COVAX Allocation Round 6 IAVG Vaccine Allocation Decision - 23 July 2021

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COVAX Allocation Round 6 IAVG Vaccine Allocation Decision - 23 July 2021
COVAX Allocation Round 6
IAVG Vaccine Allocation Decision
             23 July 2021
Background
                                                                                ❑    Context for Round 6 & Vaccine Scope
                                                                                ❑    Humanitarian Buffer
                                                                                ❑    Dose Donations
                                                                                ❑    Participant Scope
                                                                                ❑    Detailed Participant Exclusion Report
   Table of Contents
                                                                       Round 6 Proposals

                                                                                ❑ Scenario 1 and 2:
                                                                                   ❑ Descriptive Statistics Summary
                                                                                   ❑ Overview Graphs
                                                                                   ❑ Distribution Proposal & Shipment Considerations
                                                                                ❑ Conclusions & Signatures

                                                                       Annex/Background
                                                                                ❑ Overview of Allocations to Date
                                                                                ❑ Overview of Dose Donations to Date
                                                                                ❑ Overview of COVAX Shipped/allocated doses vs total population coverage

*Please kindly note that the Round 6 VAD proposal is supplemented with a single accompanying spreadsheet: the Round 6 output from the Allocation Portal. In particular, two tabs on this
                                                                                                                                                                                           2
spreadsheet, Output and Exclusion report, outline which Participants are proposed to receive an allocation in this Round and which are not.
Background
Context for COVAX Allocation Round 6 & Vaccine Scope
                                                                                                                           Minimum Shipment Size
                                   Context for Round 6
 Timing of Round 6                                                                                               Product Name        Minimum Shipment Size (doses)
 • The timing of COVAX Allocation Rounds is triggered when supply of vaccines with                             Sinopharm BIBP        •    1,200
   global regulatory approval is confirmed for a defined period. Round 6 includes the                                                •    20,400 for pop. over 1M
   following two products:
         • Beijing CNBG - BIBP-CorV (also known as “Sinopharm”) – EUL 07 May 2021
                                                                                                               Sinovac               •    1,200
                                                                                                                                     •    20,400 for pop. over 1M
         • Sinovac – CoronaVac (“Sinovac”) – EUL 01 June 2021.
 • A status overview of COVID-19 vaccines in the WHO EUL evaluation process is
   available here.                                                                                                       Overview of Available Supply
 • The COVAX Facility announced it had secured advance purchase agreements                                          Product Name                Total Supply (doses)
   (APA) for the two products on 12 July 2021, with a portion available for immediate
   delivery.                                                                                                   Sinopharm BIBP                        42,649,200
 • Round 6 allocations are intended for delivery during Q3-2021, the Total Monthly
                                                                                                               Sinovac                               42,650,400
   Supply Availability table on the right outlines the breakdown of available supply.
 • Due to close timing between COVAX Allocation Rounds 5 and 6, the Facility will                              Humanitarian Buffer                   14,700,400
   ensure close communication with participants to confirm their ability to absorb
                                                                                                               TOTAL                                100,000,000
   doses before they are shipped.
 Round Supply Considerations                                                                                         Total Monthly Supply Availability
 • Sinopharm BIBP has 2 different minimum shipment sizes for Participants with a
   population above or below 1 million (see Minimum Shipment Size table above on                                Product Name             July        Aug            Sept
   the right).
                                                                                                               Sinopharm BIBP            10M         20M            20M
 • Details on the supply for the Humanitarian Buffer are outlined on the next slide.
                                                                                                               Sinovac                   5M          25M            20M

 Information on supply availability was provided to the JAT by the COVAX Procurement Coordinator, UNICEF SD.                                                          3
Background
Humanitarian Buffer

                                              Overall Humanitarian Buffer Allocation
                               Product Name                                                          Total Supply (doses)
     Sinopharm BIBP                                                                                         7,350,800
     Sinovac                                                                                                7,349,600
     TOTAL                                                                                                 14,700,400

