Ema, includere trombocitopenia nel bugiardino vaccino J&J – Medicina

By Lombardia Salute On Ago 6, 2021

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L’Ema ha raccomandato, in una nota, di aggiornare le informazioni sul bugiardino del vaccino di Johnson & Johnson (Janssen Covid-19) per includere la trombocitopenia immunitaria (condizione in cui il sistema immunitario attacca e distrugge erroneamente le piastrine) come reazione avversa, oltre ad un’avvertenza su questo possibile effetto collaterale.
L’Agenzia europea ha anche raccomandato un aggiornamento del piano di gestione del rischio del vaccino di J&J per riclassificare la trombocitopenia, attualmente segnalata come importante rischio potenziale, a importante rischio identificato.

L’Ema ha inoltre concluso che i casi di vertigini e acufeni (fischi o altri rumori in una o entrambe le orecchie) sono collegati alla somministrazione del vaccino della Johnson & Johnson (Janssen Covid-19), e ha raccomandato di modificare il bugiardino per aggiungere vertigini e acufeni come reazioni avverse per avvisare di questi potenziali effetti collaterali. “Il rapporto rischi-benefici del vaccino rimane invariato”. Si legge in una nota dell’Agenzia europea.

In merito alla terza dose, l’Agenzia europea, rispondendo a una domanda dell’ANSA, ribadisce: “Al momento è troppo presto per confermare se e quando sarà necessaria una dose di richiamo per i vaccini Covid-19, perché non ci sono ancora dati sufficienti dalle campagne di vaccinazione e dagli studi in corso per capire quanto durerà la protezione dei sieri. L’Ema esaminerà rapidamente questi dati non appena saranno disponibili”.

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