Israel presentó a la vacuna contra el coronavirus desarrollada en el país

Israel presentó la vacuna contra el coronavirus
Israel presentó la vacuna contra el coronavirus

El Instituto de Investigación Biológica de Israel anunció la aprobación para lanzar ensayos clínicos en humanos para una vacuna contra el coronavirus desarrollada 100% en Israel.

Tras completar rigurosos preparativos de I + D, el Instituto de Investigación Biológica de Israel (IIBR) ha recibido todas las aprobaciones necesarias del Ministerio de Salud y del Comité de Helsinki para comenzar la etapa más crucial en el desarrollo de una vacuna.

Los ensayos clínicos de la vacuna comenzarán el domingo 1 de noviembre.

El ministro de Defensa, Benny Gantz, acogió con satisfacción la aprobación de los ensayos clínicos: “este es un día de esperanza para los ciudadanos de Israel gracias a los investigadores del IIBR. Hace apenas dos meses recibí el primer frasco de la vacuna. Hoy ya tenemos 25.000 dosis de vacuna y están comenzando la siguiente fase de la prueba. Me gustaría agradecer a las decenas de investigadores que trabajan día y noche en esta misión nacional en plena cooperación con el Ministerio de Salud”.

Los ensayos clínicos en participantes humanos se llevarán a cabo durante un período de varios meses e incluirán tres fases distintas.

Fase 1:
La primera fase incluye una serie de pruebas de seguridad con la participación de 80 voluntarios sanos (de 18 a 55 años), designados por los centros médicos de Sheba y Hadassah. La prueba comenzará el domingo 1 de noviembre con dos participantes iniciales. Dependiendo de sus respuestas, la vacuna se administrará gradualmente a un total de 80 voluntarios (40 en cada centro médico).

Cada voluntario recibirá una inyección (vacuna o placebo). Después de unas horas de supervisión, será dado de alta del hospital y será monitoreado durante un período de tres semanas. Los científicos comprobarán los posibles efectos secundarios y controlarán si los voluntarios desarrollan anticuerpos contra el virus. El desarrollo de anticuerpos indica una respuesta al virus en los pacientes que recibieron la vacuna.

Fase 2:
La segunda fase incluye extensas pruebas de seguridad con la participación de 960 voluntarios sanos (mayores de 18 años). Se espera que el ensayo comience en diciembre y se llevará a cabo simultáneamente en varios centros médicos de todo el país. En esta fase, los científicos tienen como objetivo completar las precauciones de seguridad de las vacunas, determinar la dosis efectiva y determinar aún más la efectividad de la vacuna.
Fase 3:
La tercera fase es un ensayo a gran escala para probar la eficacia de la vacuna, con la participación de hasta 30.000 voluntarios. El experimento está programado para comenzar en abril / mayo (sujeto al éxito de las dos primeras fases). Esta es la última etapa y después de su finalización exitosa, la vacuna puede aprobarse para uso masivo.

El director del Instituto de Investigación Biológica de Israel, Prof. Shmuel Shapira nos dijo: “ahora estamos comenzando una fase crucial [en el desarrollo de la vacuna]: la fase de ensayos clínicos. Creo en las habilidades de nuestros científicos y estoy seguro de que puede producir una vacuna segura y eficaz. El nombre comercial de la vacuna es “BriLife”.

La primera parte del nombre, “Bri”, alude a la palabra hebrea para salud, “briut”, la segunda parte, “il” alude a Israel, y la “vida” habla de la importancia de la vacuna. El nombre del instituto, IIBR también está oculto en el nombre. Continuaremos trabajando para beneficiar la salud de los ciudadanos de Israel, así como la economía y la sociedad de el Estado de Israel.

Leer más:La vacuna israelí contra el coronavirus comenzará la prueba en humanos

Nuestro objetivo final son 15 millones de vacunas para los residentes del Estado de Israel y para nuestros vecinos cercanos”.

El IIBR ha estado preparando sus capacidades de respuesta durante varios años para un escenario con una amenaza desconocida (Desconocido X).

Como parte de sus evaluaciones científicas, el instituto compró y desarrolló plataformas avanzadas, incluida la infraestructura para la identificación rápida de patógenos epidémicos y herramientas para el diseño rápido de vacunas eficaces en respuesta a brotes.

Se han implementado modelos animales para probar la seguridad y eficacia de las vacunas y los tratamientos y se ha desarrollado y establecido una nueva infraestructura para la producción rápida y eficiente de millones de vacunas, todo esto bajo estrictas condiciones regulatorias.

La vacuna desarrollada por el IIBR se basa en un virus existente (VSV). Los picos del virus corona se han “diseñado” en el VSV, lo que permite que la vacuna se adhiera a las células del cuerpo. Se trata de una vacuna moderna a la vanguardia de la tecnología, que proporciona el nivel de protección requerido en una sola dosis.

La vacuna se ha probado con éxito en varios “modelos animales”. La vacuna provocó una respuesta inmunitaria eficaz tanto en animales pequeños (ratones, hámsteres y conejos) como en animales grandes (cerdos). La seguridad de la vacuna ha sido demostrada en varias pruebas, abriendo así la puerta a ensayos clínicos con participantes humanos.

El instituto ha adaptado un dispositivo para la producción a gran escala de vacunas (aproximadamente 15 millones). Hasta la fecha, el instituto ha producido más de 25.000 dosis de vacunas para la primera y segunda fase de los ensayos clínicos.

Fuente: Latam Israel

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