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3 de mayo de 2024
COVID-19
Moderna afirma que su vacuna es efectiva contra las cepas británica y sudafricana lunes 25 de enero de 2021 17:56
La compañía estadounidense Moderna anunció este lunes que su vacuna generó anticuerpos neutralizantes que serían suficientes para tener efecto protector contra las variantes de coronavirus del Reino Unido y de Sudáfrica, según un ensayo realizado en laboratorio con suero de personas vacunadas en esquema de dos dosis. El estudio, cuyos resultados fueron difundidos por la compañía pero aún no se encuentra publicados en ninguna revista científica, fue realizado en colaboración con el Centro de Investigación de Vacunas (VRC) en el Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID) de Estados Unidos. Según Moderna, su vacuna "produjo títulos neutralizantes contra todas las variantes emergentes clave probadas, incluidas B.1.1.7 y B.1.351, identificadas por primera vez en el Reino Unido y República de Sudáfrica, respectivamente". El estudio in vitro evaluó la capacidad de su vacuna (cuyo nombre es ARNm-1273) para provocar anticuerpos neutralizantes potentes contra las nuevas variantes del SARS-CoV-2, utilizando sueros de ocho participantes del ensayo clínico de fase 1 (de 18 a 55 años de edad) que recibieron dos dosis de 100 µg, y utilizando por separado sueros de primates no humanos (NHP) inmunizados con dos dosis de 30 µg o 100. "El estudio no mostró un impacto significativo en la neutralización de los títulos contra la variante B.1.1.7 (Reino Unido) en relación con las variantes anteriores", indicó la compañía. En relación a la variante B.1.351 (Sudáfrica), Moderna informó que "se observó una reducción de seis veces en los títulos de neutralización con la variante " pero aún así "permanecen por encima de los niveles que se espera sean protectores". En conclusión, la empresa afirmó que "se espera que el régimen de dos dosis de la vacuna Moderna Covid-19 a la dosis de 100 µg proteja contra las cepas emergentes detectadas hasta la fecha", aunque advirtió que en el caso de la variante de Sudáfrica "los títulos más bajos pueden sugerir un riesgo potencial de disminución temprana de la inmunidad". En este contexto, Moderna anunció nuevos ensayos clínicos "para abordar de manera proactiva la pandemia a medida que el virus continúa evolucionando". Por un lado, probará una dosis de refuerzo adicional de la vacuna "para estudiar la capacidad de aumentar aún más los títulos neutralizantes contra las cepas emergentes más allá de la serie de vacunación primaria existente". Por el otro, está promoviendo una variante candidata de refuerzo emergente (ARNm-1273.351) contra la variante B.1.351(Sudáfrica): sobre esa vacuna variante está realizando "estudios preclínicos y un estudio de Fase 1 para evaluar el beneficio inmunológico de potenciar con proteínas de pico específicas de la cepa", según informó. La vacuna de Moderna ha sido autorizada para uso de emergencia por la Administración de Drogas y Alimentos de Estados Unidos (FDA) para la inmunización para la prevención del SARS-CoV-2 en personas mayores de 18 años.