COVAX: STRUCTURE AND PRINCIPLES 1 9 NOVEMBER 20209 NOVEMBER
ACCELERATOR ACCELERATOR )
ACT
PRINCIPLES STRUCTURE AND ( COVID-19 TOOLS OF THE ACCESS TO VACCINES PILLAR COVAX: THE COVAX: THE COVAX: STRUCTURE AND PRINCIPLES 2 : The work of the COVAX Facility is is Facility the COVAX of Disclaimer: The work complex of a range across being accomplished evolve continually that and variables matters on the pandemic becomes information more as a from contributions and involves available, a As individuals and organisations. number of including specific details this document, result, should be groups, various of on membership publication. of the date of as indicative as taken COVAX: STRUCTURE AND PRINCIPLES 3 7 7 7 7 7 7 7 5 5 5 8 8 8 8 8 6 6 6 6 6 6 6 9 9 9 9 11 11 10 10 10 10 10
Members Overview focus of Areas Decision-making principles Members Format Overview Objectives focus of Areas Decision-making principles Members Format Overview Objectives focus of Areas Decision-making principles Members Format Overview teams and RAG all SWAT for Objectives focus of Areas Decision-making principles Research and Development and Manufacturing and and Development Research Investment Committee (RDMIC) Investment
SWAT teams and Regulatory Advisory Group (RAG) Group Advisory Regulatory teams and SWAT
2.1 Areas of Inter-Organisational Coordination Inter-Organisational of 1.2 Areas COVAX Coordination Meeting (CCM) Meeting Coordination 1.1 COVAX Technical Review Group (TRG) Group Review 2.2 Technical 2.3 2. Workstream – Development and Manufacturing and Development – 2. Workstream 1. Cross-cutting What is this document? is What What is COVAX? is What Section 1: Overview of key bodies key of 1: Overview Section
Introduction CONTENTS COVAX: STRUCTURE AND PRINCIPLES 4 15 15 15 14 14 12 13 13 13 13 13 13 27 27 27 27 16 16 16 19 19 24 24 22 22 22 28 28 23 23 20 20 20 20 20
Objectives Office of the COVAX Facility the COVAX Office of Council Shareholders COVAX Group AMC Engagement COVAX Consensus Group COVAX (IPG) Group Product Independent (PRG) Group Reference Procurement Board Gavi Committee Decisions (MSDC) Market-Sensitive and Finance Committee (AFC) Audit Overview Members Format Overview Members vaccines on Covid-19 Group Working SAGE (JAT) Taskforce Allocation Joint (IAVG) Group Validation Allocation Independent Group Sub-Working Strategy Vaccine Group Sub-Working Policy Vaccine Group Sub-Working and Allocation Access Background Definitions Principles Governing principles Governing the COVAX for Interest of Conflicts managing Principles for and its Committees (CCM) Meeting Coordination WHO Strategic Advisory Group of Experts (SAGE) of Group Advisory WHO Strategic on Immunization Learning, Monitoring and Evaluation Monitoring and Learning, Policy and Allocation Working Groups Working and Allocation Policy 1. 2. 4.1 4.1 Country Readiness and Delivery (CRD) and Delivery Readiness Country 3.2 3.3 COVAX Facility COVAX 3.1 Allocation Mechanism Allocation 4.2 4.3 4. Workstream: Policy and Allocation Policy Workstream: 4. Scale at and Delivery Procurement – Workstream 3. Section 2 – Principles – 2 Section COVAX: STRUCTURE AND PRINCIPLES 5 WHAT IS THIS DOCUMENT WHAT outlines the current document The following guiding principles of and overall structure working involved the organisations between collaboration bodies Building on existing COVAX. in implementing to emerging and adapting possible, wherever to will continue structure this working needs, needed. as evolve Developing one or more safe and effective and effective safe one or more Developing complex the most is one of vaccines COVID-19 vaccine with past Unlike time. our challenges of and scaling up manufacturing development, candidates vaccine human trials for of completion with accelerated Even be done in parallel. must and the completion in manufacturing, investment safe are candidates vaccine trials to ensure of which supply is no scenario in there and effective, – demand will exceed 18 months next the over some trajectory, anticipated today’s although at within could become available candidates vaccine this time frame. equitable access: is a global solution for COVAX pooling of diversification, portfolio through and economies resources, financial and scientific and regional governments participating scale, of unsuccessful backing blocs can hedge the risk of with limited or no governments as just candidates, procurement bilateral ability to finance their own that vaccines to life-saving access can be assured been beyond their reach. have otherwise would
COVAX is the vaccines pillar of the ACT the ACT pillar of is the vaccines COVAX Epidemic co-led by the Coalition for Accelerator, the Vaccine Gavi, (CEPI), Innovations Preparedness (WHO). Health Organization and the World Alliance, the global of phase Its goal is to help end the acute access 2021 by providing pandemic by the end of and effective safe 2 billion doses of least to at in all vulnerable to the most vaccines COVID-19 If it succeeds in this goal, economies. participating and safe of allocation the appropriate through determined in phases vaccines doses of effective and by epidemiology and public health to slow save it could the pandemic, to stop ultimately the economic and transform lives millions of and individuals. governments of prospects Many leaders have called for a global solution a global solution called for have Many leaders a collaborative For this global issue. to address science to shared the best involves that endeavor, a pandemic possible time, in the shortest resolve, and territory on the region every involves that to COVID-19 the Access In response, planet. a groundbreaking – Accelerator (ACT) Tools development, to accelerate collaboration to COVID-19 and equitable access production was – and vaccines treatments diagnostics, in April 2020. launched Developing a vaccine against COVID-19 is one COVID-19 against a vaccine Developing The our time. challenges of pressing the most of the loss of caused already global pandemic has the lives and disrupted than one million lives more the tragic reducing as well As billions more. of the will prevent vaccines introducing life, loss of to the global dollars billions of of loss hundreds month. economy every WHAT IS COVAX WHAT
WHAT IS COVAX? WHAT INTRODUCTION: INTRODUCTION: COVAX: STRUCTURE AND PRINCIPLES 6
: Mesfin Teklu Teklu : Mesfin representative Civil society Committee) Rescue (International Tessema : Omar Abdi UNICEF representative and the Research : Chair of By invitation Investment and Manufacturing Development the Independent Chair of Committee (RDMIC), (IPG) Group Product : Jane Halton (Board Chair, CEPI); CEPI); Chair, : Jane Halton (Board Co-chairs Gavi) Chair, (Board Okonjo-Iweala Ngozi Institutional Berkley (Gavi); : Seth Leads Soumya (CEPI); Hatchett Richard (WHO) Swaminathan (Gavi); Nguyen : Aurélia leads Workstream (CEPI) Melanie Saville (WHO); O’Brien Kate : Roger partner representatives Industry International through selected Connor (GSK), Manufacturers Pharmaceutical of Federation Mahima Datla (IFPMA); & Associations through (Biological E. Limited), selected Manufacturers Vaccine Countries Developing (DCVMN) Network CCM acts as bridge and steering group and group bridge and steering as CCM acts and coordination for responsible is therefore COVAX. of driving the work bodies management builds on existing COVAX management. new than creating rather COVAX of decisions beyond the mandate For the broader or affect implicate may or that be must there the organisations, of work Boards. relevant from approval explicit within fully remains Financial accountability No decision can be organisation. each a decision contradict would that taken CEPI and of Boards by the respective by the be approved must exceptions Gavi; Board. organisation’s
Members • • • • • • • • • • •
Each partner must act with integrity to with integrity act partner must Each Interest Organisational aims. COVAX further be managed must Interest of and Conflicts degree with the highest transparently integrity. of Take responsibility for progress towards goals towards progress for responsibility Take Address bottlenecks as needed, including as bottlenecks Address management stakeholder high-level through Discuss major strategic questions questions Discuss major strategic Inform major workstream decisions major workstream Inform Ensure alignment between partners and the partners between alignment Ensure Accelerator wider ACT
Decision-making principles The CCM provides guidance across the various the various guidance across The CCM provides on the with a particular focus workstreams, COVAX and collaboration. interdependency of many areas Areas of focus of Areas Objectives Overview to meets body that The CCM is the high-level elements the different across efforts coordinate to the Access pillar of the vaccines COVAX, of The CCM is Accelerator. (ACT) Tools COVID-19 CEPI and Gavi, of Chairs by the Board chaired all three of leads and includes the institutional a link to the established providing organisations, to help It meets organisation. each of governance COVAX. issues across guide and resolve coordinate, 1.1 COVAX COORDINATION MEETING (CCM) COORDINATION COVAX 1.1 1. CROSS-CUTTING1. • • • • • •
OVERVIEWOF SECTION 1: SECTION 1: KEY BODIES COVAX: STRUCTURE AND PRINCIPLES 7 Monitoring of overall project progress and progress project overall Monitoring of issues. project escalated of resolution challenges, cross-portfolio of Identification and decisions. interdependencies Identify and address cross-portfolio challenges cross-portfolio and address Identify and interdependencies. candidate vaccine COVAX-funded of Definition portfolio enabling project and cross-cutting allocation investment composition, diversity, and risk. decisions on project for Recommendations and investment. selection prioritisation, for recommendations of Final endorsement projects. new for recommendations of Final endorsement reviews). gate (stage progression project of Development/endorsement overruns budget project for recommendations US$ 5 million or timeline delays than greater months. three than greater Drive portfolio strategy and investment and investment strategy portfolio Drive overall aligned with decision recommendations objectives. strategic COVAX composition, diversity, the target Define the of risk profile and allocation investment candidate vaccine COVAX-funded of portfolio enabling projects. and cross-cutting projects investment and selection project Recommend for – US$ 5 million than decisions greater gate stage selections, project new example, selections), down (+ reviews portfolio reviews, major change requests. COVAX-funded of progress overall Oversee cross-cutting and projects candidate vaccine enabling projects.