                                       Proposed Allocation to the Humanitarian Buffer
     Allocation of Doses to the COVAX Humanitarian Buffer
     •   The JAT proposes to allocate a total of 14.7M doses to the Humanitarian Buffer (for immediate approval by the Inter-Agency Standing
         Committee). More information on how the Humanitarian Buffer is managed and governed may be accessed here.
     •   This sum is the total amount owed to the Buffer from COVAX Allocation Rounds 1-6, constituting 5% of available supply from the
         COVAX APA-secured deals for each Round.
     •   From Rounds 1-5, a total of 9.7M doses were owed to the Buffer, yet none were available for use until Round 6.
     •   The number of applications to the Buffer are expected to rise as manufacturers waive indemnity and liability (I&L) requirements, which
         to date include Sinopharm and Sinovac.
     •   Sinopharm and Sinovac are programmatically suitable products for use in humanitarian settings and have a fridge-temperature shelf
         life of 12-24 months.
     •   Supply not used by the Buffer will be reallocated to Facility Participants to ensure that available doses do not go idle.
           •   The JAT will monitor closely the use of HB doses and applications across Q3 and will reallocate quickly to ensure this.

                                                                                                                                                  4
Background
Round Context - Donations

                                                    Context for Round 6
        Vaccine Donations to COVAX
        •   Following COVAX Allocation Round 5, several dose donations have been executed. This constituted a total of
            8,756,720 doses of AZ vaccine, donated by France, Norway, Spain, Sweden and the United Kingdom.
        •   The increase in benefitting Participants’ percent total population coverage achieved through COVAX-secured
            doses as a result of these donations is factored into this Allocation Round.
        •   Adjustments to the dose donations from the United States of America and from Japan have been processed in
            the Allocation Portal in advance of running Allocation Round 6. While the adjustment to the dose donation from
            Japan was minor, the donation from the USG increased by 25 million doses since the donation was originally
            entered into the Portal before Round 5.
        •   Therefore, additional dose donations from Round 5 to Round 6 constitute a total of roughly 33.7 million doses.
        •   An aggregated overview of dose donations to date may be accessed on slides 18 and 19 in the Annex of this
            PowerPoint.

                                                                                                                             5
Snapshot
Scenario 1 vs. Scenario 2
                            Scenario 1                                                              Scenario 2
 Scenario Overview                                                        Scenario Overview

 •   Participants receiving allocations: 83                               •   Participants receiving allocations: 60

 •   Participants excluded: 79                                            •   Participants excluded: 102

 Scenario Issues                                                          Changes Made to Scenario 1

 •   Several Participants received only the Round minimum (i.e.           •   Round minimum set to 0
     100,800 doses)
                                                                          •   Batch size for Sinopharm changed to 1,200
      •   Due to algorithm rule that Round minimum must be given to all
          Participants who have not yet reached 20%                       •   Minimum shipment for Sinovac changed to 20,400 for
                                                                              population over 1 million and 1,200 for population less than
      •   This happened to 22 Participants, 20 of whom had benefitted         1 million
          from dose donations in advance of Round 6 (the other 2 were
          small population participants nearing 20% coverage—)            •   2 participants marked to voluntary delay in this round
 •   As this is likely to be the only Allocation Round with a             •   2 participants earmarked for Sinopharm
     significant volume of Sinovac and Sinopharm for distribution,
     it does not make sense to allocate the Round minimum to              •   Pro-rata shares for Sinopharm corrected for 3 participants
     Participants, given its low potential for impact vis-à-vis the           since there was a rounding error before
     tremendous efforts associated with introducing another
     vaccine in country

