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CARPHA UPDATE FOR Incident Manager / SITUATION REPORT

COVID-19 Update Supplement Week of: 28th June, 2021

I. Overview of Development and Regulatory Approvals:

• 104 candidate are in clinical development: 18 in Phase 3 trials, and 5 in Phase 4 trials – Table 1; Figure in COVID-19 Vaccines and Therapeutics Regulatory Tracker (Phases tab). • 18 vaccines have received regulatory approvals in various countries, and 18 are at various stages of engagement with WHO for emergency use listing (EUL) including vaccines made in (Soberana, ). Performance of various vaccines against variants of concern is shown in Table 2. • 8 vaccines have been approved by WHO for EUL to date: -BioNTech’s vaccine: COMIRNATY®, AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), Janssen-Cilag, AstraZeneca (Vaxzevria™), Moderna (mRNA-1273), Sinopharm-BIBP and Sinovac COVID-19 vaccine – CoronaVac: Table 4. • Tozinameran COVID-19 vaccine (COMIRNATY™) by Pfizer-BioNTech may be given to persons 12 years and older, following an extraordinary meeting of the WHO Strategic Advisory Group of Experts on (SAGE) on 27th May, 2021. The updated Interim recommendations refer. • Interim recommendations by the SAGE may be found at: SAGE COVID-19 materials. • CARPHA’s COVID-19 vaccine regulatory tracker provides vaccine profiles, and regulatory approvals for various candidate vaccines and therapeutics. • CARPHA-CRS has recommended 7 COVID-19 vaccines to Member States to date, and is finalizing the recommendation for the 8th vaccine: CoronaVac by Sinovac Life Sciences – Table 4.

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

Platform Description WHO Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 Phase 4 Total EUL PS Protein subunit 8 11 6 2 6 0 33 0

VVnr Viral Vector (non-replicating) 7 4 0 1 2 2 16 4 DNA DNA 4 3 0 2 1 0 10 0 IV Inactivated Virus 4 2 1 1 7 1 16 2

RNA RNA 8 2 3 0 2 2 17 2 VVr Viral Vector (replicating) 0 1 1 0 0 0 2 0 VLP Virus Like Particle 2 2 0 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 36 28 10 7 18 5 104 8 Source: World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 25th June 2021. Available at: Draft landscape of COVID-19 candidate vaccines (who.int).

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Table 2: Vaccine performance against variants of concern (VOC) relative to ancestral stains (22 June)

Developers Alpha (B.1.1.7) Beta (B.1.351) Gamma (P.1) Delta (B.1.617.2) (Vaccine name) Impacts on vaccine efficacy/effectiveness Protection retained Reduced protection Protection likely against Protection likely against against disease against disease, disease, very limited disease (for B.1.617.2), limited evidence evidence on only one very limited evidence on vaccine only two vaccines AstraZeneca- • Symptomatic Mild-moderate • Severe disease: Vaxzevria disease: No/minimal disease: Inconclusive/ No/minimal loss loss substantial loss, • Symptomatic disease • Asymptomatic limited sample size and : No/minimal infection: to moderate loss Inconclusive/ moderate/ substantial loss, limited sample size Pfizer BioNTech- Severe disease, • Severe disease: Symptomatic disease: • Severe disease: Comirnaty Infection & No/minimal loss no/minimal to modest No/minimal loss Symptomatic loss: single dose • Symptomatic disease disease, and • Infection: Moderate and Infection: Asymptomatic loss No/minimal to modest loss infection: • Infection: No/minimal No/minimal loss to moderate loss Sinovac - Symptomatic Disease CoronaVac and Infection: No/minimal loss Janssen • Severe disease: Ad26.COV 2.5 No/minimal loss: • Mild-moderate disease: No/minimal loss Moderna-mRNA- Symptomatic disease: 1273 no/minimal to modest loss: single dose - Symptomatic Mild-moderate Covavax disease: No/minimal disease: Moderate loss: loss Impacts on neutralization by vaccine AstraZeneca- Minimal/moderate Moderate to No/minimal loss Substantial loss: single Vaxzevria loss substantial loss dose Pfizer BioNTech- No/minimal loss Minimal to substantial Minimal/moderate loss No/Minimal to moderate Comirnaty loss: loss

