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    August 30, 2024 - La FDA autoriza la vacuna contra el COVID-19 de Novavax actualizada para brindar una mejor protección contra las variantes que circulan actualmente.

    9/3/24 2:26:49 PM ET
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    For Immediate Release:
    August 30, 2024

    English

    Hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) otorgó una autorización de uso de emergencia (EUA, por sus siglas en inglés) para una versión actualizada de la vacuna contra el COVID-19 de Novavax que ataca más de cerca a las variantes que circulan actualmente para brindar una mejor protección contra las consecuencias graves del COVID-19, incluidas la hospitalización y la muerte. La vacuna actualizada está autorizada para su uso en personas de 12 años o mayores. Incluye un componente monovalente (único) que corresponde a la cepa JN.1 de la variante ómicron del SARS-CoV-2. 

    “Las vacunas contra el COVID-19 han tenido un enorme impacto positivo en la salud pública y la vacunación sigue siendo el método más eficaz para la prevención del COVID-19”, afirmó el doctor Peter Marks, director del Centro de Evaluación e Investigación de Productos Biológicos de la FDA. “El COVID-19 sigue siendo un riesgo muy real para muchas personas, y animamos a las personas a que consideren recibir la vacuna actualizada contra el COVID-19 cuando reúnan las condiciones para ello. La autorización de hoy proporciona una opción adicional de vacuna contra el COVID-19 que cumple con las normas de inocuidad, eficacia y calidad de manufactura de la FDA necesarias para respaldar la autorización de uso de emergencia”.

    Esta autorización sigue a las aprobaciones y autorizaciones recientes de la FDA de vacunas actualizadas de ARNm contra el COVID-19 para 2024-2025 fabricadas por ModernaTX Inc. y Pfizer Inc.

    Lo que necesita saber

    • Las personas de 12 años o mayores que nunca hayan recibido ninguna vacuna contra el COVID-19 pueden recibir dos dosis de esta vacuna actualizada, con un intervalo de 3 semanas.
    • Las personas que hayan recibido una sola dosis de cualquier vacuna contra el COVID-19 de Novavax pueden recibir una dosis de la vacuna actualizada contra el COVID-19 de Novavax al menos 3 semanas después de la dosis anterior.  
    • Las personas que hayan recibido una fórmula anterior de una vacuna contra el COVID-19 de otro fabricante o dos o más dosis de una fórmula anterior de la vacuna contra el COVID-19 de Novavax pueden recibir una dosis única de la vacuna actualizada contra el COVID-19 de Novavax al menos 2 meses después de la última dosis de una vacuna contra el COVID-19.

    La FDA evaluó los datos de manufactura y no clínicos para respaldar el cambio a la fórmula 2024-2025. La vacuna actualizada se fabrica mediante un proceso similar al de las fórmulas anteriores de esta vacuna. Las personas que reciben esta vacuna pueden experimentar efectos secundarios similares a los informados por las personas que recibieron fórmulas anteriores de esta vacuna contra el COVID-19 y que se describen en las hojas informativas. 

    La FDA ha determinado que la vacuna actualizada contra el COVID-19 de Novavax ha cumplido con los criterios legales para la emisión de una EUA, incluido que los beneficios conocidos y potenciales de la vacuna superan sus riesgos conocidos y potenciales en personas de 12 años o mayores. 

    Como parte de la medida de hoy, la vacuna contra el COVID-19 de Novavax con adyuvante (fórmula 2023-2024) ya no está autorizada para su uso.

    La FDA otorgó la autorización de uso de emergencia de la vacuna contra el COVID-19 de Novavax con adyuvante (fórmula 2024-2025) a Novavax Inc. de Gaithersburg, Maryland.

    Información relacionada

    • La vacuna contra el COVID-19 de Novavax con adyuvante (fórmula 2024-2025)
    • Los recursos de la FDA para la temporada de enfermedades respiratorias de otoño
    • Las vacunas actualizadas contra el COVID-19 para su uso en los Estados Unidos a partir del otoño de 2024
    • 5 de junio de 2024, reunión del Comité Asesor de Vacunas y Productos Biológicos Relacionados 

    ###

    Boilerplate

    La FDA, una agencia del Departamento de Salud y Servicios Humanos de los Estados Unidos, protege la salud pública garantizando la inocuidad, eficacia y seguridad de los medicamentos para uso humano y veterinario, vacunas y otros productos biológicos para uso humano, y dispositivos médicos. La agencia también es responsable por la inocuidad del suministro de alimentos, cosméticos, suplementos dietéticos, productos electrónicos que emiten radiación y de regular los productos de tabaco de nuestra nación.


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