Vaccino coronavirus – Iniziato l’iter di approvazione. Le ultime notizie sul Covid dall’Italia e dal mondo 24 ore su 24 in tempo reale e la news dell’Agenzia Europea del Farmaco sul vaccino anti-coronavirus.
L’EMA ha iniziato ad analizzare i dati del vaccino contro il Covid-19 messo a punto da AstraZeneca e dall’università di Oxford, il primo passo dell’iter di approvazione.
Lo scrive la stessa agenzia europea del farmaco sul proprio sito, che precisa che è il primo candidato che arriva a questa fase.
Questo non significa, si sottolinea, che si possa già arrivare a conclusioni sull’efficacia e sulla sicurezza del siero.
Gran parte dei dati deve essere ancora sottoposto all’analisi del CHMP (Comitato per i medicinali per uso umano).
“L’inizio della “rolling review” – spiega però l’Ema – vuol dire che il comitato per i medicinali umani ha iniziato a valutare il primo set di dati, che viene dagli studi di laboratorio (non dai dati clinici)”.
Normalmente, tutti i dati sull’efficacia, la sicurezza e la qualità di un medicinale e tutti i documenti richiesti devono essere presentati all’inizio della valutazione in una domanda formale di autorizzazione all’immissione in commercio.
Nel caso di una rolling review, invece, il comitato esamina i dati appena diventano disponibili.
Vaccino coronavirus – AstraZeneca più avanti nella sperimentazione
La decisione di avviare l’esame del vaccino di AstraZeneca, come riportato dall’edizione online de La Repubblica, si basa sui risultati preliminari di studi non clinici e clinici preliminari.
Secondo questi il vaccino innesca la produzione di anticorpi e cellule T (cellule del sistema immunitario) che prendono di mira il virus.
Sperimentazioni cliniche su larga scala su migliaia di persone sono in corso, e i risultati saranno disponibili nelle prossime settimane e nei prossimi mesi.
Questi forniranno informazioni su quanto sia efficace il vaccino nel proteggere dal Covid-19, cosa che verrà valutata in cicli di revisione successivi.
Il vaccino di AstraZeneca è uno di quelli più avanti nella sperimentazione.
Questo nonostante uno stop di alcuni giorni dovuto alla revisione dei dati su alcuni pazienti che avevano mostrato effetti collaterali gravi.
Intanto, la multinazionale Sanofi di Anagni, in provincia di Frosinone, nel Lazio, ha inaugurato le linee di produzione del vaccino anti-covid.
Quest’ultima sta sviluppando il vaccino insieme al colosso farmaceutico Gsk, ma ancora in fase di sperimentazione.
L’inaugurazione è avvenuta nel corso dell’evento ‘empowering italia’ alla presenza, tra gli altri, del ministro della Salute, Roberto Speranza.
L’hub italiano, insieme a Francia e Germania, sarà uno dei quattro impegnati nella produzione e nella realizzazione delle dosi vaccino anti-covid.
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