Areas of focus of Areas • • Objectives to: are the RDMIC of The principal objectives • • • • • • • • • • investment recommendations that the CEPI Board Board the CEPI that recommendations investment Committee) and Investment itsExecutive (through decision- for Accountability reviews/endorses. clearly remains requirements investor making and bodies. governance institutional respective with the
: Two hours hours : Two Length : Fortnightly (once every two weeks) two every (once : Fortnightly Frequency : Video/teleconference Forum COORDINATION AREAS OF INTER-ORGANISATIONAL AND MANUFACTURING INVESTMENT MANUFACTURING AND COMMITTEE (RDMIC) RESEARCH DEVELOPMENT AND
AND MANUFACTURING AND WORKSTREAM – DEVELOPMENT
The RDMIC provides portfolio strategy and strategy portfolio The RDMIC provides to rapidly recommendations decision investment COVID-19 and manufacture develop identify, scale to address can be deployed at that vaccines as The RDMIC operates global health needs. to make primarily group, advisory an expert The RDMIC also reviews non-COVAX-funded non-COVAX-funded The RDMIC also reviews and manufacturing development vaccine challenges, cross-portfolio to ensure projects and decisions can be surfaced interdependencies appropriately. and addressed Overview and and Development The Research Committee is a Investment Manufacturing expertise with industry multidisciplinary group under the funds of the allocations manages that Workstream and Manufacturing Development decision investment It provides COVAX. of of and progression selection for recommendations candidate vaccine COVAX-funded of the portfolio that enabling projects and cross-cutting projects R&D and manufacturing. vaccine accelerate
2.1 2.1 2. 2. The three lead COVAX organisations – CEPI, Gavi CEPI, Gavi – organisations COVAX lead The three closely on the following coordinate – and WHO mobilisation; and resource funding costing; issues: data; and liability; consolidated indemnification civil of engagement principles; Interest of Conflict (including regulatory (CSOs); organisations society end-to-end and guidance; preparedness safety) and deals with manufacturers. operationalisation; 1.2 1.2 Format • • • COVAX: STRUCTURE AND PRINCIPLES 8 Peter Paradiso (Independent Consultant) (Independent Paradiso Peter Group Review Technical Melanie Saville, Chair (CEPI) (CEPI) Advisor Strategic Debruyne, Luc Video/teleconference Forum: Weekly Frequency: hours Two Length: John Nkengasong (Africa Centres for Disease Disease for Centres (Africa Nkengasong John and Prevention) Control
The Technical Review Group (TRG) is a cross- (TRG) Group Review The Technical with group cutting, multidisciplinary advisory and research vaccine of in all areas expertise clinical including enabling sciences, development, affairs, regulatory manufacturing, development, is responsible The TRG public health and industry. support oversight, technical review, the overall for projects development vaccine of and steering and Manufacturing under the Development speed, the challenges of to meet Workstream scale. and manufacturing access Vaccine is supported by a project vaccine Each Project Leader; a Project composed of: Team and functional Manager; Contract Manager; clinical development, studies, in preclinical experts issues. and regulatory manufacturing TRG below), (objectives session” In an “open for recommendations provide members identify enabling projects; cross-cutting of formation and approve interdependencies; to challenges in order to address teams SWAT across R&D and manufacturing vaccine accelerate candidates. all vaccine TRG below), (objectives session” In a “closed provide Interest of with no Conflicts members specific vaccine of technical review extensive selection and recommend projects, development COVAX-funded of the portfolio of and progression to the RDMIC. candidates vaccine Extended members: Format 2.2 TECHNICAL REVIEW GROUP (TRG) Overview • • • • • • • Kiran Mazumdar-Shaw (Biocon) Mazumdar-Shaw Kiran Foundation) Mundel (Bill & Melinda Gates Trevor Michael King (Independent Consultant, King (Independent Michael Merck/MSD) retired Subhash Kapre (Inventprise) Kapre Subhash Seth Berkley (Gavi) Seth (CEPI) Hatchett Richard Chris Viehbacher, Chair (Gurnet Point Capital) Point Chair (Gurnet Chris Viehbacher, Technical aspects of proposals to the RDMIC to the proposals of aspects Technical reviewed and objectively will be actively (TRG) Group Review the Technical through prior to RDMIC. Voting requires quorum of at least two thirds thirds two least at quorum of requires Voting and includes the members RDIMC core of the of delegate) (or the CEO RDMIC Chair and funds. allocating institution Decisions are driven by consensus. If by consensus. driven Decisions are will be decision be reached, consensus cannot Chair. by the RDMIC made All members must act with integrity and and integrity with act must All members in accordance all times, at impartiality the COVAX of with policies or principles Workstream. and Manufacturing Development
Core (voting) members: (voting) Core Extended members – including the Chair of including the Chair of – Extended members and external Group Review the Technical also attend – appropriate as advisors, strategic R&D and expert to contribute RDMIC meetings Extended members perspectives. manufacturing members. non-voting are The RDMIC is comprised of the CEPI CEO, Gavi Gavi the CEPI CEO, The RDMIC is comprised of President Foundation Bill & Melinda Gates CEO, (ex-) R&D experts, industry Global Health, (ex-) of active current experts, manufacturing industry and senior global leaders (non-vaccine) industry (including a CEPI Board public health leaders to and is accountable linkages) to ensure member, the CEPI Board. Members Decision-making principles are: RDMIC for principles Decision-making • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 9 Derrick Sim (Gavi) Derrick Sim (Gavi) – (Médecins Sans Frontières Grais Rebecca MSF) Foundation) Emilio Emini (Bill & Melinda Gates (CEPI) Kristiansen Paul Technical review of SWAT teams’ inputs (cross- teams’ SWAT of review Technical to include additional cutting, non-proprietary), with express members) (extended experts the Chair. permission of and do observers are Extended members Conflicts avoid (to hold decision rights not Interest). of thirds two least at quorum of requires Voting and includes the TRG members core TRG of If by consensus. driven Decisions are Chair. decision will be be reached, consensus cannot Chair. by the TRG made Chair (CEPI) Melanie Saville, Moorthy (WHO) Vasee Technical review and recommendations for for and recommendations review Technical and deliverables creation, group working and timelines; and deliverables teams’ SWAT of Review bottlenecks addressing for recommendations vaccine across and common challenges projects. development and with integrity act must All members in accordance all times, impartiality at the COVAX with policies or principles of Workstream. and Manufacturing Development plans to be development of review Technical members. TRG by non-conflicted conducted escalation of budget overruns greater than than greater overruns budget of escalation than greater or timeline delays US$ 5 million to RDMIC. months three
Members members Core • • • • Decision-making principles are: the TRG Decision-making principles for • • • • • • • • • TRG open sessions TRG Review of budget overruns or project timeline timeline or project overruns budget of Review or approval for and recommendations delays, Recommendations based on review of of on review based Recommendations and technical, financial, operational scientific, and Teams; Vaccine from risk reports Stage gate recommendations for projects projects for recommendations gate Stage milestones; of on review based Provide technical support and guidance to technical Provide Advisory and the Regulatory teams SWAT challenges on project-agnostic (RAG) Group and issues. Approve working group creation, deliverables deliverables creation, group working Approve and and timelines; Provide end-to-end oversight of SWAT team SWAT of oversight end-to-end Provide and monitoring to include review execution, and milestones progress, teams’ SWAT of challenges; Make stage gate recommendations to recommendations gate stage Make the RDMIC. Raise challenges or issues from Vaccine Teams Teams Vaccine Raise challenges or issues from and teams; by SWAT to be addressed Support and provide guidance to Vaccine guidance to Vaccine Support and provide technical and scientific, through Teams and risks; projects of review operational Recommend project selection based on based selection project Recommend less decisions and investment technical review selections, project new than US$ 5 million (e.g. change requests); reviews, gate stage in projects deviations significant Review or and approve or budget) time (scope, to RDMIC; escalate Provide end-to-end oversight of project project of oversight end-to-end Provide and monitoring review to include execution, milestones progress, Teams’ Vaccine of and budgets;
