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CARPHA's COVID-19 Vaccine Update

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CARPHA UPDATE FOR Incident Manager / SITUATION REPORT COVID-19 Vaccine Update Supplement Week of: 5th July, 2021 I. Overview of Development and Regulatory Approvals: • 105 candidate vaccines are in clinical development: 18 in Phase 3 trials, and 5 in Phase 4 trials – Table 1; Figure in COVID-19 Vaccines and Therapeutics Regulatory Tracker (Phases tab). • 18 vaccines have received regulatory approvals in various countries, and 18 are at various stages of engagement with WHO for emergency use listing (EUL) including vaccines made in Cuba (Soberana, Abdala). • 8 vaccines have been approved by WHO for EUL to date: Pfizer-BioNTech’s vaccine: COMIRNATY®, AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), Janssen-Cilag, AstraZeneca (Vaxzevria™), Moderna (mRNA-1273), Sinopharm-BIBP and Sinovac COVID-19 vaccine – CoronaVac: Table 3. • Two additional vaccine nodes of COVID-19 vaccine AstraZeneca are under review based on assessments by regulatory authorities in Japan and Australia. • In June, the WHO Strategic Advisory Group of Experts (SAGE) for Immunization updated their interim recommendations for 3 vaccines including: o Myocarditis as a serious adverse event under investigation (Moderna, Pfizer-BioNTech, Janssen) o Thrombosis with thrombocytopenia syndrome as a very rare serious adverse event under precautions (Janssen) o Information on interchangeability with other vaccines in the context of ongoing mix-and- match studies, and o Summaries of vaccine efficacy against the 4 variants of concern of the SARS-CoV-2 virus. The updated interim recommendations may be found at: SAGE COVID-19 materials. • CARPHA’s COVID-19 vaccine regulatory tracker provides vaccine profiles, and regulatory approvals for various candidate vaccines and therapeutics. • CARPHA-CRS has recommended 8 COVID-19 vaccines to Member States to date. The most recent recommendation was issued for CoronaVac by Sinovac Life Sciences – 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 8 11 6 2 6 0 33 0 VVnr Viral Vector (non-replicating) 7 4 0 1 2 2 16 4 DNA DNA 4 3 0 2 1 0 10 0 IV Inactivated Virus 4 2 1 1 7 1 16 2 RNA RNA 8 2 2 1 2 3 18 2 VVr Viral Vector (replicating) 0 1 1 0 0 0 2 0 1: 05.july.2021 VLP Virus Like Particle 2 2 0 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 36 28 9 8 18 6 105 8 Source: World Health Organization. Draft landscape of COVID-19 candidate vaccines. WHO, Geneva, 29th June 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. ▪ 14 Caribbean countries have received vaccine deliveries from COVAX as of 5th July, 2021. The most recent delivery to a Member State was 9th June. ▪ Based on data collected by the Global Change Data Lab’s Our World in Data site, between 2.6% and 69% of persons in CARPHA Member States have been fully vaccinated against COVID-19 (Figure 1). Completed schedules, based on data from PAHO are shown in Figure 2. ▪ Based on the PAHO Dashboard of COVID-19 Vaccination in the Americas as of 2nd July, 2021, among CARPHA Member States, vaccine administration (at least 1 dose) ranges from 8.4 to 148.4 doses per capita (Figure 3). Approximately 2,351,277 doses have been administered, with an average of 26 doses per capita among CMS – Table 2. 2: 05.july.2021 FIGURE 1: Share of People vaccinated against COVID-19 in CARPHA Member States (3rd July) Source: https://ourworldindata.org/ FIGURE 2: Completed Schedules of COVID-19 Vaccination per 100 persons, as of 2nd July, 2021 (PAHO) Source: PAHO COVID-19 Vaccination in the Americas Dashboard. 3: 05.july.2021 FIGURE 3: COVID-19 Vaccine Doses Administered per 100 persons, as of 2nd July, 2021 Table 2: COVID-19 Vaccines Deployed Among CARPHA Member States as of 2nd July, 2021 Country ¥ Vaccine(s) Number of Doses Doses per 100 persons Anguilla AstraZeneca - Vaxzevria 16, 460 89.3 Antigua & Barbuda AstraZeneca – not specified 64, 617 65.5 Aruba Information not available 126, 979 118.5 Bahamas AstraZeneca – not specified 91, 067 22.9 Barbados AstraZeneca – not specified 166, 567 57.9 Bonaire Pfizer BioNTech - Comirnaty 27, 175 135.2 Belize AstraZeneca – not specified 115, 628 28.6 Bermuda Information not available 79, 854 110.9 Cayman Islands Pfizer BioNTech - Comirnaty 93, 652 148.4 Curacao Pfizer BioNTech - Comirnaty 167, 633 101.7 Dominica Beijing CNBG – Inactivated; AstraZeneca – not 53.7 39, 938 specified Grenada AstraZeneca – not specified 34, 331 30.4 Guyana Information not available 344, 466 43.6 Jamaica AstraZeneca – not specified 249, 938 8.4 Montserrat AstraZeneca - Vaxzevria 2, 651 49.1 Saba Information not available 1, 300 67.3 Sint Eustatius Information not available 2, 348 74.8 Sint Maarten Pfizer BioNTech - Comirnaty 39, 460 88.8 St. Kitts & Nevis AstraZeneca – not specified 41, 850 77.3 4: 05.july.2021 Country ¥ Vaccine(s) Number of Doses Doses per 100 persons St. Lucia AstraZeneca – not specified 52, 921 28.7 St. Vincent & Gamaleya - Sputnik V; AstraZeneca – not 22.2 24, 737 Grenadines specified Suriname AstraZeneca – not specified 197, 723 33.4 Trinidad & Tobago Beijing CNBG – Inactivated; AstraZeneca – not 21.5 302, 348 specified Turks and Caicos Pfizer BioNTech - Comirnaty 45, 342 79.5 Virgin Islands (British) AstraZeneca - Vaxzevria 22, 247 58.3 Source: PAHO COVID-19 Vaccination in the Americas Dashboard. ¥ No information on doses/100p found for Haiti. 