CARPHA UPDATE FOR Incident Manager / SITUATION REPORT

COVID-19 Update Supplement Week of: 23rd August, 2021

I. Overview of Development and Regulatory Approvals:

• 112 candidate are in clinical development: 20 in Phase 3 trials, and 8 in Phase 4 trials – Table 1; Figure in COVID-19 Vaccines and Therapeutics Regulatory Tracker (Phases tab). • 22 vaccines have received regulatory approvals in various countries, and 22 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 4. • US FDA Approves First COVID-19 Vaccine. In its 23rd August 2021 press announcement, FDA stated that Pfizer-BioNTech COVID-19 Vaccine will now be marketed as Comirnaty™, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. • On 18th August, 2021 the U.S. Food and Drug Administration issued a joint statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. The group concluded that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability. FDA will be conducting an independent evaluation to determine the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. • CARPHA-CRS has reviewed and recommended all 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 4. • 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 Protein subunit 10 12 5 2 9 0 38 0 VVnr Viral Vector (non-replicating) 7 4 0 2 1 3 17 4

DNA DNA 4 4 0 2 1 0 11 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 0 1 1 0 0 2 0

VLP Virus Like Particle 1 2 1 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 37 28 9 10 20 8 112 8 Source: World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 20th 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 23rd 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 0.02% 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 in the Americas as of 20th August, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 0.22 to 157.9 doses per capita (Figure 4). Approximately 3,490,549 doses have been administered, with an average of 43.2 doses per capita among CMS – Table 2.

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FIGURE 1: Share of People vaccinated against COVID-19 in CARICOM Member States (22nd August)

FIGURE 2: Share of People vaccinated against COVID-19 in CARICOM Associates / Other CARPHA Member States (22nd August)

Source: https://ourworldindata.org/

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FIGURE 3: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 20th August, 2021 (PAHO)

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

FIGURE 4: COVID-19 Vaccine Doses Administered per 100 persons, as of 20th August, 2021

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Note: For vaccines that require multiple doses, each individual dose is counted. As the same person may receive more than one dose, the number of doses per 100 people can be higher than 100.

Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 20th August, 2021

Country ¥ Vaccine(s) Doses per 100 Number of Doses persons Anguilla AstraZeneca - Vaxzevria 18, 458 100.2 Antigua & Barbuda AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 72.4 CorV; Gamaleya- Sputnik V; Pfizer BioNTech – 71, 434 Comirnaty; SII- Covishield Aruba Janssen- Ad26.COV 2.5; Pfizer BioNTech - 133.8 143, 396 Comirnaty Bahamas AstraZeneca – Vaxzevria; Pfizer BioNTech – 30.1 119, 473 Comirnaty; SII- Covishield Barbados AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 65.7 189, 080 CorV; Pfizer BioNTech – Comirnaty; SII- Covishield Bonaire Pfizer BioNTech - Comirnaty 28, 859 143.5 Belize AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 52.8 213, 929 CorV; Pfizer BioNTech – Comirnaty; SII- Covishield Bermuda AstraZeneca – Vaxzevria; Pfizer BioNTech - 116.7 84, 022 Comirnaty Cayman Islands Pfizer BioNTech - Comirnaty 99, 635 157.9 Curacao AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 109.2 Pfizer BioNTech - Comirnaty 179, 915

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Dominica AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 55.8 41, 435 CorV; Pfizer BioNTech – Comirnaty; SII- Covishield Grenada AstraZeneca – Vaxzevria; SII- Covishield 40, 075 35.5 Guyana AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 56.8 CorV; Gamaleya- Sputnik V; Moderna- mRNA- 448, 492 1273; SII- Covishield Haiti Moderna- mRNA-1273; Janssen- Ad26.COV 2.5 25, 238 0.2 Jamaica AstraZeneca – Vaxzevria; Janssen- Ad26.COV 2.5; 14.2 420, 627 SII- Covishield 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, 734 87.1 Sint Maarten AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 107.2 47, 636 Pfizer BioNTech - Comirnaty St. Kitts & Nevis AstraZeneca – Vaxzevria; Pfizer BioNTech - 82.3 44, 586 Comirnaty; SII- Covishield St. Lucia AstraZeneca – Vaxzevria; Pfizer BioNTech - 33.1 61, 015 Comirnaty; SII- Covishield St. Vincent & Gamaleya - Sputnik V; AstraZeneca – Vaxzevria; 23.8 26, 449 Grenadines Pfizer BioNTech – Comirnaty; SII- Covishield Suriname AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 48.7 287, 925 CorV; SII- Covishield Trinidad & Tobago AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 58 813, 470 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 77.1 29, 431 (British) Source: PAHO COVID-19 Vaccination in the Americas Dashboard. Note: For vaccines that require multiple doses, each individual dose is counted. As the same person may receive more than one dose, the number of doses per 100 people can be higher than 100.