Areas of focus of Areas closed sessions TRG The principal objectives of TRG open sessions TRG of The principal objectives to: are Objectives closed sessions TRG of objectives The principal to: are • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 10 Clinical science elements for clinical trials, clinical trials, for Clinical science elements adaptive definitions, case endpoint such as and protection of correlates trial designs, options. optimisation Act as an open source of information for for information of an open source as Act in definition (see Teams Vaccine COVAX vaccine and COVID-19 above) section, TRG broadly; more developers and comparability harmonisation Promote and projects; across stakeholders different Bring together in the players other with and coordinate to maximise efforts. ecosystem by readiness Clinical and operational and supporting: clinical trial sites in low- analyses; landscape middle-income economies; or networks. databases of and creation considerations safety vaccine Addressing definitions, including case during development, clinical trials and vaccine planning towards surveillance. safety Focus on resolving common technical cross- on resolving Focus speed; and challenges at questions project
Areas of focus of Areas SWAT and Operations Clinical Development • Objectives for all SWAT teams and RAG teams all SWAT for Objectives • • • • • • technical issues and challenges common common challenges and issues technical development vaccine all COVID-19 across vaccine and accelerate promote to projects represent members core SWAT development. development vaccine in the stakeholders diverse in enabling expertise providing ecosystem, and operations; development clinical sciences; Regulatory The to scale. and manufacturing regulators composed of (RAG), Group Advisory to resolve works all global regions, representing to pathways harmonised guidance for and provide to in order science challenges, regulatory address development. vaccine accelerate Clinical Development (1) teams include: SWAT and (3) Sciences; (2) Enabling and Operations; guidance provides The RAG Manufacturing. science challenges and regulatory for by all three escalated interdependencies disciplines. SWAT SWAT TEAMS ADVISORY REGULATORY AND SWAT GROUP (RAG) : Weekly Frequency : One hour Length : Video/teleconference : Video/teleconference Forum Ivana Knezevic (WHO) Knezevic Ivana Emer Cooke (WHO) Emer Cooke David Robinson (Bill & Melinda Gates Foundation) (Bill & Melinda Gates Robinson David Foundation) (Bill & Melinda Gates Dull Peter Nicolas Havelange (CEPI) Havelange Nicolas Jean Lang (IFPMA) (CEPI) Jim Robinson Consultant, King (Independent Michael MSF/Merck) retired Adriansjah Azhari (DCVMN) Adriansjah Ricardo Palacios (DCVMN) Palacios Ricardo Meng (DCVMN) Weining Norio Tamura (IFPMA) Norio Tamura Steve Lockhart (IFPMA) Lockhart Steve Gabrielle Breugelmans (CEPI) Gabrielle Breugelmans Ingrid Kromann (CEPI) Ingrid Kromann (CEPI) Nick Jackson Svein Rune Andersen (CEPI) Andersen Rune Svein Jakob Cramer (CEPI) Cramer Jakob (CEPI) Yeskey Debra
Overview Teams) to Advance Work (Support SWAT on resolving focused experts of groups are 2.3 Format Additional members included in TRG open sessions included in TRG members Additional • • • • • • • • • • • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 11 Paul Kristiansen, co-lead (CEPI) co-lead Kristiansen, Paul (WHO) co-lead Knezevic, Ivana (IFPMA) Jenny Hendriks Foundation) (Bill & Melinda Gates Markar Karen Robert Chen (Brighton Collaboration) Chen (Brighton Robert Khan Foundation) (Aga Kumar Farah (CEPI) Gabrielle Breugelmans (CEPI) Yeskey Debra (CEPI) Andersen Rune Svein (WHO) Restrepo Ana Maria Henao Hygiene of School Smith (London Peter Medicine) & Tropical (PATH) Kaslow David (Gavi) Sophie Mathewson Trust) (Wellcome Charlie Weller Jakob Cramer, co-lead (CEPI) co-lead Cramer, Jakob Gates (Bill & Melinda Dull, co-lead Peter Foundation) Health, of Institutes (National Hilary Marston USA) (IFPMA) Roman François (IFPMA) Lockhart Stephen (DCVMN) Palacios Ricardo
Enabling Sciences SWAT: Core members Core Enabling Sciences SWAT: • • • • Core members for each SWAT team and the team and the SWAT each for members Core deliverables questions, key and revise define RAG activities drive needed and as and timelines members Core deliverables. to defined according additional with decision-making, with involved are or core workshops groups, working joining experts hoc basis. on an ad team meetings SWAT: and Operations Clinical Development members Core • • • • • • • • • • Members • • • • • • If consensus cannot be reached on a topic be reached If consensus cannot the SWAT is required, expertise and further the decision to the can escalate team co-leads (TRG). Group Review Technical SWAT team co-leads develop and assess work work and assess develop team co-leads SWAT description. per deliverables as packages, Core team experts are involved with decision- involved are team experts Core expertise. of making in their area Guidance for regulatory science challenges regulatory Guidance for towards team activities, to SWAT related processes and streamlined harmonisation on is focused Membership feasible. where from authorities regulatory of representatives the world. around Support for batch release assays (including assays release batch Support for mutual requirements); assay potency timely national for the process of recognition additional support for and release; batch analytical capacity. Supply chain strategy to include securing Supply chain strategy labelling and mutually agreed materials, raw partners. with COVAX alignment Drug product and drug substance strategy strategy substance and drug Drug product scale-up and for identification and capacity products. scale-out of Guidance on animal model evaluation for for model evaluation Guidance on animal (VMED) disease enhanced vaccine-mediated protection. of and correlates Animal model testing network to ensure to ensure network Animal model testing animal models appropriate of development candidates. vaccine of testing and high-quality development through standardisation Assay standard; antibody an international of clinical for capacity laboratory centralised of performance type and defining trials; regulatory addressing and assays; diagnostic challenges in standardisation.
Decision-making principles Regulatory Advisory Group (RAG) Group Advisory Regulatory Manufacturing SWAT Manufacturing Enabling SciencesEnabling SWAT • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 12
: Weekly, plus monthly topic- plus monthly Weekly, : Frequency members with extended specific workshops and developers – One hour; workshops – : Weekly Length hours to four two Tiziana Scarna, Observer (Gavi) Scarna, Observer Tiziana : Video/teleconference Forum : Biweekly Frequency hours : One to one-and-a-half Length : Video/teleconference Forum : Monthly Frequency hours : Two Length : Video/teleconference Forum Kristy Tomas (Therapeutic Goods (Therapeutic Tomas Kristy Australia) TGA, – Administration the for Directorate (European Mallet Laurent EDQM) – Medicines Quality of – Sciences Authority Ling Choong (Health May Singapore) HSA, – and Drugs Authority (Food Mimi Darko Ghana) FDA, of Administration (National Aprea Patricia ANMAT, – Devices and Medical Foods Drugs, Argentina) Health (National Souza Sobral Regina Flavia Brazil) ANVISA, – Agency Surveillance Australia) (TGA, Weissman Michael and Medical (Pharmaceuticals Yasuhiro Araki Japan) PMDA, – Agency Devices Dean Smith (Health Canada) Smith (Health Dean
Format teams core SWAT RAG groups Working • • • • • • • • • • • • • • • • • • • Marion Gruber (Food and Drug Administration and Drug Administration Marion Gruber (Food USA) FDA, – Marco Cavaleri (European Medicines Agency – – Medicines Agency (European Cavaleri Marco EMA) Emer Cooke, co-lead (WHO) co-lead Emer Cooke, Debra Yeskey, co-lead (CEPI) co-lead Yeskey, Debra (CEPI) co-lead Andersen, Rune Svein Svein Rune Andersen (CEPI) Andersen Rune Svein (Gavi) Dominique Maugeais Debra Yeskey (CEPI) Yeskey Debra Diane Wilkinson (Vaccines Europe) Diane Wilkinson (Vaccines (CEPI) Jim Robinson Carmen Rodriguez Hernandez (WHO) Hernandez Carmen Rodriguez Mike Thein (IFPMA) Thein Mike Azhari (DCVMN) Adriansjah Alain Alsalhani (Médecins Sans Frontières – – Alain Alsalhani (Médecins Sans Frontières MSF) David Robinson, co-lead (Bill & Melinda Gates (Bill & Melinda Gates co-lead Robinson, David Foundation) Nicolas Havelange, co-lead (CEPI) co-lead Havelange, Nicolas Ingrid Kromann, co-lead (CEPI) co-lead Ingrid Kromann, Sheetal Sharma (Safari Doctors) (Safari Sheetal Sharma Debra Yeskey (CEPI) Yeskey Debra (CEPI) Andersen Rune Svein Valentina Bernasconi (CEPI) Bernasconi Valentina Carolyn Clark (CEPI) Carolyn (CEPI) William Dowling Janet Lathey (National Institutes of Health, of Institutes (National Lathey Janet USA)
Regulatory Advisory Group (RAG): Core members Core (RAG): Group Advisory Regulatory Manufacturing SWAT: Core members Core SWAT: Manufacturing • • • • • • • • • • • • • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 13 To be determined – potentially, Chair and potentially, – be determined To of co-Chairs Board; the Gavi Vice Chair of Council; co-Chairs Shareholders the COVAX in an – and Group; the AMC Engagement of the three – capacity non-voting, ex-officio, the pillar of the vaccines of leads institutional COVAX). (i.e. Accelerator ACT To be determined – potentially implementing implementing potentially – be determined To in parties engaged and other donors countries, COVAX the Gavi of the financing and operation they choose to invite and participants AMC, be determined To *Provisionally approved by the Gavi Board
