CARPHA UPDATE FOR Incident Manager / SITUATION REPORT

COVID-19 Update Supplement Week of: 30th August, 2021

I. Overview of Development and Regulatory Approvals:

• 112 candidate are in clinical development: 21 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. 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 COVID-19 mRNA Vaccine: 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 10 11 5 2 10 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 0 1 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 26 10 10 21 8 112 8 Source: World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 27th August, 2021. Available at: Draft landscape of COVID-19 candidate vaccines (who.int).

1: 30.aug.2021

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. Saint Lucia will receive 24,000 doses of the Astra Zeneca COVID-19 Vaccine on 1st September, 2021 in their third roll out of vaccines through the COVAX facility. Approximately 2,066,400 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 0.03% and 73.82% of persons in CARPHA Member States have been fully vaccinated (Figures 1-2). Counts may be out of date, as these are subject to data collection by OWID. . Completed schedules, based on data from PAHO, are shown in Figure 3. . Based on the PAHO Dashboard COVID-19 Vaccination in the Americas as of 27th August, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 0.3 to 159 doses per capita (Figure 4). Approximately 3,734,136 doses have been administered, with an average of 73.4 doses per capita among CMS – Table 2.

FIGURE 1: Share of People vaccinated against COVID-19 in CARICOM Member States (29th August)

2: 30.aug.2021

FIGURE 2: Share of People vaccinated against COVID-19 in CARICOM Associates / Other CARPHA Member States (29th August)

Source: https://ourworldindata.org/

FIGURE 3: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 27th August, 2021 (PAHO)

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

3: 30.aug.2021

FIGURE 4: COVID-19 Vaccine Doses Administered per 100 persons, as of 27th August, 2021

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 27th 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- 73.8 CorV; Gamaleya- Sputnik V; BioNTech – 72, 902 Comirnaty; SII- Covishield Aruba Janssen- Ad26.COV 2.5; Pfizer BioNTech - 137.3 147, 211 Comirnaty Bahamas AstraZeneca – Vaxzevria; Pfizer BioNTech – 32.5 129, 017 Comirnaty; SII- Covishield Barbados AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 69 198, 370 CorV; Pfizer BioNTech – Comirnaty; SII- Covishield Bonaire Pfizer BioNTech - Comirnaty 28, 978 144.1 Belize AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 55.7 225, 615 CorV; Pfizer BioNTech – Comirnaty; SII- Covishield Bermuda AstraZeneca – Vaxzevria; Pfizer BioNTech - 117.7 84, 748 Comirnaty Cayman Islands Pfizer BioNTech - Comirnaty 100, 362 159

4: 30.aug.2021

Curacao AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 110 Pfizer BioNTech - Comirnaty 181, 272 Dominica AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 56.4 41, 932 CorV; Pfizer BioNTech – Comirnaty; SII- Covishield Grenada AstraZeneca – Vaxzevria; SII- Covishield 42, 484 37.6 Guyana AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 59.2 CorV; Gamaleya- Sputnik V; Moderna- mRNA- 468, 218 1273; SII- Covishield Haiti Moderna- mRNA-1273; Janssen- Ad26.COV 2.5 29, 227 0.3 Jamaica AstraZeneca – Vaxzevria; Janssen- Ad26.COV 2.5; 16.7 496, 976 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, 741 87.4 Sint Maarten AstraZeneca – Vaxzevria; Moderna- mRNA-1273; 108.2 48, 042 Pfizer BioNTech - Comirnaty St. Kitts & Nevis AstraZeneca – Vaxzevria; Pfizer BioNTech - 83.7 45, 327 Comirnaty; SII- Covishield St. Lucia AstraZeneca – Vaxzevria; Pfizer BioNTech - 34.3 63, 262 Comirnaty; SII- Covishield St. Vincent & Gamaleya - Sputnik V; AstraZeneca – Vaxzevria; 24 26, 690 Grenadines Pfizer BioNTech – Comirnaty; SII- Covishield Suriname AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 54 319, 434 CorV; SII- Covishield Trinidad & Tobago AstraZeneca – Vaxzevria; Beijing CNBG – BBIBP- 62.7 879, 807 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 78.1 29, 828 (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.

5: 30.aug.2021

Table 3: COVID-19 Vaccines with Regulatory Approvals by WHO EUL Consideration

Dosing and WHO EUL status WHO Approved Drug Product site(s) Developers (Vaccine name) Vaccine Platform Storage ¥ Authorized by and anticipated

decision date: WHO EUL status – Approved

Recommended by CRS Pfizer-BioNTech mRNA 2 doses I.M. WHO EUL + CARPHA + 98 Baxter Oncology GmbH, Kantstraße 2, 33790 Halle/Westfalen, Germany Approved: 31st INN: tozinameran; BNT162b2 countries December 2020 -90⁰C to -60⁰C BioNTech Manufacturing GmbH, Kupferbergterrasse 17 - 19, 55116 Mainz, Commercial names: (6 mo.); Germany Additional sites COMIRNATY™; -25°C to -15°C approved: 16th Pfizer-BioNTech COVID-19 (2 wks.) Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium July, 2021 vaccine 2⁰C to 8⁰C (31 days); Pharma Stein AG, Schaffhauserstrasse, 4332 Stein, Switzerland 30°C (2 hrs) Mibe GmbH Arzneimittel, Münchener Straβe 15, 06796 Brehna, Germany

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

Grand River Aseptic Manufacturing Inc. 140 Front Ave. SW. Grand Rapids, Michigan (MI) 49504, USA.

