CARPHA UPDATE FOR Incident Manager / SITUATION REPORT

COVID-19 Update Supplement Week of: 16th August, 2021

I. Overview of Development and Regulatory Approvals:

• 110 candidate 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). • There are 8 COVID-19 vaccines (6 different moieties) by 7 developers that have been approved by WHO for EUL to date: Table 3. • The WHO Strategic Advisory Group of Experts for has issued interim statements on 3 areas related to the use of COVID-19 vaccines on 10th August, 2021:  COVID-19 Vaccine Booster Doses: The evidence remains limited and inconclusive on any widespread need for booster doses following a primary series.  Fractionated Doses (smaller volumes): SAGE considers there is currently insufficient evidence to recommend the use of fractional doses and at present constitutes this as an off-label use of the vaccine.  Heterologous priming (different vaccine product used for 2nd dose) for COVID-19 vaccines: WHO recommends that the same vaccine product should be used for both doses. If different COVID-19 vaccine products are inadvertently administered in the two doses, no additional doses of either vaccine are recommended. This should only be used if benefits outweigh the risks such as in situations of interrupted vaccine supply. WHO notes that while studies of immune responses are encouraging, they require cautious interpretation given the limited sample sizes and lack of follow up, especially related to safety data, and the uncertain relevance of immunological readouts in relation to clinical impact. • CARPHA-CRS has reviewed and recommended all of the WHO EUL COVID-19 vaccines to Member States to date, with updates inclusive of additional sites approved for Moderna COVID-19 mRNA Vaccine – Table 3. • CARPHA’s COVID-19 vaccine regulatory tracker provides vaccine profiles, and regulatory approvals for various candidate vaccines and therapeutics.

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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 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 + 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, 13th August, 2021. Available at: Draft landscape of COVID-19 candidate vaccines (who.int).

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 16th August, 2021. Guyana received 38,400 doses of the AstraZeneca COVID-19 vaccine in their third roll out through the COVAX facility, and an additional 19,200 doses as a donation from the French Government on 14th August, 2021. Approximately 2,032,800 doses have been delivered through the COVAX facility to date to CARPHA Member States. . Based on data collected by the Global Change Data Lab’s Our World in Data site, between 4.6% and 74% 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 13th August, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 0.17 to 157.2 doses per capita (Figure 4). Approximately 3,275,501 doses have been administered, with an average of 40.5 doses per capita among CMS – Table 2.

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FIGURE 1: Share of People vaccinated against COVID-19 in CARICOM Member States (15th August)

FIGURE 2: Share of People vaccinated against COVID-19 in CARICOM Associates / Other CARPHA Member States (14th August)

Source: https://ourworldindata.org/

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FIGURE 3: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 13th August, 2021 (PAHO)

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

FIGURE 4: COVID-19 Vaccine Doses Administered per 100 persons, as of 13th August, 2021

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Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 13th 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- 71 70, 129 CorV; Gamaleya- Sputnik V; SII- Covishield Aruba Janssen- Ad26.COV 2.5; Pfizer BioNTech - 131.7 141, 205 Comirnaty Bahamas AstraZeneca – Vaxzevria; SII- Covishield 110, 443 27.8 Barbados AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 63.8 183, 493 CorV; SII- Covishield Bonaire Pfizer BioNTech - Comirnaty 28, 717 142.8 Belize AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 50.7 205, 129 CorV; SII- Covishield Bermuda AstraZeneca – Vaxzevria; Pfizer BioNTech - 115.7 82, 297 Comirnaty Cayman Islands Pfizer BioNTech - Comirnaty 99, 194 157.2 Curacao AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 108.1 Pfizer BioNTech - Comirnaty 178, 217

Dominica AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 54.9 40, 795 CorV; SII- Covishield Grenada AstraZeneca – Vaxzevria; SII- Covishield 39, 121 34.6 Guyana AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 53.8 CorV; Gamaleya- Sputnik V; Moderna- mRNA- 425, 580 1273; SII- Covishield Haiti Moderna- mRNA-1273; Janssen- Ad26.COV 2.5 19, 182 0.2 Jamaica AstraZeneca – Vaxzevria; SII- Covishield 391, 076 13.2 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, 705 86.2 Sint Maarten AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 106 47, 084 Pfizer BioNTech - Comirnaty St. Kitts & Nevis AstraZeneca – Vaxzevria; SII- Covishield 43, 966 81.2 St. Lucia AstraZeneca – Vaxzevria; SII- Covishield 59, 319 32.2 St. Vincent & Gamaleya - Sputnik V; AstraZeneca – Vaxzevria; 25.2 28, 063 Grenadines Pfizer BioNTech – Comirnaty; SII- Covishield Suriname AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 45.3 267, 959 CorV; SII- Covishield Trinidad & Tobago AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 50.6 709, 963 CorV; Pfizer BioNTech – Comirnat; SII- Covishield Turks and Caicos Pfizer BioNTech - Comirnaty 49, 107 86.1 Virgin Islands AstraZeneca – Vaxzevria; Janssen- Ad26.COV 2.5 76.4 29, 172 (British) Source: PAHO COVID-19 Vaccination in the Americas Dashboard.

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Table 3: 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; 68 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 + National Inactivated 2 doses 2°C to 8°C (24 mo.) 60 countries Approved: 7th May Pharmaceutical Group + virus I.M.

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Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: Beijing Institute of Biological including China, Bahrain, United Arab Emirates, Egypt, Products (BBIBP-CorV) Jordan, Iraq, , Serbia, Peru, Argentina, Chile, Guyana, Trinidad & Tobago

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 71 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) (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)

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Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: Anhui Zhifei Longcom Recombinant 2 or 3 2⁰C to 8⁰C 2 countries: China, Response to 2nd EOI sent 29 Biopharmaceutical, China + (protein Doses I.M. Jan 2021. Additional IMBCAMS (ZF2001) subunit) information requested

Bharat Biotech + Indian Whole virion 2 Doses 2°C to 8°C 9 countries: India, , Zimbabwe, Nepal, Mauritius, Rolling data started 06 July Council of Medical Research inactivated I.M. Mexico, Guyana, Paraguay, Philippines 2021 (ICMR) () 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 – SARS-CoV-2 2 doses 2°C to 8°C None to date In discussion on submission (Soberana 01, I.M. strategy and timelines Soberana Plus, ) ¥ - 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 13th 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, 13th 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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