CARPHA UPDATE FOR Incident Manager / SITUATION REPORT

COVID-19 Vaccine Update Supplement Week of: 5th July, 2021

I. Overview of Development and Regulatory Approvals:

• 105 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 (Soberana, Abdala). • 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 3. • Two additional vaccine nodes of COVID-19 vaccine AstraZeneca are under review based on assessments by regulatory authorities in Japan and Australia. • In June, the WHO Strategic Advisory Group of Experts (SAGE) for Immunization updated their interim recommendations for 3 vaccines including: o Myocarditis as a serious adverse event under investigation (Moderna, Pfizer-BioNTech, Janssen) o Thrombosis with thrombocytopenia syndrome as a very rare serious adverse event under precautions (Janssen) o Information on interchangeability with other vaccines in the context of ongoing mix-and- match studies, and o Summaries of vaccine efficacy against the 4 variants of concern of the SARS-CoV-2 virus. The updated interim recommendations 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 8 COVID-19 vaccines to Member States to date. The most recent recommendation was issued for CoronaVac by Sinovac Life Sciences – Table 3.

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 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 2 1 2 3 18 2

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

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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 9 8 18 6 105 8 Source: World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 29th June 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.

▪ 14 Caribbean countries have received vaccine deliveries from COVAX as of 5th July, 2021. The most recent delivery to a Member State was 9th June. ▪ Based on data collected by the Global Change Data Lab’s Our World in Data site, between 2.6% and 69% 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 Vaccination in the Americas as of 2nd July, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 8.4 to 148.4 doses per capita (Figure 3). Approximately 2,351,277 doses have been administered, with an average of 26 doses per capita among CMS – Table 2.

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FIGURE 1: Share of People vaccinated against COVID-19 in CARPHA Member States (3rd July)

Source: https://ourworldindata.org/

FIGURE 2: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 2nd July, 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 2nd July, 2021

Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 2nd July, 2021

Country ¥ Vaccine(s) Number of Doses Doses per 100 persons Anguilla AstraZeneca - Vaxzevria 16, 460 89.3 Antigua & Barbuda AstraZeneca – not specified 64, 617 65.5 Aruba Information not available 126, 979 118.5 Bahamas AstraZeneca – not specified 91, 067 22.9 Barbados AstraZeneca – not specified 166, 567 57.9 Bonaire Pfizer BioNTech - Comirnaty 27, 175 135.2 Belize AstraZeneca – not specified 115, 628 28.6 Bermuda Information not available 79, 854 110.9 Cayman Islands Pfizer BioNTech - Comirnaty 93, 652 148.4 Curacao Pfizer BioNTech - Comirnaty 167, 633 101.7 Dominica Beijing CNBG – Inactivated; AstraZeneca – not 53.7 39, 938 specified Grenada AstraZeneca – not specified 34, 331 30.4 Guyana Information not available 344, 466 43.6 Jamaica AstraZeneca – not specified 249, 938 8.4 Montserrat AstraZeneca - Vaxzevria 2, 651 49.1 Saba Information not available 1, 300 67.3 Sint Eustatius Information not available 2, 348 74.8 Sint Maarten Pfizer BioNTech - Comirnaty 39, 460 88.8 St. Kitts & Nevis AstraZeneca – not specified 41, 850 77.3

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Country ¥ Vaccine(s) Number of Doses Doses per 100 persons St. Lucia AstraZeneca – not specified 52, 921 28.7 St. Vincent & Gamaleya - Sputnik V; AstraZeneca – not 22.2 24, 737 Grenadines specified Suriname AstraZeneca – not specified 197, 723 33.4 Trinidad & Tobago Beijing CNBG – Inactivated; AstraZeneca – not 21.5 302, 348 specified Turks and Caicos Pfizer BioNTech - Comirnaty 45, 342 79.5 Virgin Islands (British) AstraZeneca - Vaxzevria 22, 247 58.3 Source: PAHO COVID-19 Vaccination in the Americas Dashboard. ¥ No information on doses/100p found for Haiti.

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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 + 91 countries including United Approved: 31st December (INN: tozinameran; BNT162b2 I.M. Store: -25°C to -15°C Kingdom, Canada, Mexico, USA, Chile, Argentina, 2020 / 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 + 44 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 + 53 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 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 + 117 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; 54 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.) 56 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: Sinovac COVID-19 vaccine Inactivated virus 2 doses 2°C to 8°C 33 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 69 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: Week of 05 University (AZD1222) [PMDA, ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), July Japan] 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 + 115 countries including UK, Anticipated date: Week of 05 University (AZD1222) [TGA, ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), July Australia] adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), 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 July 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 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 Planned for 28 July 2021 CVnCoV/CV07050101) lipid I.M. nanoparticle Vector State Research Ctre of Peptide vaccine 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: Bharat Biotech + Indian Whole virion 2 Doses 2°C to 8°C 9 countries: India, Iran, Zimbabwe, Nepal, Mauritius, Rolling data starting July 2021 Council of Medical Research inactivated I.M. Mexico, Guyana, Paraguay, Philippines (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 2nd July 2021. Available at: https://covid19.trackvaccines.org/.

World Health Organization. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. Updated 2nd 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, 29th 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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