                                                                                                                                       6
7
Eligible Participant Summary
Background – Scenario 1
Participant Scope                                                                                                                           Criteria                                       Participants (n)
                                                                                                                 Inclusion
                                   Participant Scope                                                                      AMC                                                                         89
COVAX Facility Participants                                                                                               OP                                                                          39
•    There are 89 Advance Market Commitment (AMC) and 73 Self
                                                                                                                          CP                                                                          31
     Financing (SFP) participants to the COVAX Facility.
Readiness Assessment                                                                                                      Team Europe                                                                  3
•    AMC participant readiness assessments are regularly conducted and                                           Total Inclusion                                                                     162
     were taken into account for this Round.
                                                                                                                 Exclusion
Eligibility Criteria
                                                                                                                          Has not met financial obligations                                            1
•    The following participants were eligible to receive available supplies of
     Sinopharm and Sinovac in this Round: All AMC participants; Optional
                                                                                                                                                                                                  • CP: 0
     Purchaser (OPs) who opted-in for the either or both vaccine deals;                                                   Opt outs
     Committed Purchasers (CPs) without price cap.                                                                                                                                               • OP: 22
Delay Toggle and Vaccine Preferences
                                                                                                                          Delay Toggle                                                                26
•    In advance of this Allocation Round, COVAX Facility Participants
     were reminded of their right to skip the present Round by activating the
     Round’s delay toggle on the COVAX Collaboration Platform (CCP) and                                                   Not Ready                                                                    0
     were invited to update their preferences in the CCP.                                                                 20% population coverage (or
                                                                                                                                                                                                      29
•    Participants also received targeted communications asking them to                                                    requested) reached
     express their preference for receiving either Sinopharm, Sinovac, or
     indifference to the two products. These inputs were accounted for when
                                                                                                                          Other Combinations Not Allowed                                               1
     making the allocation.                                                                                      Total Exclusion                                                                      79
Several Participants were excluded for more than one reason, but for the table on this slide, only one reason was selected in the following hierarchy to avoid double-counting: coverage achieved, delay toggle, OP who
                                                                                                                                                                                                                   8
opted out, has not met financial obligations, other. The full exclusion report is included as a tab on the Round output spreadsheet.
Descriptive Statistics Summary of the Participants, Their Allocation and Total Coverage
Scenario 1

                                                                                          9
Overview of the Total Round 6 Allocation on top of Previous Allocations
(All Participants with Allocations) – Scenario 1

                                                                          10
Distribution Proposal & Shipment Considerations – Scenario 1
COVAX Allocation Round 6

                                                           Distribution Proposal
        • The average population coverage across all 83 participants achieved with doses allocated in Round 6 is
          1.68%. The average cumulative coverage from Rounds 1 to 6 for these same 83 participants is 7.61%.
        • After Round 6, the average cumulative coverage from Rounds 1 to 6 for all 153 participants who have received an allocation from
          COVAX in any round is 10.21%. The median cumulative coverage for these same 153 participants is 5.72%.
        • In alignment with the standard reallocation process, Participants will be notified that they are allotted a six-week period to clear all
          post-allocation preparedness checks following notification of the Round’s outcome.
        • Subsequent changes to Participants’ total coverage from this Round resulting from the standard reallocation process will be
          communicated to the Participants upon execution. These modifications will also be visible to the IAVG in the Allocation Portal
          once completed.

                                                        Shipment Considerations
        •   Normally, to facilitate logistics planning, a prioritized shipping order is recommended for distribution of doses allocated in a
            Round. In developing this order, a stratified randomization approach was adopted in past Rounds to ensure that all participants
            are given an equal chance in the initial shipment queue.
        •   For Round 6, a decision was taken to inform the sequencing of shipments based on participants’ overall achieved population
            coverage (from all sources of supply) and their epidemiological situation.
        •   The Facility recommends that, closer to the date of the planned shipment, participants’ absorption capacity be assessed to
            ensure all the planned quantities can be used by participants within the vaccines’ expiry dates.

                                                                                                                                                     11
12
Eligible Participant Summary
Background – Scenario 2
Participant Scope                                                                                                                           Criteria                                       Participants (n)
                                                                                                                 Inclusion
                                   Participant Scope                                                                      AMC                                                                         89
COVAX Facility Participants                                                                                               OP                                                                          39
•    There are 89 Advance Market Commitment (AMC) and 73 Self
                                                                                                                          CP                                                                          31
     Financing (SFP) participants to the COVAX Facility.
Readiness Assessment                                                                                                      Team Europe                                                                  3
•    AMC participant readiness assessments are regularly conducted and                                           Total Inclusion                                                                     162
     were taken into account for this Round.
                                                                                                                 Exclusion
Eligibility Criteria
                                                                                                                          Has not met financial obligations                                            1
•    The following participants were eligible to receive available supplies of
     Sinopharm and Sinovac in this Round: All AMC participants; Optional
                                                                                                                                                                                                  • CP: 0
     Purchaser (OPs) who opted-in for the either or both vaccine deals;                                                   Opt outs
     Committed Purchasers (CPs) without price cap.                                                                                                                                               • OP: 22
Delay Toggle and Vaccine Preferences
                                                                                                                          Delay Toggle                                                                27
•    In advance of this Allocation Round, COVAX Facility Participants
     were reminded of their right to skip the present Round by activating the
     Round’s delay toggle on the COVAX Collaboration Platform (CCP) and                                                   Received 0 Allocation                                                       22
     were invited to update their preferences in the CCP.                                                                 20% population coverage (or
                                                                                                                                                                                                      29
•    Participants also received targeted communications asking them to                                                    requested) reached
     express their preference for receiving either Sinopharm, Sinovac, or
     indifference to the two products. These inputs were accounted for when
                                                                                                                          Other Combinations Not Allowed                                               1
     making the allocation.                                                                                      Total Exclusion                                                                     102
Several Participants were excluded for more than one reason, but for the table on this slide, only one reason was selected in the following hierarchy to avoid double-counting: coverage achieved, delay toggle, OP who
                                                                                                                                                                                                                  13
opted out, has not met financial obligations, other. The full exclusion report is included as a tab on the Round output spreadsheet.
Descriptive Statistics Summary of the Participants, Their Allocation and Total Coverage
Scenario 2

