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CARPHA COVID-19 Vaccine Update 015 April 19, 2021

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CARPHA COVID-19 Vaccine Update 015 April 19, 2021 CARPHA UPDATE FOR Incident Manager / SITUATION REPORT COVID-19 Vaccines Update Supplement Week of: 19th April, 2021 I. Overview of Development and Regulatory Approvals: • 88 candidate vaccines are in clinical development: 16 in Phase 3 trials, and 4 in Phase 4 trials – see Figure in CARPHA COVID-19 Vaccine Regulatory Tracker (Phases tab). • 15 vaccines have received regulatory approvals in various countries, and 18 vaccines are at various stages of engagement with WHO for emergency use listing (EUL). • One additional AstraZeneca vaccine was approved by the WHO for Emergency Use Listing on 15th April, bringing the total number of listed COVID-19 vaccines by different manufacturers to 5: Pfizer-BioNTech’s vaccine: COMIRNATY®, AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), Janssen-Cilag, AstraZeneca (EU node; Vaxzevria™) • 2 additional vaccines are expected to be approved by WHO in April, and 1 in May: Tables 1 and 3. • There is one additional vaccine being considered by WHO however it is at the stage of submitting expressions of interest: Bayer AG – Germany (CureVAC) • The WHO Global Advisory Committee on Vaccine Safety (GACVS) issued an interim statement indicating that based on current information, a causal relationship between the vaccine and the occurrence of rare blood clots with low platelets is considered plausible but is not confirmed. Specialised studies are needed to fully understand the potential relationship between vaccination and possible risk factors. The WHO maintains that the benefit-risk balance of the vaccine remains favorable. • CARPHA has shared its COVID-19 vaccine regulatory tracker with Member States for viewing as updates are made. • CARPHA-CRS has completed its review of the COVID-19 vaccine by Janssen-Cilag Pharmaceuticals (Johnson & Johnson), which will be finalized and shared with chief medical officers this week. Table 1: Predicted WHO EUL Approvals in April and May 2021 Month Vaccines by April - AstraZeneca-Oxford (Vaxzevria) – approved - Moderna + NIAID - Sinopharm + Beijing Institute of Biological Products May - Sinovac Research and Development (Coronavac) 1: 19Apr 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 18th April, 2021. A search of the PAHO Dashboard of COVID-19 Vaccination in the Americas provided information on COVID-19 vaccinations by 24 countries of the Caribbean / CARPHA Member States, as of 19th April, 2021. Figure 1 shows the share of the population that received at least one dose based on the PAHO data. Saba is noted to have vaccinated 67.2% of its population against COVID-19. Figure 2 provides number of doses administered per capita. FIGURE 1: Share of population who received at least one dose of COVID-19 Vaccines in CARPHA Member States as of 19th April, 2021 Source of base graphic: Metric Pioneer | CARICOM 2: 19Apr Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 19th April, 2021 Country ¥ Vaccine(s) Total Doses Doses per 100 persons Anguilla AstraZeneca - AZD1222 6,160 33.43 Antigua & Barbuda SII - Covishield 28,027 28.39 Aruba Pfizer-BioNTech – Comirnaty 48,254 45.02 Bahamas SII - Covishield 7,000 1.76 Barbados SII - Covishield 66.211 23.01 Bonaire Pfizer BioNTech - Comirnaty 13,460 66.95 Virgin Islands (British) AstraZeneca - AZD1222 8,374 21.94 Belize SII - Covishield 32.150 7.94 Bermuda Pfizer BioNTech - Comirnaty 45,761 63.55 Cayman Islands Pfizer BioNTech - Comirnaty 60,637 96.09 Curacao Pfizer BioNTech - Comirnaty 53,519 32.43 Dominica SII – Covishield; Beijing CNBG - Inactivated 18,503 24.61 Grenada SII - Covishield 11,266 9.97 Guyana SII – Covishield; Beijing CNBG - Inactivated 48,454 6.13 Jamaica SII - Covishield 135,473 4.56 Montserrat AstraZeneca - AZD1222 1,751 32.40 Saba Information not available 1300 of 1933 persons completed full schedule Sint Maarten Pfizer BioNTech - Comirnaty 16,395 36.91 St. Kitts & Nevis SII - Covishield 11,152 20.59 St. Lucia SII - Covishield 23,448 12.72 St. Vincent & Grenadines SII – Covishield; Gamaleya - Sputnik V 12,181 10.95 Suriname SII - Covishield 34,129 5.77 Trinidad & Tobago SII - Covishield 12,725 0.91 Turks and Caicos Pfizer BioNTech - Comirnaty 27,122 47.56 Source: PAHO COVID-19 Vaccination in the Americas Dashboard. ¥ No information on doses/100p found for Haiti, Saba, or Sint Eustatius. FIGURE 2: COVID-19 Vaccine Doses per 100 population as of 19th April, 2021 Note: Chart excludes Saba due to lack of information on doses per 100 persons. 