Las compañías dijeron el viernes que enviaron los hallazgos de las pruebas de estabilidad en curso a la Administración de Alimentos y Medicamentos de Estados Unidos (FDA), la cual autorizó el uso de emergencia de la vacuna en el país y que enviarán los datos a los reguladores de todo el mundo en las próximas semanas.
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Los refrigeradores que se usan en muchas farmacias y hospitales comúnmente alcanzan esas temperaturas, pero no al rango de temperatura actualmente autorizado para la inyección de Pfizer/BioNTech, de -80 a -60 grados Celsius (-112 a -76 Fahrenheit). La vacuna puede permanecer estable a esas temperaturas ultrabajas hasta por seis meses.
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Las empresas han estado probando la estabilidad de lotes de vacunas fabricados en diferentes momentos durante los últimos nueve meses y continúan investigando formas de aumentar la vida útil de la inyección.
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La vacuna fabricada por Moderna comenzó con requisitos de temperatura igualmente fría en estudios en etapa temprana antes de que las pruebas de estabilidad mostraran que podía almacenarse a temperaturas normales de congelación.
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