La farmacéutica estadounidense Pfizer y su socia BioNtech solicitaron, el martes 1 de febrero de 2022, la autorización de emergencia en Estados Unidos de su vacuna contra la covid-19 para niños de entre seis meses y cinco años, anunciaron las compañías en un comunicado.
En el texto destacan la urgente necesidad de que ese sector de la población tenga acceso a la vacuna.
“Tras una solicitud de la Administración de Drogas y Alimentos de los EE. UU. (FDA), las empresas han iniciado una presentación para modificar la autorización de uso de emergencia, para incluir a niños de entre seis meses y cinco años, en respuesta a una urgente necesidad”, aseguran las empresas.
De aprobarse, esta sería la primera vacuna contra el coronavirus para niños de esas edades.
Poco después de darse a conocer el anuncio, la FDA convocó para el 15 de febrero la reunión de su comité asesor para revisar los datos aportados por Pfizer para la vacuna de niños de seis meses a cinco años.
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Según Pfizer y BioNtech han aportado información sobre la seguridad y la eficacia de dos dosis de tres microgramos en los niños de este rango de edad, como parte de una serie de tres dosis.
Sin embargo, Pfizer advirtió de que la información sobre la dosis de refuerzo en este rango de edad no se presentará hasta dentro de unos meses.
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“Tener una vacuna segura y eficaz disponible para los niños de este grupo de edad es una prioridad para la agencia y estamos comprometidos con una revisión oportuna de los datos”, aseguró la comisionada en funciones de la FDA, Janet Woodcock, en otro comunicado.
El pasado octubre, la FDA autorizó la vacuna de estas farmacéuticas para niños de entre cinco y once años y, recientemente, dio luz verde a una dosis de refuerzo para los menores de entre doce y quince años.
Mientras llega la vacuna, “la mejor manera de proteger a los niños, incluso cuando están en la escuela o en la guardería, es practicar el distanciamiento social y el uso de mascarillas, de acuerdo con las recomendaciones de salud pública”, agregó Woodcock.