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Report of the Joint Allocation Taskforce (JAT) on the distribution of COVAX Facility secured vaccines

COVAX ALLOCATION ROUND 4 – Second Dose Needs Date of report: 8 June 2021

Summary • COVAX Allocation Round 4 concerns the allocation of AstraZeneca/AZD1222-Vaxzevria (“AZ”)1 to resolve the second dose needs of COVAX Facility participants who were previously allocated AstraZeneca/Covishield™ (“SII”) in February 2021. These participants allocated SII doses were impacted by the unexpected global SII supply shortage and related shipment delays. As such, Round 4 is an exceptional round. Important considerations for this Round include the following: o The second dose needs for Round 4 were quantified by matching the equivalent number of doses delivered to affected participants in their first tranche shipment of the SII doses originally allocated to them in February 2021. These first tranche shipments were executed between February and April 2021. o In addition, five participants who had not received first shipments against their full SII allocation due to preparedness and/or supply issues have been exceptionally allocated AZ doses in this Round. o Supply needs for the Humanitarian Buffer are not factored into this fourth Allocation Round. This decision, made by the COVAX Allocation Leadership Group, is based on the principle that no doses should sit idle, and it reflects the fact that there were no applications for the Humanitarian Buffer at the time that Round 4 was run. Provisions to the Humanitarian Buffer will be made in following Allocation Rounds. • The overall number of AZ doses allocated in this Round is 17,366,400 doses to 43 participants.

1 Previously COVID-19 Vaccine AstraZeneca. Classified as Internal

Table of Contents Summary ...... 1 Table of Contents ...... 2 Purpose ...... 2 Overview of Allocations to Date ...... 3 Scope ...... 3 Round 4 Allocation Approach ...... 4 Supply Reserved for Allocation Round 4 ...... 6 Final Allocation ...... 6 Others – Shipment Considerations ...... 6 Conclusions ...... 7 Signatures ...... 7 ANNEX 1. Allocation Round 4 Results ...... 8 ANNEX 2. Past Allocations...... 14

Purpose This report documents the allocation of AstraZeneca/AZD1222-Vaxzevria (“AZ”)2 during the COVAX Allocation Round 4 to achieve the following: i.) To cover second dose needs of COVAX participants previously allocated AstraZeneca/Covishield™ (“SII”), who had used either the majority or the entirety of their first tranche shipment as first doses, rather than conserving half of the doses delivered to complete the vaccine regimen. These participants were subsequently impacted by the unexpected SII supply shortage3 and related delays in shipments. ii.) To service a small number of participants who had not received any shipment of SII doses due to preparedness and/or supply issues, in accordance with an approach developed by the cross-COVAX Facility SWAT4 team with JAT refinement for consistency. The importance of addressing second dose needs among participants emerged when COVAX participants largely reported using initial shipments of SII and AZ vaccines to target high priority populations with one dose in conformity with the WHO guidance note on Considerations for optimizing deployment of ChAdOx1-S [recombinant] vaccines in a time-limited constrained supply situation. Reduction in supply and related delays in shipments impacted participants’ ability to serve these populations with a second dose.

2 International Nonproprietary Name (INN): COVID-19 Vaccine (ChAdOx1-S [recombinant]) 3 https://www.gavi.org/news/media-room/covax-updates-participants-delivery-delays-vaccines-serum-institute--sii-az 4 The SWAT team is composed of senior representatives from the COVAX partner organizations (CEPI, Gavi, PAHO, UNICEF, and WHO). It is the primary body for operational decision making. The SWAT team’s role and responsibilities include, among others: i) to problem solve operational issues, developing proposals and scenarios to address them as they arise; ii) to escalate decisions to higher levels of COVAX governance, and iii) to coordinate the implementation of operational decisions with workstreams.

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Therefore, this Allocation Round primarily aims to ensure that participants receive the supply required to administer second doses to these target populations who received their first dose through the initial shipment of SII doses. Further guidance published in May 2021 on the implications of delayed shipments on the administration of second doses can be accessed in a technical note on the WHO website.