                                                                                          14
Overview of the Total Round 6 Allocation on top of Previous Allocations
(All Participants with Allocations) – Scenario 2

                                                                          15
Distribution Proposal & Shipment Considerations – Scenario 2
COVAX Allocation Round 6

                                                           Distribution Proposal
        • The average population coverage across all 83 participants achieved with doses allocated in Round 6 is
          1.76%. The average cumulative coverage from Rounds 1 to 6 for these same 60 participants is 5.58 %.
        • After Round 6, the average cumulative coverage from Rounds 1 to 6 for all 153 participants who have received an allocation from
          COVAX in any round is 9.98%. The median cumulative coverage for these same 153 participants is 5.78%.
        • In alignment with the standard reallocation process, Participants will be notified that they are allotted a six-week period to clear all
          post-allocation preparedness checks following notification of the Round’s outcome.
        • Subsequent changes to Participants’ total coverage from this Round resulting from the standard reallocation process will be
          communicated to the Participants upon execution. These modifications will also be visible to the IAVG in the Allocation Portal
          once completed.

                                                        Shipment Considerations
        •   Normally, to facilitate logistics planning, a prioritized shipping order is recommended for distribution of doses allocated in a
            Round. In developing this order, a stratified randomization approach was adopted in past Rounds to ensure that all participants
            are given an equal chance in the initial shipment queue.
        •   For Round 6, a decision was taken to inform the sequencing of shipments based on participants’ overall achieved population
            coverage (from all sources of supply) and their epidemiological situation.
        •   The Facility recommends that, closer to the date of the planned shipment, participants’ absorption capacity be assessed to
            ensure all the planned quantities can be used by participants within the vaccines’ expiry dates.

                                                                                                                                                     16
Conclusion & Signatures
COVAX Allocation Round 6

                                                                 Conclusion
   The IAVG unanimously validates the allocation proposal contained in scenario 2.

                               Next Steps                                                         Signatures
                                                                       Signature Assistant Director General,     Signature Managing Director,
                 Process Step                            Date            Access to Medicines and Health        Office of the COVAX Facility, Gavi
                                                                                 Products, WHO

   JAT sends allocation proposal to IAVG               21 July 2021

                                                                      Mariângela SIMÃO/Bruce AYLWARD           Aurélia NGUYEN
   IAVG Decision Meeting                               23 July 2021
                                                                      On date:                                 On date:
   JAT notifies the Office of the COVAX Facility and
                                                       23 July 2021
   the Procurement Coordinator

   WHO DDG communicates to Allocation
                                                       26 July 2021
   Leadership (Dr SIMAO/Dr AYLWARD)/JAT

   IAVG report sent to the WHO DDG                     28 July 2021

                                                                                                                                                    17
Thank you
19
Overview of the Total Round 6 Allocation on top of Previous Allocations (Only
Participants with Allocations This Round)