Sinovac - No/minimal loss Minimal/modest loss No/minimal loss CoronaVac Beijing CNPG- No/minimal loss Minimal/modest loss BBIBP-CorV Moderna-mRNA- No/minimal loss Minimal to substantial Minimal/moderate loss 1273 loss

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Developers Alpha (B.1.1.7) Beta (B.1.351) Gamma (P.1) Delta (B.1.617.2) (Vaccine name) No/minimal loss Minimal/modest loss No/minimal loss Bharat- No/Minimal to moderate loss Gamaleya- No/minimal loss Moderate to Sputnik V substantial loss Novavax- No/minimal loss Moderate to Covavax substantial loss Janssen Moderate to Modest loss Ad26.COV 2.5 substantial loss Anhui ZL - Minimal/modest loss Recombinant Extracted from WHO Weekly Epidemiological Update 22nd June, 2021. Available at: https://www.who.int/publications/m/item/weekly- epidemiological-update-on-covid-19---22-june-2021

II. Vaccine Deployment in the Caribbean

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

▪ 14 Caribbean countries have received vaccine deliveries from COVAX as of 28th June, 2021. ▪ Based on data collected by the Global Change Data Lab’s Our World in Data site, between 2.6% and 66% of persons in CARPHA Member States have been fully vaccinated against COVID-19 (Figure 1). Completed schedules, based on data from PAHO are shown in Figure 2. ▪ Based on the PAHO Dashboard of COVID-19 in the Americas as of 25th June, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 8.4 to 142 doses per capita (Figure 3). Approximately 2,211,162 doses have been administered, with an average of 62 doses per capita among CMS – Table 3.

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FIGURE 1: Share of People vaccinated against COVID-19 in CARPHA Member States (27 June)

Source: https://ourworldindata.org/

FIGURE 2: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 25th June, 2021 (PAHO)

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

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FIGURE 3: COVID-19 Vaccine Doses Administered per 100 persons, as of 25th June, 2021

Table 3: COVID-19 Vaccines Deployed Among CARPHA Member States as of 25th June, 2021

Country ¥ Vaccine(s) Number of Doses Doses per 100 persons Anguilla AstraZeneca - Vaxzevria 15, 789 85.7 Antigua & Barbuda AstraZeneca – not specified 63, 755 64.6 Aruba Information not available 125, 182 116.8 Bahamas AstraZeneca – not specified 79, 246 20 Barbados AstraZeneca – not specified 161, 059 56 Bonaire Pfizer BioNTech - Comirnaty 26, 941 134 Belize AstraZeneca – not specified 106, 010 26.2 Bermuda Information not available 78, 413 108.9 Cayman Islands Pfizer BioNTech - Comirnaty 89, 619 142 Curacao Pfizer BioNTech - Comirnaty 165, 545 100.5 Dominica Beijing CNBG – Inactivated; AstraZeneca – not 52.9 39, 309 specified Grenada AstraZeneca – not specified 31, 494 27.9 Guyana Information not available 335, 091 42.4 Jamaica AstraZeneca – not specified 249, 938 8.4 Montserrat AstraZeneca - Vaxzevria 2, 640 48.9 Saba Information not available 1, 300 67.3 Sint Eustatius Information not available 2, 348 74.8 Sint Maarten Pfizer BioNTech - Comirnaty 38, 290 86.2 St. Kitts & Nevis AstraZeneca – not specified 35, 659 65.8 St. Lucia AstraZeneca – not specified 51, 849 28.1

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Country ¥ Vaccine(s) Number of Doses Doses per 100 persons St. Vincent & Gamaleya - Sputnik V; AstraZeneca – not 21.5 23, 970 Grenadines specified Suriname AstraZeneca – not specified 184, 583 31.2 Trinidad & Tobago Beijing CNBG – Inactivated; AstraZeneca – not 17.4 243, 574 specified Turks and Caicos Pfizer BioNTech - Comirnaty 38, 110 66.8 Virgin Islands (British) AstraZeneca - Vaxzevria 21, 403 56.1 Source: PAHO COVID-19 Vaccination in the Americas Dashboard. ¥ No information on doses/100p found for Haiti.

