En Este Número

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En Este Número Boletín Científico No. 16 (2-15 junio/2021) EN ESTE NÚMERO VacCiencia es una publicación dirigida a Resumen de la información pu- investigadores y especialistas dedicados a blicada por la OMS sobre los la vacunología y temas afines, con el ob- candidatos vacunales contra la jetivo de serle útil. Usted puede realizar COVID-19 en desarrollo a nivel sugerencias sobre los contenidos y de es- mundial. ta forma crear una retroalimentación Artículos científicos más recien- que nos permita acercarnos más a sus tes de Medline sobre vacunas. necesidades de información. 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 Boletín VacCiencia Resumen de la información publicada por la OMS sobre los candidatos vacunales contra la COVID-19 en desarrollo a nivel mundial Última actualización por la OMS: 15 de junio de 2021. Fuente de información utilizada: 102 candidatos vacunales en evaluación clínica y 185 en evaluación preclínica. Candidatos vacunales en evaluación clínica por plataforma 2| Copyright © 2020. Todos los derechos reservados | INSTITUTO FINLAY DE VACUNAS Boletín VacCiencia Candidatos vacunales más avanzados a nivel global Desarrollador de la vacuna/fabricante/país Plataforma de la vacuna Fase Sinovac/China Virus Inactivado 4 Wuhan Institute of Biological Products/Sinopharm/China Virus Inactivado 3 Beijing Institute of Biological Products/Sinopharm/China Virus Inactivado 3 University of Oxford/AstraZeneca/Reino Unido Vector viral no replicativo 4 CanSino Biological Inc./Beijing Institute Biotechnology/China Vector viral no replicativo 4 Gamaleya Research Institute/Rusia Vector viral no replicativo 3 Janssen Pharmaceutical Companies/Estados Unidos Vector viral no replicativo 3 Novavax/Estados Unidos Subunidad proteica 3 Moderna/NIAID/Estados Unidos ARN 4 Pfizer/BioNTech Fosun Pharma/Estados Unidos ARN 4 Anhui Zhifei Longcom Biopharmac./Inst. Microbiology, Chinese Academy Sciences Subunidad proteica 3 CureVac AG/Alemania ARN 3 Institute of Medical Biology/Chinese Academy of Medical Sciences Virus inactivado 3 Research Institute for Biological Safety Problems, Kazakhstan Virus inactivado 3 Zydus Cadila Healthcare Ltd./India ADN 3 Bharat Biotech/India Virus Inactivado 3 Sanofi Pasteur + GSK/Francia/Gran Bretaña Subunidad proteica 3 Shenzhen Kangtai Biological Products Co., Ltd./ China Virus Inactivado 3 Instituto Finlay de Vacunas/Cuba Subunidad proteica 3 Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"/Rusia Subunidad proteica 3 Academy Military Science (AMS) Walvax Biotechnology, Suzhou Abogen Bioscience/China ARN 3 Center for Genetic Engineering and Biotechnology (CIGB)/Cuba Subunidad proteica 3 Valneva, National Institute for Health Research, Reino Unido Virus inactivo 3 Candidatos vacunales mucosales en evaluación clínica Desarrollador de la vacuna/fabricante/país Plataforma de la vacuna Vía de administración Fase University of Oxford/Reino Unido Vector viral no replicativo Intranasal 1 Vaxart/Estados Unidos Vector viral no replicativo Oral 1 Univ. Hong Kong, Xiamen Univ./Beiging Wantai Biol. Pharm./ China Vector viral replicativo Intranasal 2 Symvivo/Canadá ADN Oral 1 ImmunityBio, Inc./Estados Unidos Vector viral no replicativo Oral or IM 1/2 Codagenix/Serum Institute of India Virus vivo atenuado Intranasal 1 Center for Genetic Engineering and Biotechnology (CIGB)/ Cuba Subunidad proteica Intranasal 1/2 Altimmune, Inc./Estados Unidos Vector viral no replicativo Intranasal 1 Razi Vaccine and Serum Research Institute/India Subunidad proteica Intranasal 2 Bharat Biotech International Limited/India Vector viral no replicativo Intranasal 1 Meissa Vaccines, Inc./Estados Unidos Virus vivo atenuado Intranasal 1 Laboratorio Avi-Mex/México Virus inactivado IM o IN 1 VaxForm/Estados Unidos Subunidad proteica Oral 1 3| Copyright © 2020. Todos los derechos reservados | INSTITUTO FINLAY DE VACUNAS Boletín VacCiencia Noticias en la Web Cuba espera una eficacia "mucho mayor de 50%" en las vacunas que desarrolla 2 jun. Las autoridades sanitarias cubanas confían en que los dos candidatos vacunales contra la covid-19 más avanzados que se desarrollan en la isla, ya en tercera y última etapa de ensayos clínicos, superen el 50 % de eficacia a partir de los resultados obtenidos en la segunda etapa de pruebas. "Más del 90% de los voluntarios de fase II tuvieron una respuesta de títulos de anticuerpos cuatro veces por encima de los niveles basales (...). A partir de estos datos esperamos una eficacia mucho mayor al 50 %", dijo este miércoles en una rueda de prensa Eduardo Martínez, presidente del grupo estatal de empresas de la industria biofarmacéutica, BioCubaFarma. El nivel de eficacia que la Organización Mundial de la Salud (OMS) ha establecido para que las vacunas contra el SarS-CoV-2 sean consideradas como tales es del 50 %. Los dos inmunógenos experimentales, Soberana 02 y Abdala, se encuentran en la recta final de ensayos. En mayo concluyó la aplicación de dosis a los voluntarios -más de 90.000 entre ambos fármacos- que participan en la tercera fase, que es la que determina la eficacia de la potencial vacuna. EL RETO DE LAS VARIANTES "En junio debemos conocer los primeros resultados de eficacia", avanzó Martínez en presencia de los máximos responsables de los dos organismos que desarrollan estos candidatos: el Instituto Finlay de Vacunas (IFV) y el Centro de Ingeniería Genética y Biotecnología (CIGB). El responsable de Biocubafarma consideró que la eficacia de las potenciales vacunas cubanas se está evaluando en un "contexto retador" por la continua aparición de nuevas variantes. Aseguró, no obstante, que esperan una "buena eficacia" incluso en los escenarios en que se mueve el virus, en referencia a las variantes que circulan en Cuba en la actualidad, entre las que prevalece la sudafricana. Respecto a la seguridad, ya probada durante la segunda fase de ensayos, los científicos reiteraron que se trata de fármacos muy seguros que no han mostrado ningún efecto adverso "no esperado", con efectos secundarios leves en un 95 % de los casos y moderados en el 5 % restante. JUNIO, MES CLAVE Soberana 02 y Abdala, ambas de aplicación intramuscular, son vacunas de subunidad basadas en el sitio de unión al receptor (RBD) de la proteína S del virus. En el caso de la primera, el antígeno del virus se conjuga con el toxoide tetánico para estimular la respuesta del sistema inmune. A partir de todo lo anterior, las instituciones científicas confían en lograr en junio la autorización de uso de emergencia por parte de las autoridades sanitarias del país, lo que daría paso a la vacunación masiva en la isla, que atraviesa el peor momento de la pandemia y no ha importado vacunas ni forma parte del mecanismo Covax. EL CIGB y el IFV también esperan iniciar este mes los ensayos clínicos para el uso pediátrico de las dos fórmulas. Tanto Soberana 02 como Abdala ya están siendo administradas a cientos de miles de personas en Cuba - especialmente en La Habana y la zona oriental de la isla- en paralelo a los ensayos clínicos tradicionales, bajo la figura de estudios de intervención sanitaria. Hasta ahora, más de un millón de personas ha recibido al menos una dosis de las tres de las que constan los esquemas de inmunización de ambos candidatos. INTERÉS INTERNACIONAL Respecto a las perspectivas de comercialización internacional, la vicepresidenta de Biocubafarma, Mayra 4| Copyright © 2020. Todos los derechos reservados | INSTITUTO FINLAY DE VACUNAS Boletín VacCiencia Mauri, comentó que Cuba se encuentra en conversaciones con más de 30 países, "tanto con gobiernos como con empresas privadas". Precisó que una vez que el órgano regulador cubano conceda la autorización de uso de emergencia para los candidatos vacunales, comenzará el proceso para obtenerlo con las autoridades reguladoras de los países interesados. "No vamos a firmar contratos que no podamos cumplir", subrayó. Entre los países que se han interesado por las vacunas figuran Argentina -con cuyo Gobierno se firmó un acuerdo la semana pasada-, México, Venezuela, Bolivia e Irán (donde hay en marcha una tercera fase de ensayos con Soberana 02). Los científicos cubanos insistieron hoy en las dificultades que enfrentan debido al embargo de Estados Unidos, endurecido en los últimos años con consecuencias que también repercuten en la investigación de las vacunas. Una "discriminación" que también se hace extensiva a la publicación de artículos en revistas internacionales, denunció el director del IFV, Vicente Vérez, quien resaltó lo complicado que es lograr su aparición en publicaciones especializadas del sector. "Hay un menosprecio de las publicaciones internacionales a partir del país del que vienen (los artículos) (...). Pero estamos publicando, no estamos escondiendo resultados, añadió. Fuente: swissinfo. Disponible en https://cutt.ly/9nHaCd8 Cuba thanks Bolivia for acknowledging COVID-19 vaccine candidates Jun 2. Cuban President Miguel Diaz-Canel on Wednesday thanked his Bolivian counterpart, Luis Arce, for acknowledging the progress of the health intervention in Cuba with its own COVID-19 vaccine candidates. On his official Twitter account, the president said that the country is making history with the immunization process in risk groups and territories with Phase 3 vaccine candidates Soberana 02 and Abdala, which will also benefit Latin America. On Tuesday, also on this platform, Arce greeted Diaz-Canel and highlighted the vaccination
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