Vaccino anti Covid Moderna – Altri passi in avanti nella lotta contro la pandemia globale. Le ultime notizie dal mondo sul coronavirus tutte le ultime news dell’ultim’ora aggiornate in tempo reale.
Dopo Pfizer anche Moderna ha registrato risultati estremamente incoraggianti nella sperimentazione in Fase 3 sul vaccino anti-Covid.
Un’analisi provvisoria pubblicata oggi, 16 novembre, e basata su 95 pazienti con infezione da Covid confermata, ha rilevato che il vaccino ha un’efficacia del 94,5%.
L’azienda ha detto che ora prevede di chiedere al regolatore americano, la Food and Drug Administration, l’autorizzazione all’uso d’emergenza nelle prossime settimane.
Il vaccino in questione dovrebbe rimanere stabile a temperature standard di refrigerazione tra 2° e 8°C per 30 giorni. Inoltre si prevedono condizioni di trasporto e conservazione a lungo termine a temperature di -20°C per sei mesi.
Il vaccino Moderna non dovrebbe essere disponibile al di fuori degli Stati Uniti fino al prossimo anno. L’azienda ha detto che avrà 20 milioni di dosi pronte per essere spedite negli Usa prima della fine del 2020.
Inoltre spera di produrre da 500 milioni a un miliardo di dosi a livello globale l’anno prossimo.
Vaccino anti Covid Moderna, EMA avvia iter approvazione
Sul fronte europeo, è di stamattina la notizia che l’Ema (Agenzia europea del farmaco) ha iniziato ad analizzare i dati del vaccino sviluppato da Moderna Biotech Spain, società controllata dall’americana Moderna.
Come precisa l’Ema sul suo sito, si è deciso di partire con la procedura del rolling review. Primo passo dell’iter di approvazione, sulla base dei risultati preliminari degli studi non clinici e dei primi studi clinici fatti sugli adulti, che sembrano indicare che il vaccino stimoli la produzione di anticorpi e cellule immunitarie T contro il virus SarsCov2.
L’Ema, precisa in una nota, valuterà il vaccino secondo i consueti standard di efficacia, sicurezza e qualità. Ma il processo dovrebbe essere più breve del normale grazie al tempo guadagnato con la rolling review.
L’Agenzia europea aveva già attivato questa procedura all’inizio di ottobre per il vaccino anti-Covid-19 messo a punto da AstraZeneca e dall’università di Oxford.
Fonte: Open
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