Los funcionarios federales otorgaron la aprobación total a la vacuna contra el COVID-19 de Moderna,
Lluego de su autorización el año pasado para uso de emergencia, la vacuna deModerna obtuvo su aprobación total, de acuerdo con el anuncio hecho por La Food and Drug Administration (FDA).
Esta medida representa el primer producto aprobado por la FDA de Moderna en los Estados Unidos y se produce después de que ya se han administrado decenas de millones de dosis de dicha vacuna en todo el país.
Las autoridades dijeron que la FDA revisó meses de datos de seguimiento adicionales presentados por Moderna para confirmar la efectividad de la vacuna contra el COVID-19, antes de aprobarla por completo mientras monitoreaba cualquier efecto secundario importante.
La aprobación completa se basa en datos de ensayos clínicos de casi 30 mil personas, que mostraron que la vacuna era una protección segura y eficaz contra la COVID-19, anotaron los expertos.
La confianza
“Si bien se han administrado cientos de millones de dosis de las vacunas Moderna contra el COVID-19 a personas bajo autorización de uso de emergencia, entendemos que para algunas personas, la aprobación de esta vacuna por parte de la FDA puede infundir confianza adicional para tomar la decisión de vacunarse”, indicó la comisionada en funciones de la FDA, Janet Woodcock.
El doctor Peter Marks, el principal regulador de vacunas de la FDA, expresó que “el público puede estar seguro de que esta vacuna fue aprobada de acuerdo con los rigurosos estándares científicos de la FDA”.
El director ejecutivo de Moderna, Stephane Bancel, señaló que la vacuna recibió previamente la aprobación total de otros departamentos de salud federales de todo el mundo.
“Nuestra vacuna contra el COVID-19 se ha administrado a cientos de millones de personas en todo el mundo, protegiendo a las personas de la infección, hospitalización y muerte por COVID-19”, agregó Bancel.
“La totalidad de los datos del mundo real y la Solicitud de Licencia Biológica completa para Spikevax en los Estados Unidos reafirma la importancia de la vacunación contra este virus”, precisó el directivo.
“Este es un hito trascendental en la historia de Moderna, ya que es nuestro primer producto en obtener la licencia en los Estados Unidos. La licencia completa de Spikevax en los Estados Unidos ahora se une a la de Canadá, Japón, la Unión Europea, el Reino Unido, Israel y otros países, donde también está aprobada la indicación para adolescentes”, finalizó Bancel.
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