CARPHA UPDATE FOR Incident Manager / SITUATION REPORT

COVID-19 Vaccine Update Supplement Week of: 9th August, 2021

I. Overview of Development and Regulatory Approvals:

• 110 candidate vaccines are in clinical development: 19 in Phase 3 trials, and 8 in Phase 4 trials – Table 1; Figure in COVID-19 Vaccines and Therapeutics Regulatory Tracker (Phases tab). • 21 vaccines have received regulatory approvals in various countries, and 21 are at various stages of engagement with WHO for emergency use listing (EUL). • An additional vaccine node of Moderna COVID-19 mRNA Vaccine was approved for Emergency Use Listing on 6th August, which brings total of 8 vaccines and 4 vaccine nodes which have been approved by WHO for EUL to date: Tozinameran - COMIRNATY® (EMA), Tozinameran- Pfizer- BioNTech COVID-19 vaccine (US FDA), AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), Janssen- Cilag, AstraZeneca AB (Vaxzevria™; EMA), Moderna (mRNA-1273), Sinopharm-BIBP, Sinovac COVID-19 vaccine – CoronaVac, AstraZeneca-TGA, AstraZeneca-MHLW and ModernaTX, Inc- USFDA- Table 3. • CARPHA-CRS will provide an update to include the additional sites approved for Moderna COVID- 19 mRNA Vaccine this week to Member States. • CARPHA’s COVID-19 vaccine regulatory tracker provides vaccine profiles, and regulatory approvals for various candidate vaccines and therapeutics.

Table 1: Candidate Vaccines under Clinical evaluation, by type or platform.

WHO Platform Description Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 Phase 4 Total EUL PS Protein subunit 10 11 6 2 8 0 37 0 VVnr Viral Vector (non-replicating) 7 4 0 2 1 3 17 4

DNA DNA 4 3 0 2 1 0 10 0

IV Inactivated Virus 4 2 0 1 7 2 16 2 RNA RNA 8 2 2 1 2 3 18 2

VVr Viral Vector (replicating) 0 1 1 0 0 0 2 0

VLP Virus Like Particle 1 2 1 1 0 0 5 0 VVr + APC VVr + Antigen Presenting Cell 1 1 0 0 0 0 2 0

LAV Live Attenuated Virus 2 0 0 0 0 0 2 0

VVnr + APC VVnr + Antigen Presenting Cell 0 1 0 0 0 0 1 0

Total 37 27 10 9 19 8 110 8 Source: World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 6th August, 2021. Available at: Draft landscape of COVID-19 candidate vaccines (who.int).

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II. Vaccine Deployment in the Caribbean

Several Caribbean countries have approved / received COVID-19 vaccines purchases and/or donations.

▪ 15 CARPHA member states have received vaccine deliveries from COVAX as of 9th August, 2021. Suriname will also receive 26,400 doses on 9th August 2021, Trinidad & Tobago will receive 33,600 doses on 11th August, 2021 and Guyana will receive 38,400 doses on 14th August, 2021 of the Astra Zeneca COVID-19 Vaccine in their third roll out of vaccines through the COVAX facility. ▪ Based on data collected by the Global Change Data Lab’s Our World in Data site, between 4.47% and 73.21% of persons in CARPHA Member States have been fully vaccinated (Figures 1-2). Completed schedules, based on data from PAHO are shown in Figure 3. ▪ Based on the PAHO Dashboard COVID-19 Vaccination in the Americas as of 6th August, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 0.11 to 156 doses per capita (Figure 4). Approximately 3,076,506 doses have been administered, with an average of 38.1 doses per capita among CMS – Table 2.

FIGURE 1: Share of People vaccinated against COVID-19 in CARICOM Member States (8th August)

Source: https://ourworldindata.org/

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FIGURE 2: Share of People vaccinated against COVID-19 in CARICOM Associates / Other CARPHA Member States (8th August)

FIGURE 3: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 6th August, 2021 (PAHO)

Source: PAHO COVID-19 Vaccination in the Americas Dashboard.

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FIGURE 4: COVID-19 Vaccine Doses Administered per 100 persons, as of 6th August, 2021

Table 3: COVID-19 Vaccines Deployed Among CARPHA Member States as of 6th August, 2021