Overview of Allocations to Date To date, three COVAX Allocation Rounds have taken place, covering the period January to June 2021 (Q1- 2021 & Q2-2021). For an overview of all allocations preceding Round 4, please refer to Table 6 in ANNEX 2. Past allocations are used as one of the inputs informing the Round 4 allocation decision. In addition, since the conclusion of COVAX Allocation Round 3, four factors have changed several participants’ total population coverage through COVAX-secured doses, including: 1. The AstraZeneca/Covishield™ (“SII”) supply shortage; 2. Reallocation5 resulting from preparedness issues or refusals; 3. Redeployment6 of doses; and 4. Donations (“dose-sharing”) received and distributed by the COVAX Facility.7 The final Round 4 allocated volumes captured in this report will be used as inputs for total population coverage in the following Allocation Round.

Scope The scope of the current report is limited to AstraZeneca/AZD1222-Vaxzevria (“AZ”). Most participants included in Allocation Round 4 were those who received a first shipment of SII doses originally allocated to them during COVAX Allocation Round 2.8 Not all COVAX participants9 were prioritized for Round 4, as this exceptional Round’s primary objective is to cover second dose needs and to serve participants who did not receive any shipment against their original allocation of SII doses.

Given the above, Table 1 below shows the characteristics of the participants included in Round 4.

5 Reallocation involves redistributing doses allocated to one participant which is not prepared or not willing to receive these doses to another participant which is. There are different reasons for reallocation, including preparedness delays or refusals. Reallocation is necessary to avoid idle doses. 6 The redeployment of COVAX-secured doses allocated and delivered to a COVAX participant occurs when a participant is unwilling or unable to use the COVAX doses already in country to vaccinate individuals in the population. This is a process outside of the standard allocation mechanism and therefore is not managed by the Joint Allocation Taskforce. 7 These include donations from (for a cumulative total of 1,701,600 doses earmarked to 14 participants in the WHO AFR region) and a donation from (211,200 doses earmarked to 6 participants in the WHO WPR & SEAR regions). 8 During Round 2, 60 participants were allocated SII, among whom 47 received their first shipment of SII doses before the supply drop was communicated. 9 At the time of writing, there are 88 Advance Market Commitment (AMC) and 71 Self Financing (SFP) participants to the COVAX Facility.

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Table 1. Allocation Round 4 participants Eligible participants for Round 4 AMC SFP Total Participants who received a first shipment of SII allocated during 47 0 47 Round 2 − Participants who received a first shipment of SII and (8)* 0 (8)* additional doses through redeployment and donations to cover their second dose needs − Participants who received their first shipment, but who (1)* 0 (1)* requested a redeployment of their doses Participants who did not receive a first shipment of SII allocated 5 0 5 during Round 2 and who are included in Round 4 TOTAL Round 4 eligible participants 43 0 43 Note: *( ) number deducted from the total number of participants eligible to the round.

Round 4 Allocation Approach The approach to Allocation Round 4 was to address the immediate second dose needs of participants that had previously received one shipment of SII. To do this, the JAT manually allocated the exact quantity of doses to match the volume of SII doses delivered from February through April 2021. This was manually allocated in the Allocation Portal—meaning that, exceptionally, the algorithm was not used.

The exceptions to this allocation approach are detailed in Table 2 on the following page. In sum, there were five participants who were not shipped any portion of their Round 2 SII allocation because they either failed to complete all necessary post-allocation preparedness steps, thereby indicating that they were not ready to receive shipments, or because of the delays resulting from the global suspension of SII supply.

The COVAX Facility decided to include the following five participants to the list of Round 4 eligible participants, with AZ quantities and rationales as outlined below: • and : Both participants allocated 1,000,800 doses each, as there is not enough available AZ in Allocation Round 4 to fully cover the quantity of doses that the participants could have received as first shipment of doses allocated in Round 2. • and : Both participants allocated the quantity of doses that would have been shipped as their respective first tranche shipment of doses allocated in Round 2. • : The participant is allocated the total quantity initially allocated to them in Round 2, rounded to Allocation Round 4’s minimum allocation size of 100,000 doses.

The five participants outlined above met the preparedness requirements needed to receive AZ doses at the time that Round 4 was run. However, there are additional participants who did not receive any shipment of SII doses following Allocation Round 2 who remain unprepared to receive the AZ vaccine and, therefore, were not included as eligible participants in Round 4.10

10 The other participants who remain unprepared are , Democratic People's Republic of Korea (DPRK), , the , and .

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In Round 4, participants’ absorptive capacity11 was considered to minimize the risks of doses sitting idle and being wasted.