Members Members Format Consensus Group COVAX Overview will be established Consensus Group* The COVAX the COVAX of operation to support effective decision-making consensus-based through Facility particularly in bodies, governing various between arise. may disagreement where areas • The COVAX Advance Market Commitment (AMC) (AMC) Commitment Market Advance The COVAX AMC in the will represent Group* Engagement of Membership the Facility. of the governance to will be open Group the AMC Engagement economies, implementing from representatives in the financing parties engaged and other donors the Facility. of the AMC portion of and operation supporting with the aim of will convene The group and providing exchange information real-time to the Office of and advice guidance strategic of aspects on the operational Facility the COVAX to it relates particularly as Facility, the COVAX Within in AMC-eligible countries. implementation will convene Group this body, an AMC Stakeholders procurement AMC donors; from representatives and PAHO; UNICEF and as such organisations development multilateral of representatives financing in the involved banks or regional banks in the It will discuss its investments the AMC. of financing; and receive additional for AMC; options against achieved on progress specific reporting the AMC. of the objectives • • COVAX AMC Engagement Group Engagement AMC COVAX Overview
be determined To *Provisionally approved by the Gavi Board To be determined – potentially all SFPs and all SFPs potentially – be determined To they choose to invite participants Housed within the Gavi Secretariat Housed within the Gavi Aurélia Nguyen, Gavi Nguyen, Gavi Aurélia WORKSTREAM – PROCUREMENT SCALE AT DELIVERY AND
Format Members Members Overview represent Council will* Shareholders The COVAX in the governance (SFPs) participants self-financing the COVAX of Membership Facility. the COVAX of in will be open to all SFPs Council Shareholders SFPs The Council will convene Facility. the COVAX information supporting real-time with the aim of guidance and strategic and providing exchange on Facility the COVAX to the Office of advice Facility. the COVAX of aspects the operational a will establish the Council that It is expected and Committee to prepare smaller Executive Committee will The Executive guide its discussions. the Council and other link between a clear provide the consolidated to ensure structures governance in the Council is considered of and views advice deliberations. relevant COVAX Shareholders Council Shareholders COVAX Format Managing Director Managing As the legal administrator of the COVAX Facility, Facility, the COVAX of administrator the legal As the COVAX the Office established of has Gavi a to ensure Secretariat Gavi within the Facility to support Facility team is available dedicated to Gavi’s disruption and to mitigate operations, work. core Overview Office of the COVAX Facility the COVAX Office of 3.1 COVAX FACILITY COVAX 3.1 3. 3. • • • • COVAX: STRUCTURE AND PRINCIPLES 14 : Video/teleconference Forum : Weekly Frequency hours : Two Length Marie-Paule Kieny, Chair (Inserm) Kieny, Marie-Paule (Emory University) Ahmed Rafi Ghana) (FDA, Delese Mimi Darko consultant) Michel de Wilde (independent consultant) Jill Gilmour (independent University) Jaap Goudsmit (Harvard Paulo) Sao of (University Kalil (George) Jorge Nocht (Bernhard César Muñoz-Fontela Medicine) Tropical for Institute Research Connie Schmaljohn (NIAID Integrated Facility) (Doherty Institute) Subbarao Kanta
Procurement Reference Group (PRG) Group Reference Procurement Overview been selected have candidates Once vaccine by informed by the Facility, to be funded the IPG, the Procurement of recommendations be responsible will then (PRG) Group Reference to the Facility advice independent providing for COVAX risk managed an appropriately to ensure perspective a commercial from portfolio probability candidates’ considering vaccine supply delivery. success and timeline for of the of Guidance will pertain to the implementation and key strategy, procurement vaccine COVID-19 purchase advance proposed business terms of these of with the manufacturers commitments volumes; terms include: Key candidates. vaccine commitment firm order of pricing; proportion trigger for metrics; performance options; vis-à-vis individual managing for remedies call; and recourse portfolio. COVAX the overall as well supplier risk, as and it will not advisory, is primarily The PRG on Based powers. decision-making have the Office the PRG, from recommendations Format • • • Members • • • • • • • • • •
Engage with other bodies including, but not bodies including, but not with other Engage Working SAGE PRG, the RDMIC, limited to, etc. Vaccines, on COVID-19 Group Regularly review the SARS-CoV-2 vaccine vaccine the SARS-CoV-2 review Regularly portfolio, Facility pipeline and the COVAX related updates consideration taking into and manufacturing to clinical development, the pipeline on both advice supply, and provide to the Office of portfolio Facility and COVAX Board; and the Gavi Facility the COVAX Provide guidance and independent technical and independent guidance Provide Facility the COVAX to the Office of advice to be candidates of the selection to inform deal-making by the COVAX prioritised for by the considered and eventually Facility, MSDC; Regularly review data and information relating relating and information data review Regularly such as example, (for candidates to vaccine CEPI WHO, manufacturers, from received that and the RDMIC Secretariat); *Provisionally approved by the Gavi Board be determined To
The IPG will: The IPG is primarily advisory, and it does not and it does not The IPG is primarily advisory, the IPG The aim of decision-making powers. have a recommendation is to make process review on vaccine Facility the COVAX to the Office of balance. and portfolio prioritisation candidate has Facility the COVAX Once the Office of taking the ensuing deal terms, into negotiated from technical advice independent consideration the deal (PRG), Group Reference the Procurement by the Market-Sensitive then be considered would Decisions Committee (MSDC). and consider any implications for the COVAX the COVAX for implications and consider any portfolio. Facility The Independent Product Group (IPG) is is (IPG) Group Product The Independent to the recommendations established to make on the inclusion of Facility the COVAX Office of review regularly Facility; in the COVAX vaccines review balance; for portfolio Facility the COVAX doses; of on timing and availability updates Overview Independent Product Group (IPG) Group Product Independent Format • • • • • COVAX: STRUCTURE AND PRINCIPLES 15 Carmen Coles Tull, Board alternate (United alternate Board Carmen Coles Tull, America) of States society (Civil member Dia, Board Maty organisations) and member; Audit Board Sidwell, David Finance Committee Chair (independent member) and member; Programme Board Helen Rees, member) Committee Chair (independent Policy Gavi) member (CEO, Berkley, non-voting Seth the COVAX from representatives Three Council Shareholders Ngozi Okonjo-Iweala, Board Chair (independent (independent Chair Board Okonjo-Iweala, Ngozi member) (independent Vice-Chair Board Goulding, Sarah member) (UNICEF) alternate Board Kadilli, Etleva Bank) (World member Board Pate, Muhammad (Bill & Melinda alternate Board Violaine Mitchell, Foundation) Gates member (Ethiopia) Board Lia Tadesse, member (Armenia) Board Torosyan, Arsen member (United Board Daniel Graymore, Kingdom) member (European Board Jan Paehler, Commission) Membership of MSDC with respect to COVAX- MSDC with respect of Membership of the exception with transactions; related Shareholders the COVAX of representatives Board be Gavi must Council, all MSDC members members. Board or alternate members
Audit and Finance Committee (AFC) Finance and Committee Audit Overview is and Finance Committee (AFC) The Audit to support the Board established by the Gavi * Members* • • • • • • • • • • • • • • • for transactions related to the COVAX Facility, Facility, COVAX to the related transactions for AMC. COVAX the Gavi for including The list of current Gavi Board members is members Board Gavi current of The list here. website on the Gavi available provide strategic oversight of the COVID-19 the COVID-19 of oversight strategic provide implementation, and effective programme engagement. including country receive updates from relevant Board Board relevant from updates receive Finance and Audit Committees (e.g. and matters; Facility on COVAX Committee) receive regular reports from the Office of the the Office of from reports regular receive and progress on operational Facility COVAX performance; provide strategic direction and policy-making; and direction strategic provide take responsibility to ensure that the Gavi the Gavi that to ensure responsibility take mandate within the operates Secretariat to it; granted To be determined To To be determined To
The Market-Sensitive Decisions Committee The Market-Sensitive to Board by the Gavi is established (MSDC) decisions which are and make oversight provide With Gavi sensitive. and/or commercially market the COVAX of the administrator established as this function the MSDC will undertake Facility, Overview Market-Sensitive Decisions Committee Decisions Committee Market-Sensitive (MSDC) Members In this role, it will: In this role, Overview Alliance is the Vaccine Gavi, of The Board the Gavi of the role overseeing for responsible and Alliance in the Facility, and the Secretariat decisions and for responsibility ultimate will have Facility. the COVAX of implementation effective Gavi Board Gavi Format Members of the COVAX Facility will advance negotiations negotiations advance will Facility COVAX the of and bring recommendations with manufacturers approval. MSDC for terms to the on final deal • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 16 Benjamin Schreiber, Co-Lead (UNICEF) Co-Lead Benjamin Schreiber, (WHO) Emiroglu Nedret Shoshanna Goldin (WHO) (Dalberg) Sagna Patrick Ann Lindstrand, Co-Lead (WHO) Co-Lead Ann Lindstrand, (WHO) Ann Moen, Co-Lead