Catalent Anagni S.R.L., Fontana del Ceraso SNC, Strada Provinciale 12, Casilina 41, 03012 Anagni, Italy.

6: 30.aug.2021

Dosing and WHO EUL status WHO Approved Drug Product site(s) Developers (Vaccine name) Vaccine Platform Storage ¥ Authorized by and anticipated

decision date: AstraZeneca-Oxford University Recombinant 2 doses I.M. WHO EUL + CARPHA + Catalent Anagni, Località Fontana del Ceraso, S.P. Casilina, 41 03012, Approved: 16th (AZD1222) Commercial name: ChAdOx1-S 121 countries Anagni (FR), Italy April VAXZEVRIA™ adenoviral 2°C to 8°C (6 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-1273) mRNA-based in 2 doses I.M. WHO EUL + CARPHA + 69 Rovi Pharma Industrial Services, S.A. Approved: 30th INN: Elasomeran lipid countries San Sebastián de los Reyes, Paseo de Europa, 50, 28703. San Sebastián de April nanoparticle -25°C to -15°C los Reyes, Madrid, Spain ModernaTX, Inc/ USFDA COVID- (LNP) (7 mo.); 19 mRNA vaccine Baxter Pharmaceutical Solutions, LLC, 927 S. Curry Pike, Bloomington, IN 2-8°C (30d) or 47403, USA. Additional sites 9-25°C (12h) approved: 6th Catalent Indiana, LLC, 1300 South Patterson Drive, Bloomington, IN 47403, August, 2021 USA Sinopharm + China National Inactivated virus 2 doses I.M. WHO EUL + CARPHA + 60 Beijing Institute of Biological Products Co., Ltd. Approved: 7th May Pharmaceutical Group + Beijing countries No. 6 (East Part) and No. 9 (West Part), Boxing 2nd Road, Beijing Economic Institute of Biological Products 2°C to 8°C (24 and Technological Development Area, Beijing, the People's Republic of (BBIBP-CorV) mo.) China, 100176. Sinovac COVID-19 vaccine (Vero Inactivated virus 2 doses I.M. WHO EUL + CARPHA + 39 Sinovac Life Sciences Co., Ltd., No. 21, Tianfu Street, Daxing Biomedicine Approved: 1st June Cell [Inactivated]) – Commercial countries Industrial Base of Zhongguancun Science Park, Daxing District, Beijing, name: CoronaVac 2°C to 8°C (12 P.R.China. mo.) AstraZeneca-Oxford University Recombinant 2 doses I.M. WHO EUL + CARPHA + Catalent Anagni S.R.L., Località Fontana del Ceraso S.P. Casilina, 41 03012 Approved: 9th July (AZD1222)/ TGA, Australia ChAdOx1-S 121 countries Anagni (FR) Italy. 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.

CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate. Wrexham LL13 9UF, UK. AstraZeneca-Oxford University Recombinant 2 doses I.M. WHO EUL + CARPHA + Catalent Anagni S.R.L., Contrada Fontana del Ceraso 03012. Anagni, Italy. Approved: 9th July (AZD1222)/ MHLW, Japan ChAdOx1-S 121 countries

7: 30.aug.2021

Dosing and WHO EUL status WHO Approved Drug Product site(s) Developers (Vaccine name) Vaccine Platform Storage ¥ Authorized by and anticipated

decision date: 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 Viral 2 doses I.M. 71 countries Not applicable On hold, awaiting Russian Health Ministry (Sputnik vector (non- completion of V) replicating) 2°C to 8°C rolling submission CanSino Biological Inc + Beijing Adenovirus; Viral 1 dose I.M. 8 countries Not applicable Rolling data Institute of Biological Products vector (non- started 09 August (Convidicea (Ad5-nCoV)) replicating) 2°C to 8°C 2021

NOVAVAX (NVX-CoV2373) Protein subunit 2 doses I.M. None to date Not applicable Rolling data starting in August 2°C to 8°C 2021 Sinopharm + China National Inactivated virus 2 doses I.M. 2 countries Not applicable Rolling data Pharma. Group + Wuhan 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 of CVnCoV/CV07050101) lipid 2021 nanoparticle 2°C to 8°C Vector State Research Ctre of 2 doses I.M. 2 countries Not applicable Pending expression Virology and Biotech. of interest (EpiVacCorona) 2°C to 8°C Anhui Zhifei Longcom Recombinant 2 or 3 Doses 2 countries Not applicable Additional Biopharmaceutical, China + (protein subunit) I.M. information IMBCAMS (ZF2001) requested 2°C to 8°C Bharat Biotech + Indian Council Whole virion 2 Doses I.M. 9 countries Not applicable Rolling data of Medical Research (ICMR) inactivated started 06 July () 2°C to 8°C 2021 Pasteur CoV2 preS dTM- Recombinant, 2 Doses I.M. None to date Not applicable Rolling data AS03 vaccine adjuvanted 2°C to 8°C started 30 July 2021 Clover Biopharmaceuticals Inc. + Protein subunit 2 doses I.M. None to date Not applicable Pre-submission GSK + Dynavax (SCB-2019) meeting: Being 2°C to 8°C planned

8: 30.aug.2021

Dosing and WHO EUL status WHO Approved Drug Product site(s) Developers (Vaccine name) Vaccine Platform Storage ¥ Authorized by and anticipated

decision date: BioCubaFarma – (Soberana SARS-CoV-2 2 doses I.M. None to date Not applicable In discussion on 01, Soberana Plus, submission ) 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 August NVX-CoV2373/ Covovax 2°C to 8°C 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 27th 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, 27th 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.

9: 30.aug.2021