III. Substandard / Falsified Medical Products for COVID-19

• The World Health Organization issued Medical Product Alert N°5/2021: Falsified COVISHIELD vaccine on 16th August 2021- Table 3. WHO advises regulatory authorities and the public to increase vigilance within the supply chains of countries and regions likely to be affected by these falsified products. All medical products for COVID-19 should be obtained from authorized or licensed suppliers, and the product’s authenticity and physical condition should be carefully checked.

Table 3: WHO COVID-19 Medical Product Alerts 2021

Alert number Product Manufacturer Alert summary and date

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N° 5/2021 COVISHIELD, ChAdOx1 Serum Institute • Batch 4121Z040 - the expiry date nCoV-19 Corona Virus of India Pvt. Ltd. (10.08.2021) on this product is falsified August 2021 Vaccine [Uganda] (Recombinant) • COVISHIELD 2ml - the genuine manufacturer does not produce COVISHIELD in 2ml (4 doses) N°4 2021 remdesivir injection GILEAD • Batch EN2005A2-B: the batch number 100mg/20ml and the expiry date (06/2023) do not August 2021 (5mg/ml) correspond to any remdesivir manufactured by GILEAD. • Batch EN2009D7-Q: the batch number does not correspond to any remdesivir manufactured by GILEAD. N°2.2021 COVID-19 Vaccine Pfizer BIONTECH • The genuine manufacturer of COVID-19 BNT162b2 Vaccine BNT162b2 confirmed they did 26 March not manufacture the product. 2021 • The batch number and expiry dates are falsified. • The glass vials and label are different from genuine COVID-19 Vaccine BNT162b2 vials.

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Table 5: COVID-19 Vaccines with Regulatory Approvals by WHO EUL Consideration

Dosing and WHO EUL status Vaccine WHO Approved Drug Product site(s) Developers (Vaccine name) Storage ¥ Authorized by and anticipated Platform decision date: WHO EUL status – Approved Recommended by CRS Pfizer-BioNTech mRNA 2 doses I.M. WHO EUL + CARPHA + Baxter Oncology GmbH, Kantstraße 2, 33790 Halle/Westfalen, Germany Approved: 31st INN: tozinameran; BNT162b2 97 countries December 2020 -90⁰C to - BioNTech Manufacturing GmbH, Kupferbergterrasse 17 - 19, 55116 Mainz, Commercial names: 60⁰C (6 Germany Additional sites

COMIRNATY™; mo.); Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium approved: 16th Pfizer-BioNTech COVID-19 -25°C to - July, 2021 vaccine 15°C (2 wks.) Novartis Pharma Stein AG, Schaffhauserstrasse, 4332 Stein, Switzerland 2⁰C to 8⁰C (31 days); Mibe GmbH Arzneimittel, Münchener Straβe 15, 06796 Brehna, Germany 30°C (2 hrs) Pharmacia & Upjohn Company LLC, 7000 Portage Road Kalamazoo, MI 49001, USA

