COVID-19 Update Supplement Week of: 7th June, 2021

I. Overview of Development and Regulatory Approvals:

• 102 candidate vaccines are in clinical development: 18 in Phase 3 trials, and 5 in Phase 4 trials – see Figure in CARPHA COVID-19 Regulatory Tracker (Phases tab). • 18 vaccines have received regulatory approvals in various countries, and 18 vaccines are at various stages of engagement with WHO for emergency use listing (EUL). • 8 vaccines have been approved by WHO for EUL to date: Pfizer-BioNTech’s vaccine: COMIRNATY®, AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), Janssen-Cilag, AstraZeneca (EU node; Vaxzevria™), Moderna (mRNA-1273, nucleoside modified), Sinopharm-BIBP and Sinovac COVID- 19 vaccine (Vero Cell [Inactivated]) – CoronaVac for EUL: Table 2. Vaccines manufactured in Cuba are listed for EUL consideration, but these are pending assessment. • COVID-19 vaccine interim recommendations by the WHO’s Strategic Advisory Group of Experts on (SAGE) for reviewed vaccines may be found at: SAGE COVID-19 materials. • See Variants of Concern and Vaccine Efficacy – Table 2. On 31st May, the World Health Organization assigned easy-to-say names to the variants of concern to reduce the stigma and discrimination that may arise with country-based nomenclature. • CARPHA has shared its COVID-19 vaccine regulatory tracker with Member States for viewing as updates are made. • CARPHA-CRS has recommended 6 COVID-19 vaccines to Member States to date – Table 3. The CRS is finalizing its review of the COVID-19 Vaccine BIBP by Sinopharm for recommendation to CARPHA Member States and will begin its review of Sinovac COVID-19 vaccine (Vero Cell [Inactivated]) – CoronaVac this week.

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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 7th June, 2021. Antigua & Barbuda are expected to receive 16,800 doses of the AstraZeneca AB COVID-19 Vaccine on 9th June, 2021 in their second 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 5.3% and 68% of populations among CARPHA Member States (where available) have received at least one dose of COVID-19 vaccines (Figure 1). ▪ Based on the PAHO Dashboard of COVID-19 in the Americas as of 4th June, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 7.7 to 133.1 doses per capita (Figure 2). Approximately 1,725,704 doses have been administered, with an average of 53.7 doses per capita among CMS – Table 3, Figure 4.

FIGURE 1: Share of population who received at least one dose of COVID-19 Vaccines in CARPHA Member States

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FIGURE 2: Doses of COVID-19 Vaccine per 100 population as of 4th June, 2021

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Table 1: COVID-19 Vaccines Deployed Among CARPHA Member States as of 4th June, 2021

Country ¥ Vaccine(s) Total Doses Doses per 100 persons Anguilla AstraZeneca - AZD1222 14, 557 79 Antigua & Barbuda SII - Covishield 51, 811 52.5 Aruba Pfizer-BioNTech – Comirnaty 116, 549 108.7 Bahamas SII - Covishield 52, 037 13.1 Barbados SII - Covishield 141, 282 49.1 Bonaire Pfizer BioNTech - Comirnaty 24, 152 122.8 Virgin Islands (British) AstraZeneca - AZD1222 17, 866 46.8 Belize SII - Covishield 77, 607 19.2 Bermuda Pfizer BioNTech - Comirnaty 70, 731 98.2 Cayman Islands Pfizer BioNTech - Comirnaty 83, 970 133.1 Curacao Pfizer BioNTech - Comirnaty 155, 292 94.6 Dominica SII – Covishield; Beijing CNBG - Inactivated 37, 700 50.7 Grenada SII - Covishield 26, 975 23.9 Guyana SII – Covishield; Beijing CNBG - Inactivated 277, 989 35.2 Jamaica SII – Covishield; AstraZeneca (SK Bio, AB) 208, 696 7 Montserrat AstraZeneca - AZD1222 2, 569 47.5 Saba Information not available 1, 300 67.3 Sint Eustatius Information not available 1, 173 37.4 Sint Maarten Pfizer BioNTech - Comirnaty 32, 025 72.1 St. Kitts & Nevis SII - Covishield 28, 980 53.5 St. Lucia SII - Covishield 47, 124 25.6 St. Vincent & Grenadines SII – Covishield; Gamaleya - Sputnik V 21, 331 19.2 Suriname SII - Covishield 90, 052 15.2 Trinidad & Tobago SII – Covishield; AstraZeneca (SK Bio) 107, 766 7.7 Turks and Caicos Pfizer BioNTech - Comirnaty 36, 170 63.4 Source: PAHO COVID-19 Vaccination in the Americas Dashboard. ¥ No information on doses/100p found for Haiti.

FIGURE 3: Completed Schedules of COVID-19 Vaccine per 100 population as of 4th June, 2021

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FIGURE 4: Doses of COVID-19 Vaccines administered in CARPHA Member States, as of 4th June, 2021.

See Table 2 for number of doses per country.

