CARPHA UPDATE FOR Incident Manager / SITUATION REPORT COVID-19 Vaccines Update Supplement Week of: 21sth 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 – 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 Cuba. • 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 (Vaxzevria™), Moderna (mRNA-1273), Sinopharm-BIBP and Sinovac COVID-19 vaccine – CoronaVac: Table 4. • COVID-19 vaccine interim recommendations by the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) for reviewed vaccines may be found at: SAGE COVID-19 materials. • CARPHA’s COVID-19 vaccine regulatory tracker provides an overview of profiles and regulatory approvals for various candidate vaccines and therapeutics. This sheet includes information on the efficacy of the vaccines in light of current variants of concern, as per WHO updates. • CARPHA-CRS has recommended 7 COVID-19 vaccines to Member States to date – Table 4. The CRS has started its review of Sinovac COVID-19 vaccine (Vero Cell [Inactivated]) – CoronaVac. Table 1: Candidate Vaccines under Clinical evaluation, by type or platform. Platform Description Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 Phase 4 Total WHO EUL PS Protein subunit 8 11 5 2 6 0 32 0 VVnr Viral Vector (non- 7 4 0 1 2 2 16 4 replicating) DNA DNA 4 3 0 2 1 0 10 0 IV Inactivated Virus 4 2 1 1 7 1 16 2 RNA RNA 7 3 2 0 2 2 16 2 VVr Viral Vector 0 1 1 0 0 0 2 0 (replicating) VLP Virus Like Particle 2 2 0 1 0 0 5 0 VVr + APC VVr + Antigen 1 1 0 0 0 0 2 0 Presenting Cell LAV Live Attenuated 2 0 0 0 0 0 2 0 Virus VVnr + VVnr + Antigen 0 1 0 0 0 0 1 0 APC Presenting Cell Total 35 28 9 7 18 5 102 8 Source: World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 18th June 2021. Available at: Draft landscape of COVID-19 candidate vaccines (who.int). 1: 21.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 21st June, 2021. ▪ Based on data collected by the Global Change Data Lab’s Our World in Data site, between 1.05% and 62% of populations in CARPHA Member States (where available) have been fully vaccinated against COVID-19 – both doses (Figure 1). Completed schedules per 100 persons, based on data from PAHO are shown in Figure 2. ▪ Based on the PAHO Dashboard of COVID-19 Vaccination in the Americas as of 18th June, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 6.5 to 137.4 doses per capita (Figure 3). Approximately 2,013,813 doses have been administered, with an average of 59.6 doses per capita among CMS – Table 3. FIGURE 1: Share of People vaccinated against COVID-19 in CARPHA Member States Source: https://ourworldindata.org/ 2: 21.june.2021 FIGURE 2: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 18th June, 2021 (PAHO) Source: PAHO COVID-19 Vaccination in the Americas Dashboard. 3: 21.june.2021 FIGURE 3: COVID-19 Vaccine Doses Administered per 100 persons, as of 18th June, 2021 Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 18th June, 2021 Country ¥ Vaccine(s) Number of Doses Doses per 100 persons Anguilla AstraZeneca - Vaxzevria 15, 198 82.5 Antigua & Barbuda AstraZeneca – not specified 60, 011 60.8 Aruba Information not available 122, 680 114.4 Bahamas AstraZeneca – not specified 68, 119 17.2 Barbados AstraZeneca – not specified 153, 350 53.3 Bonaire Pfizer BioNTech - Comirnaty 26, 469 131.7 Belize AstraZeneca – not specified 95, 452 23.6 Bermuda Information not available 76, 526 106.3 Cayman Islands Pfizer BioNTech - Comirnaty 86, 711 137.4 Curacao Pfizer BioNTech - Comirnaty 163, 328 99.1 Dominica Beijing CNBG – Inactivated; AstraZeneca – not 52 38, 646 specified Grenada AstraZeneca – not specified 29, 157 25.8 Guyana Information not available 319, 096 40.4 Jamaica AstraZeneca – not specified 194, 315 6.5 Montserrat AstraZeneca - Vaxzevria 2, 600 48.1 Saba Information not available 1, 300 67.3 Sint Eustatius Information not available 2, 236 71.3 Sint Maarten Pfizer BioNTech - Comirnaty 36, 209 81.5 St. Kitts & Nevis AstraZeneca – not specified 32, 804 60.6 4: 21.june.2021 Country ¥ Vaccine(s) Number of Doses Doses per 100 persons St. Lucia AstraZeneca – not specified 50, 869 27.6 St. Vincent & Gamaleya - Sputnik V; AstraZeneca – not 20.7 22, 980 Grenadines specified Suriname AstraZeneca – not specified 161, 829 27.4 Trinidad & Tobago Beijing CNBG – Inactivated; AstraZeneca – not 13.9 195, 540 specified Turks and Caicos Pfizer BioNTech - Comirnaty 38, 110 66.8 Virgin Islands (British) AstraZeneca - Vaxzevria 20, 278 53.1 Source: PAHO COVID-19 Vaccination in the Americas Dashboard. ¥ No information on doses/100p found for Haiti. 5: 21.june.2021 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 + 88 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 Serum Institute of India + Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 42 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 + 49 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 + 110 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) 6: 21.june.2021 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 + 110 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 + 110 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 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.