Members Members Group Working Coordination • • • • Overview (CRD) and Delivery Readiness The Country and Gavi, UNICEF is led by WHO, workstream and donor agencies and it includes implementing and the global at together working and partners and disseminate (1) develop to: levels regional trainings, guidance, goods (e.g. global adaptable (2) support and materials); advocacy tools, for and economies to prepare all countries high and to achieve introduction vaccine COVID-19 uptake. and acceptance a is composed of The CRD workstream oversight has that group working coordination (1) groups: sub-working other seven of (2) and training; advocacy communications, (4) introduction; and monitoring; (3) vaccine data (6) demand; (5) supply and logistics; vaccination CRD working to scale. and (7) innovation costing; the ACT closely across collaborate groups a cohesive and beyond to promote Accelerator for readiness vaccine to COVID-19 approach introduction and deployment. technical will develop The CRD workstream building of capacity and support resources introduction. vaccine COVID-19 for countries a country include: deliverables Workstream tool and dashboard; assessment readiness Plan; Vaccine Deployment a National guidance for a range technical guidance across adaptable chain and supply (e.g. areas programmatic of and community generation demand logistics, training and monitoring); data engagement, materials; communications/advocacy packages; monitoring for indicators and recommended and use. preparedness • • 3.2 COUNTRY3.2 READINESS (CRD) DELIVERY AND alternate Board Vilasanjuan, Rafael organisations) society (Civil Committee delegate Morrow, Tom (United Kingdom) Gianmarco Cocozza, Committee delegate Committee delegate Cocozza, Gianmarco (Italy) alternate Board Carmen Coles Tull, America) of (United States Andreas Karlberg Pettersen, Committee Pettersen, Karlberg Andreas (Norway) delegate Emmanuel Maina Djoulde, Committee delegate Committee delegate Emmanuel Maina Djoulde, (Cameroon) Etleva Kadilli, Board alternate (UNICEF) alternate Board Kadilli, Etleva alternate Board Agyeman-Manu, Kwaku (Ghana) Committee delegate Beniamin Carcani, Bank) (World Teresa Ressel, Board member Board Ressel, Teresa member) (independent David Sidwell, Chair; Board member Chair; Board Sidwell, David member) (independent monitoring risk to Gavi and the COVAX Facility. and the COVAX monitoring risk to Gavi ensuring the COVAX Facility is properly is properly Facility ensuring the COVAX Financial Report; Annual in Gavi’s represented and ensuring funding availability for COVAX Facility Facility COVAX for availability ensuring funding the financial of review including operations, transactions; Facility-related of implications
Members With respect to the COVAX Facility, the AFC will will the AFC Facility, the COVAX to With respect for: be responsible Board in fulfilling its oversight responsibilities in in responsibilities its oversight in fulfilling Board organisation’s the of manner in respect a timely framework, risk and control management; financial and audit; and external internal including good of standards to appropriate adherence will undertake The AFC and ethics. practices the legal as role to Gavi’s in relation this function Facility. COVAX the of administrator • • • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 17 Lora Shrimp (JSI) Lora Bon (UNICEF ESARO) Helena Ballester Navqi Naureen Emily Ramos (UNICEF) Jason Mwenda Mathiu (WHO) Mathiu Mwenda Jason (CDC) Apophia Namageyo Mehl (WHO) Livingston Garrett (WHO) Thiyagarajan Amuthavalli Jotheeswaran (UNICEF) Co-Lead Diane Summers, (GAVI) Co-Lead Susan Mackay, (UNICEF) Corbin Kappler Lisa Menning (WHO) (CDC) Abad Neetu James Angus Thomson(UNICEF) (JSI) Bagshaw Kate Marta Gacic-Dobo, Lead (WHO) Lead Marta Gacic-Dobo, Hope Johnson (Gavi) (Gavi) Craw Laura Diallo (UNICEF) S. Mamadou Foundation)) (Bill & Melinda Gates Ryman Tove (WHO) Pastore Roberta (WHO) Jorgensen Pernille (WHO) Mark Katz (WHO) Martha Velandia (WHO) Jan Grevendonk (WHO) Danovaro Carolina Carla Toko (VillageReach) (VillageReach) Toko Carla
Sub-working group: Demand group: Sub-working • • • • • • • • • • • • • • • Sub-working group: Data and Monitoring Data group: Sub-working • • • • • • • • • • • • Diane Scott (BMGF) Diane Scott Denise Traicoff (CDC) Denise Traicoff Jhilmil Bahl (WHO) (WHO) Elmaghraby Tamer Katja Schemionek (Gavi) Schemionek Katja Shushan Mebrahtu (UNICEF) Shushan Mebrahtu (PAHO) Alvarez Alba Maria Ropero Lisa Menning (WHO) Mindy Frost (WHO) Mindy Frost (WHO) Vicky Houssiere Shoshanna Goldin, Lead (WHO) Shoshanna Goldin, Lead Sulzhan Bali (WB) Sulzhan Bali (WB) Clark (IFRC) Kathy Kent Ranson (World Bank) Ranson (World Kent Ulla Griffin (UNICEF) (CEPI) Jim Robinson Diana Chang-Blanc (WHO) Marta Gacic-Dobo (WHO) Marta Gacic-Dobo (UNICEF) Diane Summers Adama Sawadogo (UNICEF) Sawadogo Adama Alba Maria Ropero (PAHO) Alba Maria Ropero Oleg Benes (WHO) Antoinette Ba (UNICEF) Antoinette Sunil Bahl (WHO) (UNICEF) Daniel Ngemra Helen Matzger (Bill & Melinda Gates Foundation) Foundation) Gates (Bill & Melinda Helen Matzger Zeenat Patel (Gavi) Patel Zeenat (Gavi) Jonquieres de Alex
Communications, group: Sub-working Training and Advocacy • • • • • • • • • • • • • • • • • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 18 Hussein Kamara (UNICEF) Hussein Kamara (UNICEF) Gonzalez Cases Leon (WHO) Lead Diana Chang Blanc, Olga Kosyak (UNICEF) Olga Kosyak (UNICEF) Ziraguma Tom (UNICEF) Modibo Dicko Hamadou Amany Ghoniem (WHO) Daniel Bridgen (WHO) (UNICEF) Zanardi Michael (WHO) Nadia Teleb (JSI) Prosser Wendy Reach) (Village Jessica Crawford Muhia (UNICEF) David Andisheh Ghazieh (UNICEF) Silvia Uneddu (UNICEF) Sonia Freitas (UNICEF) Sonia Freitas (UNICEF) Isabelle Cantin Sanusi (UNICEF) Olayinka (UNICEF) Hailu Kenea Joselito Nuguid (UNICEF) Maiola (UNICEF) Anne-Laure (UNICEF) Jose Medina Valle (UNICEF) Panadero Pablo (UNICEF) Olamide Folorunso Jean-Cedric Meeus (UNICEF) (UNICEF) Ocran Samuel Kweku (UNICEF) Kavaliova Sviatlana Zhang Guomin (CDC China) (CDC Guomin Zhang
Sub-working group: Vaccine Introduction Vaccine group: Sub-working • • • • • • • • • • • • • • • • • • • • • • • • • • • • Dorcas Noertoft (UNICEF) Noertoft Dorcas (WHO) Abdulhady Sarah Morio, Matt (PATH) Matt Morio, Kelly Hamblin (BMGF) Kelly (UNICEF) Aung Khin Devi Nora Rodriguez (PAHO) Rodriguez Nora Mike Brison (Gavi) Mike (Gavi) Luthra Karuna Chandrasegarar Soloman (UNICEF) Chandrasegarar Srihari Dutta (UNICEF) Musa (WHO) Nasrin Thomas Sorensen (UNICEF) Sorensen Thomas Oleg Benes (WHO) (UNICEF) Oweg Lennox Dereje Haile (UNICEF) Dereje Maricel Castro (WHO) Maricel Castro (UNICEF) Ganivet Serge Claude Mangobo (WHO) Claude Michelle Seidel (UNICEF) (UNICEF) Gaparayi Patrick Kone Souleymane, Co-Lead (WHO) Co-Lead Souleymane, Kone Adama Sawadogo, Co-Lead (UNICEF) Co-Lead Sawadogo, Adama (Gavi) Co-Lead Sagar, Karan Gwendolyn Eamer (IFRC) Eamer (IFRC) Gwendolyn Vision) (World Kanwagi Robert Kathleen Clark (IFRC) Clark (IFRC) Kathleen Matthew Steele (BMGF) Steele Matthew (BMGF) Ohail Agha
Sub-working group: Supply and Logistics group: Sub-working • • • • • • • • • • • • • • • • • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 19 A holistic theory of change that documents documents that change theory of A holistic and assumptions; risks results, intended key will that Indicators Performance Key of A set entire the across be used to monitor results to impact; inputs through chain, from results results compiles key that A monitoring report and learning; beginning approach, evaluation A multi-stage assessment, and baseline with an evaluability example. for Anne Cronin (Gavi) Anne Cronin (Gavi) Simon Allen (Thinkwell) Boonstoppel Laura : Video/teleconference Forum : Varied Frequency : Varied Length Marcia Attaran (UNICEF) Attaran Marcia
This learning, monitoring and evaluation work will work This learning, monitoring and evaluation stakeholders COVAX of range a broad engage (gathering approach and employ a mixed-methods and inputs), data and quantitative qualitative both documents, existing building on and making use of inputs Key possible. where tools and processes alignment will be critical to ensure partners from pillar. the COVAX across these efforts throughout Format LEARNING,3.3 MONITORING EVALUATION AND Objectives It ambitious goals and objectives. has COVAX working of ways new many challenges, presents As involved. all stakeholders and opportunities for learning, to ensure desire is a strong such, there of early stages from monitoring and evaluation to its eventual pillar through the COVAX design of trying to of while balancing the realities results during a pandemic. impact to have fast move being finalised is still approach Although the overall the following stakeholders, with key in consultation in consideration: currently are components • • • • • • • • • • • Alex Adjagba (UNICEF) Adjagba Alex Nathalie Vande Maele (WHO) (WHO) Maele Vande Nathalie Karene Yeung (WHO) Yeung Karene Hutubessy (WHO) Raymond Allison Portnoy (Harvard University) (Harvard Allison Portnoy Logan Brenzel (BMGF) Brenzel Logan University) (Harvard Resch Stephen Ulla Griffin, Lead (UNICEF) Ulla Griffin, Lead Jason Mathiu (WHO) (WHO) Mathiu Jason Eltayeb Elfakki (WHO) Elfakki Eltayeb Emily Nickels/Kendall Krause (Bill & Melinda Krause Emily Nickels/Kendall Foundation) Gates Reena Doshi (CDC) Reena Momeni (UNICEF) Yalda Stephen Sosler (Gavi) Sosler (Gavi) Stephen Ahmadu Yakubu (UNICEF) (UNICEF) Yakubu Ahmadu Anissa Sidibe (Gavi) Ado Bwaka (WHO) (WHO) Bwaka Ado Liudmila Mosina (WHO) Ba (UNICEF) Antoinette Christoph Steffen (WHO) Steffen Christoph Louise Henaff (WHO) Henaff Louise Hyde (CDC) Terri Nadia Teleb (WHO) (WHO) Teleb Nadia Nathalie Chenavard (WHO) Chenavard Nathalie (WHO) Dassanayake Hermanthi Ioana Ghiga (WHO) (WHO) Ioana Ghiga Alejandro Ramirez Gonzalez (WHO) (WHO) Gonzalez Ramirez Alejandro (WHO) Gurung Santosh
