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En Este Número Boletín Científico No. 17 (16-30 junio/2021) EN ESTE NÚMERO VacCiencia es una publicación dirigida a Resumen de candidatos vacu- investigadores y especialistas dedicados a nales contra la COVID-19 ba- la vacunología y temas afines, con el ob- sadas en la plataforma de sub- jetivo de serle útil. Usted puede realizar unidad proteica en desarrollo a sugerencias sobre los contenidos y de es- nivel mundial. ta forma crear una retroalimentación Artículos científicos más que nos permita acercarnos más a sus recientes de Medline sobre necesidades de información. vacunas. Patentes más recientes en Patentscope sobre vacunas. Patentes más recientes en USPTO sobre vacunas. 1| Copyright © 2020. Todos los derechos reservados | INSTITUTO FINLAY DE VACUNAS Resumen de vacunas contra la COVID-19 basadas en la plataforma de subunidad proteica en desarrollo a nivel mundial Las vacunas de subunidades antigénicas son aquellas en las que solamente se utilizan los fragmentos específicos (llamados «subunidades antigénicas») del virus o la bacteria que es indispensable que el sistema inmunitario reconozca. Las subunidades antigénicas suelen ser proteínas o hidratos de carbono. La mayoría de las vacunas que figuran en los calendarios de vacunación infantil son de este tipo y protegen a las personas de enfermedades como la tos ferina, el tétanos, la difteria y la meningitis meningocócica. Este tipo de vacunas solo incluye las partes del microorganismo que mejor estimulan al sistema inmunitario. En el caso de las desarrolladas contra la COVID-19 contienen generalmente, la proteína S o fragmentos de la misma como el Dominio de Unión al Receptor (RBD, por sus siglas en inglés). Una vez que el sistema inmunitario reconoce el antígeno, crea anticuerpos y glóbulos blancos de defensa. Si una persona se infecta con el virus SARS-CoV-2, los anticuerpos combatirán al virus. Vacunas reportadas en el draft landscape de la Organización Mundial de la Salud hasta el 29 de junio, basadas en la plataforma de subunidades proteicas. Nombre: NVX-CoV2373 Fabricante/País: Novavax/Estados Unidos Descripción: El antígeno es la proteína S recombinante del SARS-CoV-2 obtenida mediante técnicas genéticas: el gen (ADN) de la proteína S se inserta en el genoma de un baculovirus, con el que se infecta a células Sf9 (procedentes de tejido ovárico de la polilla del maíz y estas producen la proteína S que se expresa en la superficie de las células infectadas y se recolecta y purifica. Utiliza como adyuvante Matrix-M (que es el mismo que utiliza la vacuna del paludismo de este fabricante) compuesto por una saponina extraída de la corteza del árbol Quillaja saponaria Molina junto con colesterol y fosfolípidos. Los componentes citados se ensamblan conformando nanopartículas con estructura similar a la proteína S del SARS-CoV-2. Fase de ensayo clínico: III Vía de administración: Intramuscular Esquema de administración: Dos dosis en un intervalo de 21 días Eficacia: 90% de eficacia general y 100% de protección contra enfermedades moderadas y graves (según datos del sitio web de Novavax). No obstante, su eficacia cae significativamente y llega al 49 % frente a la cepa sudafricana. Nombre: Zifivax (ZF-UZ-Vac2001) Fabricante/País: Anhui Zhifei Longcom Biopharmaceutical, Institute of Microbiology, Chinese Academy of Sciences/China Descripción: Utiliza una forma dimérica del RBD como antígeno (dos copias repetida en tándem), obtenidas en la línea celular CHOZN CHO K1. Usa hidróxido de aluminio como adyuvante. Fase de ensayo clínico: III Vía de administración: Intramuscular Esquema de inmunización: Dos y tres dosis con intervalo de 28 días. Nombre: KBP-COVID-19 Fabricante/País: Kentucky Bioprocessing Inc. subsidiaria de la compañía tabacalera British-American Tobacco/Estados Unidos. Descripción: La vacuna está basada en una proteína del virus recombinante (RBD) producida en plantas de tabaco. Fase de ensayo clínico: I/II. Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 21 días. Nombre: Sanofi–GSK COVID-19 (VAT00002) Fabricante/País: Sanofi Pasteur y GlaxoSmithKline (GSK) / Francia y Gran Bretaña Descripción: Utiliza como antígeno la proteína S recombinante, que se produce en células de insectos a través de un vector de baculovirus. También incluye un adyuvante elaborado por GSK. Fase de ensayo clínico: III. Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 21 días. Nombre: SCB-2019 Fabricante/País: Clover Biopharmaceuticals Inc, GSK, Dynavax / China, Gran Bretaña, Estados Unidos Descripción: Se basa en la proteína S trimérica similar a la nativa. Contiene CpG 1018 e hidróxido de aluminio como adyuvantes. El CpG1018 está formado por citosina fosfoguanina (CpG), que es una forma sintética de ADN que imita el material genético bacteriano y viral, lo cual potencia la respuesta inmunitaria del cuerpo. Fase de ensayo clínico: II/III. Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 21 días. Nombre: COVAX-19® Fabricante/País: Vaxine Pty Ltd., CinnaGen Co./Australia, Irán Descripción: Contiene un antígeno de proteína S recombinante formulado con el adyuvante Advax-SM propiedad de Vaxine, que impulsa una potente respuesta de células T y anticuerpos neutralizantes contra el virus SARS-CoV-2. Fase de ensayo clínico: II Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 21 días. Nombre: MVC-COV1901 Fabricante/País: Medigen Vaccine Biologics, Dynavax, National Institute of Allergy and Infectious Diseases (NIAID)/Taiwán, Estados Unidos Descripción: Está compuesta por el antígeno S-2P recombinante complementado con CpG 1018 como adyuvante, suministrado por Dynavax, e hidróxido de aluminio. El antígeno S-2P es la proteína S recombinante trimérica y estable a la prefusión, desarrollado por NIH de EE. UU. Fase de ensayo clínico: II Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 28 días. Nombre: FINLAY-FR1 (Soberana 01) Fabricante/País: Instituto Finlay de Vacunas/Cuba Descripción: Utiliza en su formulación la proteína RBD producida por biotecnología en células CHO adyuvado con vesícula de membrana externa de meningococo B. Fase de ensayo clínico: II Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 28 días. Nombre: FINLAY-FR2 (SOBERANA®02) Fabricante/País: Instituto Finlay de Vacunas/Cuba Descripción: Está compuesta por la proteína RBD producida por biotecnología en células CHO, conjugada covalentemente al Toxoide Tetánico y absorbida en gel de hidróxido de aluminio. Cada unidad de Toxoide Tetánico contiene entre 4 y 8 unidades de la proteína del SARS-CoV-2. Fase de ensayo clínico: III Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 28 días. Eficacia: Según datos preliminares SOBERANA®02 mostró una eficacia de 62 % con dos dosis. Se esperan próximamente los resultados de eficacia con el esquema completo de dos dosis de SOBERANA®02 más la dosis de SOBERANA®Plus. Fuentes: World Health Organization. Draft landscape of COVID-19 candidate vaccines https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines World Health Organization. Los distintos tipos de vacunas que existen https://www.who.int/es/news- room/feature-stories/detail/the-race-for-a-covid-19-vaccine-explained Neolife. Vacuna contra el Coronavirus, entendiendo el mecanismo de la vacunación. https://www.neolifesalud.com/blog/vacuna-contra-el-coronavirus-entendiendo-el-mecanismo-de-la- vacunacion/ CNN en español. ¿Cómo funciona la vacuna Novavax contra el covid-19? https://cnnespanol.cnn.com/2021/04/02/como-funciona-la-vacuna-novavax-contra-el-covid-19/ Mayo Clinic. Diferentes tipos de vacunas contra la COVID-19: cómo funcionan. https://www.mayoclinic.org/es-es/diseases-conditions/coronavirus/in-depth/different-types-of-covid-19- vaccines/art-20506465 Novavax website. Coronavirus Vaccine Candidate Updates. https://www.novavax.com/covid-19- coronavirus-vaccine-candidate-updates DW. Novavax la nueva esperanza contra el coronavirus. https://www.dw.com/es/novavax-la-nueva- esperanza-contra-el-coronavirus/a-57925188 FIERCE Biotech. Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine https://www.fiercebiotech.com/biotech/weak-clinical-data-force-sanofi-gsk-to-delay-covid-19-vaccine Precisión VACCINATIONS. Zifivax (ZF2001) COVID-19 Vaccine https://www.precisionvaccinations.com/vaccines/zifivax-zf2001-covid-19-vaccine Precisión VACCINATIONS. Novavax COVID-19 Vaccine https://www.precisionvaccinations.com/vaccines/novavax-covid-19-vaccine Precisión VACCINATIONS. Protein-based COVID-19 Vaccine Candidate Narrows Adjuvant Partner. https://www.precisionvaccinations.com/protein-based-covid-19-vaccine-candidate-narrows-adjuvant- partner Reuters. Clover anuncia que sus vacunas de COVID-19 desencadenan "fuertes respuestas inmunológicas". https://www.reuters.com/article/salud-coronavirus-clover-idESKBN28E1B6 Vaxine website. Start of the Phase 2 Clinical Study of the Vaxine-originated COVID-19 vaccine in Iran. https://vaxine.net/start-of-the-phase-2-clinical-study-of-the-vaxine-originated-covid-19-vaccine-in-iran/ Dynavax website. Medigen Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax's CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in Taiwan. https://investors.dynavax.com/news- releases/news-release-details/medigen-vaccine-biologics-covid-19-vaccine-adjuvanted-dynavaxs Instituto Finlay de Vacunas sitio web. Fichas
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