(CNN) — En un anuncio muy esperado, Pfizer dijo el lunes que un ensayo de fase 2/3 mostró que su vacuna de covid-19 era segura y generó una respuesta de anticuerpos “robusta” en niños de 5 a 11 años.
Estos son los primeros resultados de este tipo publicados para este grupo de edad para una vacuna de covid-19 en EE. UU., y los datos aún no han sido revisados por pares ni publicados. Pfizer dijo que planea presentar pronto a la Administración de Medicamentos y Alimentos de EE.UU. (FDA) para una autorización de uso de emergencia (EUA).
El ensayo incluyó a 2.268 participantes de entre 5 y 11 años y utilizó un régimen de dos dosis de la vacuna administrada con 21 días de diferencia. Estos ensayos utilizaron una dosis de 10 microgramos, menor que la dosis de 30 microgramos que se ha utilizado para los mayores de 12 años.
“La dosis de 10 microgramos se seleccionó cuidadosamente como la dosis preferida por seguridad, tolerabilidad e inmunogenicidad en niños de 5 a 11 años”, dijo Pfizer en un comunicado de prensa.
Las respuestas inmunitarias de los participantes se midieron observando los niveles de anticuerpos neutralizantes en la sangre y comparando esos niveles con un grupo de control de personas de 16 a 25 años que recibieron un régimen de dos dosis con la dosis más grande de 30 microgramos. Pfizer dijo que los niveles se comparan bien con los de las personas mayores que recibieron la dosis mayor, lo que demuestra una “fuerte respuesta inmunitaria en esta cohorte de niños un mes después de la segunda dosis”.
“Además, la vacuna de covid-19 fue bien tolerada, con efectos secundarios generalmente comparables a los observados en participantes de 16 a 25 años”, dijo la compañía.
Un portavoz de Pfizer también confirmó que no hubo casos de miocarditis, un tipo de inflamación del corazón que se ha relacionado con las vacunas de ARN
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you have a great blog here! would you like to make some invite posts on my blog?
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After I originally commented I appear to have clicked the -Notify me when new comments are added- checkbox and from now on every time a comment is added I receive 4 emails with the same comment. Perhaps there is a means you are able to remove me from that service? Thanks!
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With havin so much content do you ever run into any problems of plagorism or copyright violation? My site has a lot of unique content I’ve either written myself or outsourced but it looks like a lot of it is popping it up all over the web without my agreement. Do you know any techniques to help stop content from being ripped off? I’d certainly appreciate it.
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