Hospira Inc., a Pfizer company, 1776 Centennial Drive, McPherson, Kansas 67460, USA AstraZeneca-Oxford + SK Recombinant 2 doses I.M. WHO EUL + South SK Bioscience Approved: 15th Bioscience (supplier)* ChAdOx1-S 2°C to 8°C (6 Korea via COVAX / 150, Saneopdanji-gil, Pungsan-eup, Andong-si, Gyeongsangbuk-do, February (AZD1222) adenoviral mo.) PAHO + CARPHA Republic of Korea vector Serum Institute of India + Recombinant 2 doses I.M. WHO EUL + CARPHA + Serum Institute of India Pvt. Ltd Approved: 15th AstraZeneca-Oxford ChAdOx1-S 45 countries 212/2, Off. Soli Poonawalla Road, Hadapsar Pune, Maharashtra, (India) - February University adenoviral 2°C to 8°C (6 411028 (AZD1222; Covishield™ vector mo.) Janssen-Cilag (Johnson & Viral vector 1 dose I.M. WHO EUL + CARPHA + Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands Approved: 12th Johnson) (JNJ-78436735) (non- 59 countries March; replicating) -25°C to - Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium 15°C (24 Aspen SVP., 8B Gibaud Road, Korsten, Port Elizabeth 6020, South Africa mo.) Catalent Indiana LLC., 1300 S Patterson Drive, Bloomington. Indiana (IN) 2-8°C (4.5 47403, USA. mo. within shelf-life) Grand River Aseptic Manufacturing Inc. 140 Front Ave. SW. Grand Rapids, Michigan (MI) 49504, USA.

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Dosing and WHO EUL status Vaccine WHO Approved Drug Product site(s) Developers (Vaccine name) Storage ¥ Authorized by and anticipated Platform decision date: Catalent Anagni S.R.L., Fontana del Ceraso SNC, Strada Provinciale 12, Casilina 41, 03012 Anagni, Italy. AstraZeneca-Oxford Recombinant 2 doses I.M. WHO EUL + CARPHA + Catalent Anagni, Località Fontana del Ceraso, S.P. Casilina, 41 03012, Approved: 16th University (AZD1222) ChAdOx1-S 121 countries Anagni (FR), Italy April Commercial name: adenoviral 2°C to 8°C (6 VAXZEVRIA™ vector mo.) CP Pharmaceuticals, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, United Kingdom.

IDT Biologika, Am Pharmapark, Dessau-Rosslau 06861, Germany

SK Bioscience, 150, Saneopdanji-gil, Pungsan-eup, Andong-si, Gyeongsangbuk-do, Republic of Korea

Universal Farma, S.L. (“Chemo”), C/Del Tejido, 2, Azugueca de Henares, Guadalajara, 19200, Spain

Amylin Ohio LLC (AZ), 8814 Trade Port Drive, West Chester, OH 45071, USA Moderna & NIAID (mRNA- mRNA-based in 2 doses I.M. WHO EUL + CARPHA + Rovi Pharma Industrial Services, S.A. Approved: 30th 1273) lipid 69 countries San Sebastián de los Reyes, Paseo de Europa, 50, 28703. San Sebastián de April INN: Elasomeran nanoparticle -25°C to - los Reyes, Madrid, Spain (LNP) 15°C (7 mo.); Baxter Pharmaceutical Solutions, LLC, 927 S. Curry Pike, Bloomington, IN ModernaTX, Inc/ USFDA 47403, USA. COVID-19 mRNA vaccine 2-8°C (30d) Additional sites or 9-25°C Catalent Indiana, LLC, 1300 South Patterson Drive, Bloomington, IN 47403, approved: 6th (12h) USA August, 2021 Sinopharm + China National Inactivated 2 doses I.M. WHO EUL + CARPHA + Beijing Institute of Biological Products Co., Ltd. Approved: 7th Pharmaceutical Group + virus 60 countries No. 6 (East Part) and No. 9 (West Part), Boxing 2nd Road, Beijing Economic May Beijing Institute of Biological 2°C to 8°C and Technological Development Area, Beijing, the People's Republic of Products (BBIBP-CorV) (24 mo.) China, 100176. Sinovac COVID-19 vaccine Inactivated 2 doses I.M. WHO EUL + CARPHA + Sinovac Life Sciences Co., Ltd., No. 21, Tianfu Street, Daxing Biomedicine Approved: 1st (Vero Cell [Inactivated]) – virus 39 countries Industrial Base of Zhongguancun Science Park, Daxing District, Beijing, June Commercial name: 2°C to 8°C P.R.China. CoronaVac (12 mo.) AstraZeneca-Oxford Recombinant 2 doses I.M. WHO EUL + CARPHA + Catalent Anagni S.R.L., Località Fontana del Ceraso S.P. Casilina, 41 03012 Approved: 9th University (AZD1222)/ TGA, ChAdOx1-S 121 countries Anagni (FR) Italy. July Australia adenoviral 2°C to 8°C (6 vector mo.) IDT Biologika GmbH, Am Pharmapark, Dessau-Rosslau 06861 Sachsen- Anhalt, Germany.

