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25 de abril de 2024
pausa y a esperar
Johnson & Johnson detiene ensayos de vacuna por enfermedad de participante martes 13 de octubre de 2020 08:17
La multinacional Johnson & Johnson anunció este lunes que detuvo los ensayos de una vacuna en investigación contra la COVID-19 debido a una "enfermedad inexplicable" en un participante. La compañía farmacéuticas Janssen de Johnson & Johnson desarrollaron la vacuna en investigación y lideran el ensayo clínico como patrocinador regulador.
"Hemos detenido temporalmente la administración de nuevas dosis en todos nuestros ensayos clínicos de la vacuna candidata COVID-19, incluido el ensayo de fase 3 ENSEMBLE, debido a una enfermedad inexplicable en un participante del estudio", indicó la firma en un comunicado.
La compañía estadounidense confirmó que "la enfermedad del participante está siendo revisada y evaluada por la Junta de Monitoreo de Seguridad de Datos (DSMB) independiente de ENSEMBLE", así como por sus médicos. La farmacéutica declinó suministrar mayores detalles al argumentar que deben "respetar la privacidad de este participante".
"Estamos aprendiendo más sobre la enfermedad de este participante y es importante tener todos los datos antes de compartir información adicional", añadió el comunicado. La firma con sede en Nuevo Brunswick (Nueva Jersey) subrayó la "distinción significativa entre una pausa de estudio y una retención reglamentaria de un ensayo clínico".
El pasado 23 de septiembre, los Institutos Nacionales de Salud de Estados Unidos (NIH, por sus siglas en inglés) dieron a conocer que había comenzado el reclutamiento de voluntarios adultos para un cuarto ensayo clínico de la Fase 3 que evalúa una vacuna en investigación contra la COVID-19.
El ensayo, diseñado para evaluar si la vacuna Janssen COVID-19 en investigación (JNJ-78436725) puede prevenir la COVID-19 sintomática después de un régimen de dosis única, buscaba inscribir hasta 60.000 voluntarios en alrededor de 215 lugares de investigación clínica, tanto nacionales como internacionales. EFE