5: 05.july.2021 Table 3: COVID-19 Vaccines with Regulatory Approvals by WHO EUL Consideration Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: WHO EUL status – Approved Recommended by CRS Pfizer-BioNTech mRNA 2 doses Ship: -80⁰C to -60⁰C; WHO EUL + CRS + 91 countries including United Approved: 31st December (INN: tozinameran; BNT162b2 I.M. Store: -25°C to -15°C Kingdom, Canada, Mexico, USA, Chile, Argentina, 2020 / COMIRNATY) (2wk); 2⁰C to 8⁰C Switzerland, EU, Colombia, Israel, Australia, Brazil, (12h) Guyana, Cayman Islands, Aruba, Bermuda, Curacao, St Maarten, Turks/Caicos, Guyana, Suriname, St Vincent & Grenadines. AstraZeneca-Oxford + SK Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + South Korea via COVAX / PAHO Approved: 15th February Bioscience (supplier)* ChAdOx1-S I.M. (AZD1222) adenoviral vector Serum Institute of India + Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 44 countries including India, Approved: 15th February AstraZeneca-Oxford ChAdOx1-S I.M. Argentina, Bangladesh, South Africa, Guyana, Canada University adenoviral (+VerityPharma), Brazil, OECS Member States, (AZD1222; Covishield) vector Barbados, Bahamas, Guyana, Trinidad & Tobago, Suriname, Jamaica, Antigua & Barbuda, Dominica, Grenada, St Kits & Nevis, St Lucia, St Vincent & Grenadines. Janssen-Cilag (Johnson & Viral vector 1 dose I.M. Sealed: 2-8°C or 9- WHO EUL + 53 countries including: USA, Canada, South Approved: 12th March; Johnson) (JNJ-78436735) (non-replicating) 25°C (12h); Open: 2- Africa, Bahrain, Colombia, via COVAX/ PAHO; African 8°C (6h) or 25°C (2h). Medical Supplies Platform (AMSP), Mexico, St Vincent & Grenadines, MHRA, Swissmedic, Brazil, MPA, AEMPS. AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C (6 mo.) WHO EUL + CRS + 117 countries including UK, Approved: 16th April University (AZD1222) ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), VAXZEVRIA™ adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), vector Guyana; via COVAX/ PAHO Moderna & NIAID mNRA-based in 2 doses Ship: -25°C to -15°C; 54 countries including Canada, Switzerland, United Approved: 30th April (mRNA-1273) lipid I.M. Sealed: 2-8°C (30d) Kingdom, United States, EU, Guyana, St Vincent & INN: elasomeran nanoparticle or 9-25°C (12h); Grenadines. (LNP) Open: 2-25°C (6h) Sinopharm + China National Inactivated virus 2 doses 2°C to 8°C (24 mo.) 56 countries including China, Bahrain, United Arab Approved: 7th May Pharmaceutical Group + I.M. Emirates, Egypt, Jordan, Iraq, Pakistan, Serbia, Peru, Beijing Institute of Biological Argentina, Chile, Guyana, Trinidad & Tobago Products (BBIBP-CorV) 6: 05.july.2021 Vaccine WHO EUL status and Developers (Vaccine name) Dosing Storage ¥ Authorized by Platform anticipated decision date: Sinovac COVID-19 vaccine Inactivated virus 2 doses 2°C to 8°C 33 countries including China, Colombia, Turkey, Approved: 1st June (Vero Cell [Inactivated]) – I.M. Indonesia, Brazil, Chile, México, Guyana CoronaVac WHO EUL status – Pending/Not under review yet (Not eligible for CRS review) Gamaleya Research Institute Adenovirus Viral 2 doses 2°C to 8°C 69 countries including Russia, Argentina, Guinea, Anticipated date will be set & Russian Health Ministry vector (non- I.M. Bolivia, Venezuela, Paraguay, México, Belize, Guyana, St once all data is submitted and (Sputnik V) replicating) Vincent & Grenadines, Antigua & Barbuda follow-up of inspection observations completed. AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C WHO EUL + CRS + 115 countries including UK, Anticipated date: Week of 05 University (AZD1222) [PMDA, ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), July Japan] adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), vector Guyana; via COVAX/ PAHO AstraZeneca-Oxford Recombinant 2 doses 2°C to 8°C WHO EUL + CRS + 115 countries including UK, Anticipated date: Week of 05 University (AZD1222) [TGA, ChAdOx1-S I.M. Argentina, Mexico, Brazil, EU, Canada (AZ Canada), July Australia] adenoviral Colombia, Chile, Anguilla, BVI, Montserrat (UK node), vector Guyana; via COVAX/ PAHO CanSino Biological Inc + Adenovirus; 1 dose I.M.