Seqirus Pty Ltd., 39-79 Poplar Road Parkville, Vic, 3052 Australia.

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Dosing and WHO EUL status Vaccine WHO Approved Drug Product site(s) Developers (Vaccine name) Storage ¥ Authorized by and anticipated Platform decision date: CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate. Wrexham LL13 9UF, UK. AstraZeneca-Oxford Recombinant 2 doses I.M. WHO EUL + CARPHA + Catalent Anagni S.R.L., Contrada Fontana del Ceraso 03012. Anagni, Italy. Approved: 9th University (AZD1222)/ ChAdOx1-S 121 countries July MHLW, Japan adenoviral 2°C to 8°C (6 Daiichi Sankyo Biotech Co., LTD., Kitamoto Site. 6-111, Arai, Kitamoto City, vector mo.) Saitama, Japan.

KM Biologics Co. Ltd., Koshi Production Center. 3766-1, Sakae, Koshi-shi, Kumamoto, Japan. WHO EUL status – Pending/Not under review yet (Not eligible for CRS review) Gamaleya Research Institute Adenovirus 2 doses I.M. 71 countries Not applicable On hold, awaiting & Russian Health Ministry Viral vector completion of (Sputnik V) (non- 2°C to 8°C rolling submission replicating) CanSino Biological Inc + Adenovirus; 1 dose I.M. 8 countries Not applicable Rolling data Beijing Institute of Biological Viral vector started 09 Products (non- 2°C to 8°C August 2021 (Convidicea (Ad5-nCoV)) replicating) NOVAVAX (NVX-CoV2373) Protein subunit 2 doses I.M. None to date Not applicable Rolling data starting in 2°C to 8°C August 2021 Sinopharm + China National Inactivated 2 doses I.M. 2 countries Not applicable Rolling data Pharma. Group + Wuhan virus started 23 July Institute of Biol. Products 2°C to 8°C 2021

CureVac (Zorecimeran: mRNA-based in 2 doses I.M. None to date Not applicable Planned for Q4 CVnCoV/CV07050101) lipid of 2021 nanoparticle 2°C to 8°C Vector State Research Ctre of Peptide 2 doses I.M. 2 countries Not applicable Pending Virology and Biotech. vaccine expression of (EpiVacCorona) 2°C to 8°C interest Anhui Zhifei Longcom Recombinant 2 or 3 Doses 2 countries Not applicable Additional Biopharmaceutical, China + (protein I.M. information IMBCAMS (ZF2001) subunit) requested 2°C to 8°C Bharat Biotech + Indian Whole virion 2 Doses I.M. 9 countries Not applicable Rolling data Council of Medical Research inactivated started 06 July (ICMR) () 2°C to 8°C 2021

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Dosing and WHO EUL status Vaccine WHO Approved Drug Product site(s) Developers (Vaccine name) Storage ¥ Authorized by and anticipated Platform decision date: Sanofi Pasteur CoV2 preS Recombinant, 2 Doses I.M. None to date Not applicable Rolling data dTM-AS03 vaccine adjuvanted 2°C to 8°C started 30 July 2021 Clover Biopharmaceuticals Protein subunit 2 doses I.M. None to date Not applicable Pre-submission Inc. + GSK + Dynavax (SCB- meeting: Being 2019) 2°C to 8°C planned

BioCubaFarma – SARS-CoV-2 2 doses I.M. None to date Not applicable In discussion on (Soberana 01, Soberana 02 submission Soberana Plus, ) 2°C to 8°C strategy and timelines Serum Institute of India + Protein subunit 2 doses I.M. None to date Not applicable Rolling data Novavax Inc. starting in NVX-CoV2373/ Covovax 2°C to 8°C August 2021

¥ - 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 20th August 2021. Available at: https://covid19.trackvaccines.org/.

World Health Organization. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. Updated 19th August 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, 20th 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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