Moderna Inc. dijo el miércoles que pedirá a los reguladores que autoricen su vacuna COVID-19 en niños menores de 6 años basándose en datos que muestran que generó una respuesta inmunitaria similar a la de los adultos en su ensayo clínico.
La variante ómicron del COVID-19 fue la predominante durante el ensayo pediátrico de Moderna, y el fabricante de medicamentos dijo que dos dosis tenían una eficacia de alrededor del 38 % en la prevención de infecciones en niños de 2 a 5 años y del 44 % en niños de 6 meses a menos de 2 años.
Afirmó que estas cifras eran coherentes con la menor eficacia contra la variante ómicron observada en los adultos que habían recibido dos dosis de su vacuna.
La vacuna de Moderna podría ser la primera autorizada para niños menores de 5 años en Estados Unidos, y muchos padres de niños pequeños han estado esperando una vacuna.
Una vacuna competidora fabricada por Pfizer Inc y la alemana BioNTech SE está autorizada para su uso en niños de 5 años o más. Pero los resultados de sus ensayos en niños de 2 a 4 años mostraron una respuesta inmunitaria más débil que en los adultos, lo que obligó a ampliar el ensayo para probar una tercera dosis. Los resultados se esperan para abril.
La doctora Jacqueline Miller, una de las principales científicas de Moderna, dijo a Reuters que la empresa estaba «a un par de semanas» de presentar la autorización para este grupo de edad en Estados Unidos, Europa y otros países.
No está claro cuántos padres estadounidenses vacunarán a sus hijos en ese grupo de edad. Sólo el 27 % de los niños de 5 a 11 años del país están totalmente vacunados, y el COVID-19 suele ser más leve en los niños que en los adultos.
En el ensayo pediátrico de Moderna no hubo casos graves ni en los que recibieron la vacuna ni en los participantes en el placebo.
Moderna dijo que las inyecciones, espaciadas cuatro semanas, fueron generalmente bien toleradas en el grupo de edad y la mayoría de los efectos secundarios experimentados fueron leves o moderados.
El tamaño de la dosis probada fue de 25 microgramos, una cuarta parte de la dosis que reciben los adultos para cada una de sus dos primeras inyecciones.
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