Covid:primo OK Ue a vaccino aggiornato BA.4/BA.5 per bambini – Focus Vaccini

By On Nov 11, 2022

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(ANSA) – ROMA, 11 NOV – Il Comitato per i farmaci a uso umano
(Chmp) dell’Agenzia europea dei medicinali ha dato il via libera
al vaccino bivalente contro Covid-19 aggiornato alla
sotto-variante BA.4/BA.5 di Pfizer/BioNTech per i bambini dai 5
agli 11 anni. Ne hanno dato notizia le due aziende in una nota.

La palla passa ora alla Commissione Europea a cui spetta
l’approvazione finale, che si attende a breve.

Il vaccino aggiornato a BA.4/BA.5 è già autorizzato per le
persone con più di 12 anni. Nelle sperimentazioni cliniche negli
adulti, il vaccino “ha dimostrato una forte risposta immunitaria
contro BA.4 e BA.5, misurata a 30 giorni dalla vaccinazione, con
un profilo di sicurezza e tollerabilità simile a quello del
vaccino originale”, fanno sapere le aziende.

A inizio ottobre il vaccino ha ricevuto l’autorizzazione in
condizioni di emergenza (Emergency Use Authorization) per l’uso
nei bambini dai 5 agli 11 anni da parte dell’americana Food and
Drug Administration. (ANSA).

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