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México – 18/Sep/2021
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El laboratorio CanSino Biologics incluyó a México en los ensayos de su vacuna infantil, que se encuentra en fase 3, y en octubre estará en posibilidades de solicitar ante Cofepris el uso de emergencia.
Annette Ortiz Austin, directora de Epic Research Cro y responsable del estudio, explicó que reclutarán a mil menores de edad sanos y sin antecedentes de haber desarrollado covid-19 para probar el biológico, que estará destinado a la población de entre seis a 17 años.
Reiteró que en octubre estarán en posibilidades de solicitar a México la autorización para uso de emergencia de la vacuna pediátrica, tanto en la modalidad de aplicación intramuscular como inhalable.
Ortiz Austin indicó que los resultados obtenidos en China de este biológico están siendo actualmente analizados por comités de ética en México. El objetivo es evaluar los índices de seguridad, inmunogenicidad del anticuerpo neutralizante, posibles reacciones adversas y aspectos relacionados a toxicidad.
Los ensayos clínicos fase 1 y 2 del biológico recombinante Ad5-nCoV contra el coronavirus (vector de adenovirus tipo 5) arrancaron en China con 481 menores sanos, a los que se les aplicó, aleatoriamente, la dosis o un placebo para determinar el tiempo de desarrollo de anticuerpos protectores.
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