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Regulador dos EUA emite alerta sobre Pfizer, Moderna jabs

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Para cada vacuna, las hojas informativas para los proveedores de atención médica se han revisado para incluir una advertencia de que los informes de eventos adversos sugieren un mayor riesgo de miocarditis y pericarditis, particularmente después de la segunda dosis y con la aparición de los síntomas pocos días después de la vacunación, dijo la FDA. .

Hasta el 11 de junio, se habían notificado más de 1.200 casos de miocarditis o pericarditis al Sistema de Notificación de Eventos Adversos de Vacunas de EE. UU., De aproximadamente 300 millones de dosis de vacunas de ARNm administradas.

Los casos parecen ser notablemente más elevados en los hombres y en la semana posterior a la segunda dosis de vacuna. Los CDC identificaron 309 hospitalizaciones por inflamación cardíaca en personas menores de 30 años, de las cuales 295 fueron dadas de alta.

Los reguladores de salud en varios países han estado investigando casos de miocarditis y pericarditis, que se encuentran con mayor frecuencia en hombres jóvenes, después de una inyección de Pfizer o Moderna, vacunas que se basan en la tecnología de ARNm.

La última actualización de la FDA sigue a una revisión exhaustiva de la información y la discusión de la reunión del Comité Asesor sobre Prácticas de Inmunización de los CDC el miércoles.

Pfizer y Moderna no respondieron de inmediato a las solicitudes de comentarios fuera del horario comercial.

Fuente: Dawn

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