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La Administración de Medicamentos y Alimentos de los Estados Unidos (FDA, por sus siglas en inglés) dio luz verde a Pfizer y a la firma biotecnológica alemana BioNTech, otorgándole el estatus de «vía rápida» para acelerar procesos de estudio en el desarrollo de dos vacunas experimentales contra el Covid-19, dieron a conocer ambas compañías hoy, reporta CNBC News.
Según un comunicado de la empresa estadounidense Pfizer y la alemana BioNTech, «la designación se basó en datos preliminares de los ensayos de las fases uno y dos de los candidatos, que aún están en curso».
El pasado 1 de julio los grupos farmacéuticos publicaron datos preliminares sobre los ensayos con BNT162b1 y BNT162b2, las más avanzadas entre varias vacunas.
Peter Honig, vicepresidente senior de asuntos regulatorios globales de Pfizer, comentó que esperan «seguir trabajando estrechamente con la FDA durante todo el desarrollo clínico de este programa, Project Lightspeed, para evaluar la seguridad y la eficacia de estos candidatos a vacunas».
Las compañías anunciaron que esperan comenzar ensayos clínicos en etapa tardía que involucrarán hasta 30,000 participantes, tan pronto como este mes.
De ser exitosos los resultados Pfizer y BioNTech prevén tener disponibles hasta 100 millones de dosis para fines de 2020, y más de 1.200 millones para el final del año próximo.
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