COVID-19 Vaccines Update Supplement Week Of: 5Th April, 2021

CARPHA UPDATE FOR Incident Manager / SITUATION REPORT

COVID-19 Vaccines Update Supplement Week of: 5th April, 2021

I. Overview of Development and Regulatory Approvals:

• 85 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). • 13 vaccines have received regulatory approvals in various countries, and 16 vaccines are at various stages of engagement with WHO for emergency use listing (EUL). • 4 vaccines have been approved by WHO for Emergency Use Listing: Pfizer-BioNTech’s vaccine: COMIRNATY®, AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), and Janssen-Cilag. • 4 additional vaccines are expected to be approved by WHO in April – Tables 1 and 3. • There are 3 additional vaccines being considered by WHO but these are at the stage of submitting expressions of interest: Bharat Biotech, Clover Biopharmaceuticals-GSK + Dynavax, and BioCubaFarma (Cuba). • The WHO Strategic Advisory Group of Experts on Immunization (SAGE) interim recommendations and background documents are available for vaccines by: Moderna, Pfizer-BioNTech, AstraZeneca-Oxford and Janssen-Cilag at SAGE Interim Guidance. The recommendations provide guidance on the use the vaccines, including use in various groups. • Reports of rare clotting events among vaccinees continue to be assessed by various regulators. The EU's European Medicines Agency (EMA) has stated that there was no evidence to support decisions by regulators to restrict the use of Oxford-AstraZeneca vaccines in some age groups. 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.

Table 1: Predicted WHO EUL Approvals in April

WHO Predicted Approval Vaccines April - Moderna + NIAID - AstraZeneca-Oxford vaccine (European or UK node) - Sinopharm + Beijing Institute of Biological Products - Sinovac Research and Development (Coronavac)

II. Vaccine Deployment in the Caribbean

Several Caribbean countries have approved / received COVID-19 vaccines purchases and/or donations. A search of the PAHO Dashboard of COVID-19 Vaccination in the Americas revealed information on COVID- 19 vaccinations by 21 countries of the Caribbean / CARPHA Member States, as of 5th April, 2021 - Figure 1.

Caribbean countries that have received COVAX deliveries as of 5th April are: Jamaica, Suriname, Guyana, Bahamas, Belize, and Trinidad and Tobago. Deliveries that are expected this week: Barbados, Antigua and Barbuda, Grenada, St Lucia, St Kitts and Nevis, Bermuda, Dominica, and St Vincent and the Grenadines.

FIGURE 1: Number of Doses of COVID-19 Vaccines Administered per 100 population in Member States as of 1st April, 2021

Source of base graphic: Metric Pioneer | CARICOM

Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 5th April, 2021

Country Vaccine(s) Total Doses Doses per 100 persons Anguilla AstraZeneca - AZD1222 5,644 30.63 Antigua & Barbuda SII - Covishield 26,424 26.76 Aruba Pfizer-BioNTech – Comirnaty 27,904 26.03 Bahamas SII - Covishield 6,145 1.55 Barbados SII - Covishield 63.711 22.14 Virgin Islands (British) AstraZeneca - AZD1222 7, 162 18.76 Belize SII - Covishield 22,922 5.66 Bermuda Pfizer BioNTech - Comirnaty 37,788 52.48 Cayman Islands Pfizer BioNTech - Comirnaty 49,561 78.54 Dominica SII – Covishield; Beijing CNBG - Inactivated 17,674 23.78 Grenada SII - Covishield 10,305 9.12 Guadeloupe Information not available 24,763 6.19 Guyana SII – Covishield; Beijing CNBG - Inactivated 32,714 4.14 Jamaica SII - Covishield 33, 642 1.13 Martinique Information not available 16,496 4.40 Montserrat AstraZeneca - AZD1222 1,542 28.53 St. Kitts & Nevis SII - Covishield 8,984 16.59 St. Lucia SII - Covishield 22, 357 12.12 St. Vincent & Grenadines SII – Covishield; Gamaleya - Sputnik V 10, 805 9.71 Suriname SII - Covishield 26, 057 4.40 Trinidad & Tobago SII - Covishield 1, 137 0.08 Source: PAHO COVID-19 Vaccination in the Americas Dashboard

FIGURE 2: COVID-19 Vaccine Doses per 100 population as of 5th April, 2021

90 78.54 80 70

60 52.48 50 40 30.63 28.53 30 26.76 26.03 23.78 22.14 18.76 20 16.59 12.12 9.71 9.12 10 6.19 5.66 4.4 4.4 4.14 1.55 1.13 0.08 0