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    REVISION RÁPIDA EVALUACIÓN DE LAS CARACTERÍSTICAS DE ALMACENAMIENTO, TRANSPORTE Y DISTRIBUCIÓN DE LAS VACUNAS COVID-19 EN ESTUDIO, Y LAS CARACTERÍSTICAS CLÍNICAS DE LA POBLACIÓN CANDIDATA A VACUNACIÓN Noviembre de 2020 El Instituto de Evaluación Tecnológica en Salud – IETS, es una corporación sin ánimo de lucro, de participación mixta y de carácter privado, con patrimonio propio, creado según lo estipulado en la Ley 1438 de 2011. Su misión es contribuir al desarrollo de mejores políticas públicas y prácticas asistenciales en salud, mediante la producción de información basada en evidencia, a través de la evaluación de tecnologías en salud y guías de práctica clínica, con rigor técnico, independencia y participación. Sus miembros son el Ministerio de Salud y Protección Social – MinSalud, el Departamento Administrativo de Ciencia, Tecnología e Innovación – Colciencias, el Instituto Nacional de Vigilancia de Medicamentos y Alimentos – INVIMA, el Instituto Nacional de Salud – INS, la Asociación Colombiana de Facultades de Medicina – ASCOFAME y la Asociación Colombiana de Sociedades Científicas – ACSC. Autores Lucas López Quiceno. Médico y cirujano, Especialista en Epidemiología, Magister en Epidemiología, Magíster en economía de la salud (c). Instituto de Evaluación Tecnológica en Salud - IETS. Jhyld Carolaind Camacho Barbosa, Nutricionista y Dietista, Magister en Epidemiología. Instituto de Evaluación Tecnológica en Salud - IETS. Kelly Estrada-Orozco. Médica, Magister en Epidemiología Clínica, Magister en Neurociencia. Doctorado en Salud Pública (actual). Doctorado en Epidemiología Clínica (actual). Instituto de Evaluación Tecnológica en Salud - IETS. Revisores Cortes-Muñoz, Ani Julieth. Bacterióloga y laboratorista clínica. MSc. Epidemiología. Instituto de Evaluación Tecnológica en salud - IETS. Ospina-Lizarazo, Nathalie. Nutricionista Dietista. MSc. Epidemiología Clínica. Instituto de Evaluación Tecnológica en salud - IETS.
  • Periodic Update on AEFI

    Periodic Update on AEFI

    CONSOLIDATED REGIONAL AND GLOBAL INFORMATION ON ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) AGAINST COVID-19 AND OTHER UPDATES WASHINGTON, DC Updated: 31 March 2021 1 OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS CANADA § As of 19 March 2021, 3,729,312 doses of the Pfizer-BioNTech, Moderna, and Covishield vaccines had been administered. § A total of 2,530 individual reports of one or more adverse events (0.068% of doses administered) were reported. Of these, 320 were considered serious events (0.009% of doses administered), with anaphylaxis being the most frequently reported. § There were a total of 7,397 adverse events following immunization (AEFI) (consisting of 2,530 reports of one or more events), mostly non-serious adverse events, such as injection-site reactions, partesia, itching, hives, headache, hyposthesia, and nausea. Only 0.8% of cases corresponded to anaphylaxis (59 cases, or 15.8 cases per million doses administered). § Most adverse events reported were among women, and in people between the ages of 18 and 49, these being the groups prioritized for vaccination § A total of 24 reported adverse events were identified as post-vaccination deaths. After medical review, it was determined that 13 of these deaths were not linked to administration of the COVID-19 vaccine, while the other 11 are still under investigation. Link: https://health-infobase.canada.ca/covid-19/vaccine-safety/ UNITED STATES § Nearly 126 million doses of the Pfizer-BioNTech and Moderna vaccines were administered between 14 December 2020 and 29 March 2021. § The Vaccine Adverse Event Reporting System (VAERS) received 2,509 reports of deaths (0.0019% of doses administered) that have not been linked to the vaccine.