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COVID-19 Vaccine Update Supplement Week Of: 23Rd August, 2021

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COVID-19 Vaccine Update Supplement Week Of: 23Rd August, 2021 CARPHA UPDATE FOR Incident Manager / SITUATION REPORT COVID-19 Vaccine Update Supplement Week of: 23rd August, 2021 I. Overview of Development and Regulatory Approvals: • 112 candidate vaccines 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 Immunization 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. 1: 23.aug.2021 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 Vaccination 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. 2: 23.aug.2021 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/ 3: 23.aug.2021 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 4: 23.aug.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 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 5: 23.aug.2021 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 6: 23.aug.2021 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. 7: 23.aug.2021 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.
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