Vaccini, Ema: parere positivo per anti-Rsv in 50-59 anni a maggior rischio infezione

Il Comitato tecnico (Chmp) dell’Agenzia europea per i medicinali (Ema) ha raccomandato di estendere l’approvazione del vaccino contro il virus respiratorio sinciziale (Rsv) di Gsk, per la prevenzione della malattia delle basse vie respiratorie (Lrtd) causata da Rsv, agli adulti di età compresa tra 50 e 59 anni a maggior rischio di infezione da questo virus. Lo annuncia, in una nota, la farmaceutica specificando che, completato il prossimo step, con l’autorizzazione all’immissione in commercio della Commissione europea, attesa entro settembre, questo sarà il primo vaccino nell’Ue con tale indicazione. Arexvy (vaccino contro il virus respiratorio sinciziale, adiuvato ricombinante) è infatti già approvato in Europa, da giugno 2023, per gli adulti di età pari o superiore a 60 anni per la prevenzione di Rsv-Lrtd.

L’Rsv è un virus che colpisce i polmoni e le vie respiratorie. Gli adulti possono essere a maggior rischio di infezione a causa di comorbilità, una compromissione immunitaria o l’età avanzata. Il virus respiratorio sinciziale può esacerbare condizioni come la broncopneumopatia cronica ostruttiva (Bpco), l’asma e l’insufficienza cardiaca cronica, portando a gravi esiti, come polmonite, ospedalizzazione e morte. Ogni anno, in Europa, l’Rsv causa circa 270 mila ricoveri e 20 mila decessi ospedalieri negli adulti di età pari o superiore a 60 anni. L’impatto dell’infezione negli adulti con un’età compresa tra 50 e 59 anni, a maggior rischio di infezione da Rsv, è simile a quello della popolazione complessiva di età pari o superiore a 60 anni.

Il parere positivo del Chmp è supportato dai risultati di uno studio di fase 3 che valuta la risposta immunitaria e la sicurezza del vaccino negli adulti, tra 50 e 59 anni, compresi quelli a maggior rischio di Rsv-Lrtd con specifiche condizioni cliniche di base. Lo scorso 7 giugno, Arexvy è stato approvato dall’Agenzia statunitense (Fda) con questa indicazione. Attualmente la richiesta di autorizzazione per l’impiego in 50-59enni a maggior rischio è stata inoltrata dalla farmaceutica in Giappone. In altre aree geografiche la pratica è in revisione. Gli studi che valutano l’immunogenicità e la sicurezza del vaccino negli adulti di età compresa tra 18 e 49 anni a maggior rischio per particolari condizioni mediche e negli adulti immunocompromessi di età pari o superiore a 18 anni – conclude la nota – dovrebbero essere pubblicati nel secondo semestre del 2024.

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