La eficacia de la Sputnik V contra el coronavirus es superior al 95%, según otro análisis preliminar

La eficacia de la vacuna Sputnik V es superior al 95% a los 21 días de la segunda dosis, anunciaron hoy el Centro Gamaleya de Rusia y el Fondo de Inversión Directa de Rusia (RDIF), en base a un segundo análisis intermedio del ensayo clínico de fase 3, en tanto que confirmaron que su valor será de menos de 10 dólares por dosis.

La evaluación de la eficacia se llevó a cabo entre 18.794 voluntarios 28 días después de recibir la primera dosis (7 días después de la segunda dosis) de la vacuna o placebo sobre la base de 39 casos confirmados de coronavirus, de los cuales 31 se dieron en quienes habían recibido placebo y 8 en los inoculados con la vacuna.

Como la relación entre el grupo placebo y el grupo vacunado es de 1 a 3, sobre esa cantidad de casos, la Sputnik V demuestra una eficacia del 91,4% siete días después de la segunda dosis.

No obstante, “los datos preliminares sobre los voluntarios en el día 42 después de la primera dosis (equivalente a 21 días después de la segunda dosis), cuando ya han formado una respuesta inmune estable, indican que la tasa de eficacia de la vacuna está por encima del 95%”, informó el Centro Gamaleya en el comunicado.

“Esta eficacia es el resultado del uso de dos adenovirus diferentes que se administra cada uno en una de las dosis, lo que aumenta la respuesta inmune“, explicó esta mañana en una conferencia de prensa con medios internacionales Denis Logunov, vicedirector del Gamaleya y quien está a cargo del equipo de desarrollo de la vacuna.

En este sentido, añadió que “este análisis preliminar es el segundo que hacemos en base al protocolo que se había establecido, el siguiente será cuando se lleguen a los 78 casos de coronavirus; no obstante estimamos que el porcentaje de eficacia no bajará ni subirá demasiado”.

Durante la conferencia virtual, de la que participó Télam, Logunov señaló que “durante este tiempo no registramos efectos adversos graves, sí tuvimos algunos efectos como febrícula o dolor en el lugar de la inyección en un 30 y un 40% de los participantes”.

Por su parte, Kirill Dmitriev, director general del Fondo Ruso de Inversión Directa (RDIF) -también presente en la conferencia-, confirmó que “el precio de la vacuna será inferior a 10 dólares por dosis, lo que implica menos de 20 dólares por esquema, una cifra que es casi la mitad de los precios anunciados por las otras vacunas que tuvieron indicadores similares en sus resultados preliminares de fase 3”.

Dmitriev ratificó, además, la elaboración de la vacuna en forma liofilizada (seca), que permite su almacenamiento a una temperatura de +2 a +8 grados Celsius, lo que facilita la distribución.

“A diferencia de otras vacunas que necesitan condiciones como el ultrafrío para conservarse, la nuestra estará disponible en forma seca lo que será de gran utilidad para muchos países”, describió.

Con respecto al momento en que llegarían las vacunas a los países que la solicitaron, Dmitriev detalló que “las dosis estarán disponibles en enero con los países con los que ya venimos cerrando los acuerdos y en marzo para el resto”.

La vacuna rusa es una sobre las que están avanzadas las conversaciones del Gobierno argentino para su adquisición, al tiempo que también fue sellado ya un acuerdo con la farmacéutica AstraZeneca, y mantiene negociaciones negociaciones con Pfizer, Janssen y Sinopharm.

Hasta el 24 de noviembre, más de 22.000 voluntarios fueron vacunados con la primera dosis y más de 1.900 voluntarios con la primera y la segunda dosis de la vacuna en 29 centros médicos en Rusia como parte de los ensayos clínicos en curso que aspiran a llegar a 20 mil participantes.

Actualmente, los ensayos clínicos de fase III están aprobados y están en curso en Bielorrusia, los Emiratos Árabes Unidos, Venezuela y otros países, así como la fase II-III en la India.

La Sputnik V es una vacuna que utiliza una tecnología que se llama “vector viral no replicante”; los vectores son virus que no tienen capacidad de reproducirse en el organismo (y por tanto son inocuos) y se utilizan para transportar material genético del virus del que se quiere inmunizar.

A diferencia de otras que utilizan esta tecnología, esta vacuna es la única que utiliza dos adenovirus (virus que causan gripe común) humanos como vectores, uno diferente en cada dosis que se dan intramuscularmente con diferencia de 21 días.

24/11/20

 

 

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65 thoughts on “La eficacia de la Sputnik V contra el coronavirus es superior al 95%, según otro análisis preliminar

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