La Agencia de Alimentos y Medicamentos de EEUU (FDA, en inglés) tiene previsto autorizar la próxima semana el uso de la vacuna contra la COVID-19 desarrollada por Pfizer y BioNTech en niños de 12 a 15 años, según informó este lunes The New York Times.
El diario, que cita a fuentes anónimas de la Administración federal, señala que la decisión puede llegar a principios de la semana próxima y que, tras ella, los Centros de Control y Prevención de Enfermedades (CDC, en inglés) se reunirán de inmediato para hacer recomendaciones sobre el uso de la vacuna en esta franja de edad.
Pfizer solicitó el mes pasado a las autoridades estadounidenses que se autorice el uso de emergencia de su vacuna entre los 12 y los 15 años, después de llevar a cabo un estudio con dos mil 260 individuos que mostró una eficacia del 100 % en ese grupo de edad.
Según la farmacéutica, la vacuna fue «bien tolerada» por los niños y los efectos secundarios fueron en general consistentes con los observados en participantes de entre 16 y 25 años.
La FDA confirmó el pasado 8 de diciembre la seguridad y eficacia de la vacuna de la COVID-19 de Pfizer y BioNTech para personas mayores de 16 años en un primer análisis previo a su autorización.
Ahora se espera que apruebe su uso para los niños de 12 a 15 años, lo que permitiría vacunar a millones de personas adicionales en Estados Unidos, donde unas 100 millones de personas -un tercio de la población- han completado su vacunación hasta ahora.
La estadounidense Pfizer también ha iniciado ensayos clínicos de su vacuna en niños de entre 6 meses y 11 años.
Por: Agencia
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