Sub-working group: Costing group: Sub-working • • • • • • • • • • • • • • • • • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 20 Peter McIntyre (New Zealand) (New McIntyre Peter (Jordan) Mohsni Ezzeddine Kim Mulholland (Australia) America) of Neuzil (United States Kathleen Hanna Nohnyek (Finland) America) of States (United Olayinka, Folake (United Kingdom) J. Pollard Andrew (Bangladesh) Qadri Firdausi Shabir Madhi (South Africa) (South Madhi Shabir
SAGE Working Group on Covid-19 Covid-19 on Group Working SAGE vaccines Overview evidence-based provide Groups Working SAGE recommendations for and options information options the various of with implications together public forum. in an open to be discussed by SAGE the WHO support of with Groups, Working systematic or coordinate, perform Secretariat analysis of such as the evidence of assessment safety, effectiveness, efficacy, addressing data immunisation of and economic aspects feasibility, by the developed questions policy to address appropriate to propose in order Group Working to SAGE. policy recommendations vaccine established the Working SAGE In June 2020, an open following vaccines on COVID-19 Group April 2020 and issued on 24 nominations call for nominations In total, 102 2020. closed on 11 May received. were WHO to advise is requested Group This Working initially on the use of and its States Member as by updates followed vaccines, pre-licensed use becomes on product information additional up this group setting The timeliness of available. with approach a coordinated ensured has (R&D) and Development Research the vaccine timelines to accelerate community, in order evidence- to make and maximise global efforts a use of the best policy decisions for informed a goal of The ultimate COVID-19. against vaccine the contain is to rapidly COVID-19 against vaccine systems, health care protect lives, save pandemic, global economies. and restore • • • • • • • • •
Jaleela Jawad (Bahrain) Jaleela Jawad (Canada) Noni MacDonald Ilesh Jani (Mozambique) Kari Johansen, SAGE Vice-Chair (Sweden) Johansen, SAGE Kari (India) Aggarwal Rakesh Alejandro Cravioto, SAGE Chair (Mexico) SAGE Cravioto, Alejandro WHO STRATEGIC ADVISORY GROUP OF WHO STRATEGIC EXPERTS (SAGE) ON IMMUNIZATION
AND ALLOCATION AND WORKSTREAM: POLICY
Members SAGE comprises 15 independent experts, who who experts, comprises 15 independent SAGE and represent capacity in their personal serve range and a broad affiliations of range a broad of many aspects disciplines encompassing of mix to the In addition and vaccines. immunization and gender balance is geographic expertise, of SAGE members. of in the selection considered and the Vice- the Chairperson including members, by the WHO Director- appointed are Chairperson, and nominations a public call for after General of determination After process. selection rigorous submitted to a selection are eligibility, nominations their of on the basis selected are panel. Members to the and ability to contribute qualifications Declaration objectives. SAGE’s of accomplishment by assessed are members all SAGE of Interests of and in advance appointment the time of WHO at meeting. SAGE each of Overview to provide mandate with WHO’s In accordance on health policy States guidance to Member of Group Advisory the Strategic matters, with is tasked on Immunization Experts (SAGE) policy immunisation evidence-based developing It is the principal external recommendations. General the WHO Director advising group expert and immunisation vaccines, to on issues related The SAGE vaccines. to deliver the health systems SAGE that out lay (ToRs) reference terms of on six areas, the WHO Director-General advises programme which is “immunization of the third public health priorities.” to current response
4.1 4.1 4. • • • • • • COVAX: STRUCTURE AND PRINCIPLES 21 Gagandeep Kang, Ex-Officio Member/Chair, Member/Chair, Ex-Officio Kang, Gagandeep Immunization Regional Asian South-East Medical (Christian Group Advisory Technical India) College, Peter Smith, Expert (London School of Hygiene School of Expert (London Smith, Peter UK) Medicine, & Tropical University Expert (Vanderbilt Talbot, H. Keipp USA) Medical Center, University Expert (Federal Toscano, Cristiana Brazil) Goiás, of for Center Expert (Chinese Yin Zundong, China) and Prevention, Control Disease Member/Chair, Cichutek, Ex-Officio Klaus WHO Expert Committee on Biological (Paul-Ehrlich-Institut, Standardization Germany): Member/Chair, Ex-Officio Figueroa, Peter Advisory Technical Immunization Regional PAHO Jamaica) Indies, the West of (University Group European Member/Chair, Finn, Ex-Officio Adam Experts on of Group Advisory Technical UK) Bristol, of (University Immunization David Durrheim, Expert (University of of (University Expert Durrheim, David Australia) Newcastle, Hopkins Berman Expert (Johns Faden, Ruth USA) Bioethics, of Institute Expert (Imperial College Grassly, Nicholas UK) London, of Expert (University Sonali Kochhar, USA) Washington, (Manhiça Health Expert Macete, Eusebio Mozambique) Centre, Research Army Reed Expert (Walter Modjarrad, Kayvon USA) Research, of Institute Disease for Expert (Centers Pallas, Sarah USA) and Prevention, Control Expert (Public Health England, Mary Ramsay, UK) Hyam Bashour, Expert (Al-Sham Private Private (Al-Sham Expert Bashour, Hyam Syria) University,
• • • • • • • • • • • • • • • • • Celia Alpuche, Expert (Instituto Nacional de Nacional Expert (Instituto Celia Alpuche, Salud Publica, Mexico) Muhammed Afolabi, Expert (London School of School of Expert (London Muhammed Afolabi, UK) Medicine, Hygiene & Tropical Folake Olayinka, SAGE Member (John Snow, Inc., Inc., Snow, Member (John SAGE Olayinka, Folake USA) Hanna Nohynek, SAGE Member, Chair of the the of Chair Member, Hanna Nohynek, SAGE Health and for (Finnish Institute Group Working Finland) Welfare, link to the terms of reference: https://www.who. reference: link to the terms of int/immunization/sage/sage_wg_covid-19/en/ provide guidance to ensure equitable access equitable guidance to ensure access provide and guidance on the safety to vaccination, wider from data when safety vaccines of in close available, use become population Committee with Global Advisory collaboration (GACVS). Safety on Vaccine prepare policy advice to SAGE on the to SAGE policy advice prepare and (pre-licensure vaccines use of accelerated the public health to mitigate post-licensure) to possibly curtail the COVID-19, of impact or to prevent as well as ongoing pandemic, in the disease of spread the risk of reduce for This will include recommendations future. when vaccine vaccines of early allocation limited; supply is still provide guidance for the development of of the development guidance for provide the optimal models to determine prediction vaccine for populations and target groups age introduction guide vaccine and introduction to updates and contribute impact, optimal for for vaccines of profiles product target of endemic use; for and outbreak provide continuous review of the available the available of review continuous provide candidate of the progress on evidence and provide COVID-19, against vaccines to SAGE; updates regular
Members While SAGE Working Groups do not permit do not Groups Working While SAGE in this exceptional that agreed it was observers, be would membership officio ex situation was membership Ex officio implemented. WHO advisory related of chairs to four offered the six WHO of and the chairs committees, Advisory Technical Immunization Regional Committees. Specifically, the Working Group has been asked to: been asked has Group the Working Specifically, • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 22 To be determined To To be comprised of Gavi and WHO staff WHO staff and Gavi of be comprised To with technical consultations members, needed as undertaken be determined To
Members • Format Group Validation Allocation Independent (IAVG) Overview Group Validation Allocation The Independent body an independent as will be established (IAVG) by the put forward proposal the VAD to validate will the IAVG technical experts, Composed of JAT. technically are VADs the proposed that validate and data available on latest based informed, are Interest of Conflicts and that evidence, appropriately. and managed documents identified, the from clarifications also request They may if needed, the model to be rerun and for JAT, is The VAD making their final determination. before with recommendation a strong as characterised on an exceptional made being any adjustments such as reasons, clearly pre-defined for basis once The VAD, considerations. specific operational to the Office will be passed by the IAVG, validated with implementation for Facility the COVAX of agencies. procuring support from comprised of will be the IAVG that It is envisaged by the core nominated jointly experts independent and CEPI), Secretariat Gavi (WHO, partners COVAX and representatives CSOs from with observers Facility. in the COVAX economies participating of jointly being defined are the IAVG for The ToRs to according organisations, COVAX by the lead constituting for processes established existing by mid- finalisation aiming for bodies, expert IAVG for process A nomination 2020. November of upon finalisation will be triggered membership Areas processes. also in line with existing the ToRs, based will be established the IAVG for expertise of immunisation include: but will likely on the final ToRs safety vaccine and service delivery; programmes medicines to and monitoring; access evaluation public health and emergency and health products; others. among response, Members • • Helen Rees, Ex-Officio Member/Chair, African African Member/Chair, Ex-Officio Helen Rees, Advisory Technical Immunization Regional the Witwatersrand, of (University Group South Africa) Saad Omer, Ex-Officio Member/Member, Member/Member, Ex-Officio Omer, Saad Safety Committee Vaccine on Global Advisory Global Health, USA) for Institute (Yale Christopher Morgan, Ex-Officio Member/ Ex-Officio Morgan, Christopher Immunization Regional Pacific Western Chair, Australia) (Jhpiego, Group Advisory Technical Ziad Memish, Ex-Officio Member/Chair, Member/Chair, Ex-Officio Memish, Ziad Immunization Regional Mediterranean Eastern Strategic Group/Member, Advisory Technical Infectious for Group Advisory and Technical Arabia) Health, Saudi of Hazards (Ministry David Kaslow, Ex-Officio Member/Chair, Member/Chair, Ex-Officio Kaslow, David Advisory Vaccines for Development Product USA) Committee (PATH,
