Allocation expert bodies, aiming for finalisation by mid-
Decision (VAD) proposal for review and validation November 2020. A nomination process for IAVG
by the Independent Allocation Validation Group membership will be triggered upon finalisation of
(IAVG). The JAT will review all the data inputs the ToRs, also in line with existing processes. Areas
needed for the allocation model and verify its of expertise for the IAVG will be established based
output. Some flexibility to enable adjustments on the final ToRs but will likely include: immunisation
for clearly defined reasons, such as operational programmes and service delivery; vaccine safety
considerations, will be accommodated and evaluation and monitoring; access to medicines
fully documented. The JAT will respond to any and health products; and emergency public health
requests for clarification from the IAVG. response, among others.
The JAT will be convened by the Office of Members
the COVAX Facility and WHO, with Terms of
Reference (ToRs) jointly defined by Gavi, WHO and • To be determined
CEPI in the coming weeks, aiming for finalisation
by mid-November.
22COVAX: STRUCTURE AND PRINCIPLES
Format The primary areas of focus were:
• To be determined • defining the overarching, high-level goals
of a COVID-19 vaccination strategy;
4.3 POLICY AND ALLOCATION WORKING GROUPS • developing an approach for identifying priority
populations and target groups for vaccination;
and
Vaccine Strategy Sub-Working Group
• identifying high-level uncertainties and risks of
Overview the COVID-19 vaccine initiative and actions to
address and mitigate these.
The Vaccine Strategy Sub-Working Group, led by
WHO, was established at the outset of COVAX Members
and was active in the initial months while various
workstreams were being initiated; it is currently • Kate O’Brien, Lead (WHO)
not an active workstream and will be reinitiated
as needed. Its work has flowed in to other • Joachim Hombach (WHO)
workstreams related to, for example, allocation,
policy, country readiness and delivery, costing, • Tania Cernuschi (WHO)
funding and procurement.
• Annelise Wilder Smith (WHO)
Its tasks were: (i) assuring that the COVAX Pillar
has an aligned global COVID-19 vaccine strategy • Raymond Hutubessey (WHO)
that includes detail on the goals of a vaccination
programme and general targets for achieving the • Mariangela Simao (WHO)
goals; (ii) addressing COVAX-wide strategic topics,
such as risks to the vaccination strategy, and core • Sylvie Briand (WHO)
scenarios to feed planning and delivery efforts.
This allows for pre-empting of strategic topics • Analia Porras (WHO)
and the creation of aligned material, while also
preventing duplication among workstreams. Close • Zeenat Patel (Gavi)
coordination and iteration was required between
sub-workstreams with overlapping and inter- • Stephen Sosler (Gavi)
dependent thinking.
• Anissa Sidibe (Gavi)
The sub-working group was established to:
• Jakob Cramer (CEPI)
• reach alignment on important definitions
and assumptions to use the same language • Melanie Saville (CEPI)
and numbers across organisations;
• Jim Robinson (CEPI)
• ensure the learnings from our work to date
are translated into an actionable action plan • Helen Matzger (Bill & Melinda Gates Foundation)
that mitigates the risks identified, with clear
accountability and timelines; and • Orin Levine (Bill & Melinda Gates Foundation)
• continue to identify and reflect on high- • Peter Dull (Bill & Melinda Gates Foundation)
priority strategic topics that have cross-
workstream impact. • Jane Barratt (International Federation
on Ageing)
The sub-working group was structured around
sprints on critical questions. The workstream
met twice weekly to review analyses and draw
inferences from those analyses that were then
passed to other workstreams as relevant.
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