Table 2. Participants Who Did Not Receive a First Shipment and Rationale for Inclusion in Round 4 Participant Rationale Bangladesh • Participant did not receive a first shipment despite being ready • Round 4 allocation is 1,000,800 AZ doses, as there is not enough available overall supply to cover the full amount that the participant could have received as a first shipment for Round 2 • In Round 2, Bangladesh was allocated 10,908,000 SII doses Bhutan • Participant did not receive first shipment due to preparedness issues • Participant is now prepared and will receive the amount equivalent to their full Round 2 allocation, adjusted for Round 4’s minimum allocation size (R4: 108,000 doses) Haiti • Participant did not receive initial shipment due to preparedness issues • Participant is now prepared and will receive an amount equivalent to what their first shipment amount would have been (R4: 129,600 doses) Kyrgyzstan • Participant did not receive shipment due to preparedness issues • Participant is now ready and will receive an amount equivalent to what their first shipment amount would have been (R4: 228,000 doses) Pakistan • Participant did not receive a first shipment despite being ready • Round 4 allocation is 1,000,800 AZ doses, as there is not enough available overall supply to cover the full amount that the participant could have received as a first shipment for Round 2 • In Round 2, Pakistan was allocated 14,640,000 SII doses and subsequently received 2,474,400 AZ doses reallocated from other participants either unprepared or unwilling to receive them during the Round’s reallocation process

11 Absorptive capacity pertains to participants’ ability to administer doses received through the Facility before the doses’ expiry date, thereby avoiding doses being wasted or sitting idle. The main objective is to optimize the use of available doses, considering supply constraints.

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Supply Reserved for Allocation Round 4 The supply reserved for Round 4 was calculated based on: i) the overall Q3-2021 supply of AZ for the COVAX Facility, and ii) the estimated needs as described in the preceding sections of this report.

Table 3 below summarizes the overview of available supply for the product allocated in this Round:

Table 3. Overview of AZ Supply in Allocation Round 4 Product Name WHO EUL Date Supply Allocated in Round 4 Min. Shipment Size (doses) (doses)

AstraZeneca/AZD1222- 15 Feb 2021 17,366,400 2,400 Vaxzevria (“AZ”)

Information on supply availability was provided to the Joint Allocation Taskforce by the COVAX Procurement Coordinator, UNICEF Supply Division. This allocation proposal was approved by the Allocation Leadership Group on 8 June 2021. The remaining doses from the overall AZ supply for Q3 will be allocated during the next regular Allocation Round (i.e. Allocation Round 5). Considering these supply and demand characteristics the overall number of AZ doses allocated during this Allocation Round is 17,366,400 doses to 43 participants.

Final Allocation The final list of Round 4 allocations is available in ANNEX 1, Table 4. The average population coverage12 across all participants achieved with doses allocated in this round is 0.85%. The average cumulative coverage from Rounds 1 to 4 for these same participants is 1.75%. A descriptive statistics summary of the participants, their allocation, and total coverage is presented in ANNEX 1, Table 5. A summary of the proposed distribution is presented in ANNEX 1, Figures 1-3.

Others – Shipment Considerations The Allocation Framework includes principles for the prioritization of shipments for the distribution of doses allocated in a Round in order to facilitate the logistics planning. A stratified randomization approach is used for the development of this list to ensure that all participants are given an equal chance in the initial shipment queue.

12 The population-weighted average coverage across all participants in this round is 0.61%.

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For this round, given its specific aim, the proposition is to follow the same shipment order that was used for the first doses to limit delays in administering second doses. Participants that have not received any shipment yet would be positioned first in the order of shipments unless shipments are prioritized for other participants to ensure their ability to administer second doses within the WHO recommended timeframe. Date of shipment of first doses are provided in Table 9 in ANNEX 2.

Conclusions The JAT proposes the allocation amounts detailed in ANNEX 1. This proposal has been validated by the COVAX Allocation Leadership Group on 8 June 2021. Considering the exceptional circumstances for Round 4, this proposal does not require approval from the Independent Allocation of Vaccines Group (IAVG). The outcomes of Allocation Round 4 will be taken into account to inform Allocation Round 5.