3: 19Apr III. Caribbean Vaccine Introduction Readiness Although some countries have received vaccines, we are monitoring vaccine readiness in the Caribbean to identify areas for strengthening. The PAHO Vaccine Introduction Readiness Tool (VIRAT) as of 19th April, 2021 for the Caribbean is shown below – Figure 3. The countries include Latin and non-Latin Caribbean countries. Indicators of areas that are pending readiness in the Caribbean are: • Safe injection and waste management • Demand generation, community engagement and communication • Human resources and security, and • Vaccination data and information management. FIGURE 3: COVID-19 Vaccine Introduction Readiness Tool Dashboard – Caribbean Region 4: 19Apr Table 3: COVID-19 Vaccines with Regulatory Approvals by WHO EUL Consideration Developers Vaccine Dosing Storage ¥ Authorized by WHO EUL status Eligible for Vaccine name Platform and anticipated CRS review? decision date: Pzifer & BioNTech mRNA 2 doses Ship: -80⁰C to -60⁰C; WHO EUL + 82 countries including United December 2020 Yes – (Tozinameran (INN); BNT162b2 / I.M. Store: -25°C to -15°C Kingdom, Canada, Mexico, USA, Chile, (completed) Recommended COMIRNATY) (2wk) Argentina, Switzerland, EU, Colombia, 2⁰C to 8⁰C (12h) Israel, Australia, Brazil, Guyana AstraZeneca-Oxford University Recombinant 2 doses 2°C to 8°C (6 mo.) 91 countries including UK, Argentina, Approved: 15th April Yes (AZD1222) ChAdOx1-S I.M. Mexico, Brazil, EU, Canada (AZ Canada), 2021 VAXZEVRIA™ adenoviral Colombia, Chile, ARTE vector AstraZeneca-Oxford + SK Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + South Korea Approved: 15th Yes - Bioscience (supplier) ChAdOx1-S I.M. For COVAX (Americas) February Recommended (AZD1222) adenoviral vector Serum Institute of India + Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 33 countries including Approved: 15th Yes - AstraZeneca-Oxford University ChAdOx1-S I.M. India, Argentina, Bangladesh, South Africa, February Recommended (AZD1222; Covishield) adenoviral Guyana, Canada (+VerityPharma) vector Janssen-Cilag (Johnson & Viral vector 1 dose Sealed: 2-8°C or 9- WHO EUL + 40 countries including: USA, Approved: 12th Yes – Johnson) (non-replicating) I.M. 25°C (12h) Canada, South Africa, Bahrain, Colombia March; Recommended (JNJ-78436735) Open: 2-8°C (6h) or Additional sites 25°C (2h). pending Moderna & NIAID mNRA-based in 2 doses To ship: -25°C to - 46 countries including Canada, Switzerland, In progress – End Yes (mRNA-1273) lipid I.M. 15°C United Kingdom, United States, EU, Guyana April nanoparticle Sealed: 2-8°C (30d) (LNP) or 9-25°C (12h) Open: 2-25°C (6h) Sinopharm + China National Inactivated 2 doses 2°C to 8°C 35 countries including China, Bahrain, In progress – End No Pharmaceutical Group + virus I.M. United Arab Emirates, Egypt, Jordan, Iraq, April Beijing Institute of Biological Pakistan, Serbia, Peru, Argentina, Chile Products (BBIBP-CorV) Sinovac Research and Inactivated 2 doses 2°C to 8°C 22 countries including China, Colombia, In progress – Early No Development Co. Ltd virus I.M. Turkey, Indonesia, Brazil, Chile, México, May (CoronaVac) Guyana Gamaleya Research Institute & Adenovirus 2 doses 2°C to 8°C 62 countries including Russia, Argentina, Information pending No Russian Health Ministry Viral vector I.M. Guinea, Bolivia, Venezuela, Paraguay, including completed (Sputnik V) (non-replicating) México, Belize, Guyana, StVincent&Gren, inspections Antigua & Barbuda CanSino Biological Inc + Adenovirus; 1 dose 2°C to 8°C 5 countries: China, Mexico, Pakistan, Rolling data review No Beijing Institute of Biological Viral vector I.M. Hungary, Chile starting in April Products (non-replicating) (Convidicea (Ad5-nCoV)) NOVAVAX (NVX-CoV2373) Protein subunit 2 doses 2°C to 8°C None to date Pending No I.M. presubmission meeting 5: 19Apr Developers Vaccine Dosing Storage ¥ Authorized by WHO EUL status Eligible for Vaccine name Platform and anticipated CRS review? decision date: Sinopharm + China National Inactivated 2 doses 2°C to 8°C 2 countries: China, United Arab Emirates Pending No Pharma. Group + Wuhan virus I.M. presubmission Institute of Biol. Products meeting Vector State Research Ctre of Peptide vaccine 2 doses 2°C to 8°C Russia, Turkmenistan Pending expression No Virology and Biotech. I.M. of interest (EpiVacCorona) Anhui Zhifei Longcom Recombinant 2 or 3 2⁰C to 8⁰C 2 countries: China, Uzbekistan Response to 2nd EOI No Biopharmaceutical, China + (protein subunit) Doses sent 29 Jan 2021. IMBCAMS I.M. Additional information (ZF2001) requested Bharat Biotech + Indian Whole virion 2 2°C to 8°C 6 countries: India, Iran, Zimbabwe, Nepal, Requested meeting No Council of Medical Research inactivated Doses Mauritius, Mexico to discuss details of (ICMR) I.M. submission/timelines (Covaxin) Clover Biopharmaceuticals Protein subunit 2 doses 2°C to 8°C None to date In discussion on No Inc. + GSK + Dynavax I.M. submission strategy (SCB-2019) and timelines BioCubaFarma - Cuba SARS-CoV-2 2°C to 8°C None to date In discussion on No (Soberana 01, Soberana 02 spike protein submission strategy Soberana Plus) and timelines Bayer AG - Germany RNA based 2 doses 2°C to 8°C None to date In discussion on No (CureVAC) vaccine I.M. submission strategy and timelines ¥ - Storage information is provided primarily for sealed vials. See product information for additional details on storage and handling. ARTE: African Regulatory Taskforce Endorsed References: McGill COVID19 Vaccine Tracker. COVID-19 Vaccines. Updated 16th April 2021.
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