                                                                                20
Overview of the Total Round 6 Allocation on top of Previous Allocations
(All Participants with Allocations)

                                                                          21
Background material

                      22
Overview of Allocations to Date
                                                                                                  Allocation Approval                                               Doses Allocated
    Allocation Round                    Product Name                   WHO EUL Date                                                 Doses Allocated                                                    Description
                                                                                                          Date                                                        Adjusted*
                                       Pfizer BioNTech –
           COVAX-1                                                        30 Dec 2021                  29 Jan 2021                      1,200,420                       1,200,420                 Pfizer Feb-Mar 2021
                                           Comirnaty
                                                                                                       23 Feb 2021,                                                                              AZ and SII-AZ Jan-May
           COVAX-2                 AstraZeneca – Vaxzevria                15 Feb 2021                                                   75,996,000                     75,412,800
                                                                                                           IAVG                                                                                          2021
                                                                                                       23 Feb 2021,                                                                              AZ and SII-AZ Jan-May
           COVAX-2                      SII – Covishield                  15 Feb 2021                                                  161,472,000                     29,790,600
                                                                                                           IAVG                                                                                          2021
                                       Pfizer BioNTech –                                               15 Mar 2021,
           COVAX-3                                                        30 Dec 2021                                                   14,109,030                     14,109,030                 Pfizer Apr-Jun 2021
                                           Comirnaty                                                      IAVG
                                                                                                                                                                                                      AZ to cover
           COVAX-4                 AstraZeneca – Vaxzevria                15 Feb 2021                   8 June 2021                     17,366,400                     17,366,400                  COVAX Round 2 SII
                                                                                                                                                                                                       shortage
           COVAX-5                     Pfizer BioNTech –                  30 Dec 2021                  15 July 2021,                    72,190,170                      67,205,970               Pfizer July-September
                                           Comirnaty                                                       IAVG                                                                                           2021
                                                                                                                                                                                                Includes dose donations
                                                                                                                                                                                                  from: France, Japan,
                                                                                                 Donations distributed as
     Dose Donations                AstraZeneca – Vaxzevria                15 Feb 2021                                                   21,820,690                      21,820,690               New Zealand, Norway,
                                                                                                    of 19 July 2021
                                                                                                                                                                                                 Spain, Sweden, and the
                                                                                                                                                                                                     United Kingdom
                                                                                                 Donations distributed as
     Dose Donations                Moderna – mRNA-1273                   30 April 2021                                                  50,151,200                      50,151,200
                                                                                                    of 19 July 2021
                                                                                                                                                                                                 Part of a United States
                                       Pfizer BioNTech –                                         Donations distributed as
     Dose Donations                                                      30 Dec 2021                                                    12,737,790                      12,737,790                 Government dose
                                           Comirnaty                                                of 19 July 2021
                                                                                                                                                                                                   donation initiative
                                                                                                 Donations distributed as
     Dose Donations               Janssen - Ad26.COV 2-S                12 March 2021                                                   22,150,150                      22,150,150
                                                                                                    of 19 July 2021
  Totals                                                                                                                               449,193,850                     311,945,050
Adjustments refer to post-allocation changes to Participants’ originally allocated doses from a given round. Adjustments are made either through the reallocation of allocated doses or redeployment of allocated doses already
in country. Both reallocation and redeployment are important to ensure no idle doses, when a COVAX Participant is not prepared or not willing to receive/use doses allocated or delivered. In addition, adjustments have been
made to reflect the delays experienced by those Participants originally allocated SII-AZ doses in Round 2, to ensure these delayed volumes do not count towards official allocated amounts and to ensure equity of coverage
                                                                                                                                                                                                                    23
across Facility Participants.
Overview of Dose Donations to Date

               Donor                      Product               Doses Donated
               France              AstraZeneca – Vaxzevria         4,463,200

                Japan              AstraZeneca – Vaxzevria        11,151,170

            New Zealand            AstraZeneca – Vaxzevria          211,200

               Norway              AstraZeneca – Vaxzevria          530,960

                Spain              AstraZeneca – Vaxzevria          756,480

               Sweden              AstraZeneca – Vaxzevria         1,027,200

           United Kingdom          AstraZeneca – Vaxzevria         3,680,480

       United States of America     Moderna – mRNA-1273           50,151,200

       United States of America   Pfizer BioNTech – Comirnaty     12,737,790

       United States of America    Janssen - Ad26.COV 2-S         22,150,150

  Totals                                                          106,859,830

                                                                                24
Overview of Dose Donations to Date

                                     25
Scenario 1 vs. Scenario 2: In scenario 2, for the mean increase in allocation across all
60 participants who received an allocation is 0.06%

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