El responsable de la estrategia de vacunas de la Agencia Europea de Medicamentos (EMA), Marco Cavaleri, ha afirmado hoy que hay un vínculo «claro» entre la vacunación con AstraZeneca y casos muy raros de trombos.
«En mi opinión ahora podemos decir que está claro que hay una asociación (de los trombos) con la vacuna. Sin embargo, todavía no sabemos qué causa esta reacción», asegura Cavaleri en una entrevista publicada hoy por el diario italiano «Il Messaggero».
«Ahora es cada vez más difícil decir que no existe una relación de causa y efecto entre la vacunación con AstraZeneca y casos muy raros de coágulos sanguíneos inusuales asociados con recuentos bajos de plaquetas», añade.
Cavaleri explica que en las próximas horas la agencia dirá «que la conexión está ahí», pero aún es necesario entender «cómo sucede».
«Estamos tratando de obtener una imagen precisa de lo que está sucediendo, para definir en detalle este síndrome debido a la vacuna», cuenta.
Indica que «entre los vacunados hay un número de casos de trombosis cerebral con deficiencia de plaquetas entre los jóvenes más alto de lo esperado» y añade: «esto lo tenemos que decir».
También se refiere a las mujeres jóvenes que, muchas veces son «protagonistas de casos de trombosis», pero «sufren menos el efecto de COVID», por lo que será fundamental que se estudie «la relación riesgo-beneficio para ellas».
«No olvidemos que incluso las mujeres jóvenes acaban en cuidados intensivos por coronavirus. Por tanto, será necesario un trabajo muy meticuloso para comprender la relación riesgo-beneficio a favor de la vacuna para todas las edades», expone.
La EMA comenzará a dar «algunas definiciones preliminares» ya desde esta semana, pero aún no puede «indicar límites de edad como han hecho varios países».
«Somos un agencia reguladora y debemos tener datos muy precisos sobre la relación riesgo-beneficio», prosigue.
Preguntado por el hecho de que países europeos como Holanda o Alemania ya han puesto límites a este fármaco para determinadas edades, Cavaleri sostiene que «quien tiene que gestionar una campaña de vacunación, incluso sin tener todos los datos a disposición, puede decidir reservar AstraZeneca a los más mayores».
«Pueden hacerlo, pueden aplicar un principio de precaución teniendo en cuenta que tienen otras vacunas a disposición. Nosotros, sin embargo, decidimos en relación a esa vacuna» en concreto, señala.
Reconoce que sería «preferible» que hubiera un consenso a nivel europeo, pero admite que «no es sencillo».
«Entiendo la exigencia europea de tener una única voz fuerte, pero no sé si ya esta semana podremos tener una indicación de este tipo. Seguramente las informaciones del fármaco serán actualizadas, afirmando que algunos eventos adversos están relacionados con la vacuna», concluye.// EFE
Cactus24/06-04-2021
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