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.
Las empresas quieren que los reguladores actualicen los requisitos de temperatura para indicar que las vacunas pueden mantener su efectividad durante dos semanas si se almacenan entre -25 y -15 grados Celsius (-13 y 5 Fahrenheit), como opción.
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.
Es por eso que BioNTech y Pfizer, con sede en Nueva York, envían los viales de la vacuna en contenedores térmicos especiales que pueden servir como almacenamiento temporal hasta por 30 días agregando hielo seco constantemente. Aun así, eso puede hacer que almacenar y luego descongelar y administrar la vacuna sea un desafío en muchos lugares, particularmente en los países en desarrollo.
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.
“Si se aprueba, esta nueva opción de almacenamiento ofrecería a las farmacias y centros de vacunación una mayor flexibilidad en la forma en que administran el suministro de vacunas”, dijo el director ejecutivo de Pfizer, Albert Bourla, en un comunicado.
Esta inyección, junto con la de Moderna, es una de las dos vacunas que tienen autorización de uso de emergencia en Estados Unidos. Se espera que una tercera vacuna, creada por Johnson & Johnson, obtenga la aprobación de la FDA para uso de emergencia dentro de dos semanas.
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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