El regulador europeo de medicamentos dijo el viernes que está revisando cuatro casos de coágulos sanguíneos a personas en Estados Unidos que recibieron la vacuna contra el COVID-19 de Johnson & Johnson.
El comité de seguridad de la Agencia Europea de Medicamentos (EMA) también ha estado analizando la asociación de la vacuna de AstraZeneca con casos muy inusuales de trombos y afirmó que ahora está revisando informes de síndrome de extravasación capilar en personas que recibieron dosis de esta firma.
Johnson & Johnson (J&J) dijo que está al tanto de los raros informes de coágulos de sangre en personas que recibieron su vacuna y está trabajando con los reguladores para evaluar los datos y proporcionar información relevante.
“En la actualidad, no se ha establecido una relación causal clara entre estos eventos raros y la vacuna de Janssen contra el COVID-19”, dijo la compañía en un comunicado enviado por correo electrónico.
De los cuatro casos graves de coagulación y plaquetas bajas, tres ocurrieron en Estados Unidos durante el lanzamiento de la vacuna de Janssen, unidad de J&J, indicó la EMA. Además está una persona que murió de un trastorno de la coagulación informado en el ensayo clínico de J&J.
Casi 5 millones de personas en Estados Unidos habían recibido la vacuna de J&J hasta el jueves por la mañana, según los Centros para el Control y la Prevención de Enfermedades.
El informe de la EMA es el primero en mencionar una prueba de coágulos sanguíneos asociados con la vacuna de J&J.
La Administración de Alimentos y Medicamentos de Estados Unidos dijo que respondería en breve a una solicitud de comentarios.
Por Agencia
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