Table 2: Summary of vaccine performance against variants of concern (VOC) relative to ancestral stains

Alpha (B.1.1.7) * Beta (B.1.351) Gamma (P.1) Delta (B.1.617.2) Efficacy/effectiveness against disease or Protection retained against Reduced protection against Protection likely against Protection likely against disease disease, disease, very limited disease (for B.1.617.2), • Severe disease: limited evidence evidence on only one very limited evidence on No/minimal loss: Pfizer • Severe disease: vaccine only two vaccines BioNTech-Comirnaty No/minimal loss: • Symptomatic Disease: Janssen Ad26.COV 2.5, o No/minimal loss: Symptomatic Disease: • Infection & symptomatic PfizerBioNTech-Comirnaty SinovacCoronaVac B.1.617.2: disease: o No/minimal loss: o No/minimal loss: • Mild-moderate disease: Infection: AstraZeneca- Vaxzevria AstraZeneca-Vaxzevria, o Moderate loss: Janssen- o No/minimal loss: after one dose and Pfizer Novavax-Covavax, Pfizer- Ad26.COV2.5, Novavax-Covavax SinovacCoronaVac BioNTech-Comirnaty BioNTech-Comirnaty o Inconclusive/substantial loss, after two doses limited sample size: AstraZeneca- • Asymptomatic infection: Vaxzevria o Minimal/modest loss: o No/minimal loss: Pfizer AstraZeneca- Vaxzevria BioNTech-Comirnaty. • Infection: after two doses o Inconclusive/moderate/ o Moderate loss: PfizerBioNTech- substantial loss, limited Comirnaty sample size: AstraZeneca- Vaxzevria • Asymptomatic infection: No evidence Antibody Neutralization • No/minimal loss: • Minimal/modest loss: • No/Minimal reduction: B.1.617 (sublineage Bharat-, Gamaleya- AstraZeneca-Vaxzevria, unspecified) Sputnik V, Moderna-mRNA- Sinovac-CoronaVac

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1273, Novavax-Covavax, Beijing CNBG-BBIBP-CorV, • Minimal/modest loss: Pfizer BioNTech-Comirnaty, Sinovac-CoronaVac, Anhui ZL - • Minimal/moderate Bharat-Covaxin Beijing CNBG-BBIBP-CorV, Recombinant reduction: Moderna- Sinovac-CoronaVac mRNA-1273, Pfizer B.1.617.1: • Minimal to large loss: BioNTech-Comirnaty • Minimal/modest loss: • Minimal/moderate loss: Moderna-mRNA-1273, Pfizer SII - Covishield AstraZeneca-Vaxzevria BioNTech-Comirnaty • Modest/moderate loss: • Moderate to substantial loss: Moderna-mRNA-1273, AstraZeneca-Vaxzevria, Gamaleya- Pfizer BioNTech Sputnik V, Novavax-Covavax Comirnaty B.1.617.2, B.1.617.3: No sublineage-specific evidence * On 31st May, the World Health Organization assigned easy-to-say names to the variants of concern. This is to reduce the stigma and discrimination that may arise with country-based nomenclature, which should no longer be used. See notice here: https://www.who.int/news/item/31-05-2021-who-announces-simple-easy-to-say-labels-for-sars-cov-2-variants-of-interest-and-concern.

Table content extracted from WHO Weekly Epidemiological Update 1st June, 2021. Available at: https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---1-june-2021

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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 + 85 countries including United Kingdom, December 2020 (completed) (INN: tozinameran; BNT162b2 I.M. Store: -25°C to -15°C Canada, Mexico, USA, , Argentina, Switzerland, EU, / COMIRNATY) (2wk); 2⁰C to 8⁰C Colombia, Israel, Australia, , Guyana, Cayman (12h) 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 Serum Institute of India + Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 40 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 + 42 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). Other sites: Pending

AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C (6 mo.) 99 countries including UK, Argentina, Mexico, Brazil, Approved: 16th April University (AZD1222) ChAdOx1-S I.M. EU, Canada (AZ Canada), Colombia, Chile, Anguilla, BVI, VAXZEVRIA™ adenoviral Montserrat (UK node), Guyana; via COVAX/ PAHO vector Moderna & NIAID mNRA-based in 2 doses Ship: -25°C to -15°C; 49 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) Pending review by CRS Sinopharm + China National Inactivated virus 2 doses 2°C to 8°C (24 mo.) 44 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 Products (BBIBP-CorV)

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Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: Sinovac COVID-19 vaccine Inactivated virus 2 doses 2°C to 8°C 25 countries including China, Colombia, , Approved: 1st June (Vero Cell [Inactivated]) – I.M. , 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, Information pending including & Russian Health Ministry vector (non- I.M. Bolivia, Venezuela, Paraguay, México, Belize, Guyana, St completed inspections (Sputnik V) replicating) Vincent & Grenadines, Antigua & Barbuda CanSino Biological Inc + Adenovirus; 1 dose I.M. 2°C to 8°C 5 countries: China, Mexico, Pakistan, Hungary, Chile Rolling data review starting in Beijing Institute of Biological Viral vector 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 Pre-submission meeting: Pharma. Group + Wuhan I.M. Planned for 14 June 2021 Institute of Biol. Products CureVac (Zorecimeran: mNRA-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 (LNP) 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

Bharat Biotech + Indian Whole virion 2 Doses 2°C to 8°C 9 countries: India, Iran, Zimbabwe, Nepal, Mauritius, Pre-submission meeting: To Council of Medical Research inactivated I.M. Mexico, Guyana, Paraguay, be planned in June 2021 (ICMR) (Covaxin) 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) ¥ - Storage information is provided primarily for sealed vials. See product information for additional details on storage and handling.

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References:

McGill COVID19 Vaccine Tracker. COVID-19 Vaccines. Updated 4th June 2021. Available at: https://covid19.trackvaccines.org/.

World Health Organization. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. Updated 3rd 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, 4th 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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