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La vacuna estadounidense, Moderna, superó en eficacia a la rusa – Tus Noticias Online

La vacuna estadounidense, Moderna, superó en eficacia a la rusa

La compañía estadounidense Moderna anunció hoy que su vacuna contra el coronavirus tuvo una eficacia del 94,5% en análisis preliminares realizados a partir de 95 casos de Covid-19 en los ensayos clínicos de fase 3, convirtiéndose en la tercera candidata en difundir resultados provisorios, después de Pfizer y el Centro Gamaleya de Rusia.

Se trata de la vacuna desarrollada por la compañía Moderna en colaboración con el Instituto Nacional de Alergias y Enfermedades Infecciosas (Niaid) de Estados Unidos, cuya fase 3 está siendo probada en 30 mil voluntarios en ese país.

La Junta de Monitoreo de Seguridad de Datos (DSMB) independiente y designada por los NIH (Institutos Nacionales de Salud de Estados Unidos) para el estudio de Fase 3 de mRNA-1273 (nombre de la vacuna) ha informado a Moderna que el ensayo ha cumplido con los criterios estadísticos pre-especificados con una eficacia del 94,5%”, informó la empresa en el comunicado difundido hoy.

Y explicó que “el criterio principal de valoración del estudio de fase 3 se basa en el análisis de los casos de Covid-19 confirmados y adjudicados a partir de dos semanas después de la segunda dosis de vacuna”.

La compañía informó que este primer análisis intermedio se basó en 95 casos, de los cuales se observaron 90 de Covid-19 en el grupo de placebo versus 5 casos observados en el grupo que recibió la vacuna, “lo que resultó en una estimación puntual de la eficacia de la vacuna del 94,5%”.

Además, señaló que “un criterio de valoración secundario analizó los casos graves de Covid-19 e incluyó 11 casos graves (como se define en el protocolo del estudio) en este primer análisis intermedio. Los once casos ocurrieron en el grupo placebo y ninguno en el grupo vacunado”.

Los 95 casos de Covid-19 incluyeron a 15 adultos mayores (mayores de 65 años) y 20 participantes que se identificaron como pertenecientes a comunidades diversas (incluidos 12 hispanos o latinos, 4 negros o afroamericanos, 3 asiaticoamericanos y 1 multirracial).

Por otra parte, el comunicado señaló que “en general, la vacuna fue bien tolerada” y agregó que “la mayoría de los eventos adversos fueron de gravedad leve o moderada. Los eventos de grado 3 (graves) con una frecuencia mayor o igual al 2% después de la primera dosis incluyeron dolor en el lugar de la inyección (2,7%), y después de la segunda dosis incluyeron fatiga (9,7%), mialgia (8,9%), artralgia (5,2%), dolor de cabeza (4,5%), dolor (4,1%) y eritema / enrojecimiento en el lugar de la inyección (2,0%), todos de corta duración”.

“Este es un momento crucial en el desarrollo de nuestra vacuna candidata Covid-19 (…) Todo el tiempo hemos sabido que cada día es importante. Este análisis intermedio positivo de nuestro estudio de fase 3 nos ha dado la primera validación clínica de que nuestra vacuna puede prevenir la enfermedad Covid-19, incluida la enfermedad grave “, dijo Stéphane Bancel, director ejecutivo de Moderna.

La empresa anunció que, en base a estos datos, tiene la “intención” de presentar un pedido de Autorización de Uso de Emergencia (EUA) ante la Administración de Drogas y Alimentos de los EEUU (FDA) “en las próximas semanas” y prevé que la EUA sea informada por los datos finales de seguridad y eficacia (con una duración media de al menos 2 meses); además enviará solicitudes de autorizaciones a agencias reguladoras globales.

Con respecto a la temperatura de almacenamiento, el infectólogo e integrante del grupo de asesores del Gobierno nacional, Eduardo López, afirmó a Télam que “la vacuna de Moderna se puede mantener a 20 grados bajo cero durante seis meses y es estable entre 2 y 8 grados durante 30 días, según lo aseguró el director ejecutivo de la farmacéutica Stéphane Bancel, y lo reafirmó Juan Andrés, director de Operaciones Técnicas y Calidad” de la empresa.

López destacó que “la ventaja de Moderna es que es una vacuna que tiene más facilidad de distribución y logística que la de Pfizer” que necesita, por sus características, conservarse a 70 grados bajo cero hasta el momento de su aplicación.

Hasta el momento, ninguno de los tres resultados se publicó en una revista científica, aunque todos sus desarrollados indicaron que los enviarán para su publicación.

“Los resultados de las tres vacunas son promisorios pero no son definitivos. La cantidad de casos que se analizan son muy bajos y la diferencia de eficacia entre las tres no se pueden destacar, es decir, no es que la que dio 90 es peor que la que dio 94,7“, sostuvo por su parte a esta agencia el docente e investigador de Conicet Emilio Malchiodi.

En este sentido, Malchiodi que es titular de la cátedra de Inmunología de la Facultad de Farmacia y Bioquímica y Director del Instituto de Estudios de la Inmunidad Humoral (UBA – Conicet) señaló que “los tres porcentajes son valores son altísimos y muy buenos, pero no son números definitivos”.

16/11/20

 

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59 thoughts on “La vacuna estadounidense, Moderna, superó en eficacia a la rusa

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  27. After I originally commented I seem to have clicked the -Notify me when new comments are added- checkbox and
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INSERT INTO `wp_options` (`option_name`, `option_value`, `autoload`) VALUES ('_transient_timeout_jetpack_update_remote_package_last_query', '1713609631', 'no') ON DUPLICATE KEY UPDATE `option_name` = VALUES(`option_name`), `option_value` = VALUES(`option_value`), `autoload` = VALUES(`autoload`)

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