Salud
Segunda vacuna COVID-19 preparada para su aprobación en EE. UU. Con respaldo del panel
Un panel asesor del gobierno aprobó el jueves una segunda vacuna COVID-19, allanando el camino para que la inyección se agregue a la campaña de vacunación de EE. UU.
Se espera que la Administración de Alimentos y Medicamentos siga la recomendación para la vacuna de Moderna y los Institutos Nacionales de Salud. Los asesores de la FDA, en una votación de 20 a 0, acordaron que los beneficios de la vacuna superan los riesgos para los mayores de 18 años.
Se espera que la luz verde de la FDA para uso de emergencia sea rápida. Moderna luego comenzaría a enviar millones de dosis, destinadas a trabajadores de la salud y residentes de hogares de ancianos, para impulsar el esfuerzo de vacunación más grande en la historia de los EE. UU.
La campaña comenzó a principios de esta semana con la primera vacuna aprobada en los EE. UU., Desarrollada por Pfizer y BioNTech. La inyección de Moderna mostró una protección igualmente fuerte, proporcionando un 94% de protección contra COVID-19 en el estudio en curso de la compañía de 30.000 personas.
Después de siete horas de debate sobre los detalles técnicos del estudio de la compañía y los planes de seguimiento, casi todos los panelistas respaldaron que la vacuna esté disponible para ayudar a combatir la pandemia. Un miembro del panel se abstuvo.
«La evidencia que se ha estudiado con gran detalle sobre esta vacuna supera con creces cualquier problema que hemos visto», dijo la Dra. Hayley Gans del Centro Médico de la Universidad de Stanford.
Se necesita con urgencia una segunda vacuna a medida que las infecciones por coronavirus, las hospitalizaciones y las muertes alcanzan nuevos máximos antes de las vacaciones. Estados Unidos lidera el mundo en totales de virus, con más de 1,6 millones de casos confirmados y casi 309.000 muertes reportadas.
La vacuna de Moderna utiliza la misma tecnología innovadora que la inyección de Pfizer-BioNTech. La mayoría de las vacunas tradicionales usan virus muertos o debilitados, pero las dos nuevas vacunas usan fragmentos del código genético de COVID-19 para entrenar al sistema inmunológico a detectar y combatir el virus. Ambos requieren dos dosis, con varias semanas de diferencia.
La revisión del jueves se produjo días después de los informes de aparentes reacciones alérgicas a la vacuna Pfizer-BioNTech en dos trabajadores de salud de Alaska. Una persona tuvo una reacción grave, que incluía dificultad para respirar, y la otra tuvo efectos secundarios menos graves, como mareos.
Si bien las dos vacunas usan la misma tecnología, no son idénticas, advirtió el Dr. Tal Zaks, director médico de Moderna. En particular, algunos de los lípidos o grasas que se utilizan para recubrir las dos vacunas son diferentes.
«No asumiría necesariamente» que cualquier reacción sería la misma, dijo.
La FDA no encontró reacciones alérgicas graves en los datos de Moderna, pero señaló una tasa ligeramente mayor de efectos secundarios menos graves (sarpullido, urticaria, picazón) entre los participantes que recibieron la vacuna, en comparación con los que recibieron una inyección simulada.
También hubo tres casos de parálisis de Bell, que paraliza temporalmente los músculos faciales, entre los que recibieron la vacuna, en comparación con solo uno entre los que recibieron una inyección simulada. La revisión de la FDA dijo que el papel de la inyección en el grupo de la vacuna «no se puede descartar».
Una pregunta sin respuesta es si la vacuna también previene a las personas de una infección asintomática, pero Moderna encontró un indicio de que sí. A los participantes del estudio se les hizo una muestra de la nariz antes de la segunda dosis de la vacuna o del placebo. En ese momento, los hisopos de 14 receptores de la vacuna y 38 receptores de placebo mostraron evidencia de infección asintomática, dijo la Dra. Jacqueline Miller de Moderna.
Después de la actuación de la FDA, los funcionarios de EE. UU. Planean trasladar un envío inicial de casi 6 millones de dosis de Moderna. La vacuna debe almacenarse a temperaturas de congelación regulares, pero no al frío ultrarrápido requerido para la inyección de Pfizer-BioNTech.
Se necesitarán cientos de millones de vacunas adicionales para eventualmente vacunar al público en general, lo que no se espera hasta la primavera o el verano. El programa Operation Warp Speed del gobierno tiene pedidos de 200 millones de dosis de la vacuna de Moderna. Eso se suma a los 100 millones de dosis de la vacuna Pfizer-BioNTech. Los funcionarios están negociando la compra de más dosis de esa vacuna.
Al igual que la primera vacuna, la vacuna de Moderna seguirá siendo experimental a medida que la compañía continúe con un estudio de dos años necesario para responder preguntas clave, incluido cuánto tiempo dura la protección.
Uno de los temas más complicados que debatieron los panelistas fue cómo evitar que los voluntarios del estudio que recibieron una inyección ficticia abandonen para obtener la vacuna real una vez que esté autorizada. Su participación es fundamental para poder comparar la seguridad y la eficacia a largo plazo.
Moderna propuso alertar inmediatamente a todos esos voluntarios de su estado y ofrecerles la vacuna. La compañía dijo que más del 25% de sus participantes son trabajadores de la salud y algunos ya se están yendo para recibir la primera vacuna.
Pero un experto invitado de la Universidad de Stanford instó a Moderna a adoptar el enfoque de Pfizer. Pfizer planea vacunar gradualmente a las personas en su grupo de placebo en función del momento en que normalmente hubieran tenido acceso a la vacuna, ya que se establecen los grupos prioritarios.
Pero la mayoría de los panelistas reconocieron que será difícil evitar que los voluntarios abandonen el estudio de Moderna si tienen que esperar para recibir la vacuna.
«La realidad puede hacer que eso sea demasiado difícil de hacer», dijo el Dr. Steven Pergam de Seattle Cancer Care Alliance.
La única muerte por COVID-19 en los 30.000 voluntarios fue en un receptor de placebo, un hombre de 54 años cuyo único factor de riesgo era la diabetes.
Saber que podría haber un coronavirus más severo en los receptores de placebo a medida que la pandemia continúa «me pesa mucho», dijo Miller de Moderna.
Fuente: Associated Press
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Hongzhi 황제는 눈썹을 치켜 올렸습니다. «오? 이유가 뭐야?»
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Hongzhi 황제는 필연적으로 Wang Bushi를 동정적으로 바라 보았습니다.
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04/09/2024 at 2:30 AM
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Zhu Houzhao는 활기차게 일어 서서 «내 아들이 여기 있습니다. «라고 행복하게 말했습니다.
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04/18/2024 at 9:50 AM
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«너… 앞으로 이렇게 장난치면 안 돼, 알겠지?»
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04/23/2024 at 3:08 AM
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처음부터 끝까지 Zhu Zhixiong은 황제에게 조금도 무례하지 않았습니다.
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아니, 결국 그는 내면이 너무 강해서 …
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그는 Liu Jian과 다른 사람들의 눈을 보았고 모두 그를 보았습니다.
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Fang Zhengqing은 고통스러운 얼굴로 «아들, 아들 … 내 마음이 아플 것입니다.»
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