Country ¥ Vaccine(s) Doses per 100 Number of Doses persons Anguilla AstraZeneca - Vaxzevria 18, 457 100.2 Antigua & Barbuda AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 70.4 69, 518 CorV; Gamaleya- Sputnik V; SII- Covishield Aruba Janssen- Ad26.COV 2.5; Pfizer BioNTech - 129.4 138, 724 Comirnaty Bahamas AstraZeneca – Vaxzevria; SII- Covishield 108, 596 27.4 Barbados AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 61.5 177, 056 CorV; SII- Covishield Bonaire Pfizer BioNTech - Comirnaty 28, 536 141.9 Belize AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 47.5 192, 222 CorV; SII- Covishield Bermuda AstraZeneca – Vaxzevria; Pfizer BioNTech - 115.2 82, 976 Comirnaty Cayman Islands Pfizer BioNTech - Comirnaty 98, 419 156 Curacao AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 106.7 Pfizer BioNTech - Comirnaty 175, 900 Dominica AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 54.6 40, 553 CorV; SII- Covishield Grenada AstraZeneca – Vaxzevria; SII- Covishield 38, 233 33.8 Guyana AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 50.6 CorV; Gamaleya- Sputnik V; Moderna- mRNA- 400, 075 1273; SII- Covishield

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Country ¥ Vaccine(s) Doses per 100 Number of Doses persons Haiti Moderna- mRNA-1273; Janssen- Ad26.COV 2.5 12, 641 0.11 Jamaica AstraZeneca – Vaxzevria; SII- Covishield 369, 960 12.4 Montserrat AstraZeneca - Vaxzevria 2, 828 52.3 Saba Moderna- mRNA-1273 1, 300 67.3 Sint Eustatius Janssen- Ad26.COV 2.5; Moderna- mRNA-1273 2, 642 84.2 Sint Maarten AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 104.7 46, 497 Pfizer BioNTech - Comirnaty St. Kitts & Nevis AstraZeneca – Vaxzevria; SII- Covishield 43, 726 80.7 St. Lucia AstraZeneca – Vaxzevria; SII- Covishield 57, 509 31.2 St. Vincent & Gamaleya - Sputnik V; AstraZeneca – Vaxzevria; 25.2 28, 063 Grenadines Pfizer BioNTech – Comirnaty; SII- Covishield Suriname AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 43.1 255, 260 CorV; SII- Covishield Trinidad & Tobago AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 43.5 610, 775 CorV; Pfizer BioNTech – Comirnat; SII- Covishield Turks and Caicos Pfizer BioNTech - Comirnaty 47, 263 82.9 Virgin Islands AstraZeneca – Vaxzevria; Janssen- Ad26.COV 2.5 75.4 28, 777 (British) Source: PAHO COVID-19 Vaccination in the Americas Dashboard.

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Table 4: COVID-19 Vaccines with Regulatory Approvals by WHO EUL Consideration

Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: WHO EUL status – Approved Recommended by CRS Pfizer-BioNTech mRNA 2 doses Ship: -80⁰C to -60⁰C; WHO EUL + CRS + 97 countries including United Approved: 31st December INN: tozinameran; BNT162b2 I.M. Store: -25°C to -15°C Kingdom, Canada, Mexico, USA, Chile, Argentina, 2020 Commercial names: (2wk); 2⁰C to 8⁰C Switzerland, EU, Colombia, Israel, Australia, Brazil, COMIRNATY™; (12h) Guyana, Cayman Islands, Aruba, Bermuda, Curacao, St Additional sites approved: Pfizer-BioNTech COVID-19 Maarten, Turks/Caicos, Guyana, Suriname, St Vincent & 16th July, 2021 vaccine Grenadines. AstraZeneca-Oxford + SK Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + South Korea via COVAX / PAHO Approved: 15th February Bioscience (supplier)* ChAdOx1-S I.M. (AZD1222) adenoviral vector Serum Institute of India + Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 45 countries including India, Approved: 15th February AstraZeneca-Oxford ChAdOx1-S I.M. Argentina, Bangladesh, South Africa, Guyana, Canada University adenoviral (+VerityPharma), Brazil, OECS Member States, (AZD1222; vector Barbados, Bahamas, Guyana, Trinidad & Tobago, Commercial name: Covishield™ Suriname, Jamaica, Antigua & Barbuda, Dominica, Grenada, St Kits & Nevis, St Lucia, St Vincent & Grenadines. Janssen-Cilag (Johnson & Viral vector 1 dose I.M. Sealed: 2-8°C or 9- WHO EUL + 59 countries including: USA, Canada, South Approved: 12th March; Johnson) (JNJ-78436735) (non- 25°C (12h); Open: 2- Africa, Bahrain, Colombia, via COVAX/ PAHO; African replicating) 8°C (6h) or 25°C (2h). Medical Supplies Platform (AMSP), Mexico, St Vincent & Grenadines, MHRA, Swissmedic, Brazil, MPA, AEMPS.

AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 121 countries including UK, Approved: 16th April University (AZD1222) ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), Commercial name: adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), VAXZEVRIA™ vector Guyana; via COVAX/ PAHO Moderna & NIAID mNRA-based in 2 doses Ship: -25°C to -15°C; 65 countries including Canada, Switzerland, United Approved: 30th April (mRNA-1273) lipid I.M. Sealed: 2-8°C (30d) Kingdom, United States, EU, Guyana, St Vincent & INN: Elasomeran nanoparticle or 9-25°C (12h); Grenadines. (LNP) Open: 2-25°C (6h) ModernaTX, Inc/ USFDA Additional sites approved: 6th COVID-19 mRNA vaccine August, 2021 Sinopharm + China National Inactivated 2 doses 2°C to 8°C (24 mo.) 59 countries including China, Bahrain, United Arab Approved: 7th May Pharmaceutical Group + virus I.M. Emirates, Egypt, Jordan, Iraq, Pakistan, Serbia, Peru, Argentina, Chile, Guyana, Trinidad & Tobago

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Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: Beijing Institute of Biological Products (BBIBP-CorV) Sinovac COVID-19 vaccine Inactivated 2 doses 2°C to 8°C 39 countries including China, Colombia, Turkey, Approved: 1st June (Vero Cell [Inactivated]) – virus I.M. Indonesia, Brazil, Chile, México, Guyana Commercial name: CoronaVac AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C WHO EUL + CRS + 121 countries including UK, Approved: 9th July University (AZD1222)/ TGA, ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), Australia adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), vector Guyana; via COVAX/ PAHO

AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C WHO EUL + CRS + 121 countries including UK, Approved: 9th July University (AZD1222)/ MHLW, ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), Japan adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), vector Guyana; via COVAX/ PAHO WHO EUL status – Pending/Not under review yet (Not eligible for CRS review) Gamaleya Research Institute Adenovirus 2 doses 2°C to 8°C 70 countries including Russia, Argentina, Guinea, Anticipated date will be set & Russian Health Ministry Viral vector I.M. Bolivia, Venezuela, Paraguay, México, Belize, Guyana, St once all data is submitted and (Sputnik V) (non- Vincent & Grenadines, Antigua & Barbuda follow-up of inspection replicating) observations completed. CanSino Biological Inc + Adenovirus; 1 dose I.M. 2°C to 8°C 8 countries: China, Mexico, Pakistan, Hungary, Chile, Rolling data starting August Beijing Institute of Biological Viral vector Argentina 2021 Products (non- (Convidicea (Ad5-nCoV)) replicating) NOVAVAX (NVX-CoV2373) Protein subunit 2 doses 2°C to 8°C None to date Pre-submission meeting held I.M. Sinopharm + China National Inactivated 2 doses 2°C to 8°C 2 countries: China, United Arab Emirates Pre-submission meeting held Pharma. Group + Wuhan virus I.M. Institute of Biol. Products CureVac (Zorecimeran: mRNA-based in 2 doses 2°C to 8°C None to date Planned for Q4 of 2021 CVnCoV/CV07050101) lipid I.M. nanoparticle Vector State Research Ctre of Peptide 2 doses 2°C to 8°C 2 countries: Russia, Turkmenistan Pending expression of interest Virology and Biotech. vaccine I.M. (EpiVacCorona) Anhui Zhifei Longcom Recombinant 2 or 3 2⁰C to 8⁰C 2 countries: China, Uzbekistan Response to 2nd EOI sent 29 Biopharmaceutical, China + (protein Doses I.M. Jan 2021. Additional IMBCAMS (ZF2001) subunit) information requested

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Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: Bharat Biotech + Indian Whole virion 2 Doses 2°C to 8°C 9 countries: India, Iran, Zimbabwe, Nepal, Mauritius, Rolling data started 06 July Council of Medical Research inactivated I.M. Mexico, Guyana, Paraguay, Philippines 2021 (ICMR) (Covaxin) Sanofi Pasteur CoV2 preS Recombinant, 2 Doses 2°C to 8°C None to date Planned for 9 July 2021 dTM-AS03 vaccine adjuvanted I.M. Clover Biopharmaceuticals Protein subunit 2 doses 2°C to 8°C None to date In discussion on submission Inc. + GSK + Dynavax (SCB- I.M. strategy and timelines 2019) BioCubaFarma – Cuba SARS-CoV-2 2 doses 2°C to 8°C None to date In discussion on submission (Soberana 01, Soberana 02 spike protein I.M. strategy and timelines Soberana Plus, Abdala) ¥ - Storage information is provided primarily for sealed vials. See product information for additional details on storage and handling.

References:

McGill COVID19 Vaccine Tracker. COVID-19 Vaccines. Updated 6th August 2021. Available at: https://covid19.trackvaccines.org/.

World Health Organization. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. Updated 15th July 2021. WHO, Geneva, 2020. Available at: https://www.who.int/teams/regulation-prequalification/eul/covid-19.

World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 6th August 2021. Available at: Draft landscape of COVID-19 candidate vaccines (who.int).

World Health Organization. Emergency Use Listing Procedure for Vaccines. WHO, Geneva 2021. Available at: https://www.who.int/teams/regulation-prequalification/eul/eul- vaccines.

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