Signatures

Signature Assistant Director General, Signature Managing Director, Access to Medicines and Health Products, WHO Office of the COVAX Facility, Gavi

Provided via email Provided via email

Mariângela SIMÃO Aurélia NGUYEN

On date: 8 June 2021 On date: 7 June 2021

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ANNEX 1. Allocation Round 4 Results

Table 4. Final List of Round 4 Allocations (N=43)13

Participant name WHO Region COVAX Doses Allocated Participation Model

Afghanistan EMR AMC92 468,000 AFR AMC92 129,600 Bangladesh SEAR AMC92 1,000,800 AFR AMC92 93,600 Bhutan SEAR AMC92 108,000 (Plurinational State of) AMR AMC92 228,000 WPR AMC92 324,000 AFR AMC92 391,200 AFR AMC92 12,000 Côte d'Ivoire AFR AMC92 355,200 EMR AMC92 24,000 AFR AMC92 1,792,800 Gambia AFR AMC92 36,000 AFR AMC92 249,600 AFR AMC92 194,400 Guinea-Bissau AFR AMC92 28,800 Haiti AMR AMC92 129,600 AFR AMC92 765,600 Kyrgyzstan EUR AMC92 228,000 Lao People's Democratic WPR AMC92 132,000 Republic AFR AMC92 96,000 AFR AMC92 360,000 SEAR AMC92 12,000 AFR AMC92 396,000 AFR AMC92 276,000 SEAR AMC92 348,000 AMR AMC92 134,400 AFR AMC92 254,400 AFR AMC92 3,924,000 Pakistan EMR AMC92 1,000,800

13 The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

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Senegal AFR AMC92 139,200 AFR AMC92 96,000 EMR AMC92 192,000 South AFR AMC92 60,000 SEAR AMC92 264,000 Sudan EMR AMC92 828,000 Syrian Arab Republic14 EMR AMC92 256,800 EUR AMC92 192,000 AFR AMC92 16,800 AFR AMC92 688,800 EUR AMC92 660,000 EMR AMC92 360,000 AFR AMC92 120,000

14 A proportion of the doses allocated will be delivered for distribution through international partners in the humanitarian response, given the unique context.

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Table 5. Descriptive Statistics Summary of the Participants, Their Allocation, and Total Coverage

Coverage for round Total Participants AMC92 participants participants 43 100% 0.6%

Participation Model Average Max Min Average Max Min AMC92 participants 0.85 6.99 0.1 1.75 7.37 0.33 OVERALL 0.85 6.99 0.1 1.75 7.37 0.33

Total Equity Deviation Preference Deviation Unique Product 0.0014 0 0

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Figure 1. Round 4 Population Coverage

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Figure 2. Overall Population Coverage after Rounds 1-4 (Only Round 4 Participants)

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Figure 3. Overall Population Coverage for All COVAX Participants Having Received Allocations

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ANNEX 2. Past Allocations

Table 6. Allocations to Date

Allocation Product Name WHO EUL Allocation Doses Allocated Doses Allocated Description Round Date Approval Adjusted for Supply Date Shortages and Redeployments

COVAX-1 COMIRNATY, 30 Dec 2021 29 Jan 2021, 1,200,420 1,200,420 Feb-Mar 2021 INN: Tozinameran

COVAX-2 AstraZeneca/AZD1222, 15 Feb 2021 23 Feb 2021, 75,996,000 75,412,800 AZ and SII-AZ Jan-May INN: COVID-19 Vaccine (ChAdOx1-S IAVG 2021 [recombinant]) COVAX-2 AstraZeneca/COVISHIELD™, 15 Feb 2021 23 Feb 2021, 161,472,000 29,862,600 AZ and SII-AZ Jan-May INN: COVID-19 Vaccine (ChAdOx1-S IAVG 2021 [recombinant]) COVAX-3 COMIRNATY, 30 Dec 2021 15Mar 2021, 14,109,030 14,109,030 Pfizer Apr-Jun 2021 INN: Tozinameran IAVG

Dose AstraZeneca/AZD1222, 15 Feb 2021 07 May 2021 1,912,800 1,912,800 Donations received sharing INN: COVID-19 Vaccine (ChAdOx1-S 12 May 2021 and allocated to date donations [recombinant]) 19 May 2021 TOTALS 254,690,250 122,497,650

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Table 7. Dose Sharing Donations Received Prior to Round 4

Source of Recipient of Shared WHO Region COVAX Doses Allocated Shared Doses Doses* Participation Model