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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 + 89 countries including United December 2020 (completed) (INN: tozinameran; BNT162b2 I.M. Store: -25°C to -15°C Kingdom, Canada, Mexico, USA, Chile, Argentina, / COMIRNATY) (2wk); 2⁰C to 8⁰C Switzerland, EU, Colombia, Israel, Australia, Brazil, (12h) Guyana, Cayman Islands, Aruba, Bermuda, Curacao, St Maarten, Turks/Caicos, Guyana, Suriname, St Vincent & 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 + Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 43 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; Covishield) vector Barbados, Bahamas, Guyana, Trinidad & Tobago, 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 + 52 countries including: USA, Canada, South Approved: 12th March; Johnson) (JNJ-78436735) (non-replicating) 25°C (12h); Open: 2- Africa, Bahrain, Colombia, via COVAX/ PAHO; African Aspen South Africa: May 2021 8°C (6h) or 25°C (2h). Medical Supplies Platform (AMSP), Mexico, St Vincent Other sites: Pending & Grenadines, MHRA, Swissmedic, Brazil, MPA, AEMPS.

AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 115 countries including UK, Approved: 16th April University (AZD1222) ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), VAXZEVRIA™ adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), vector Guyana; via COVAX/ PAHO Moderna & NIAID mNRA-based in 2 doses Ship: -25°C to -15°C; 53 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) Sinopharm + China National Inactivated virus 2 doses 2°C to 8°C (24 mo.) 53 countries including China, Bahrain, United Arab Approved: 7th May Pharmaceutical Group + I.M. Emirates, Egypt, Jordan, Iraq, Pakistan, Serbia, Peru, Beijing Institute of Biological Argentina, Chile, Guyana, Trinidad & Tobago Products (BBIBP-CorV)

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Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: Pending review by CRS Sinovac COVID-19 vaccine Inactivated virus 2 doses 2°C to 8°C 29 countries including China, Colombia, Turkey, Approved: 1st June (Vero Cell [Inactivated]) – I.M. Indonesia, Brazil, Chile, México, Guyana CoronaVac WHO EUL status – Pending/Not under review yet (Not eligible for CRS review) Gamaleya Research Institute Adenovirus Viral 2 doses 2°C to 8°C 68 countries including Russia, Argentina, Guinea, Anticipated date will be set & Russian Health Ministry vector (non- I.M. Bolivia, Venezuela, Paraguay, México, Belize, Guyana, St once all data is submitted and (Sputnik V) replicating) Vincent & Grenadines, Antigua & Barbuda follow-up of inspection observations completed. AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C WHO EUL + CRS + 115 countries including UK, Anticipated date will be set University [PMDA] ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), once all information has been adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), received. vector Guyana; via COVAX/ PAHO

AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C WHO EUL + CRS + 115 countries including UK, Anticipated date will be set University [TAG] ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), once all information has been adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), received. vector Guyana; via COVAX/ PAHO

CanSino Biological Inc + Adenovirus; 1 dose I.M. 2°C to 8°C 8 countries: China, Mexico, Pakistan, Hungary, Chile, Rolling data review starting in Beijing Institute of Biological Viral vector Argentina June 2021 Products (non-replicating) (Convidicea (Ad5-nCoV)) 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 virus 2 doses 2°C to 8°C 2 countries: China, United Arab Emirates Presubmission meeting held Pharma. Group + Wuhan I.M. Institute of Biol. Products CureVac (Zorecimeran: mRNA-based in 2 doses 2°C to 8°C None to date Pre-submission meeting: CVnCoV/CV07050101) lipid I.M. Planned for 15 July 2021, nanoparticle based on company request Vector State Research Ctre of 2 doses 2°C to 8°C 2 countries: Russia, Turkmenistan Pending expression of interest Virology and Biotech. 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: + Indian Whole virion 2 Doses 2°C to 8°C 9 countries: India, , Zimbabwe, Nepal, Mauritius, Pre-submission meeting: To Council of Medical Research inactivated I.M. Mexico, Guyana, Paraguay, Philippines be planned for 23 June 2021 (ICMR) (Covaxin) Sanofi Pasteur CoV2 preS Recombinant, 2 Doses 2°C to 8°C None to date Planning in process 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, 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 22nd June 2021. Available at: https://covid19.trackvaccines.org/.

World Health Organization. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. Updated 16th June 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, 25th June 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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