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COVID-19 Vaccines Update Supplement Week Of: 26Th April, 2021

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COVID-19 Vaccines Update Supplement Week Of: 26Th April, 2021 CARPHA UPDATE FOR Incident Manager / SITUATION REPORT COVID-19 Vaccines Update Supplement Week of: 26th April, 2021 I. Overview of Development and Regulatory Approvals: • 91 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). • 5 COVID-19 vaccines have been approved by the WHO for Emergency Use Listing: Pfizer- BioNTech’s vaccine: COMIRNATY®, AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), Janssen- Cilag, AstraZeneca (EU node; Vaxzevria™) • 3 additional vaccines are expected to be approved by WHO: 2 in April, and 1 in May: Tables 1 and 3. • COVID-19 vaccine technical documents (including interim recommendations) by the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) for reviewed vaccines may be found at: SAGE COVID-19 materials. These include updated recommendations for the ChAdOx1-S COVID-19 vaccine by Oxford-AstraZeneca published 21st April, 2021. • WHO Guidance on the use of extra vaccine doses has been published. See Extra Vaccine Doses. • The WHO Global Advisory Committee on Vaccine Safety (GACVS) has provided an interim statement noting that a causal relationship between the vaccine and the occurrence of rare blood clots with low platelets is considered plausible but is not confirmed. Specialized studies are needed. The WHO maintains that the benefit-risk balance of the vaccine remains favorable. • EMA confirms overall benefit-risk of Janssen vaccine remains positive. At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine. • CARPHA has shared its COVID-19 vaccine regulatory tracker with Member States for viewing as updates are made. • CARPHA-CRS has recommended 4 COVID-19 vaccines to Member States, as of 23rd April, 2021 – Table 3. Table 1: Predicted WHO EUL Approvals in April and May 2021 Month Vaccines by April - Moderna + NIAID - Sinopharm + Beijing Institute of Biological Products May - Sinovac Research and Development (Coronavac) 1: 26.Apr.2021 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 26th April, 2021. The second round of deliveries to CARPHA Member States will begin this week, starting with Jamaica. ▪ A search of the PAHO Dashboard of COVID-19 Vaccination in the Americas provided information on COVID-19 vaccinations by CARPHA Member States, as of 26th April, 2021, which indicates a total of 894,550 doses administered regionally. Figure 1 shows the share of the population that received at least one dose based on the PAHO data. 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 26th April, 2021 Source of base graphic: Metric Pioneer | CARICOM 2: 26.Apr.2021 Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 26th April, 2021 Country ¥ Vaccine(s) Total Doses Doses per 100 persons Anguilla AstraZeneca - AZD1222 6,035 32.76 Antigua & Barbuda SII - Covishield 29,995 30.38 Aruba Pfizer-BioNTech – Comirnaty 62,343 58.16 Bahamas SII - Covishield 21,907 5.52 Barbados SII - Covishield 74,326 25.83 Bonaire Pfizer BioNTech - Comirnaty 15,591 77.55 Virgin Islands (British) AstraZeneca - AZD1222 9,430 24.70 Belize SII - Covishield 37,097 9.16 Bermuda Pfizer BioNTech - Comirnaty 50,992 70.81 Cayman Islands Pfizer BioNTech - Comirnaty 63,838 101.2 Curacao Pfizer BioNTech - Comirnaty 80,619 48.92 Dominica SII – Covishield; Beijing CNBG - Inactivated 23,055 31.02 Grenada SII - Covishield 12,341 10.92 Guyana SII – Covishield; Beijing CNBG - Inactivated 113,596 14.37 Jamaica SII - Covishield 135,725 4.56 Montserrat AstraZeneca - AZD1222 1,909 35.33 Saba Information not available 1,300 67.25 Sint Maarten Pfizer BioNTech - Comirnaty 19,412 43.70 St. Kitts & Nevis SII - Covishield 11,848 21.87 St. Lucia SII - Covishield 24,035 13.03 St. Vincent & Grenadines SII – Covishield; Gamaleya - Sputnik V 12,832 11.53 Suriname SII - Covishield 36,206 6.12 Trinidad & Tobago SII - Covishield 22,996 1.64 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 or Sint Eustatius. FIGURE 2: COVID-19 Vaccine Doses per 100 population as of 26th April, 2021 110.0 101.2 100.0 90.0 77.6 80.0 70.8 67.3 70.0 58.2 60.0 48.947.6 50.0 43.7 40.0 35.3 32.831.030.4 25.8 30.0 24.721.9 20.0 14.413.0 11.510.9 9.2 6.1 5.5 10.0 4.6 1.6 0.0 3: 26.Apr.2021 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 26th 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: 26.Apr.2021 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 + 83 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), VAXZEVRIA™ adenoviral Colombia, Chile 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 Pre-submission No I.M. meeting- Planned on 07 May 5: 26.Apr.2021 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.
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