France AFR AMC92 115,200 France Cabo Verde AFR AMC92 31,200 France AFR AMC92 14,400 France Ethiopia AFR AMC92 391,200 France Kenya AFR AMC92 182,400 France AFR AMC92 36,000 France AFR AMC92 105,600 France Mozambique AFR AMC92 108,000 France AFR AMC92 117,600 France São Tomé and AFR AMC92 24,000 Principe France AFR AMC92 184,800 France Somalia EMR AMC92 108,000 France Uganda AFR AMC92 175,200 France Zambia AFR AMC92 108,000 New Zealand WPR AMC92 2,400 New Zealand WPR AMC92 146,400 New Zealand WPR AMC92 28,800 New Zealand Timor-Leste SEAR AMC92 24,000 New Zealand WPR AMC92 4,800 New Zealand WPR AMC92 4,800

*Note: All donations distributed through the COVAX dose-sharing mechanism have taken place between Allocation Rounds 3 and 4 at the time of report writing.

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Table 8. Round 2 – Allocated Doses vs Delivered Doses & Date of Shipment of Round 2 SII Doses

Total Allocated Delivered Delivery Date Participant Quantity Quantity (M/DD/YYYY)

2,580,000 468,000 3/05/2021 10,908,000 Bangladesh 792,000 144,000 3/07/2021 Benin 108,000 - Bhutan 672,000 228,000 3/18/2021 Bolivia 1,380,000 - Burkina Faso 108,000 24,000 3/08/2021 Cabo Verde 1,104,000 324,000 3/01/2021 Cambodia 1,752,000 391,200 2/25/2021 Cameroon 1,080,000 - Chad 108,000 12,000 4/11/2021 Comoros 360,000 - Congo, Rep. 1,740,000 504,000 2/24/2021 Côte d'Ivoire 1,704,000 - Democratic People's Republic of Korea 5,928,000 1,716,000 2/28/2021 Democratic Republic of the Congo 108,000 24,000 3/04/2021 Djibouti 108,000 12,000 3/10/2021 Eswatini 7,620,000 2,184,000 3/06/2021 Ethiopia

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Total Allocated Delivered Delivery Date Participant Quantity Quantity (M/DD/YYYY)

156,000 36,000 2/28/2021 Gambia 864,000 194,000 4/09/2021 Guinea 120,000 28,800 4/09/2021 Guinea-Bissau 756,000 - Haiti 49,992,000 10,000,000 1/29/2021 India 3,564,000 1,020,000 3/01/2021 Kenya 432,000 - Kyrgyzstan 480,000 132,000 3/17/2021 Lao People's Democratic Republic 132,000 36,000 3/1/2021 Lesotho 324,000 96,000 3/03/2021 Liberia 1,260,000 360,000 3/03/2021 Malawi 108,000 12,000 3/05/2021 Maldives 1,332,000 396,000 3/02/2021 Mali 300,000 69,600 4/11/2021 Mauritania 2,064,000 384,000 3/06/2021 Mozambique 3,600,000 - Myanmar 1,920,000 348,000 3/05/2021 Nepal 432,000 135,000 3/14/2021 Nicaragua 1,596,000 355,200 4/11/2021 Niger

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Total Allocated Delivered Delivery Date Participant Quantity Quantity (M/DD/YYYY)

13,656,000 3,924,000 3/01/2021 Nigeria 588,000 132,000 4/09/2021 Papua New Guinea 744,000 240,000 3/01/2021 Rwanda 96,000 24,000 3/01/2021 São Tomé and Principe 1,104,000 324,000 3/01/2021 Senegal 528,000 96,000 3/05/2021 Sierra Leone 108,000 24,000 3/16/2021 Solomon Islands 1,044,000 300,000 3/04/2021 Somalia 732,000 132,000 3/21/2021 1,440,000 264,000 3/05/2021 Sri Lanka 2,904,000 828,000 3/02/2021 Sudan 1,152,000 256,800 4/21/2021 Syrian Arab Republic 624,000 192,000 3/07/2021 Tajikistan 3,024,000 864,000 3/03/2021 Uganda 2,256,000 660,000 3/14/2021 Uzbekistan 1,968,000 360,000 3/28/2021 Yemen 1,212,000 228,000 4/10/2021 Zambia 984,000 - Zimbabwe

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