Israel está por probar vacuna oral contra COVID-19

Israel está por probar vacuna oral contra COVID-19
Israel está por probar vacuna oral contra COVID-19

Israel está a punto de convertirse en el primer país del mundo en probar la vacuna oral COVID-19 desarrollada por Oramed Pharmaceuticals, informó el director ejecutivo de la compañía, Nadav Kidron.

La subsidiaria de Oramed, Oravax Medical, se está preparando para comenzar los ensayos clínicos de su vacuna en el Centro Médico Sourasky en Tel Aviv después de recibir la aprobación de su protocolo de estudio por parte de la Junta de Revisión Institucional del hospital.

Ahora está esperando la aprobación del Ministerio de Salud israelí, que se espera dentro de unas semanas de acuerdo a información de Enlace Judío.

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Oravax ya completó la fabricación GMP en Europa de varios miles de cápsulas que estarían disponibles para el ensayo israelí y, finalmente, en otros países.

Oramed es una empresa farmacéutica en fase clínica basada en tecnología desarrollada por el Centro Médico de la Universidad Hadassah de Jerusalén.

En marzo, anunció una empresa conjunta con Premas Biotech, con sede en India, para desarrollar una nueva vacuna oral. Juntos formaron Oravax. La vacuna se basa en la tecnología de administración oral “POD” de Oramed y en la tecnología de vacunas de Premas.

La tecnología de Oramed se puede utilizar para administrar por vía oral una serie de terapias basadas en proteínas, que de otro modo se administrarían mediante inyección.

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Oramed se encuentra en medio de un ensayo clínico de fase III a través de la Administración de Drogas y Alimentos de EE. UU. De una cápsula de insulina oral para la diabetes tipo 1 y tipo 2.

Premas ha estado trabajando en el desarrollo de una vacuna contra el nuevo coronavirus desde marzo.

La nueva vacuna candidata de Oravax se dirige a tres proteínas estructurales del nuevo coronavirus, a diferencia de la proteína de pico único dirigida por las vacunas Moderna y Pfizer actuales, destacó Kidron.

Como tal, “esta vacuna debería ser mucho más resistente a las variantes de COVID-19. Incluso si el virus pasa por una línea, hay una segunda línea, y si pasa por la segunda línea, hay una tercera”, resaltó.

La vacuna se está probando en estudios preclínicos contra variantes de COVID-19, incluida la de Delta.

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La empresa completó un estudio piloto en animales y descubrió que la vacuna promovía el desarrollo de anticuerpos de inmunoglobulina G (IgG) e inmunoglobulina A (IgA). La IgA es necesaria para la inmunidad a más largo plazo.

El protocolo para el ensayo inaugural de Fase I / II con el que la compañía espera avanzar en Sourasky involucraría a 24 voluntarios que aún no han sido inoculados con otra vacuna.

La mitad del grupo tomaría una cápsula y la otra mitad tomaría dos, dijo Kidron, y agregó que no hay un grupo placebo porque el objetivo es medir el nivel de anticuerpos y otros indicadores de inmunidad.

“La idea aquí es que queremos mostrar una prueba de concepto: que funciona para las personas. Rezo y espero que lo hagamos. Imagínese que pudiéramos darle a alguien una vacuna oral y se vacunará. Esta sería una revolución para el mundo entero”, comentó.

Con la prueba del concepto, “el mundo entero se abre”, dijo Kidron.

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“Una vacuna oral COVID-19 eliminaría varias barreras para una distribución rápida y a gran escala, lo que podría permitir que las personas se tomen la vacuna en casa”, dijo a la prensa israelí.

“Si bien la facilidad de administración es fundamental hoy en día para acelerar las tasas de inoculación, una vacuna oral podría ser aún más valiosa en el caso de que se recomiende una vacuna COVID-19 anualmente como la vacuna estándar contra la gripe”, agregó.

Las ventajas de una vacuna oral van más allá de la seguridad y la eficacia porque los medicamentos orales tienden a tener menos efectos secundarios, detalló Kidron.

La vacuna puede enviarse a temperatura de refrigerador e incluso almacenarse a temperatura ambiente, “lo que facilita logísticamente su obtención en cualquier parte del mundo”, agregó.

Finalmente, una vacuna oral no requeriría una administración profesional.

Se espera que el ensayo de Fase I / II tome alrededor de seis semanas desde el momento del reclutamiento.

Si el ensayo tiene éxito, Kidron dijo que planea poner la vacuna en un camino acelerado para recibir la aprobación de uso de emergencia en los países que más la necesitan, como los de América del Sur que no han podido adquirir suficientes vacunas para inocular su poblaciones.

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La compañía llevaría a cabo su ensayo de fase III con un número limitado de voluntarios y buscaría la primera aprobación en uno de estos “mercados emergentes”, apuntó Kidron, y solo más tarde buscaría la autorización de la Administración de Alimentos y Medicamentos de EE. UU.

“Israel y EE. UU. y algunos de los otros países más ricos fueron los primeros en obtener Pfizer y Moderna. Pero me parece que las personas que están atrás en la carrera se harán cargo al ser las primeras en recibir la vacuna oral”, concluyó.

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