The JAT will be convened by the Office of by the Office of will be convened The JAT of with Terms and WHO, Facility the COVAX WHO and by Gavi, defined jointly (ToRs) Reference finalisation for aiming CEPI in the coming weeks, by mid-November. The Joint Allocation Taskforce (JAT), comprised comprised (JAT), Taskforce Allocation The Joint the the WHO and the Office of from staff of on a data-driven will, based Facility, COVAX Allocation a Vaccine model, prepare allocation and validation review for proposal Decision (VAD) Group Validation Allocation by the Independent inputs all the data will review The JAT (IAVG). its model and verify the allocation needed for to enable adjustments output. Some flexibility operational such as reasons, clearly defined for and will be accommodated considerations, to any will respond The JAT documented. fully the IAVG. from clarification for requests Overview Joint Allocation Taskforce (JAT) Taskforce Allocation Joint will apply the WHO-developed The Facility vaccine for the basis as Framework Allocation Fair participants, Facility for decisions allocation Mechanism. the Allocation through operationalised will Mechanism governance The Allocation and (JAT) Taskforce Allocation comprise the Joint (IAVG). Group Validation Allocation the Independent 4.2 ALLOCATION MECHANISM 4.2 ALLOCATION • • • • • COVAX: STRUCTURE AND PRINCIPLES 23 Federation (International Jane Barratt on Ageing) Sylvie Briand (WHO) (WHO) Analia Porras (Gavi) Patel Zeenat Sosler (Gavi) Stephen Anissa Sidibe (Gavi) (CEPI) Cramer Jakob (CEPI) Melanie Saville (CEPI) Jim Robinson Foundation) (Bill & Melinda Gates Helen Matzger Foundation) (Bill & Melinda Gates Orin Levine Foundation) Dull (Bill & Melinda Gates Peter defining the overarching, high-level goals high-level the overarching, defining strategy; vaccination a COVID-19 of priority identifying for an approach developing vaccination; for groups and target populations and of and risks uncertainties high-level identifying to and actions initiative vaccine the COVID-19 these. mitigate and address (WHO) Lead O’Brien, Kate (WHO) Hombach Joachim (WHO) Cernuschi Tania Annelise Wilder Smith (WHO) Hutubessey (WHO) Raymond (WHO) Mariangela Simao
• Members • • • • • • • • • • • • • • • • • • • • The primary areas of focus were: focus of areas The primary continue to identify and reflect on high- and reflect to identify continue cross- have topics that priority strategic impact. workstream ensure the learnings from our work to date to date our work the learnings from ensure plan action an actionable into translated are with clear identified, the risks mitigates that and and timelines; accountability definitions on important alignment reach to use the same language and assumptions organisations; across and numbers To be determined To
The sub-working group was structured around around structured was group The sub-working The workstream on critical questions. sprints analyses and draw to review weekly twice met then were those analyses that from inferences relevant. as workstreams to other passed The sub-working group was established to: established was group The sub-working Its tasks were: (i) assuring that the COVAX Pillar COVAX the that (i) assuring were: Its tasks strategy vaccine an aligned global COVID-19 has a vaccination on the goals of includes detail that the achieving for targets and general programme topics, strategic COVAX-wide (ii) addressing goals; and core strategy, to the vaccination risks such as efforts. planning and delivery scenarios to feed topics strategic of pre-empting for This allows while also aligned material, of and the creation Close among workstreams. duplication preventing between required was and iteration coordination and inter- with overlapping sub-workstreams thinking. dependent The Vaccine Strategy Sub-Working Group, led by Group, Sub-Working Strategy The Vaccine COVAX of outset the at established was WHO, while various months in the initial active and was it is currently initiated; being were workstreams and will be reinitiated workstream an active not in to other flowed has needed. Its work as allocation, example, for to, related workstreams costing, and delivery, readiness policy, country and procurement. funding Overview Vaccine Strategy Sub-Working Group Sub-Working Strategy Vaccine 4.3 POLICY AND ALLOCATION WORKING4.3 POLICY GROUPS ALLOCATION AND Format • • • • COVAX: STRUCTURE AND PRINCIPLES 24 Yalda Momeni (UNICEF SD) Yalda Gian Gandhi (UNICEF SD) Mounir Bouazar (UNICEF SD) Fund) Revolving John Fitzsimmons (PAHO Ann Moen (WHO) Chepynoga (WHO) Kateryna (WHO) Brown Jeffrey (WHO) Lee Yejin Anissa Sidibe (Gavi) Kim Harper (Gavi) (Gavi) Hannah Kettler (Gavi) Sophie Mathewson (Gavi) Reynolds Keightley Brison (Gavi) Mike Elen Høeg (CEPI) Ann Ottosen (UNICEF Supply Division) Anissa Sidibe (Gavi) Anissa Sidibe (Gavi) Sophie Mathewson (Gavi) Reynolds Keightley Elen Høeg (CEPI) Children) the (Save Karrar Karrar (WHO) Co-Lead Mariangela Simao, (WHO) Sylvie Briand, Co-Lead Nannei (WHO) Claudia (WHO) Cernuschi Tania Ioana Ghiga (WHO) (PAHO) Analia Porras Analia Porras (PAHO) Porras Analia
• • • • Allocation process design and data needs design and data process Allocation • • • • • • • • • • • • • • • • • • • • • • • •
Tania Cernuschi (WHO) Tania Ioana Ghiga (WHO) Claudia Nannei (WHO) Claudia Mariangela Simao, Co-Lead (WHO) Co-Lead Mariangela Simao, (WHO) Sylvie Briand, Co-Lead the scope, governance and operationalisation and operationalisation governance the scope, Buffer. Emergency the COVAX of the governance of the Allocation Mechanism, Mechanism, the Allocation of the governance and the operationalisation of the WHO-developed the WHO-developed of the operationalisation , Framework Allocation Fair See WHO SAGE section above section See WHO SAGE This topic is handled through the SAGE the SAGE is handled through This topic section. earlier in this described processes and integration IT requirements Allocation systems. existing with other
Allocation Mechanism governance Allocation The working groups meet on a regular basis to basis on a regular meet groups The working partners. all relevant across this work forward drive Members 4. Emergency Buffer; and Buffer; 3. Emergency Allocation process design and data needs; design and data process 2. Allocation Allocation Mechanism governance; 1. Allocation The Access and Allocation Sub-Working Group is Group Sub-Working and Allocation The Access groups: working four composed of Overview Sub-Working Group Sub-Working Group, Sub-Working and Allocation The Access COVAX of a range together brings led by WHO, to design: together who work partners Access and Allocation Access Members Overview Vaccine Policy Sub-Working Group Sub-Working Policy Vaccine • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 25 Jason Mathiu (WHO) Mathiu Jason Boulanger (WHO) Lucy (Gavi) Lisa Wei (UNICEF) Gemma Orta-Martinez Liudmila Mosina (WHO) (WHO) Alba Maria Ropero Mamahit (WHO) Raspati Awandha (WHO) Marta Gacic-Dobo (WHO) Anne Yu RF) Ozturk (PAHO Murat Kim Harper (Gavi) (WHO) Escalante Socorro RF) John Fitzsimmons (PAHO (Gavi) Craw Laura Lisa Hedman (WHO) (WHO) Suryantoro Ludy Swathi Iyengar (WHO) Swathi (WHO) Ann Lindstrand Houda Langar (WHO) (WHO) Queyras Guillaume Nikiema (WHO) Jean Baptiste (WHO) Ruiz Cuauhtemoc Cernuschi (WHO) Tania Ellen Hynes (WHO) Griffin (Gavi) Caroline (WHO) Quamrul Hasan Jones (UNICEF) Stephen (WHO) James McGonagle Ioana Ghiga (WHO) Ghiga Ioana
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • Tifenn Humbert (WHO) Tifenn Sunil Bahl (WHO) Keightley Reynolds (Gavi) Reynolds Keightley (UNICEF) Capriotti Luigi Jayantha Liyanage (WHO) Liyanage Jayantha Ann Moen (WHO) Oleg Benes (WHO) Sandra Orogodo (WHO) Orogodo Sandra Yejin Lee (WHO) Lee Yejin (WHO) Rolland Erwan Kateryna Chepynoga (WHO) Chepynoga Kateryna Claudia Nannei (WHO) Claudia (WHO) Brown Jeffrey Elen Høeg (CEPI) Talha Jalal (Gavi) Jalal Talha (Gavi) Malarski Maya Kim Harper (Gavi) Tania Cernuschi (WHO) Cernuschi Tania (PAHO) Analia Porras Claudia Nannei (WHO) Claudia Ioana Ghiga (WHO) (WHO) De Weerdt Van Reinhilde Soce Fall, Co-Lead (WHO) Co-Lead Soce Fall, Mariangela Simao, Co-Lead (WHO) Co-Lead Mariangela Simao, (WHO) Sylvie Briand, Co-Lead Murat Ozturk (PAHO RF) Ozturk (PAHO Murat RF) (PAHO Ruiz Cuauhtemoc
