Page created by Mitchell Powell

          9 NOVEMBER 2020

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.

                                                            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
      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

                                                                                                              COVAX: STRUCTURE AND PRINCIPLES

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.

                                                                                                         COVAX: STRUCTURE AND PRINCIPLES

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
                                                         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.
                                                     •    o-chairs: Jane Halton (Board Chair, CEPI);
•   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);
•   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
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
    transparently with the highest degree                Development and Manufacturing Investment
    of integrity.                                        Committee (RDMIC), Chair of the Independent
                                                         Product Group (IPG)
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:
     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

                                                           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.
     COMMITTEE (RDMIC)                                 •   Identify and address cross-portfolio challenges
                                                           and interdependencies.

                                                       Areas of focus
                                                       •   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.
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.
•   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)
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.
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).
                                                        •   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)
•   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
                                                       •   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
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
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)
•   Janet Lathey (National Institutes of Health,    •   Dean Smith (Health Canada)
                                                    •   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,
•   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)
                                                    •   Araki Yasuhiro (Pharmaceuticals and Medical
•   Alain Alsalhani (Médecins Sans Frontières –         Devices Agency – PMDA, Japan)
                                                    •   Tiziana Scarna, Observer (Gavi)
•   Mike Thein (IFPMA)
•   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)
•   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
                                                       COVAX AMC Engagement Group
    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.
•   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).
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)
                                                      •   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
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.
                                                      •   Ngozi Okonjo-Iweala, Board Chair (independent
•   To be determined                                      member)

Format                                                •   Sarah Goulding, Board Vice-Chair (independent
•   To be determined
                                                      •   Etleva Kadilli, Board alternate (UNICEF)
Gavi Board
                                                      •   Muhammad Pate, Board member (World Bank)
                                                      •   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
•   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)
                                                      •   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

                                                                                                             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)
•   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)
•   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)
•   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)
                                                        •   Shabir Madhi (South Africa)

    AND ALLOCATION                                      •   Peter McIntyre (New Zealand)

                                                        •   Ezzeddine Mohsni (Jordan)
     EXPERTS (SAGE) ON IMMUNIZATION                     •   Kim Mulholland (Australia)

                                                        •   Kathleen Neuzil (United States of America)
                                                        •   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)
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)
                                                       •   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)
•   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)
•   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.
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;
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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