II. 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 5th 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

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

Developers Vaccine Dosing Storage ¥ Authorized by WHO EUL status and Eligible for CRS Vaccine name Platform anticipated decision review? date: Pzifer & BioNTech mRNA 2 doses WHO EUL + 80 countries including December 2020 Yes – Ship: -80⁰C to -60⁰C; (Tozinameran (INN); BNT162b2 / I.M. United Kingdom, Canada, Mexico, (completed) Recommended Store: -25°C to -15°C COMIRNATY) USA, Chile, Argentina, Switzerland, (2wk) EU, Colombia, Israel, Australia, Brazil, 2⁰C to 8⁰C (12h) Guyana AstraZeneca-Oxford University Recombinant 2 doses 2°C to 8°C (6 mo.) 82 countries including UK, Argentina, In progress: 1st wk Yes (AZD1222) ChAdOx1-S I.M. Mexico, Brazil (local production by April adenoviral Fiocruz), EU, Canada (AZ Canada), vector Colombia, Chile 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 + 32 countries Approved: 15th Yes - AstraZeneca-Oxford University ChAdOx1-S I.M. including India, Argentina, Bangladesh, February Recommended (AZD1222; Covishield) adenoviral South Africa, Guyana, Canada vector (+VerityPharma) Janssen-Cilag (Johnson & Viral vector 1 dose Sealed: 2-8°C or 9- WHO EUL + 37 countries including: Approved: 12th March; Yes Johnson) (non-replicating) I.M. 25°C (12h) USA, Canada, South Africa, Bahrain, Additional sites (JNJ-78436735) Open: 2-8°C (6h) or Colombia pending 25°C (2h). Moderna & NIAID mNRA-based in 2 doses To ship: -25°C to - 42 countries including Canada, In progress – Mid. Yes (mRNA-1273) lipid I.M. 15°C Switzerland, United Kingdom, United April nanoparticle Sealed: 2-8°C (30d) States, EU, Guyana (LNP) or 9-25°C (12h) Open: 2-25°C (6h) Sinopharm + China National Inactivated 2 doses 2°C to 8°C 28 countries including China, In progress – Mid. No Pharmaceutical Group + virus I.M. Argentina, Bahrain, United Arab April Beijing Institute of Biological Emirates, Egypt, Jordan, Iraq, Products (BBIBP-CorV) Pakistan, Peru, Guyana Sinovac Research and Inactivated 2 doses 2°C to 8°C 19 countries including China, In progress – Mid. No Development Co. Ltd virus I.M. Colombia, Turkey, Indonesia, Brazil, April (CoronaVac) Chile, México, Guyana Gamaleya Research Institute & Adenovirus 2 doses 2°C to 8°C 59 countries including Russia, Information pending No Russian Health Ministry Viral vector I.M. Argentina, Guinea, Bolivia, Venezuela, including completed (Sputnik V) (non-replicating) Paraguay, México, Belize, Guyana, inspections StVincent&Gren CanSino Biological Inc + Adenovirus; 1 dose 2°C to 8°C 4 countries: China, Mexico, Pakistan, Rolling data review No Beijing Institute of Biological Viral vector I.M. Hungary 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 presubmission No I.M. meeting

Developers Vaccine Dosing Storage ¥ Authorized by WHO EUL status and Eligible for CRS Vaccine name Platform anticipated decision review? date: Sinopharm + China National Inactivated 2 doses 2°C to 8°C 2 countries: China, United Arab Pending presubmission No Pharma. Group + Wuhan virus I.M. Emirates meeting Institute of Biol. Products

Vector State Research Ctre of Peptide vaccine 2 doses 2°C to 8°C Russia, Turkmenistan Pending expression of No Virology and Biotech. I.M. interest (EpiVacCorona)

Bharat Biotech + Indian Whole virion 2 2°C to 8°C 5 countries: India, Iran, Zimbabwe, Requested meeting to No Council of Medical Research inactivated Doses Nepal, Mauritius discuss details of (ICMR) I.M. submission/timelines (Covaxin) Clover Biopharmaceuticals Inc. Protein subunit 2 doses 2°C to 8°C None to date In discussion on No + GSK + Dynavax I.M. submission strategy (SCB-2019) and timelines

BioCubaFarma - Cuba SARS-CoV-2 None to date In discussion on No (Soberana 01, Soberana 02 spike protein submission strategy Soberana Plus) and timelines

¥ - 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 2nd April 2021. Available at: https://covid19.trackvaccines.org/.

World Health Organization. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. Updated 1st April 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, 2nd April 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.