and integration IT requirements Allocation systems existing with other Emergency Buffer Emergency • • • • • • • • • • • • • • • • • • • • • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 26 Sophie Mathewson (Gavi) Sophie Mathewson Elen Høeg (CEPI) Alex Beecher (Gavi) Alex Shoshanna Goldin (WHO) Shoshanna Goldin Bellon (UNICEF) Anthony Manisha Shridhar (WHO) Manisha Sarah Garnger (WHO) Garnger Sarah (WHO) Jinho Shin
• • • • • • • • COVAX: STRUCTURE AND PRINCIPLES 27 In order to join forces in the fight against against in the fight to join forces In order pandemic and to develop, the COVID-19 against a vaccine and distribute manufacture joined CEPI and WHO have Gavi, COVID-19, hoc coordination up an ad and set forces COVAX mechanism under the name of (CCM). Meeting Coordination and enables equitable access to these vaccines vaccines to these and enables equitable access during outbreaks. Representative Members may be required to to be required may Members Representative on impact a direct have that consider matters or organisations governments, of the interests been or have they represent that institutions past. with in the recent associated The CCM is co-led by the Chairs of the Gavi the Gavi of The CCM is co-led by the Chairs and includes Representative and CEPI Boards described in the COVAX as Members, Document. Management Unaffiliated Members will be appointed in their in their will be appointed Members Unaffiliated on the Committees. to serve capacity personal The World Health Organization (WHO) is is (WHO) Organization Health The World and organisation an inter-governmental and the United Nations of specialised agency on authority and coordinating is the directing leadership health, and provides international health matters, on global environmental sets agenda, shapes the health research articulates health norms and standards, provides policy options, evidence-based and monitors technical support to countries, health trends. and assesses The CCM will be advised by its Committees The CCM will be advised Members comprise Representative which may below. defined as Members, and/or Unaffiliated Members may face Conflicts of Interest in in Interest of Conflicts face may Members on the and decision making in their role advising CCM and Committees.
c) d) e) f) g) h) i)
to provide transparency on critical discussions transparency to provide in a timely manner. providing and progress, to ensure Individual and Organisational Individual and Organisational to ensure and identified are Interest of Conflicts principles the agreed according managed the for Interest of Conflicts managing for and its (CCM) Meeting Coordination COVAX and committees; to ensure that decision-making is done in an decision-making that to ensure manner with appropriate impartial and fair Interest; of to Conflicts given consideration to select appropriate members of critical of members appropriate to select groups; advisory to ensure a comprehensive view on the view a comprehensive to ensure to be able to take public funds, of investment decisions in a timely manner; the right
MEETING ITS (CCM) AND COMMITTEES INTEREST FOR COORDINATION THE COVAX PRINCIPLES CONFLICTS FOR MANAGING OF The Gavi Alliance is a global vaccine alliance, alliance, Alliance is a global vaccine The Gavi sectors public and private bringing together people's and protect lives children's to save vaccines equitable use of health by increasing countries. in lower-income The Coalition for Epidemic Preparedness Epidemic Preparedness The Coalition for of development accelerates (CEPI) Innovations diseases infectious emerging against vaccines
b) a) Background 2. The key principles agreed upon by the three lead lead upon by the three principles agreed The key in the to guide good governance organisations, follows: as are collaboration, COVAX 1. GOVERNING PRINCIPLES 1. • • • • •
PRINCIPLES SECTION 2: COVAX: STRUCTURE AND PRINCIPLES 28
means a person serving serving Member means a person Unaffiliated capacity. on a Committee in their personal means when a a means when Interest Organisational director, officer, is an or Family Member is directly or employee of, partner, trustee, that to[1], an entity in any manner linked right, profit, obtain an advantage, may a in any manner from benefit or may share on. should vote the Member recommendation means each of CEPI, CEPI, of Member means each Organisational IFPMA, WHO and any other Gavi, DCVMN, assigned has that or institution organisation a Representative Member to sit a Representative on a Committee. means a person Member means a person Representative sitting on the CCM or a Committee and Member. an Organisational representing means when a Member means when a Member Interest Personal a from benefit personally may or Family under arrangement or other transaction discussion by the CCM or its Committees. Committee convened under the COVAX Pillar. COVAX the under Committee convened means the World Health Organisation. WHO means the World Members may not allow themselves to obtain to obtain themselves allow not may Members on their position or role through any advantage the CCM or any Committee. Members are expected to act with integrity with integrity to act expected are Members within the CCM and its Committees and to be any Interest, of in the disclosure transparent that to recommendations particularly in regard on allocation the CCM or Committees make resources. of and disbursement Unaffiliated Members are expected to to expected are Members Unaffiliated of and in the case bring their experience, and their experience Members, Representative the goals and objectives to advance affiliations, described the CCM and its as Committees, of Document. Management in the COVAX Members must ensure that in participating in participating that ensure must Members their activities in the CCM and Committees, with their conflict duties do not and other to use good judgment and must responsibilities Interest. of Conflicts avoid Principles Principles shall apply to the CCM The Following and Committees: a) b) c) d) 12. 13. 16. 17. 14. 15.
means the Gavi Alliance. means the Gavi means a Financial Interest, Personal Personal means a Financial Interest, Interest Interest. or Organisational Interest means a Representative Member Member Member means a Representative a Member of and/or an Unaffiliated means any spouse, domestic partner, partner, domestic means any spouse, Family and any other children, siblings, parents, a in the same household as who resides relative that relationship familial Member and any other a conflict. of the appearance could create Gavi Gavi means the advisory bodies to the means the advisory Committees CCM, including, its advisory sub-committees, and vaccine groups portfolio bodies, and review and Development including: the Research teams, Committee Investment and Manufacturing Group Product the Independent (RDMIC), SAGE (TRG), Group Review the Technical (IPG), or and all advisory sub-groups workstreams, Pillar. COVAX under the bodies convened other means the International Federation of of Federation IFPMA means the International & Associations. Manufacturers Pharmaceutical means the Coalition for Epidemic Epidemic for CEPI means the Coalition Innovations. Preparedness means Developing Countries Vaccine Vaccine Countries means Developing DCVMN Network. Manufacturers a Member has an actual, potential or perceived or perceived potential an actual, a Member has conduct the Member’s affect may that Interest CCM or at in the decision-making process its Committees. means a situation where means a situation Interest of Conflict means the COVAX Coordination Coordination CCM means the COVAX Committee. Financial arises when a Member Interest a financially from benefit may or Family financial any other or from transaction under discussion by the CCM or arrangement its Committees. Organisational Interest and Conflicts of of Conflicts and Interest Organisational with transparently be managed must Interest to safeguard integrity of degree the highest any of participation that perception any against in decisions undue advantage confers Member CCM or its the Committees. of 11. 10. 9. 8. 7. 5. 6. 2. 3. 4. 1. The following definitions apply in this Policy: in this Policy: apply definitions The following Definitions j) COVAX: STRUCTURE AND PRINCIPLES 29
Members must recuse themselves from all all from themselves recuse must Members in relation and recommendations discussions a Financial they have where to the matters Interest Organisational Interest. or Personal and basis, a case-by-case on will be evaluated the request may the meeting of the Chair voting from to refrain person conflicted withdraw or to also on a recommendation discussions. from g) any type in any manner” means linked [1] “Directly or Family by which the Member agreement of such whether with an entity, a relationship has an employment, through is formalised relationship secondment agency, venture, joint participation, contract. type of or any other A Member who previously had a relationship a relationship had previously who A Member their from (different with an organisation create would that affiliation), current will be Interest, of Conflict a perceived Interest Organisational an to have considered 12 months for organisation in the original the relationship of since the cessation counted that in any matters organisation, with that Interest. of Conflict kind of any create might Members must disclose all Interests in entities in entities all Interests disclose must Members of recommendations from benefit may that the CCM or its Committees upon joining the the beginning CCM or a Committee and at the CCM or a Committee of any meeting of with financial recommendations where meeting be will Such declarations made. are implications minutes. in the meeting noted f) e)